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Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis

Summary
EudraCT number	2011-002326-49
Trial protocol	CZ GB BE EE BG ES NL
Global end of trial date	22 Sep 2017

Results information
Results version number	v1(current)
This version publication date	30 Sep 2018
First version publication date	30 Sep 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

I1F-MC-RHAP

ISRCTN number

US NCT number

NCT01695239

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 13731

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

22 Sep 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

22 Sep 2017

Was the trial ended prematurely?

Main objective of the trial

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Dec 2012

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

2 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Russian Federation: 34

Country: Number of subjects enrolled

United States: 83

Country: Number of subjects enrolled

Japan: 12

Country: Number of subjects enrolled

Ukraine: 35

Country: Number of subjects enrolled

United Kingdom: 16

Country: Number of subjects enrolled

Spain: 13

Country: Number of subjects enrolled

Canada: 4

Country: Number of subjects enrolled

Czech Republic: 92

Country: Number of subjects enrolled

Netherlands: 2

Country: Number of subjects enrolled

Belgium: 5

Country: Number of subjects enrolled

Poland: 60

Country: Number of subjects enrolled

Mexico: 12

Country: Number of subjects enrolled

France: 3

Country: Number of subjects enrolled

Bulgaria: 16

Country: Number of subjects enrolled

Estonia: 29

Worldwide total number of subjects

416

EEA total number of subjects

236

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

372

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

No Text Entered

Screening details

Participants were randomized to treatment at Week 0 and entered the Double-Blind Treatment Period (Week 0 up to Week 24). Inadequate Responders (IR) were identified at Week 16. The combined extension period and long-term extension period occurred from Week 24 to Week 156.

Period 1 title

Double-Blind (DB) Treatment Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Placebo (PBO)

Arm description

Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Adalimumab (ADA) Q2W

Arm description

Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.

Arm type

Active comparator

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ixekizumab (Ixe) Q4W

Arm description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Arm type

Experimental

Investigational medicinal product name

ixekizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ixe Q2W

Arm description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Arm type

Experimental

Investigational medicinal product name

ixekizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Number of subjects in period 1	Placebo (PBO)	Adalimumab (ADA) Q2W	Ixekizumab (Ixe) Q4W	Ixe Q2W
Started	106	101	107	103
Received at least 1 dose of study drug	106	101	107	102
Classified as Inadequate Responder (IR)	27 ^[1]	9 ^[2]	11 ^[3]	10 ^[4]
Completed	91	97	97	96
Not completed	15	4	10	7
Consent withdrawn by subject	3	1	1	-
On Study Treatment	-	-	1	-
Adverse event, non-fatal	2	2	2	3
Sponsor Decision	3	-	1	-
Lost to follow-up	1	-	-	-
Entry Criteria Not Met	1	1	3	4
Lack of efficacy	4	-	2	-
Protocol deviation	1	-	-	-

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: All participants who received at least one dose of study drug are a subset to those who started the period.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: All participants who received at least one dose of study drug are a subset to those who started the period.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: All participants who received at least one dose of study drug are a subset to those who started the period.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: All participants who received at least one dose of study drug are a subset to those who started the period.

Period 2 title

IR Participants (Week 16 Up To Week 24)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Inadequate Responders (IR)/Ixe Q4W

Arm description

Placebo Week 16 inadequate responders (IRs) re-randomized to ixekizumab 80 mg every 4 weeks (Q4W) received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab Q4W IRs received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab 80 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants continuing on 1 injection of ixekizumab 80 mg Q4W starting on Week 24 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 28 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 32 and ending on Week 156 alternating with placebo injections Q4W starting on Week 34 and ending on Week 154.

IR/Ixe Q2W

Arm description

Placebo IRs re-randomized to ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab 80 mg Q2W IRs received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab 80 mg Q4W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

IR PBO Washout

Arm description

Adalimumab Q2W IRs re-randomized to ixekizumab 80 mg Q4W or ixekizumab 80 mg Q2W. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 16. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 18 to Week 22. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab 80 mg Q4W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Number of subjects in period 2	Inadequate Responders (IR)/Ixe Q4W	IR/Ixe Q2W	IR PBO Washout
Started	24	24	9
Completed	24	24	9

Period 3 title

Placebo Washout (Week 24 Up To Week 32)

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Blinding implementation details

Treatment remained blinded to investigators, study site personnel, and participants until participants have completed Week 24 or have discontinued from the study (moved into Period 5) and the clinical trial database through Week 24 has been locked. Thus, to maintain blinding, each participant will continue to receive 1 dose Q2W of investigational product regardless of his/her assigned treatment group (that is, placebo for ixekizumab was given every other week to maintain blinding.

PBO Washout

Arm description

Adalimumab Q2W participants re-randomized to ixekizumab 80 mg Q4W or ixekizumab Q2W Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 24. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 26 to Week 30. Participants received a dose of 80 mg of ixekizumab given as 1 SC injection at Week 32.

Arm type

Active comparator

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Number of subjects in period 3	PBO Washout
Started	88
Completed	77
Not completed	11
Adverse event, non-fatal	1
Entry Criteria Not Met	1
Lack of efficacy	9

Period 4 title

Extension Long-Term Extension Periods

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Blinding implementation details

Are arms mutually exclusive

Ixe Q4W/Ixe Q4W

Arm description

Arm type

Experimental

Investigational medicinal product name

Ixekizumab 80 mg Q4W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ixe Q2W/Ixe Q2W

Arm description

Participants continuing on 1 injection of ixekizumab 80 mg Q2W starting on Week 24 and ending on Week 156. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg Q2W at Week 16 and Week 24. Placebo washout participants who re-randomized at Week 16 receive a starting dose of 160 mg ixekizumab given as 2 SC injections of 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 28 and ending on Week 156. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 32 and ending on Week 156.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab 80 mg Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Number of subjects in period 4	Ixe Q4W/Ixe Q4W	Ixe Q2W/Ixe Q2W
Started	187	183
Completed	121	122
Not completed	66	61
Adverse event, serious fatal	1	-
Consent withdrawn by subject	6	7
Physician decision	3	-
Adverse event, non-fatal	15	21
Sponsor Decision	2	1
Lost to follow-up	2	1
Lack of efficacy	37	31

Period 5 title

Post-Treatment Follow-Up Period

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Blinding implementation details

Are arms mutually exclusive

Placebo Post-Treatment Follow-up Period

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.

Adalimumab Post-Treatment Follow-up Period

Arm description

Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.

Arm type

Active comparator

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.

Ixekizumab 80mg Q4W Post-Treatment Follow-up Period

Arm description

Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.

Arm type

Active comparator

Investigational medicinal product name

Ixekizumab 80 mg Q4W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ixekizumab 80mg Q2W Post-Treatment Follow-up Period

Arm description

Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab 80 mg Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Number of subjects in period 5	Placebo Post-Treatment Follow-up Period	Adalimumab Post-Treatment Follow-up Period	Ixekizumab 80mg Q4W Post-Treatment Follow-up Period	Ixekizumab 80mg Q2W Post-Treatment Follow-up Period
Started	20	1	165	171
Completed	20	1	156	166
Not completed	0	0	9	5
Consent withdrawn by subject	-	-	6	3
Physician decision	-	-	2	-
Lost to follow-up	-	-	1	1
Protocol deviation	-	-	-	1

Period 6 title

Baseline Period

Is this the baseline period?

Yes ^[5]

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

All participants who were enrolled in the study at baseline less 1 participant who did not have age data, was not part of safety evaluation and did not take any dose.

All participants

Arm description

Total number of participants enrolled at baseline

Arm type

No treatment received

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Investigational medicinal product name

Adalimumab (ADA) Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SCinjections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg ofadalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.

Investigational medicinal product name

Ixe Q4W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Investigational medicinal product name

Ixe Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Notes
[5] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: Period 1, the double-blind treatment period start number is based on the number of participants enrolled prior to receiving a dose of drug. The selected baseline period includes all the participants enrolled and received drug less 1 participant that did not have documented age data.

Number of subjects in period 6	All participants
Started	416
Completed	416

Baseline characteristics

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Reporting group title

Baseline Period

Reporting group description

Reporting group values	Baseline Period	Total
Number of subjects	416	416
Age categorical
1 participant didn’t have age data, was not part of safety evaluation and did not take any dose.
Units: Subjects
In utero		0
Preterm newborn infants (gestational age < 37 wks)		0
Newborns (0-27 days)		0
Infants and toddlers (28 days-23 months)		0
Children (2-11 years)		0
Adolescents (12-17 years)		0
Adults (18-64 years)		0
From 65-84 years		0
85 years and over		0
Age Continuous
Units: years
arithmetic mean (standard deviation)	49.52 ( 11.87 )	-
Gender, Male/Female
Units: Participants
Female	225	225
Male	191	191
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	9	9
Asian	15	15
Native Hawaiian or Other Pacific Islander	0	0
Black or African American	0	0
White	391	391
More than one race	1	1
Unknown or Not Reported	0	0
Race/Ethnicity, Customized
Units: Subjects
Hispanic or Latino	20	20
Not Hispanic or Latino	355	355
Unknown or Not Reported	41	41
Region of Enrollment
Units: Subjects
Russia	34	34
United States	83	83
Japan	12	12
Ukraine	35	35
United Kingdom	16	16
Spain	13	13
Canada	4	4
Czechia	92	92
Netherlands	2	2
Belgium	5	5
Poland	60	60
Mexico	12	12
France	3	3
Bulgaria	16	16
Estonia	29	29

End points

Top of page

Reporting group title

Placebo (PBO)

Reporting group description

Reporting group title

Adalimumab (ADA) Q2W

Reporting group description

Reporting group title

Ixekizumab (Ixe) Q4W

Reporting group description

Reporting group title

Ixe Q2W

Reporting group description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Reporting group title

Inadequate Responders (IR)/Ixe Q4W

Reporting group description

Reporting group title

IR/Ixe Q2W

Reporting group description

Reporting group title

IR PBO Washout

Reporting group description

Reporting group title

PBO Washout

Reporting group description

Reporting group title

Ixe Q4W/Ixe Q4W

Reporting group description

Reporting group title

Ixe Q2W/Ixe Q2W

Reporting group description

Reporting group title

Placebo Post-Treatment Follow-up Period

Reporting group description

Reporting group title

Adalimumab Post-Treatment Follow-up Period

Reporting group description

Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.

Reporting group title

Ixekizumab 80mg Q4W Post-Treatment Follow-up Period

Reporting group description

Reporting group title

Ixekizumab 80mg Q2W Post-Treatment Follow-up Period

Reporting group description

Reporting group title

All participants

Reporting group description

Total number of participants enrolled at baseline

Subject analysis set title

Double-Blind PBO

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.

Subject analysis set title

Double-Blind ADA Q2W

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Double-Blind Ixe Q4W

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Double-Blind Ixe Q2W

Subject analysis set type

Full analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Full analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

ADA Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Ixe Q2W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Primary: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: American College of Rheumatology 20 Index [ACR20])

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End point title

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: American College of Rheumatology 20 Index [ACR20])

End point description

ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).

End point type

Primary

End point timeframe

Week 24

End point values	Placebo (PBO)	Adalimumab (ADA) Q2W	Ixekizumab (Ixe) Q4W	Ixe Q2W
Number of subjects analysed	106 ^[1]	101 ^[2]	107 ^[3]	103 ^[4]
Units: percentage of participants
number (not applicable)	30	57	58	62

Notes
[1] - Nonresponder Imputation (NRI) is applied for Inadequate Responders (IR) who had missing data.
[2] - All randomized participants. NRI is applied for IR and participants who had missing data.
[3] - All randomized participants. NRI is applied for IR and participants who had missing data.
[4] - the 1 participant didn’t have age data, was not part of safety evaluation and did not take any dose.

ACR20 Additional Statistical Analysis

Comparison groups

Placebo (PBO) v Adalimumab (ADA) Q2W

Number of subjects included in analysis

207

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Confidence interval

ACR20 Additional Statistical Analysis

Comparison groups

Placebo (PBO) v Ixekizumab (Ixe) Q4W

Number of subjects included in analysis

213

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Confidence interval

ACR20 Additional Statistical Analysis

Comparison groups

Placebo (PBO) v Ixe Q2W

Number of subjects included in analysis

209

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Confidence interval

Secondary: Percentage of Participants Achieving ACR20 Response

Top of page

End point title

Percentage of Participants Achieving ACR20 Response

End point description

ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo (PBO)	Adalimumab (ADA) Q2W	Ixekizumab (Ixe) Q4W	Ixe Q2W
Number of subjects analysed	106 ^[5]	101 ^[6]	107 ^[7]	103 ^[8]
Units: percentage of participants
number (not applicable)	31	52	57	60

Notes
[5] - All randomized participants. NRI is applied for IR and participants who had missing data.
[6] - All randomized participants. NRI is applied for IR and participants who had missing data.
[7] - All randomized participants. NRI is applied for IR and participants who had missing data.
[8] - All randomized participants. NRI is applied for IR and participants who had missing data.

No statistical analyses for this end point

Secondary: Percentage of Participants achieving American College of Rheumatology 50 (ACR50) Response

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End point title

Percentage of Participants achieving American College of Rheumatology 50 (ACR50) Response

End point description

ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo (PBO)	Adalimumab (ADA) Q2W	Ixekizumab (Ixe) Q4W	Ixe Q2W
Number of subjects analysed	106 ^[9]	101 ^[10]	107 ^[11]	103 ^[12]
Units: percentage of participants
number (not applicable)	15	39	40	47

Notes
[9] - All randomized participants. NRI is applied for IR and participants who had missing data.
[10] - All randomized participants. NRI is applied for IR and participants who had missing data.
[11] - All randomized participants. NRI is applied for IR and participants who had missing data.
[12] - All randomized participants. NRI is applied for IR and participants who had missing data.

No statistical analyses for this end point

Secondary: Percentage of Participants achieving American College of Rheumatology 70 (ACR70) Score

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End point title

Percentage of Participants achieving American College of Rheumatology 70 (ACR70) Score

End point description

ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo (PBO)	Adalimumab (ADA) Q2W	Ixekizumab (Ixe) Q4W	Ixe Q2W
Number of subjects analysed	106 ^[13]	101 ^[14]	107 ^[15]	103 ^[16]
Units: percentage of participants
number (not applicable)	6	26	23	34

Notes
[13] - All randomized participants. NRI is applied for IR and participants who had missing data.
[14] - All randomized participants. NRI is applied for IR and participants who had missing data.
[15] - All randomized participants. NRI is applied for IR and participants who had missing data.
[16] - All randomized participants. NRI is applied for IR and participants who had missing data.

No statistical analyses for this end point

Secondary: Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

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End point title

Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

End point description

HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant’s self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	105 ^[17]	97 ^[18]	103 ^[19]	98 ^[20]
Units: units on a scale
least squares mean (standard error)	-0.1797 ( 0.0524 )	-0.3712 ( 0.0510 )	-0.4431 ( 0.0503 )	-0.4963 ( 0.0507 )

Notes
[17] - All randomized participants with baseline and post baseline HAQ-DI data.
[18] - All randomized participants with baseline and post baseline HAQ-DI data.
[19] - All randomized participants with baseline and post baseline HAQ-DI data.
[20] - All randomized participants with baseline and post baseline HAQ-DI data.

No statistical analyses for this end point

Secondary: Change from Baseline in Modified Total Sharp Score (mTSS) (Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: modified Total Sharp Score [mTSS])

Top of page

End point title

Change from Baseline in Modified Total Sharp Score (mTSS) (Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: modified Total Sharp Score [mTSS])

End point description

The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	106 ^[21]	101 ^[22]	107 ^[23]	103 ^[24]
Units: units on a scale
least squares mean (standard error)	0.49 ( 0.086 )	0.10 ( 0.085 )	0.17 ( 0.082 )	0.08 ( 0.083 )

Notes
[21] - All randomized participants with baseline and post baseline mTSS data.
[22] - All randomized participants with baseline and post baseline mTSS data.
[23] - All randomized participants with baseline and post baseline mTSS data.
[24] - All randomized participants with baseline and post baseline mTSS data.

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)

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End point title

Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)

End point description

The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	67 ^[25]	68 ^[26]	73 ^[27]	59 ^[28]
Units: percentage of participants
number (not applicable)
PASI 75	8	34	75	70
PASI 90	2	22	52	58
PASI 100	2	15	32	41

Notes
[25] - All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied.
[26] - All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied.
[27] - All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied.
[28] - All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied.

No statistical analyses for this end point

Secondary: Change from baseline in Leeds Enthesitis Index (LEI)

Top of page

End point title

Change from baseline in Leeds Enthesitis Index (LEI)

End point description

The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	57 ^[29]	55 ^[30]	70 ^[31]	56 ^[32]
Units: units on a scale
least squares mean (standard error)	-0.8 ( 0.24 )	-0.8 ( 0.24 )	-0.9 ( 0.21 )	-1.5 ( 0.24 )

Notes
[29] - All randomized participants with baseline enthesitis, LEI score, and post baseline LEI score.
[30] - All randomized participants with baseline enthesitis, LEI score, and post baseline LEI score.
[31] - All randomized participants with baseline enthesitis, LEI score, and post baseline LEI score.
[32] - All randomized participants with baseline enthesitis, LEI score, and post baseline LEI score.

No statistical analyses for this end point

Secondary: Change from baseline in itching severity using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

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End point title

Change from baseline in itching severity using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

End point description

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	67 ^[33]	68 ^[34]	73 ^[35]	59 ^[36]
Units: units on a scale
least squares mean (standard error)	0.2 ( 0.27 )	-1.4 ( 0.28 )	-2.6 ( 0.27 )	-2.8 ( 0.30 )

Notes
[33] - All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA.
[34] - All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA.
[35] - All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA.
[36] - All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA.

No statistical analyses for this end point

Secondary: Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

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End point title

Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

End point description

The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no fatigue” and 10 representing “as bad as you can imagine.” Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	ADA Q2W	Placebo	Ixe Q4W	Ixe Q2W
Number of subjects analysed	97 ^[37]	103 ^[38]	101 ^[39]	97 ^[40]
Units: units on a scale
least squares mean (standard error)	-1.5 ( 0.24 )	-1.3 ( 0.25 )	-1.6 ( 0.24 )	-1.9 ( 0.24 )

Notes
[37] - All randomized participants who had baseline and post baseline fatigue NRS data.
[38] - All randomized participants who had baseline and post baseline fatigue NRS data.
[39] - All randomized participants who had baseline and post baseline fatigue NRS data.
[40] - All randomized participants who had baseline and post baseline fatigue NRS data.

No statistical analyses for this end point

Secondary: Change from Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)

Top of page

End point title

Change from Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)

End point description

JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	91 ^[41]	95 ^[42]	97 ^[43]	96 ^[44]
Units: units on a scale
least squares mean (standard error)
Joint Space Narrowing Score	0.07 ( 0.031 )	0.01 ( 0.031 )	0.04 ( 0.030 )	0.01 ( 0.030 )
Bone Erosion Score	0.44 ( 0.077 )	0.12 ( 0.077 )	0.15 ( 0.075 )	0.08 ( 0.075 )

Notes
[41] - All randomized participants who had baseline and post baseline JSN data.
[42] - All randomized participants who had baseline and post baseline JSN data.
[43] - All randomized participants who had baseline and post baseline JSN data.
[44] - All randomized participants who had baseline and post baseline JSN data.

No statistical analyses for this end point

Secondary: Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

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End point title

Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

End point description

SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	ADA Q2W	Placebo	Ixe Q4W	Ixe Q2W
Number of subjects analysed	95 ^[45]	99 ^[46]	98 ^[47]	95 ^[48]
Units: units on a scale
least squares mean (standard error)
PCS Score	6.78 ( 0.904 )	2.94 ( 0.958 )	7.45 ( 0.894 )	8.24 ( 0.898 )
MCS Score	4.22 ( 0.943 )	2.67 ( 1.013 )	4.86 ( 0.933 )	3.39 ( 0.936 )

Notes
[45] - All randomized participants who had baseline and post baseline PCS data.
[46] - All randomized participants who had baseline and post baseline PCS data.
[47] - All randomized participants who had baseline and post baseline PCS data.
[48] - All randomized participants who had baseline and post baseline PCS data.

No statistical analyses for this end point

Secondary: Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])

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End point title

Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])

End point description

The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	101 ^[49]	98 ^[50]	102 ^[51]	99 ^[52]
Units: units on a scale
least squares mean (standard error)	-0.9 ( 0.36 )	-1.6 ( 0.33 )	-0.8 ( 0.32 )	-0.7 ( 0.32 )

Notes
[49] - All randomized participants who had baseline and post baseline QIDS-SR16 data.
[50] - All randomized participants who had baseline and post baseline QIDS-SR16 data.
[51] - All randomized participants who had baseline and post baseline QIDS-SR16 data.
[52] - All randomized participants who had baseline and post baseline QIDS-SR16 data.

No statistical analyses for this end point

Secondary: Change From Baseline in Disease Activity Score (28 diarthrodial joint count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease

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End point title

Change From Baseline in Disease Activity Score (28 diarthrodial joint count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease

End point description

The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant’s Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Ixe Q2W	Placebo	ADA Q2W	Ixe Q4W
Number of subjects analysed	99 ^[53]	104 ^[54]	99 ^[55]	106 ^[56]
Units: units on a scale
least squares mean (standard error)	-2.036 ( 0.1225 )	-0.835 ( 0.1307 )	-1.743 ( 0.1215 )	-1.955 ( 0.1206 )

Notes
[53] - All randomized participants who had baseline and post baseline DAS28-CRP data.
[54] - All randomized participants who had baseline and post baseline DAS28-CRP data.
[55] - All randomized participants who had baseline and post baseline DAS28-CRP data.
[56] - All randomized participants who had baseline and post baseline DAS28-CRP data.

No statistical analyses for this end point

Secondary: Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC modified)

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End point title

Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC modified)

End point description

The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	106 ^[57]	101 ^[58]	107 ^[59]	103 ^[60]
Units: percentage of participants
number (not applicable)	32	59	58	66

Notes
[57] - All randomized participants. NRI is applied for IR and participants who had missing data.
[58] - All randomized participants. NRI is applied for IR and participants who had missing data.
[59] - All randomized participants. NRI is applied for IR and participants who had missing data.
[60] - All randomized participants. NRI is applied for IR and participants who had missing data.

No statistical analyses for this end point

Secondary: Percentage of Participants achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline

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End point title

Percentage of Participants achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline

End point description

The sPGA is the physician’s determination of the severity of the participant’s psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	41 ^[61]	37 ^[62]	52 ^[63]	41 ^[64]
Units: percentage of participants
number (not applicable)	17	62	65	73

Notes
[61] - All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied.
[62] - All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied.
[63] - All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied.
[64] - All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied.

No statistical analyses for this end point

Secondary: Percent change from Baseline in Body Surface Area (BSA)

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End point title

Percent change from Baseline in Body Surface Area (BSA)

End point description

The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant’s handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	ixe Q2W
Number of subjects analysed	99 ^[65]	94 ^[66]	100 ^[67]	91 ^[68]
Units: percent change in BSA
least squares mean (standard error)	-2.7 ( 1.36 )	-9.5 ( 1.35 )	-12.0 ( 1.32 )	-10.6 ( 1.39 )

Notes
[65] - All randomized participants who have plaque psoriasis.
[66] - All randomized participants who have plaque psoriasis.
[67] - All randomized participants who have plaque psoriasis.
[68] - All randomized participants who have plaque psoriasis.

No statistical analyses for this end point

Secondary: Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline

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End point title

Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline

End point description

The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	ADA Q2W	Placebo	Ixe Q4W	Ixe Q2W
Number of subjects analysed	68 ^[69]	69 ^[70]	66 ^[71]	69 ^[72]
Units: units on a scale
least squares mean (standard error)	-10.7 ( 1.49 )	-2.4 ( 1.66 )	-14.0 ( 1.54 )	-15.5 ( 1.49 )

Notes
[69] - All randomized participants who had baseline fingernail involvement.
[70] - All randomized participants who had baseline fingernail involvement.
[71] - All randomized participants who had baseline fingernail involvement.
[72] - All randomized participants who had baseline fingernail involvement.

No statistical analyses for this end point

Secondary: Change from baseline in Leeds Dactylitis Index-Basic (LDI-B)

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End point title

Change from baseline in Leeds Dactylitis Index-Basic (LDI-B)

End point description

The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Ixe Q2W	Placebo	ADA Q2W	Ixe Q4W
Number of subjects analysed	41 ^[73]	39 ^[74]	23 ^[75]	54 ^[76]
Units: units on a scale
least squares mean (standard error)	-48.3 ( 6.31 )	-25.4 ( 6.53 )	-57.1 ( 7.84 )	-57.1 ( 5.67 )

Notes
[73] - All randomized participants who had baseline and post baseline LDI-score.
[74] - All randomized participants who had baseline and post baseline LDI-score.
[75] - All randomized participants who had baseline and post baseline LDI-score.
[76] - All randomized participants who had baseline and post baseline LDI-score.

No statistical analyses for this end point

Secondary: Change from Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

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End point title

Change from Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

End point description

The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	75 ^[77]	73 ^[78]	85 ^[79]	71 ^[80]
Units: units on a scale
least squares mean (standard error)	-1.25 ( 0.268 )	-2.42 ( 0.249 )	-2.74 ( 0.234 )	-2.91 ( 0.251 )

Notes
[77] - All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4.
[78] - All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4.
[79] - All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4.
[80] - All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4.

No statistical analyses for this end point

Secondary: Number of Participants with Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)

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End point title

Number of Participants with Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)

End point description

Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.

End point type

Secondary

End point timeframe

Baseline to Week 24

End point values	Ixe Q4W	Placebo	Ixe Q2W
Number of subjects analysed	107 ^[81]	103 ^[82]	100 ^[83]
Units: participants
number (not applicable)
Treatment Emergent (TE)	6	0	5
NAb	0	0	0

Notes
[81] - All randomized participants received at least 1 dose of ixe and had evaluable antibody measurement.
[82] - All randomized participants received at least 1 dose of ixe and had evaluable antibody measurement.
[83] - All randomized participants received at least 1 dose of ixe and had evaluable antibody measurement.

No statistical analyses for this end point

Secondary: American College of Rheumatology-N (ACR-N) Score

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End point title

American College of Rheumatology-N (ACR-N) Score

End point description

The ACR-N is defined as each participant's lowest percent improvement from Baseline to Week 24 of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the median of the percent change in the remaining 5 ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein). A positive score indicated an improvement from baseline to Week 24. The higher the ACR-N score the better ranging up to 100%. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, 24 Weeks

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	106 ^[84]	101 ^[85]	107 ^[86]	103 ^[87]
Units: units on a scale
least squares mean (standard error)	-4.182 ( 6.1417 )	28.517 ( 5.9189 )	33.509 ( 5.8905 )	30.391 ( 5.9736 )

Notes
[84] - All randomized participants with post-baseline ACR data.
[85] - All randomized participants with post-baseline ACR data.
[86] - All randomized participants with post-baseline ACR data.
[87] - All randomized participants with post-baseline ACR data.

No statistical analyses for this end point

Secondary: Change from Baseline in TJC

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End point title

Change from Baseline in TJC

End point description

TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	Ixe Q4W	ADA Q2W	Ixe Q2W
Number of subjects analysed	106 ^[88]	107 ^[89]	100 ^[90]	102 ^[91]
Units: units on a scale
least squares mean (standard error)	-4.7 ( 1.14 )	-11.9 ( 1.08 )	-10.1 ( 1.10 )	-13.6 ( 1.09 )

Notes
[88] - All randomized participants with baseline and post-baseline TJC data.
[89] - All randomized participants with baseline and post-baseline TJC data.
[90] - All randomized participants with baseline and post-baseline TJC data.
[91] - All randomized participants with baseline and post-baseline TJC data.

No statistical analyses for this end point

Secondary: Change from Baseline in SJC

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End point title

Change from Baseline in SJC

End point description

SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	Ixe Q4W	ADA Q2W	Ixe Q2W
Number of subjects analysed	106 ^[92]	107 ^[93]	100 ^[94]	102 ^[95]
Units: units on a scale
least squares mean (standard error)	-3.5 ( 0.62 )	-7.0 ( 0.59 )	-6.1 ( 0.59 )	-8.3 ( 0.59 )

Notes
[92] - All randomized participants with baseline and post-baseline SJC data.
[93] - All randomized participants with baseline and post-baseline SJC data.
[94] - All randomized participants with baseline and post-baseline SJC data.
[95] - All randomized participants with baseline and post-baseline SJC data.

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Assessment of Pain VAS

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End point title

Change from Baseline in Patient's Assessment of Pain VAS

End point description

The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	Ixe Q2W	ADA Q2W	Ixe Q4W
Number of subjects analysed	105 ^[96]	98 ^[97]	99 ^[98]	104 ^[99]
Units: units on a scale
least squares mean (standard error)	-14.0 ( 2.68 )	-31.6 ( 2.54 )	-30.0 ( 2.52 )	-29.6 ( 2.51 )

Notes
[96] - All randomized participants with baseline and post-baseline patient's assessment of pain data.
[97] - All randomized participants with baseline and post-baseline patient's assessment of pain data.
[98] - All randomized participants with baseline and post-baseline patient's assessment of pain data.
[99] - All randomized participants with baseline and post-baseline patient's assessment of pain data.

No statistical analyses for this end point

Secondary: Change from Baseline in PatGA

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End point title

Change from Baseline in PatGA

End point description

The Patient's Global Assessment of Disease Severity is a single-item patient reported outcome measure on which participants are asked to rate by circling a number on a 0 to 5 NRS the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	Ixe Q2W	ADA Q2W	Ixe Q4W
Number of subjects analysed	105 ^[100]	98 ^[101]	99 ^[102]	104 ^[103]
Units: units on a scale
least squares mean (standard error)	-14.8 ( 2.65 )	-35.6 ( 2.50 )	-31.6 ( 2.49 )	-33.8 ( 2.48 )

Notes
[100] - All randomized participants with baseline and post-baseline PaTGA.
[101] - All randomized participants with baseline and post-baseline PaTGA.
[102] - All randomized participants with baseline and post-baseline PaTGA.
[103] - All randomized participants with baseline and post-baseline PaTGA.

No statistical analyses for this end point

Secondary: Change from Baseline in Physician's Global Assessment of Disease Activity VAS

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End point title

Change from Baseline in Physician's Global Assessment of Disease Activity VAS

End point description

The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, 24 Weeks

End point values	Ixe Q2W	Placebo	ADA Q2W	Ixe Q4W
Number of subjects analysed	95 ^[104]	100 ^[105]	88 ^[106]	96 ^[107]
Units: units on a scale
least squares mean (standard error)	-42.0 ( 1.99 )	-24.2 ( 2.14 )	-34.7 ( 2.10 )	-38.5 ( 2.06 )

Notes
[104] - All randomized participants with physician's global assessment of disease activity data.
[105] - All randomized participants with physician's global assessment of disease activity data.
[106] - All randomized participants with physician's global assessment of disease activity data.
[107] - All randomized participants with physician's global assessment of disease activity data.

No statistical analyses for this end point

Secondary: Change from Baseline in CRP

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End point title

Change from Baseline in CRP

End point description

CRP was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	106 ^[108]	101 ^[109]	107 ^[110]	103 ^[111]
Units: units on a scale
least squares mean (standard error)	-3.873 ( 1.4292 )	-7.512 ( 1.2674 )	-8.804 ( 1.2602 )	-8.942 ( 1.2552 )

Notes
[108] - All randomized participants with baseline and post-baseline CRP data.
[109] - All randomized participants with baseline and post-baseline CRP data.
[110] - All randomized participants with baseline and post-baseline CRP data.
[111] - All randomized participants with baseline and post-baseline CRP data.

No statistical analyses for this end point

Secondary: Change from baseline in Leeds Enthesitis Index (LEI)

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End point title

Change from baseline in Leeds Enthesitis Index (LEI)

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Ixe Q2W	Placebo	Ixe Q4W	ADA Q2W
Number of subjects analysed	59 ^[112]	57 ^[113]	70 ^[114]	56 ^[115]
Units: units on a scale
least squares mean (standard error)	-1.4 ( 0.24 )	-0.8 ( 0.26 )	-1.3 ( 0.21 )	-0.9 ( 0.23 )

Notes
[112] - All randomized participants who had baseline and post baseline LEI score.
[113] - All randomized participants who had baseline and post baseline LEI score.
[114] - All randomized participants who had baseline and post baseline LEI score.
[115] - All randomized participants who had baseline and post baseline LEI score.

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)

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End point title

Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	38 ^[116]	61 ^[117]	60 ^[118]	49 ^[119]
Units: percentage of participants
number (not applicable)
PASI 75	11	55	71	80
PASI 90	6	37	56	68
PASI 100	3	24	43	54

Notes
[116] - All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied.
[117] - All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied.
[118] - All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied.
[119] - All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied.

No statistical analyses for this end point

Secondary: Change from baseline in itching severity using the Itch NRS

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End point title

Change from baseline in itching severity using the Itch NRS

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W
Number of subjects analysed	67 ^[120]	68 ^[121]	73 ^[122]	59 ^[123]
Units: units on a scale
least squares mean (standard error)	-0.3 ( 0.32 )	-1.7 ( 0.29 )	-2.9 ( 0.29 )	-2.8 ( 0.31 )

Notes
[120] - All randomized participants who had psoriatic lesion(s) involving >=3% BSA and itch NRS score.
[121] - All randomized participants who had psoriatic lesion(s) involving >=3% BSA and itch NRS score.
[122] - All randomized participants who had psoriatic lesion(s) involving >=3% BSA and itch NRS score.
[123] - All randomized participants who had psoriatic lesion(s) involving >=3% BSA and itch NRS score.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

I1F-MC-RHAP

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

Placebo (PBO) Double-Blind Period

Reporting group description

Reporting group title

ADA Double-Blind Period

Reporting group description

Reporting group title

Ixe Q2W Double-Blind Period

Reporting group description

Reporting group title

Ixe Q4W Double-Blind Period

Reporting group description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Reporting group title

IR PBO Washout

Reporting group description

Reporting group title

IR Ixe Q4W

Reporting group description

Reporting group title

IR Ixe Q2W

Reporting group description

Reporting group title

PBO Washout

Reporting group description

Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Reporting group title

Ixe Q4W

Reporting group description

Ixekizumab every 4 weeks (IxeQ4W) and IR IxeQ4W participants received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 24 to Week 156. Placebo and IR placebo (PBO) Washout participants re-randomized to Ixekizumab 80 mg Q4W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of alternating placebo for ixekizumab or ixekizumab Q2W from Week 26 to Week 156. PBO Washout participants re-randomized to ixekizumab 80 mg Q4W received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 32 to Week 156.

Reporting group title

Ixe Q2W

Reporting group description

Ixekizumab Q2W (IxeQ2W) and IR IxeQ2W participants received one SC injection of 80 mg of ixekizumab Q2W from Week 24 to Week 156. Placebo and IR PBO Washout participants re-randomized to Ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 26 to Week 156. PBO Washout participants re-randomized to ixekizumab 80 mg Q2W received one SC injection of 80 mg of ixekizumab Q2W from Week 32 to Week 156.

Reporting group title

PBO Post-Treatment Follow-up Period

Reporting group description

Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.

Reporting group title

ADA Post-Treatment Follow-up Period

Reporting group description

Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.

Reporting group title

Ixe Q4W Post-Treatment Follow-up Period

Reporting group description

Reporting group title

Ixe Q2W Post-treatment Follow-up Period

Reporting group description

Placebo (PBO) Double-Blind Period

ADA Double-Blind Period

Ixe Q2W Double-Blind Period

Ixe Q4W Double-Blind Period

IR PBO Washout

IR Ixe Q4W

IR Ixe Q2W

PBO Washout

Ixe Q4W

Ixe Q2W

PBO Post-Treatment Follow-up Period

ADA Post-Treatment Follow-up Period

Ixe Q4W Post-Treatment Follow-up Period

Ixe Q2W Post-treatment Follow-up Period

Total subjects affected by serious adverse events

subjects affected / exposed

2 / 106 (1.89%)

5 / 101 (4.95%)

6 / 107 (5.61%)

3 / 102 (2.94%)

0 / 9 (0.00%)

0 / 24 (0.00%)

1 / 88 (1.14%)

28 / 187 (14.97%)

19 / 183 (10.38%)

0 / 20 (0.00%)

0 / 1 (0.00%)

2 / 165 (1.21%)

2 / 171 (1.17%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

acoustic neuroma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

breast cancer

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

invasive ductal breast carcinoma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

large intestine benign neoplasm

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

melanocytic naevus

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

parathyroid tumour benign

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

prostate cancer

alternative dictionary used: MedDRA 20.0

subjects affected / exposed ^[1]

0 / 48 (0.00%)

0 / 51 (0.00%)

0 / 45 (0.00%)

0 / 47 (0.00%)

0 / 1 (0.00%)

0 / 8 (0.00%)

0 / 50 (0.00%)

0 / 78 (0.00%)

0 / 92 (0.00%)

0 / 10 (0.00%)

0 / 1 (0.00%)

0 / 71 (0.00%)

1 / 87 (1.15%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Vascular disorders

hypertension

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

1 / 88 (1.14%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

0 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

hip arthroplasty

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

anaphylactic reaction

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

1 / 165 (0.61%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

acquired phimosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

1 / 102 (0.98%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

bartholin's cyst

alternative dictionary used: MedDRA 20.0

subjects affected / exposed ^[2]

1 / 58 (1.72%)

0 / 50 (0.00%)

0 / 62 (0.00%)

0 / 55 (0.00%)

0 / 8 (0.00%)

0 / 16 (0.00%)

0 / 38 (0.00%)

0 / 109 (0.00%)

0 / 91 (0.00%)

0 / 10 (0.00%)

0 / 1 (0.00%)

0 / 94 (0.00%)

0 / 84 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

metrorrhagia

alternative dictionary used: MedDRA 20.0

subjects affected / exposed ^[3]

0 / 58 (0.00%)

1 / 50 (2.00%)

0 / 62 (0.00%)

0 / 55 (0.00%)

0 / 8 (0.00%)

0 / 16 (0.00%)

0 / 38 (0.00%)

0 / 109 (0.00%)

0 / 91 (0.00%)

0 / 10 (0.00%)

0 / 1 (0.00%)

0 / 94 (0.00%)

0 / 84 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

uterine polyp

alternative dictionary used: MedDRA 20.0

subjects affected / exposed ^[4]

0 / 58 (0.00%)

0 / 50 (0.00%)

1 / 62 (1.61%)

0 / 55 (0.00%)

0 / 8 (0.00%)

0 / 16 (0.00%)

0 / 38 (0.00%)

0 / 109 (0.00%)

0 / 91 (0.00%)

0 / 10 (0.00%)

0 / 1 (0.00%)

0 / 94 (0.00%)

0 / 84 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

vulval disorder

alternative dictionary used: MedDRA 20.0

subjects affected / exposed ^[5]

0 / 58 (0.00%)

0 / 50 (0.00%)

0 / 62 (0.00%)

0 / 55 (0.00%)

0 / 8 (0.00%)

0 / 16 (0.00%)

0 / 38 (0.00%)

1 / 109 (0.92%)

0 / 91 (0.00%)

0 / 10 (0.00%)

0 / 1 (0.00%)

0 / 94 (0.00%)

0 / 84 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

confusional state

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

hepatic enzyme increased

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 106 (0.94%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

anastomotic stenosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

clavicle fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

fall

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

fibula fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

1 / 107 (0.93%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

humerus fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

joint dislocation

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

ligament injury

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

limb injury

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

lumbar vertebral fracture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

meniscus injury

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

perirenal haematoma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

post procedural haematoma

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

tendon rupture

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

acute myocardial infarction

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

atrial fibrillation

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

cardiac disorder

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

coronary artery disease

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

2 / 183 (1.09%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

coronary artery occlusion

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

myocardial ischaemia

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

carotid artery occlusion

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

1 / 101 (0.99%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

carotid artery stenosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

cerebrovascular accident

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

cervical myelopathy

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

1 / 102 (0.98%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

depressed level of consciousness

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

guillain-barre syndrome

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ischaemic stroke

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

post-traumatic headache

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

1 / 107 (0.93%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

sciatica

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

transient ischaemic attack

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

retinal detachment

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

abdominal pain

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

colitis ulcerative

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

5 / 5

0 / 0

deaths causally related to treatment / all

0 / 0

duodenitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gastric ulcer

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

1 / 101 (0.99%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gastrointestinal inflammation

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

impaired gastric emptying

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

1 / 102 (0.98%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

irritable bowel syndrome

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

1 / 171 (0.58%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

oesophagitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

1 / 101 (0.99%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

pancreatitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

1 / 107 (0.93%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pancreatitis acute

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

cholecystitis acute

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

2 / 187 (1.07%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

cholelithiasis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

1 / 107 (0.93%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

tubulointerstitial nephritis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

intervertebral disc protrusion

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

lumbar spinal stenosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

1 / 107 (0.93%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

osteoarthritis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

psoriatic arthropathy

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

1 / 165 (0.61%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

arthritis bacterial

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

cellulitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

1 / 101 (0.99%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

chronic tonsillitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

1 / 183 (0.55%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gastroenteritis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

1 / 107 (0.93%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gastroenteritis clostridial

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gastroenteritis rotavirus

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

herpes zoster

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

1 / 102 (0.98%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

latent tuberculosis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

lower respiratory tract infection

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

oesophageal candidiasis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

1 / 102 (0.98%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pneumonia

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

2 / 187 (1.07%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

pneumonia mycoplasmal

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

1 / 101 (0.99%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

0 / 187 (0.00%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

upper respiratory tract infection

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

obesity

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

0 / 101 (0.00%)

0 / 107 (0.00%)

0 / 102 (0.00%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

1 / 187 (0.53%)

0 / 183 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: The event is gender specific, only occurring in male and female subjects. The number of subjects exposed is adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: The event is gender specific, only occurring in male and female subjects. The number of subjects exposed is adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: The event is gender specific, only occurring in male and female subjects. The number of subjects exposed is adjusted accordingly.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: The event is gender specific, only occurring in male and female subjects. The number of subjects exposed is adjusted accordingly.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: The event is gender specific, only occurring in male and female subjects. The number of subjects exposed is adjusted accordingly.

Frequency threshold for reporting non-serious adverse events: 5%

Placebo (PBO) Double-Blind Period

ADA Double-Blind Period

Ixe Q2W Double-Blind Period

Ixe Q4W Double-Blind Period

IR PBO Washout

IR Ixe Q4W

IR Ixe Q2W

PBO Washout

Ixe Q4W

Ixe Q2W

PBO Post-Treatment Follow-up Period

ADA Post-Treatment Follow-up Period

Ixe Q4W Post-Treatment Follow-up Period

Ixe Q2W Post-treatment Follow-up Period

Total subjects affected by non serious adverse events

subjects affected / exposed

16 / 106 (15.09%)

18 / 101 (17.82%)

33 / 107 (30.84%)

31 / 102 (30.39%)

0 / 9 (0.00%)

0 / 24 (0.00%)

7 / 88 (7.95%)

62 / 187 (33.16%)

66 / 183 (36.07%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

General disorders and administration site conditions

injection site erythema

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

2 / 101 (1.98%)

7 / 107 (6.54%)

13 / 102 (12.75%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

3 / 187 (1.60%)

5 / 183 (2.73%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences all number

injection site reaction

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

3 / 101 (2.97%)

13 / 107 (12.15%)

16 / 102 (15.69%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

12 / 187 (6.42%)

13 / 183 (7.10%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences all number

180

Musculoskeletal and connective tissue disorders

back pain

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

0 / 106 (0.00%)

3 / 101 (2.97%)

2 / 107 (1.87%)

2 / 102 (1.96%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

11 / 187 (5.88%)

6 / 183 (3.28%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences all number

Infections and infestations

bronchitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

3 / 106 (2.83%)

4 / 101 (3.96%)

3 / 107 (2.80%)

3 / 102 (2.94%)

0 / 9 (0.00%)

0 / 24 (0.00%)

0 / 88 (0.00%)

10 / 187 (5.35%)

10 / 183 (5.46%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences all number

pharyngitis

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

1 / 106 (0.94%)

0 / 101 (0.00%)

1 / 107 (0.93%)

2 / 102 (1.96%)

0 / 9 (0.00%)

0 / 24 (0.00%)

2 / 88 (2.27%)

5 / 187 (2.67%)

12 / 183 (6.56%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences all number

upper respiratory tract infection

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

7 / 106 (6.60%)

5 / 101 (4.95%)

5 / 107 (4.67%)

3 / 102 (2.94%)

0 / 9 (0.00%)

0 / 24 (0.00%)

2 / 88 (2.27%)

21 / 187 (11.23%)

18 / 183 (9.84%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences all number

viral upper respiratory tract infection

alternative dictionary used: MedDRA 20.0

subjects affected / exposed

5 / 106 (4.72%)

6 / 101 (5.94%)

6 / 107 (5.61%)

2 / 102 (1.96%)

0 / 9 (0.00%)

0 / 24 (0.00%)

3 / 88 (3.41%)

21 / 187 (11.23%)

21 / 183 (11.48%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 165 (0.00%)

0 / 171 (0.00%)

occurrences all number

More information

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Were there any global substantial amendments to the protocol? Yes

02 Oct 2012

The changes overall made to the protocol were as follows: -Rescue therapy modified -Participant Level discontinuation criteria applied -Total Study Duration shortened to 3 years -Exclusion Criteria Modified - Added discontinuation for positive HBV DNA test results - Monitoring added to study schedule and preference on the participant's geographic location during self-injection - Appropriate premedication and modification to allowed concomitant therapy - Updated study schedule by deleting visits 25-33

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: American College of Rheumatology 20 Index [ACR20])

Primary: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: American College of Rheumatology 20 Index [ACR20])

Secondary: Percentage of Participants Achieving ACR20 Response

Secondary: Percentage of Participants Achieving ACR20 Response

Secondary: Percentage of Participants achieving American College of Rheumatology 50 (ACR50) Response

Secondary: Percentage of Participants achieving American College of Rheumatology 50 (ACR50) Response

Secondary: Percentage of Participants achieving American College of Rheumatology 70 (ACR70) Score

Secondary: Percentage of Participants achieving American College of Rheumatology 70 (ACR70) Score

Secondary: Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

Secondary: Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

Secondary: Change from Baseline in Modified Total Sharp Score (mTSS) (Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: modified Total Sharp Score [mTSS])

Secondary: Change from Baseline in Modified Total Sharp Score (mTSS) (Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: modified Total Sharp Score [mTSS])

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)

Secondary: Change from baseline in Leeds Enthesitis Index (LEI)

Secondary: Change from baseline in Leeds Enthesitis Index (LEI)

Secondary: Change from baseline in itching severity using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

Secondary: Change from baseline in itching severity using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

Secondary: Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

Secondary: Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

Secondary: Change from Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)

Secondary: Change from Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)

Secondary: Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

Secondary: Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

Secondary: Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])

Secondary: Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])

Secondary: Change From Baseline in Disease Activity Score (28 diarthrodial joint count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease

Secondary: Change From Baseline in Disease Activity Score (28 diarthrodial joint count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease

Secondary: Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC modified)

Secondary: Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC modified)

Secondary: Percentage of Participants achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline

Secondary: Percentage of Participants achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline

Secondary: Percent change from Baseline in Body Surface Area (BSA)

Secondary: Percent change from Baseline in Body Surface Area (BSA)

Secondary: Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline

Secondary: Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline

Secondary: Change from baseline in Leeds Dactylitis Index-Basic (LDI-B)

Secondary: Change from baseline in Leeds Dactylitis Index-Basic (LDI-B)

Secondary: Change from Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Secondary: Change from Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Secondary: Number of Participants with Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)

Secondary: Number of Participants with Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)

Secondary: American College of Rheumatology-N (ACR-N) Score

Secondary: American College of Rheumatology-N (ACR-N) Score

Secondary: Change from Baseline in TJC

Secondary: Change from Baseline in TJC

Secondary: Change from Baseline in SJC

Secondary: Change from Baseline in SJC

Secondary: Change from Baseline in Patient's Assessment of Pain VAS

Secondary: Change from Baseline in Patient's Assessment of Pain VAS

Secondary: Change from Baseline in PatGA

Secondary: Change from Baseline in PatGA

Secondary: Change from Baseline in Physician's Global Assessment of Disease Activity VAS

Secondary: Change from Baseline in Physician's Global Assessment of Disease Activity VAS

Secondary: Change from Baseline in CRP

Secondary: Change from Baseline in CRP

Secondary: Change from baseline in Leeds Enthesitis Index (LEI)

Secondary: Change from baseline in Leeds Enthesitis Index (LEI)

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)

Secondary: Change from baseline in itching severity using the Itch NRS

Secondary: Change from baseline in itching severity using the Itch NRS

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis