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Clinical Trial Results:
A 52-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Evaluating the Efficacy and Safety of Ixekizumab versus Adalimumab in Patients with Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

Summary
EudraCT number	2016-004585-25
Trial protocol	HU FI DE NL BE AT SE DK ES GB FR IT PL
Global end of trial date	04 Sep 2019

Results information
Results version number	v1(current)
This version publication date	16 Sep 2020
First version publication date	16 Sep 2020
Other versions

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

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Trial information

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Sponsor protocol code

I1F-MC-RHCF

ISRCTN number

US NCT number

NCT03151551

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16687

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

04 Sep 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

04 Sep 2019

Was the trial ended prematurely?

Main objective of the trial

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

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

24 Aug 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 58

Country: Number of subjects enrolled

Hungary: 33

Country: Number of subjects enrolled

Ukraine: 26

Country: Number of subjects enrolled

United Kingdom: 20

Country: Number of subjects enrolled

Switzerland: 4

Country: Number of subjects enrolled

India: 46

Country: Number of subjects enrolled

Spain: 42

Country: Number of subjects enrolled

Canada: 10

Country: Number of subjects enrolled

Sweden: 6

Country: Number of subjects enrolled

Austria: 8

Country: Number of subjects enrolled

Netherlands: 3

Country: Number of subjects enrolled

Belgium: 11

Country: Number of subjects enrolled

Finland: 11

Country: Number of subjects enrolled

Poland: 53

Country: Number of subjects enrolled

Denmark: 4

Country: Number of subjects enrolled

Mexico: 65

Country: Number of subjects enrolled

South Africa: 36

Country: Number of subjects enrolled

Italy: 39

Country: Number of subjects enrolled

Israel: 28

Country: Number of subjects enrolled

Australia: 17

Country: Number of subjects enrolled

France: 12

Country: Number of subjects enrolled

Germany: 34

Worldwide total number of subjects

566

EEA total number of subjects

276

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)

519

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Per protocol and statistical analysis plan (SAP), the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

Screening details

Open-Label Treatment Period from Week 0 to Week 52 inclusive followed by Post-Treatment Follow-Up Period of up to a minimum of 12 weeks.

Period 1 title

Open-Label Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

A blinded assessor completed the following assessments: Tender joint count/Swollen joint count (TJC/SJC), Psoriasis Area and Severity Index (PASI), Percentage of body surface area (BSA), Enthesitis, Leeds Dactylitis Index—Basic (LDI-B), Nail Psoriasis Severity Index (NAPSI) Fingernails and static Physician Global Assessment of psoriasis (sPGA).

Are arms mutually exclusive

Yes

Ixekizumab

Arm description

160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

Other name

LY2439821

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC

Adalimumab

Arm description

80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

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

Administered SC

Number of subjects in period 1	Ixekizumab	Adalimumab
Started	283	283
Received at least one dose of study drug	283	283
IXE 160 mg at baseline, 80 mg Q2W/Q4W	49 ^[1]	0 ^[2]
IXE 160 mg at baseline, 80 mg Q4W	218 ^[3]	0 ^[4]
ADA 80 mg at baseline, 40 mg Q2W	0 ^[5]	51 ^[6]
ADA 40 mg at baseline, 40 mg Q2W	0 ^[7]	219 ^[8]
Completed	265	259
Not completed	18	24
Consent withdrawn by subject	12	18
Physician decision	3	-
Protocol Deviation	1	2
Adverse event, non-fatal	-	2
Lost to follow-up	1	1
Lack of efficacy	1	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: The number of participants in this milestone represents only participants who received Ixekizumab.
[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: The number of participants in these milestone represents only participants who received Adalimumab.
[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: The number of participants in this milestone represents only participants who received Ixekizumab.
[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: The number of participants in this milestone represents only participants who received Adalimumab.
[5] - 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: The number of participants in this milestones represents only participants who received Ixekizumab.
[6] - 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: The number of participants in this milestone represents only participants who received Adalimumab.
[7] - 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: The number of participants in this milestone represents only participants who received Ixekizumab.
[8] - 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: The number of participants in this milestone represents only participants who received Adalimumab.

Period 2 title

Post-Treatment Follow-Up Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Ixekizumab

Arm description

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

Other name

LY2439821

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC

Adalimumab

Arm description

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

Administered SC

Number of subjects in period 2 ^[9]	Ixekizumab	Adalimumab
Started	265	258
Completed	240	230
Not completed	25	28
Consent withdrawn by subject	20	22
Physician decision	-	1
Adverse event, non-fatal	1	3
Lost to follow-up	4	2

Notes
[9] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: All participants who received at least one dose of study drug could enter the follow-up period.

Baseline characteristics

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Reporting group title

Ixekizumab

Reporting group description

Reporting group title

Adalimumab

Reporting group description

Reporting group values	Ixekizumab	Adalimumab	Total
Number of subjects	283	283	566
Age categorical
Units: Subjects
Age continuous
Units: years
median (standard deviation)	47.5 ( 12.02 )	48.3 ( 12.30 )	-
Gender categorical
Units: Subjects
Female	121	133	254
Male	162	150	312
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	63	65	128
Not Hispanic or Latino	198	194	392
Unknown or Not Reported	22	24	46
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	27	27	54
Asian	29	33	62
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	222	211	433
More than one race	5	11	16
Unknown or Not Reported	0	0	0
Region of Enrollment
Units: Subjects
Argentina	31	27	58
Hungary	15	18	33
Ukraine	15	11	26
United Kingdom	13	7	20
Switzerland	1	3	4
India	20	26	46
Spain	24	18	42
Canada	5	5	10
Sweden	3	3	6
Austria	4	4	8
Netherlands	2	1	3
Belgium	6	5	11
Finland	5	6	11
Poland	24	29	53
Denmark	1	3	4
Mexico	32	33	65
South Africa	15	21	36
Italy	14	25	39
Israel	14	14	28
Australia	12	5	17
France	9	3	12
Germany	18	16	34

End points

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Reporting group title

Ixekizumab

Reporting group description

Reporting group title

Adalimumab

Reporting group description

Reporting group title

Ixekizumab

Reporting group description

Reporting group title

Adalimumab

Reporting group description

Primary: Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)

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End point title

Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)

End point description

ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)& swollen joint count (SJC)& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% & PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 & BSA=0 at week 24.

End point type

Primary

End point timeframe

Week 24 Analysis Population Description: All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab versus all adalimumab participants.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	283	283
Units: percentage of participants
number (confidence interval 95%)	36 (30.4 to 41.6)	27.9 (22.7 to 33.1)

% of Participants Achieving ACR50 & PASI100

Statistical analysis description

After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 & BSA≥3% were considered PASI100 responders if, and only if, PASI=0 & BSA=0 achieved at week 24.

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.036

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

8.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

15.8

Secondary: Percentage of Participants Achieving ACR50

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End point title

Percentage of Participants Achieving ACR50

End point description

ACR50 response is defined as a ≥50% 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 (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP). Analysis Population description (APD): All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Secondary

End point timeframe

Week 24

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	283	283
Units: percentage of participants
number (confidence interval 95%)	50.5 (44.7 to 56.4)	46.6 (40.8 to 52.5)

Percentage of Participants Achieving ACR50

Statistical analysis description

If the lower bound of the 2-sided 95% CI for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

Rate Difference

Point estimate

3.9

Confidence interval

level

95%

sides

2-sided

lower limit

-4.3

upper limit

12.1

Secondary: Percentage of Participants Achieving PASI100

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End point title

Percentage of Participants Achieving PASI100

End point description

PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if & only if they had achieved PASI=0 & BSA=0 at week 24. Analysis Population Description: All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Secondary

End point timeframe

Week 24

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	283	283
Units: percentage of participants
number (confidence interval 95%)	60.1 (54.4 to 65.8)	46.6 (40.8 to 52.5)

Percentage of Participants Achieving PASI100

Statistical analysis description

Comparison groups

Adalimumab v Ixekizumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

13.4

Confidence interval

level

95%

sides

2-sided

lower limit

5.3

upper limit

21.6

Other pre-specified: Change from Baseline in Tender Joint Counts (TJC)

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End point title

Change from Baseline in Tender Joint Counts (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 MMRM model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement,visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. Analysis Population Description: All randomized participants who had a baseline and at least one post-baseline TJC value.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	242	239
Units: score on a scale
least squares mean (standard error)	-15.91 ( 0.566 )	-14.88 ( 0.569 )

Change from Baseline in TJC

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

481

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.155

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.03

Confidence interval

level

95%

sides

2-sided

lower limit

-2.46

upper limit

0.39

Variability estimate

Standard error of the mean

Dispersion value

0.725

Other pre-specified: Change from Baseline in Swollen Joint Counts (SJC)

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End point title

Change from Baseline in Swollen Joint Counts (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 MMRM model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. Analysis Population Description: All randomized participants who had a baseline and at least one post-baseline SJC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	242	239
Units: score on a scale
least squares mean (standard error)	-9.58 ( 0.196 )	-9.53 ( 0.198 )

Change from Baseline in SJC

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

481

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.823

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-0.54

upper limit

0.43

Variability estimate

Standard error of the mean

Dispersion value

0.249

Other pre-specified: Change from Baseline in Participant's Assessment of Pain Visual analogue score (VAS)

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End point title

Change from Baseline in Participant's Assessment of Pain Visual analogue score (VAS)

End point description

The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	242	246
Units: millimeters (mm)
least squares mean (standard error)	-37.21 ( 1.623 )	-36.54 ( 1.621 )

Change from Baseline in Participant's Pain VAS

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

488

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.752

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.67

Confidence interval

level

95%

sides

2-sided

lower limit

-4.8

upper limit

3.47

Variability estimate

Standard error of the mean

Dispersion value

2.104

Other pre-specified: Change from Baseline in Participant's Global Assessment of Disease Activity (PatGA)

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End point title

Change from Baseline in Participant's Global Assessment of Disease Activity (PatGA)

End point description

The patient's overall assessment of his or her PsA activity was recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	242	246
Units: Millimeter (mm)
least squares mean (standard error)	-40.61 ( 1.594 )	-37.82 ( 1.596 )

Change from Baseline in PatGA

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

488

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.177

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-2.79

Confidence interval

level

95%

sides

2-sided

lower limit

-6.83

upper limit

1.26

Variability estimate

Standard error of the mean

Dispersion value

2.06

Other pre-specified: Change from Baseline in Physician's Global Assessment of Disease Activity (PhyGA)

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End point title

Change from Baseline in Physician's Global Assessment of Disease Activity (PhyGA)

End point description

The investigator was 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. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	223	230
Units: Millimeter (mm)
least squares mean (standard error)	-48.15 ( 1.113 )	-46.79 ( 1.097 )

Change from Baseline in PhyGA

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

453

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.332

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.35

Confidence interval

level

95%

sides

2-sided

lower limit

-4.08

upper limit

1.38

Variability estimate

Standard error of the mean

Dispersion value

1.391

Other pre-specified: Change from Baseline in C-Reactive Protein (CRP)

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End point title

Change from Baseline in C-Reactive Protein (CRP)

End point description

CRP is the ACR Core Set laboratory measure of acute-phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on the participant’s PsA. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline and at least one post-baseline CRP value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	234	238
Units: Milligram per Liter (mg/L)
least squares mean (standard error)	-5.68 ( 0.462 )	-6.01 ( 0.461 )

Change from Baseline in CRP

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

472

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.592

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.32

Confidence interval

level

95%

sides

2-sided

lower limit

-0.86

upper limit

1.5

Variability estimate

Standard error of the mean

Dispersion value

0.599

Other pre-specified: Change from Baseline in HAQ-DI

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End point title

Change from Baseline in HAQ-DI

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 reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 All randomized participants who had a baseline and at least one post-baseline HAQ-DI value.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	242	246
Units: score on a scale
least squares mean (standard error)	-0.68 ( 0.035 )	-0.62 ( 0.035 )

Change from Baseline in HAQ-DI

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

488

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.176

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-0.15

upper limit

0.03

Variability estimate

Standard error of the mean

Dispersion value

0.045

Other pre-specified: Percentage of Participants Simultaneously Achieving ACR50 and PASI100

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End point title

Percentage of Participants Simultaneously Achieving ACR50 and PASI100

End point description

ACR50 response is a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of VAS, Pts Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, participant assessment of physical function using the HAQ-DI, or High Sensitivity(assay) C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participant achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% & PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 & BSA=0 at week 52.

End point type

Other pre-specified

End point timeframe

Week 52 APD: All randomized participants who had a baseline and at least one post-baseline ACR50 and PASI100 value.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	283	283
Units: percentage of participants
number (confidence interval 95%)	39.2 (33.5 to 44.9)	26.1 (21.0 to 31.3)

% of Participants Achieving ACR50 & PASI100

Statistical analysis description

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

13.1

Confidence interval

level

95%

sides

2-sided

lower limit

5.4

upper limit

20.7

Other pre-specified: Change from Baseline in Disease Activity Score-CRP (DAS28-CRP)

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End point title

Change from Baseline in Disease Activity Score-CRP (DAS28-CRP)

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 milligrams per liter), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 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 model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 APD: All randomized participants who had a baseline and at least one post-baseline DAS28-CRP value.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	226	228
Units: score on a scale
least squares mean (standard error)	-2.45 ( 0.071 )	-2.36 ( 0.071 )

Change From Baseline in DAS28-CRP

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

454

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.368

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-0.26

upper limit

0.1

Variability estimate

Standard error of the mean

Dispersion value

0.091

Other pre-specified: Percentage of Participants Achieving Minimal Disease Activity (MDA)

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End point title

Percentage of Participants Achieving Minimal Disease Activity (MDA)

End point description

MDA is a composite of 7 key outcome measures: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures. APD: All randomized participants who had a baseline and at least one post-baseline MDA value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	283	283
Units: percentage of participants
number (confidence interval 95%)
MDA-6 Entheseal Points	48.1 (42.2 to 53.9)	42.8 (37.0 to 48.5)
MDA-18 Entheseal Points	47.3 (41.5 to 53.2)	41.0 (35.3 to 46.7)

% of Participants Achieving MDA-18 Entheseal Point

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.108

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

6.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

14.5

% of Participants Achieving MDA-6 Entheseal Points

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.179

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

5.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

13.5

Other pre-specified: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)

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End point title

Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)

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. APD: All randomized participants who had a baseline and at least one post-baseline PsARC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	283	283
Units: percentage of participants
number (confidence interval 95%)	66.8 (61.3 to 72.3)	65.7 (60.2 to 71.3)

Percentage of Participants Achieving PsARC

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.846

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-8.9

upper limit

6.7

Other pre-specified: Change from Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score

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End point title

Change from Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score

End point description

The CPDAI is a validated instrument intended to assess composite psoriatic disease activity and response to therapy. Domains include peripheral arthritis as assessed by the number of tender and swollen joints and the HAQ-DI, skin as assessed by the PASI and the Dermatology Life Quality Index (DLQI), enthesitis as assessed by the number of sites with enthesitis and the HAQ-DI, and dactylitis as assessed by the number of digits affected. Each domain with the exception of spinal disease is scored from 0-3. Individual domain scores are summed to give an overall composite score (range 0-12) with a higher score indicating higher disease activity. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 All randomized participants who had a baseline and at least one post-baseline CPDAI value.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	237	234
Units: score on a scale
least squares mean (standard error)	-4.35 ( 0.136 )	-3.85 ( 0.136 )

Change from Baseline in mCPDAI

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

471

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.49

Confidence interval

level

95%

sides

2-sided

lower limit

-0.83

upper limit

-0.16

Variability estimate

Standard error of the mean

Dispersion value

0.17

Other pre-specified: Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline

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End point title

Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline

End point description

The SPARCC enthesitis index evaluates tenderness in a total of 16 entheseal sites: the greater trochanter (right/left [R/L]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles of humerus (R/L),Lateral epicondyle humerus (R/L) and the supraspinatus insertion (R/L). Tenderness at each site is quantified on a dichotomous basis: 0 = nontender and 1 = tender. The results from each site are then added to produce a total score (range 0 to 16) with the Higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 APD: All randomized participants who had a baseline SPARCC score > 0.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	163	139
Units: score on a scale
least squares mean (standard error)	-3.93 ( 0.234 )	-4.06 ( 0.241 )

Change from Baseline in SPARCC Enthesitis Index

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

302

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.687

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-0.48

upper limit

0.72

Variability estimate

Standard error of the mean

Dispersion value

0.305

Other pre-specified: Change from Baseline in the Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline

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End point title

Change from Baseline in the Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline

End point description

The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle,(R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline enthesitis (LEI >0). Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	141	121
Units: score on a scale
least squares mean (standard error)	-1.93 ( 0.113 )	-2.02 ( 0.116 )

Change from Baseline in LEI

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

262

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.507

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.19

upper limit

0.38

Variability estimate

Standard error of the mean

Dispersion value

0.144

Other pre-specified: Change from Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants with Dactylitis at Baseline

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End point title

Change from Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants with Dactylitis at Baseline

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 is 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. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 APD: All randomized participants who had a baseline dactylitis (LDI-B >0).

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	35	47
Units: score on a scale
least squares mean (standard error)	-52.28 ( 11.495 )	-48.89 ( 9.855 )

Change from Baseline in LDI-B

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.82

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-3.4

Confidence interval

level

95%

sides

2-sided

lower limit

-32.78

upper limit

25.99

Variability estimate

Standard error of the mean

Dispersion value

14.951

Other pre-specified: Change from Baseline in Psoriasis Body Surface Area (BSA)

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End point title

Change from Baseline in Psoriasis Body Surface Area (BSA)

End point description

The investigator evaluates 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 model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline and at least one post-baseline BSA value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	246	246
Units: units on a scale
least squares mean (standard error)	-12.33 ( 0.623 )	-10.79 ( 0.613 )

Change from Baseline in BSA

Comparison groups

Adalimumab v Ixekizumab

Number of subjects included in analysis

492

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.052

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.54

Confidence interval

level

95%

sides

2-sided

lower limit

-3.09

upper limit

0.02

Variability estimate

Standard error of the mean

Dispersion value

0.79

Other pre-specified: Change from Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants with Fingernail Involvement at Baseline

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End point title

Change from Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants with 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 model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 APD: All randomized participants who had baseline fingernail involvement (NAPSI >0).

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	169	154
Units: score on a scale
least squares mean (standard error)	-17.78 ( 0.731 )	-15.08 ( 0.742 )

Change from Baseline in NAPSI Fingernails Score

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

323

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.005

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.57

upper limit

-0.84

Variability estimate

Standard error of the mean

Dispersion value

0.949

Other pre-specified: Change from Baseline in the Itch NRS

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End point title

Change from Baseline in the Itch NRS

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 is indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline and at least one post-baseline NRS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	242	246
Units: score on a scale
least squares mean (standard error)	-3.83 ( 0.159 )	-3.54 ( 0.159 )

Change from Baseline in Itch NRS

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

488

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.158

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-0.68

upper limit

0.11

Variability estimate

Standard error of the mean

Dispersion value

0.202

Other pre-specified: Change from Baseline in Fatigue Severity NRS (Fatigue NRS) Score

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End point title

Change from Baseline in Fatigue Severity NRS (Fatigue NRS) Score

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 rate their fatigue (weariness, tiredness) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline and at least one post-baseline Fatigue NRS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	241	246
Units: score on a scale
least squares mean (standard error)	-3.03 ( 0.161 )	-2.95 ( 0.161 )

Change from Baseline in Fatigue NRS

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

487

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.711

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-0.49

upper limit

0.33

Variability estimate

Standard error of the mean

Dispersion value

0.21

Other pre-specified: Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)

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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)

End point description

The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 APD: All randomized participants who had a baseline and at least one post-baseline PCS value.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	240	246
Units: score on a scale
least squares mean (standard error)	10.07 ( 0.526 )	9.55 ( 0.524 )

Change From Baseline in SF-36: PCS

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

486

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.439

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

1.85

Variability estimate

Standard error of the mean

Dispersion value

0.674

Other pre-specified: Change From Baseline in SF-36: Mental Component Summary (MCS)

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End point title

Change From Baseline in SF-36: Mental Component Summary (MCS)

End point description

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 APD: All randomized participants who had a baseline and at least one post-baseline MCS value.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	240	246
Units: score on a scale
least squares mean (standard error)	5.23 ( 0.660 )	4.77 ( 0.656 )

Change From Baseline in SF-36: MCS

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

486

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.594

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

0.46

Confidence interval

level

95%

sides

2-sided

lower limit

-1.23

upper limit

2.15

Variability estimate

Standard error of the mean

Dispersion value

0.86

Other pre-specified: Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score

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End point title

Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score

End point description

The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The descriptive part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension.This produced participant-level index scores between -0.594 and 1.0 (worse to better health). LS mean was calculated using MMRM model that included treatment group,concomitant csDMARD use at baseline,moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 APD: All randomized participants who had a baseline and at least one post-baseline EQ-5D 5L value.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	240	245
Units: millimeters (mm)
least squares mean (standard deviation)	0.21 ( 0.013 )	0.21 ( 0.013 )

Change from Baseline in EQ-5D 5L Index Score (UK)

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

485

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.979

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.03

upper limit

0.03

Variability estimate

Standard error of the mean

Dispersion value

0.017

Other pre-specified: Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score

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End point title

Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score

End point description

EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health you can imagine) to 100mm VAS (best health you can imagine). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms. APD: All randomized participants who had a baseline and at least one post-baseline EQ-5D 5L value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	240	245
Units: millimeters (mm)
least squares mean (standard deviation)	22.26 ( 1.37 )	17.48 ( 1.36 )

Change from Baseline in EQ-5D VAS

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

485

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

4.78

Confidence interval

level

95%

sides

2-sided

lower limit

1.28

upper limit

8.28

Variability estimate

Standard error of the mean

Dispersion value

1.782

Other pre-specified: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score

End point description

The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

End point type

Other pre-specified

End point timeframe

Baseline, Week 52 APD: All randomized participants who had a baseline and at least one post-baseline DLQI value.

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	241	246
Units: score on a scale
least squares mean (standard error)	-8.03 ( 0.273 )	-6.91 ( 0.272 )

Change from Baseline in DLQI

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

487

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-1.12

Confidence interval

level

95%

sides

2-sided

lower limit

-1.78

upper limit

-0.46

Variability estimate

Standard error of the mean

Dispersion value

0.335

Other pre-specified: Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)

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End point title

Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)

End point description

The TSQ is a clinician-administered questionnaire that provides an assessment of the patient’s opinion of the effectiveness, safety, and overall satisfaction of the study medication. Participants were asked to respond to questionnaire items using a 4-point Likert scale (from "mostly satisfied" to "mostly dissatisfied"). APD: All randomized participants who had a baseline and at least one post-baseline TSQ value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

End point type

Other pre-specified

End point timeframe

Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	283	283
Units: percentage of participants
number (confidence interval 95%)
Effectiveness of Medication	64.3 (58.7 to 69.9)	58.7 (52.9 to 64.4)
Effectiveness over Time of Medication	62.9 (57.3 to 68.5)	56.2 (50.4 to 62.0)
Long Term Safety of Medication	63.3 (57.6 to 68.9)	58.7 (52.9 to 64.4)
Overall Satisfaction with Medication	64.0 (58.4 to 69.6)	59.0 (53.3 to 64.7)
Mostly Satisfied to any Questions	70.0 (64.6 to 75.3)	67.8 (62.4 to 73.3)

% of TSQ: Effectiveness of Medication

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.165

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

5.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

13.7

% of TSQ: Effectiveness over Time of Medication

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.098

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

6.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

14.8

Notes
[1] - Effectiveness over Time of Medication

% of TSQ: Long Term Safety of Medication

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.241

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

4.6

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

12.6

Notes
[2] - Long Term Safety of Medication

% of TSQ: Overall Satisfaction with Medication

Comparison groups

Adalimumab v Ixekizumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

= 0.215

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

4.9

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

Notes
[3] - Overall Satisfaction with Medication

% of TSQ: Mostly Satisfied to any Questions

Comparison groups

Ixekizumab v Adalimumab

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

superiority ^[4]

P-value

= 0.561

Method

Regression, Logistic

Parameter type

Rate Difference

Point estimate

2.1

Confidence interval

level

95%

sides

2-sided

lower limit

-5.5

upper limit

9.7

Notes
[4] - Mostly Satisfied to any Questions

Other pre-specified: Number of Participants Who Answered "Yes" to any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)

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End point title

Number of Participants Who Answered "Yes" to any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)

End point description

The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Non-fatal suicide attempt 10. Completed suicide APD: All randomized participants.

End point type

Other pre-specified

End point timeframe

Week 52

End point values	Ixekizumab	Adalimumab
Number of subjects analysed	283	283
Units: participants	9	7

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up To Week 52

Adverse event reporting additional description

All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.1

Reporting group title

Ixekizumab

Reporting group description

Reporting group title

Adalimumab

Reporting group description

Reporting group title

Adalimumab Follow-up

Reporting group description

Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.

Reporting group title

Ixekizumab Follow-up

Reporting group description

Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.

Serious adverse events	Ixekizumab	Adalimumab	Adalimumab Follow-up	Ixekizumab Follow-up
Total subjects affected by serious adverse events
subjects affected / exposed	12 / 283 (4.24%)	35 / 283 (12.37%)	4 / 260 (1.54%)	7 / 265 (2.64%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrointestinal stromal tumour
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pituitary tumour benign
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
rectal adenocarcinoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
squamous cell carcinoma of skin
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
necrosis ischaemic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
peripheral artery occlusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	1 / 260 (0.38%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
injection site rash
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
non-cardiac chest pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pyrexia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 283 (0.71%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	1 / 2	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
menometrorrhagia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed ^[1]	1 / 121 (0.83%)	0 / 133 (0.00%)	0 / 123 (0.00%)	0 / 111 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
prostatitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed ^[2]	0 / 162 (0.00%)	1 / 150 (0.67%)	0 / 137 (0.00%)	0 / 154 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
dyspnoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vocal cord thickening
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
depression
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
hepatic enzyme increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
ankle fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
fall
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	2 / 283 (0.71%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hip fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
humerus fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
maternal exposure during pregnancy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed ^[3]	0 / 121 (0.00%)	1 / 133 (0.75%)	0 / 123 (0.00%)	0 / 111 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
road traffic accident
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tendon rupture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
upper limb fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
angina unstable
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
atrial fibrillation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	1 / 283 (0.35%)	1 / 260 (0.38%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
atrial flutter
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cardiac failure congestive
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
myocardial ischaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
haemorrhagic stroke
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
polyneuropathy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
radiologically isolated syndrome
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sciatica
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
seizure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	1 / 260 (0.38%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
transient ischaemic attack
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	1 / 260 (0.38%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
acute abdomen
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
cholecystitis chronic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cholelithiasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
erythrodermic psoriasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
nephrolithiasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
renal failure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
bursitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
osteoarthritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pain in extremity
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
abscess
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
appendicitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
arthritis bacterial
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cellulitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
large intestine infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lower respiratory tract infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lymph node tuberculosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
meningitis viral
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia legionella
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pyelonephritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pyoderma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sepsis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
staphylococcal sepsis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	0 / 260 (0.00%)	1 / 265 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
viral infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	0 / 283 (0.00%)	1 / 260 (0.38%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
diabetic ketoacidosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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

Non-serious adverse events	Ixekizumab	Adalimumab	Adalimumab Follow-up	Ixekizumab Follow-up
Total subjects affected by non serious adverse events
subjects affected / exposed	65 / 283 (22.97%)	44 / 283 (15.55%)	5 / 260 (1.92%)	8 / 265 (3.02%)
General disorders and administration site conditions
injection site reaction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	16 / 283 (5.65%)	4 / 283 (1.41%)	0 / 260 (0.00%)	0 / 265 (0.00%)
occurrences all number	30	9	0	0
Infections and infestations
nasopharyngitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	38 / 283 (13.43%)	23 / 283 (8.13%)	3 / 260 (1.15%)	5 / 265 (1.89%)
occurrences all number	46	26	3	5
upper respiratory tract infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	18 / 283 (6.36%)	18 / 283 (6.36%)	2 / 260 (0.77%)	3 / 265 (1.13%)
occurrences all number	21	23	2	3

More information

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Were there any global substantial amendments to the protocol? Yes

26 May 2017

Protocol Amendment (a): Changes to bring adverse event (AE) information in line with updated risk profile and Informed Consent Document (ICD).

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 52-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Evaluating the Efficacy and Safety of Ixekizumab versus Adalimumab in Patients with Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)

Primary: Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)

Secondary: Percentage of Participants Achieving ACR50

Secondary: Percentage of Participants Achieving ACR50

Secondary: Percentage of Participants Achieving PASI100

Secondary: Percentage of Participants Achieving PASI100

Other pre-specified: Change from Baseline in Tender Joint Counts (TJC)

Other pre-specified: Change from Baseline in Tender Joint Counts (TJC)

Other pre-specified: Change from Baseline in Swollen Joint Counts (SJC)

Other pre-specified: Change from Baseline in Swollen Joint Counts (SJC)

Other pre-specified: Change from Baseline in Participant's Assessment of Pain Visual analogue score (VAS)

Other pre-specified: Change from Baseline in Participant's Assessment of Pain Visual analogue score (VAS)

Other pre-specified: Change from Baseline in Participant's Global Assessment of Disease Activity (PatGA)

Other pre-specified: Change from Baseline in Participant's Global Assessment of Disease Activity (PatGA)

Other pre-specified: Change from Baseline in Physician's Global Assessment of Disease Activity (PhyGA)

Other pre-specified: Change from Baseline in Physician's Global Assessment of Disease Activity (PhyGA)

Other pre-specified: Change from Baseline in C-Reactive Protein (CRP)

Other pre-specified: Change from Baseline in C-Reactive Protein (CRP)

Other pre-specified: Change from Baseline in HAQ-DI

Other pre-specified: Change from Baseline in HAQ-DI

Other pre-specified: Percentage of Participants Simultaneously Achieving ACR50 and PASI100

Other pre-specified: Percentage of Participants Simultaneously Achieving ACR50 and PASI100

Other pre-specified: Change from Baseline in Disease Activity Score-CRP (DAS28-CRP)

Other pre-specified: Change from Baseline in Disease Activity Score-CRP (DAS28-CRP)

Other pre-specified: Percentage of Participants Achieving Minimal Disease Activity (MDA)

Other pre-specified: Percentage of Participants Achieving Minimal Disease Activity (MDA)

Other pre-specified: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)

Other pre-specified: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)

Other pre-specified: Change from Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score

Other pre-specified: Change from Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score

Other pre-specified: Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline

Other pre-specified: Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline

Other pre-specified: Change from Baseline in the Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline

Other pre-specified: Change from Baseline in the Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline

Other pre-specified: Change from Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants with Dactylitis at Baseline

Other pre-specified: Change from Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants with Dactylitis at Baseline

Other pre-specified: Change from Baseline in Psoriasis Body Surface Area (BSA)

Other pre-specified: Change from Baseline in Psoriasis Body Surface Area (BSA)

Other pre-specified: Change from Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants with Fingernail Involvement at Baseline

Other pre-specified: Change from Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants with Fingernail Involvement at Baseline

Other pre-specified: Change from Baseline in the Itch NRS

Other pre-specified: Change from Baseline in the Itch NRS

Other pre-specified: Change from Baseline in Fatigue Severity NRS (Fatigue NRS) Score

Other pre-specified: Change from Baseline in Fatigue Severity NRS (Fatigue NRS) Score

Other pre-specified: Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)

Other pre-specified: Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)

Other pre-specified: Change From Baseline in SF-36: Mental Component Summary (MCS)

Other pre-specified: Change From Baseline in SF-36: Mental Component Summary (MCS)

Other pre-specified: Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score

Other pre-specified: Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score

Other pre-specified: Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score

Other pre-specified: Change from Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score

Other pre-specified: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score

Other pre-specified: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score

Other pre-specified: Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)

Other pre-specified: Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)

Other pre-specified: Number of Participants Who Answered "Yes" to any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)

Other pre-specified: Number of Participants Who Answered "Yes" to any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A 52-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Evaluating the Efficacy and Safety of Ixekizumab versus Adalimumab in Patients with Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive