Download PDF

Clinical Trial Results:
A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients with Chronic Plaque Psoriasis

Summary
EudraCT number	2013-003275-36
Trial protocol	GR DE BE FR
Global end of trial date	27 Apr 2016

Results information
Results version number	v1(current)
This version publication date	11 May 2017
First version publication date	11 May 2017
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

M13-674

ISRCTN number

US NCT number

NCT02016482

WHO universal trial number (UTN)

Sponsor organisation name

AbbVie Deutschland GmbH & Co.KG

Sponsor organisation address

AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB

Public contact

Carol A Kotkin, BS, AbbVie, carol.kotkin@abbvie.com

Scientific contact

David Williams, MD, AbbVie, david.williams@abbvie.com

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

27 Apr 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

27 Apr 2016

Was the trial ended prematurely?

Main objective of the trial

This study was conducted to assess the safety and efficacy of adalimumab in subjects with nail psoriasis.

Protection of trial subjects

Participant and/or legal guardian read and understood the information provided about the study and gave written permission.

Background therapy

Evidence for comparator

Actual start date of recruitment

30 Jan 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 26

Country: Number of subjects enrolled

Belgium: 17

Country: Number of subjects enrolled

Canada: 50

Country: Number of subjects enrolled

France: 21

Country: Number of subjects enrolled

Germany: 22

Country: Number of subjects enrolled

Greece: 24

Country: Number of subjects enrolled

Puerto Rico: 1

Country: Number of subjects enrolled

United States: 56

Worldwide total number of subjects

217

EEA total number of subjects

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)

199

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

The study included a 3- to 35-day screening period.

Period 1 title

Period A

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

All AbbVie personnel with direct oversight of the conduct and management of the trial (with the exception of AbbVie Drug Supply Management Team), the Investigator, study site personnel and the subject were to remain blinded to each subject's treatment throughout the blinded period of the study.

Are arms mutually exclusive

Yes

Placebo

Arm description

Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA 80) mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Arm type

Placebo

Investigational medicinal product name

placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects randomized to the placebo treatment group received 2 injections of placebo at Baseline (Day 1), and then starting at Week 1, received a single injection of placebo eow through Week 25.

Adalimumab EOW

Arm description

Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Arm type

Experimental

Investigational medicinal product name

adalimumab

Investigational medicinal product code

Other name

Humira 40 mg solution for injection in pre-filled syringe

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects randomized to the adalimumab treatment group received 80 mg sc adalimumab at Baseline (Day 1) administered as 2 injections of 40 mg adalimumab, and then starting at Week 1 received a single injection of adalimumab 40 mg sc eow through Week 25.

Number of subjects in period 1	Placebo	Adalimumab EOW
Started	108	109
Completed	94	94
Not completed	14	15
Consent withdrawn by subject	3	4
Adverse event, non-fatal	3	5
Not Specified	3	-
Required Alternative/Prohibited Therapy	-	1
Lost to follow-up	3	3
Lack of efficacy	2	1
Protocol deviation	-	1

Period 2 title

Period B

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Placebo

Arm description

Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Arm type

Placebo

Investigational medicinal product name

adalimumab

Investigational medicinal product code

Other name

Humira 40 mg solution for injection in pre-filled syringe

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At the Week 26 visit subjects from the placebo group were to receive 80 mg sc adalimumab administered as 2 injections of 40 mg adalimumab. Starting at the Week 27 study visit, all subjects were to receive 1 injection of 40 mg sc of adalimumab eow through Week 51. No medication was to be dispensed or injected at the Week 52 study visit.

Adalimumab EOW

Arm description

Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Arm type

Experimental

Investigational medicinal product name

placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At Week 26. subjects from the adalimumab group were to receive 2 injections of matching placebo.

Investigational medicinal product name

adalimumab

Investigational medicinal product code

Other name

Humira 40 mg solution for injection in pre-filled syringe

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Starting at the Week 27 study visit, all subjects were to receive 1 injection of 40 mg sc of adalimumab eow through Week 51. No medication was to be dispensed or injected at the Week 52 study visit.

Number of subjects in period 2	Placebo	Adalimumab EOW
Started	94	94
Completed	81	87
Not completed	13	7
Consent withdrawn by subject	1	1
Not Specified	4	-
Required Alternative/Prohibited Therapy	-	2
Lost to follow-up	2	-
Lack of efficacy	6	4

Baseline characteristics

Top of page

Reporting group title

Placebo

Reporting group description

Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA 80) mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Reporting group title

Adalimumab EOW

Reporting group description

Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Reporting group values	Placebo	Adalimumab EOW	Total
Number of subjects	108	109	217
Age, Customized
Units: participants
< 40 years	34	30	64
40 to ≤ 64 years	65	70	135
≥ 65 years	9	9	18
Age Continuous
Units: years
arithmetic mean (standard deviation)	46.16 ± 12.134	47.21 ± 11.858	-
Gender, Male/Female
Units: Participants
Female	21	13	34
Male	87	96	183

End points

Top of page

Reporting group title

Placebo

Reporting group description

Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA 80) mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Reporting group title

Adalimumab EOW

Reporting group description

Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Reporting group title

Placebo

Reporting group description

Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Reporting group title

Adalimumab EOW

Reporting group description

Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Primary: Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26

Top of page

End point title

Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26

End point description

Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.

End point type

Primary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	3.4	46.6

Statistical Analysis 1

Statistical analysis description

For US regulatory purposes, ranked first secondary endpoint.

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[1]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

43.2

Confidence interval

level

95%

sides

2-sided

lower limit

32.8

upper limit

53.6

Notes
[1] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Primary: For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26

Top of page

End point title

For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26

End point description

The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of “clear” (0) or “minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.

End point type

Primary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	6.9	48.9

Statistical Analysis 1

Statistical analysis description

Ranked sixth secondary endpoint. For US regulatory purposes, this was the primary endpoint.

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

30.8

upper limit

53.2

Notes
[2] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26

Top of page

End point title

Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26

End point description

Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percent change
least squares mean (standard error)	-11.5 ± 3.19	-56.2 ± 3.12

Statistical Analysis 1

Statistical analysis description

Ranked first secondary endpoint. For US regulatory purposes, ranked second secondary endpoint.

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[3]

Method

ANCOVA

Parameter type

LS Mean

Point estimate

-44.8

Confidence interval

level

95%

sides

2-sided

lower limit

-53.5

upper limit

-36

Notes
[3] - P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26

Top of page

End point title

Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26

End point description

Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	0	6.6

Statistical Analysis 1

Statistical analysis description

Ranked second secondary endpoint. For US regulatory purposes, ranked third secondary endpoint.

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[4]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

6.6

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

11.3

Notes
[4] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26

Top of page

End point title

Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26

End point description

An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percent change
least squares mean (standard error)	-1.1 ± 0.24	-3.7 ± 0.23

Statistical Analysis 1

Statistical analysis description

Ranked third secondary endpoint. For US regulatory purposes, ranked fourth secondary endpoint.

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[5]

Method

ANCOVA

Parameter type

LS Mean Percent Change

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-3.3

upper limit

-2

Notes
[5] - P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

Top of page

End point title

Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

End point description

Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)	-0.8 ± 0.24	-3.7 ± 0.25

Statistical Analysis 1

Statistical analysis description

Ranked fourth secondary endpoint. For US regulatory purposes, ranked fifth secondary endpoint.

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[6]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

-2.2

Notes
[6] - P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26

Top of page

End point title

Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26

End point description

The range of possible scores was 0 to 20 for scalp psoriasis, with a score of 0 indicating absence of psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the scalp component of the B-SNIPI among participants with Baseline scalp score of ≥ 6.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	12	18
Units: percentage of participants
number (not applicable)	0.4	58.3

Statistical Analysis 1

Statistical analysis description

Ranked fifth secondary endpoint. For US regulatory purposes, ranked sixth secondary endpoint.

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[7]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

57.9

Confidence interval

level

95%

sides

2-sided

lower limit

33.8

upper limit

Notes
[7] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26

Top of page

End point title

Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26

End point description

The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail bed component of the PGA-F that met definition of "clear" (0) or "minimal" (1) among those with a Baseline nail bed component of "moderate" or "worse."

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	101	98
Units: percentage of participants
number (not applicable)	8.2	51.4

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

199

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[8]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

43.3

Confidence interval

level

95%

sides

2-sided

lower limit

31.3

upper limit

55.2

Notes
[8] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26

Top of page

End point title

Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26

End point description

The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail matrix component of the PGA-F that met definition of "clear" (0) or "minimal" (1) among those with a Baseline nail matrix component of "moderate" or "worse."

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	99	102
Units: percentage of participants
number (not applicable)	8.5	53.3

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

201

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[9]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

44.8

Confidence interval

level

95%

sides

2-sided

lower limit

33.2

upper limit

56.5

Notes
[9] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26

Top of page

End point title

Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26

End point description

The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	1.3	19.9

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[10]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

18.6

Confidence interval

level

95%

sides

2-sided

lower limit

10.6

upper limit

26.6

Notes
[10] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26

Top of page

End point title

Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26

End point description

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	7.3	43.3

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[11]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

46.9

Notes
[11] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26

Top of page

End point title

Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26

End point description

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	0.2	13.4

STATISTICAL_ANALYSIS_TITLE

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[12]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

13.3

Confidence interval

level

95%

sides

2-sided

lower limit

6.5

upper limit

Notes
[12] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Change From Baseline in Target Fingernail mNAPSI Score at Week 26

Top of page

End point title

Change From Baseline in Target Fingernail mNAPSI Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)	-2.1 ± 0.27	-5.7 ± 0.27

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[13]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-3.5

Confidence interval

level

95%

sides

2-sided

lower limit

-4.3

upper limit

-2.8

Notes
[13] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26

Top of page

End point title

Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percent change
least squares mean (standard error)	-23 ± 2.92	-61.9 ± 2.91

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[14]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-38.9

Confidence interval

level

95%

sides

2-sided

lower limit

-46.9

upper limit

-30.8

Notes
[14] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Change From Baseline in Total Fingernail mNAPSI Score at Week 26

Top of page

End point title

Change From Baseline in Total Fingernail mNAPSI Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)	-7.5 ± 1.78	-36.1 ± 1.8

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[15]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-28.6

Confidence interval

level

95%

sides

2-sided

lower limit

-33.5

upper limit

-23.7

Notes
[15] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26

Top of page

End point title

Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percent change
least squares mean (standard error)	-13.2 ± 3.06	-63.3 ± 3.02

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[16]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-50.1

Confidence interval

level

95%

sides

2-sided

lower limit

-58.3

upper limit

-41.9

Notes
[16] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26

Top of page

End point title

Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26

End point description

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	0	7.5

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[17]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

7.4

Confidence interval

level

95%

sides

2-sided

lower limit

2.4

upper limit

12.4

Notes
[17] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26

Top of page

End point title

Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26

End point description

The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	2.4	20.8

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[18]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

18.5

Confidence interval

level

95%

sides

2-sided

lower limit

10.1

upper limit

26.8

Notes
[18] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Change from Baseline in Target Fingernail NAPSI Score at Week 26

Top of page

End point title

Change from Baseline in Target Fingernail NAPSI Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)	-1.1 ± 0.21	-3.6 ± 0.21

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[19]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

-1.9

Notes
[19] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percent Change from Baseline in Target Fingernail NAPSI Score at Week 26

Top of page

End point title

Percent Change from Baseline in Target Fingernail NAPSI Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percent change
least squares mean (standard error)	-14.4 ± 3.5	-54.6 ± 3.47

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[20]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-40.2

Confidence interval

level

95%

sides

2-sided

lower limit

-50

upper limit

-30.4

Notes
[20] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Change from Baseline in Total Fingernail NAPSI Score at Week 26

Top of page

End point title

Change from Baseline in Total Fingernail NAPSI Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)	-6.7 ± 1.51	-26.2 ± 1.47

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[21]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-19.5

Confidence interval

level

95%

sides

2-sided

lower limit

-23.6

upper limit

-15.3

Notes
[21] - Across all strata, P values were calculated from ANCOVA with stratum, Baseline value, and treatment in the model.

Secondary: Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26

Top of page

End point title

Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)	-0.9 ± 0.7	-9 ± 0.7

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[22]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-8.1

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

-6.1

Notes
[22] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percent Change From Baseline in PASI Score at Week 26

Top of page

End point title

Percent Change From Baseline in PASI Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percent change
least squares mean (standard error)	2.4 ± 5.77	-68.7 ± 5.7

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[23]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-71.2

Confidence interval

level

95%

sides

2-sided

lower limit

-87.3

upper limit

-55

Notes
[23] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26

Top of page

End point title

Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. PASI-75, 50, 90, and 100 responses are the percentage of participants with a Baseline PASI score ≥ 5 who achieved at least a 75%, 50%, 90%, or 100% reduction (improvement), respectively, from Baseline in PASI score at Week 26. A 100% reduction was considered complete clearance of psoriasis. Data presents the percentage of participants achieving PASI 75/50/90/100 responses at Week 26 among participants with a Baseline PASI score ≥ 5.

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	95	97
Units: percentage of participants
number (not applicable)
PASI 75	13.8	64.8
PASI 50	25.3	77.8
PASI 90	7.1	48
PASI 100	2.9	29.3

Statistical Analysis 1

Statistical analysis description

PASI 75

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[24]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

51.1

Confidence interval

level

95%

sides

2-sided

lower limit

38.6

upper limit

63.5

Notes
[24] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Statistical Analysis 1

Statistical analysis description

PASI 50

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[25]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

52.5

Confidence interval

level

95%

sides

2-sided

lower limit

39.9

upper limit

Notes
[25] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Statistical Analysis 1

Statistical analysis description

PASI 90

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[26]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

40.9

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

52.9

Notes
[26] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Statistical Analysis 1

Statistical analysis description

PASI 100

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[27]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

26.4

Confidence interval

level

95%

sides

2-sided

lower limit

15.8

upper limit

36.9

Notes
[27] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26

Top of page

End point title

Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26

End point description

The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of "clear" (0) or "minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	11.2	63.4

STATISTICAL_ANALYSIS_TITLE

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[28]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

52.2

Confidence interval

level

95%

sides

2-sided

lower limit

40.8

upper limit

63.7

Notes
[28] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving PGA-S of "Clear" at Week 26

Top of page

End point title

Percentage of Participants Achieving PGA-S of "Clear" at Week 26

End point description

The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of "clear" (0) with at least a 2-grade improvement relative to Baseline at Week 26.

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of participants
number (not applicable)	4	28.8

STATISTICAL_ANALYSIS_TITLE

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[29]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

24.8

Confidence interval

level

95%

sides

2-sided

lower limit

15.3

upper limit

34.3

Notes
[29] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26

Top of page

End point title

Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26

End point description

The range of possible B-SNIPI scores was 0 to 20 for inverse psoriasis, with a score of 0 indicating absence of psoriasis and a score of 20 indicating most severe psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the inverse component of the B-SNIPI among participants with a Baseline inverse psoriasis score of ≥ 6.

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	11	12
Units: percentage of participants
number (not applicable)	0.5	90.8

STATISTICAL_ANALYSIS_TITLE

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[30]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

90.4

Confidence interval

level

95%

sides

2-sided

lower limit

72.5

upper limit

108.3

Notes
[30] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Change From Baseline in Total Body Surface Area (BSA) at Week 26

Top of page

End point title

Change From Baseline in Total Body Surface Area (BSA) at Week 26

End point description

BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percentage of affected BSA
least squares mean (standard error)	0.4 ± 1	-10.7 ± 1

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[31]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-11.1

Confidence interval

level

95%

sides

2-sided

lower limit

-13.9

upper limit

-8.4

Notes
[31] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percent Change From Baseline in Total BSA at Week 26

Top of page

End point title

Percent Change From Baseline in Total BSA at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percent change
least squares mean (standard error)	12.8 ± 6.08	-67.8 ± 6.01

STATISTICAL_ANALYSIS_TITLE

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[32]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-80.6

Confidence interval

level

95%

sides

2-sided

lower limit

-97.9

upper limit

-63.3

Notes
[32] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26

Top of page

End point title

Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	103	103
Units: percent change
least squares mean (standard error)	-18 ± 4.8	-68.9 ± 4.7

STATISTICAL_ANALYSIS_TITLE

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

206

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[33]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-50.9

Confidence interval

level

95%

sides

2-sided

lower limit

-64

upper limit

-37.8

Notes
[33] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

Top of page

End point title

Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	105	104
Units: percent change
least squares mean (standard error)	-9.9 ± 5.51	-67.6 ± 5.63

STATISTICAL_ANALYSIS_TITLE

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

209

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[34]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-57.7

Confidence interval

level

95%

sides

2-sided

lower limit

-73.1

upper limit

-42.4

Notes
[34] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26

Top of page

End point title

Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26

End point description

Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)	-0.4 ± 0.07	-1.3 ± 0.07

STATISTICAL_ANALYSIS_TITLE

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[35]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.7

Notes
[35] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26

Top of page

End point title

Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26

End point description

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: percent change
least squares mean (standard error)	-11.7 ± 2.24	-39.5 ± 2.23

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[36]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-27.7

Confidence interval

level

95%

sides

2-sided

lower limit

-33.9

upper limit

-21.6

Notes
[36] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26

Top of page

End point title

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26

End point description

Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	93	94
Units: units on a scale
least squares mean (standard error)	-1.9 ± 0.6	-8 ± 0.6

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

187

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[37]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-6.1

Confidence interval

level

95%

sides

2-sided

lower limit

-7.8

upper limit

-4.5

Notes
[37] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26

Top of page

End point title

Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26

End point description

End point type

Secondary

End point timeframe

Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	93	94
Units: percentage of participants
number (not applicable)
DLQI = 0	2.5	18.2
DLQI = 0/1	3.7	30.8

Statistical Analysis 1

Statistical analysis description

DLQI = 0

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

187

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[38]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

15.7

Confidence interval

level

95%

sides

2-sided

lower limit

7.1

upper limit

24.3

Notes
[38] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Statistical Analysis 1

Statistical analysis description

DLQI = 0/1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

187

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[39]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in percentage

Point estimate

27.1

Confidence interval

level

95%

sides

2-sided

lower limit

16.7

upper limit

37.4

Notes
[39] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26

Top of page

End point title

Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26

End point description

The WPAI: NPSO assessed impact of fingernail psoriasis on work productivity and non-work activity limitation. Participants were asked during the past 7 days, how many hours did you miss from work because of problems associated with your fingernail psoriasis (absenteeism), during the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your fingernail psoriasis affect your productivity while you were working (overall work impairment), and much did your fingernail psoriasis affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "fingernail psoriasis had no effect on this" and 10 indicating "fingernail psoriasis completely prevented me from this." A decrease in the WPAI:NPSO score indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)
Absenteeism; n=65, 74	-1 ± 0.73	-0.3 ± 0.65
Presenteeism; n=70, 77	-3.4 ± 2.08	-20.7 ± 2.06
Overall Work impairment; n=65, 74	-6.2 ± 2.2	-21.3 ± 2.05
Activity impairment; n=106, 108	-1.8 ± 2.09	-23.1 ± 2.18

STATISTICAL_ANALYSIS_TITLE

Statistical analysis description

Absenteeism

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.416 ^[40]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

2.5

Notes
[40] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Statistical Analysis 1

Statistical analysis description

Presenteeism

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[41]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-17.3

Confidence interval

level

95%

sides

2-sided

lower limit

-22.9

upper limit

-11.6

Notes
[41] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Statistical Analysis 1

Statistical analysis description

Overall work impairment

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[42]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-15.2

Confidence interval

level

95%

sides

2-sided

lower limit

-21

upper limit

-9.3

Notes
[42] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Statistical Analysis 1

Statistical analysis description

Activity impairment

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[43]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-21.4

Confidence interval

level

95%

sides

2-sided

lower limit

-27.3

upper limit

-15.4

Notes
[43] - Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26

Top of page

End point title

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26

End point description

The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from –0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	107	109
Units: units on a scale
least squares mean (standard error)	0 ± 0.01	0.1 ± 0.01

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

216

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[44]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.2

Notes
[44] - P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Change From Baseline in EQ-5D Visual analogue Scale (VAS) at Week 26

Top of page

End point title

Change From Baseline in EQ-5D Visual analogue Scale (VAS) at Week 26

End point description

The EQ-5D VAS records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	107	109
Units: units on a scale
least squares mean (standard error)	-0.1 ± 1.53	5.5 ± 1.53

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

216

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.012 ^[45]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

5.5

Confidence interval

level

95%

sides

2-sided

lower limit

1.2

upper limit

9.8

Notes
[45] - P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26

Top of page

End point title

Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26

End point description

Participants rated their anxiety and depression over the past 7 days at Week 26. The range of possible scores was 0 to 21, with a score of 0 indicating absence of anxiety and depression and 21 indicating the most severe anxiety and depression. A decrease in HADS score indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	108	109
Units: units on a scale
least squares mean (standard error)
HADS anxiety score; n=106, 109	-0.1 ± 0.33	-1.1 ± 0.33
HADS depression score; n=106, 108	0 ± 0.33	-1.4 ± 0.32

Statistical Analysis 1

Statistical analysis description

HADS anxiety score

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.025 ^[46]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

-0.1

Notes
[46] - P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Statistical Analysis 1

Statistical analysis description

HADS depression score

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005 ^[47]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

-0.4

Notes
[47] - P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Secondary: Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study

Top of page

End point title

Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study

End point description

The percentage of participants with a new diagnosis of PsA (ie, with an adverse event of PsA) during the study, among participants without PsA at Baseline.

End point type

Secondary

End point timeframe

up to Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	76	79
Units: percentage of participants
number (not applicable)	0	2

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

155

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.164 ^[48]

Method

Chi-squared

Parameter type

Difference in percentage

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

Notes
[48] - Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).

Secondary: Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26

Top of page

End point title

Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26

End point description

Participants were asked how their fingernail psoriasis impacted their overall quality of life over the past 7 days on an 11-point scale, with 0 indicating no impact, and 10 indicating severe impact. A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	Placebo	Adalimumab EOW
Number of subjects analysed	107	109
Units: units on a scale
least squares mean (standard error)	-0.6 ± 0.23	-3.3 ± 0.23

Statistical Analysis 1

Comparison groups

Placebo v Adalimumab EOW

Number of subjects included in analysis

216

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[49]

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

-2.1

Notes
[49] - P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.

Adverse events

Top of page

Timeframe for reporting adverse events

Adverse events were collected from Baseline through Week 52 +70 day follow up phone call; serious adverse events were collected from Screening through Week 52 + 70 day follow up call.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

Placebo (Period A)

Reporting group description

Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Reporting group title

Adalimumab EOW (Period A)

Reporting group description

ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg.

Reporting group title

Placebo/Adalimumab EOW (Period B)

Reporting group description

Following Period A (placebo sc eow for 25 weeks), ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Reporting group title

Adalimumab EOW/Adalimumab EOW (Period B)

Reporting group description

Following Period A (ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg), placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Serious adverse events	Placebo (Period A)	Adalimumab EOW (Period A)	Placebo/Adalimumab EOW (Period B)	Adalimumab EOW/Adalimumab EOW (Period B)
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 108 (4.63%)	8 / 109 (7.34%)	3 / 94 (3.19%)	3 / 94 (3.19%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events
Vascular disorders
HYPERTENSIVE CRISIS
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
Immune system disorders
ANAPHYLACTIC REACTION
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
Reproductive system and breast disorders
PROSTATITIS
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
subjects affected / exposed	1 / 108 (0.93%)	0 / 109 (0.00%)	0 / 94 (0.00%)	0 / 94 (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
Psychiatric disorders
MAJOR DEPRESSION
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
SUICIDAL IDEATION
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
ARTHROPOD STING
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
ATRIAL FIBRILLATION
subjects affected / exposed	1 / 108 (0.93%)	0 / 109 (0.00%)	0 / 94 (0.00%)	0 / 94 (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
CARDIAC FAILURE CONGESTIVE
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
MYOCARDIAL INFARCTION
subjects affected / exposed	0 / 108 (0.00%)	0 / 109 (0.00%)	1 / 94 (1.06%)	0 / 94 (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
Nervous system disorders
CAROTID ARTERY STENOSIS
subjects affected / exposed	1 / 108 (0.93%)	0 / 109 (0.00%)	0 / 94 (0.00%)	0 / 94 (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
SEIZURE
subjects affected / exposed	0 / 108 (0.00%)	0 / 109 (0.00%)	0 / 94 (0.00%)	1 / 94 (1.06%)
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
Gastrointestinal disorders
DIVERTICULAR PERFORATION
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
PSORIASIS
subjects affected / exposed	1 / 108 (0.93%)	0 / 109 (0.00%)	0 / 94 (0.00%)	0 / 94 (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
Renal and urinary disorders
BLADDER SPHINCTER ATONY
subjects affected / exposed	0 / 108 (0.00%)	0 / 109 (0.00%)	0 / 94 (0.00%)	1 / 94 (1.06%)
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
STRESS URINARY INCONTINENCE
subjects affected / exposed	0 / 108 (0.00%)	0 / 109 (0.00%)	0 / 94 (0.00%)	1 / 94 (1.06%)
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
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
subjects affected / exposed	0 / 108 (0.00%)	0 / 109 (0.00%)	0 / 94 (0.00%)	1 / 94 (1.06%)
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
Infections and infestations
BRONCHITIS
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
DIVERTICULITIS
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	1 / 94 (1.06%)	0 / 94 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ENDOCARDITIS
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
ERYSIPELAS
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	0 / 94 (0.00%)	0 / 94 (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
INFLUENZA
subjects affected / exposed	0 / 108 (0.00%)	0 / 109 (0.00%)	0 / 94 (0.00%)	1 / 94 (1.06%)
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
LUNG INFECTION
subjects affected / exposed	0 / 108 (0.00%)	0 / 109 (0.00%)	1 / 94 (1.06%)	0 / 94 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	2 / 108 (1.85%)	0 / 109 (0.00%)	0 / 94 (0.00%)	1 / 94 (1.06%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Placebo (Period A)	Adalimumab EOW (Period A)	Placebo/Adalimumab EOW (Period B)	Adalimumab EOW/Adalimumab EOW (Period B)
Total subjects affected by non serious adverse events
subjects affected / exposed	43 / 108 (39.81%)	45 / 109 (41.28%)	28 / 94 (29.79%)	34 / 94 (36.17%)
Investigations
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	2 / 108 (1.85%)	0 / 109 (0.00%)	0 / 94 (0.00%)	2 / 94 (2.13%)
occurrences all number	2	0	0	2
ASPARTATE AMINOTRANSFERASE INCREASED
subjects affected / exposed	2 / 108 (1.85%)	0 / 109 (0.00%)	1 / 94 (1.06%)	2 / 94 (2.13%)
occurrences all number	2	0	1	2
BLOOD TRIGLYCERIDES INCREASED
subjects affected / exposed	3 / 108 (2.78%)	0 / 109 (0.00%)	1 / 94 (1.06%)	1 / 94 (1.06%)
occurrences all number	3	0	1	1
Injury, poisoning and procedural complications
LACERATION
subjects affected / exposed	0 / 108 (0.00%)	3 / 109 (2.75%)	0 / 94 (0.00%)	0 / 94 (0.00%)
occurrences all number	0	3	0	0
Vascular disorders
HYPERTENSION
subjects affected / exposed	2 / 108 (1.85%)	4 / 109 (3.67%)	0 / 94 (0.00%)	1 / 94 (1.06%)
occurrences all number	2	5	0	1
Nervous system disorders
HEADACHE
subjects affected / exposed	0 / 108 (0.00%)	6 / 109 (5.50%)	2 / 94 (2.13%)	1 / 94 (1.06%)
occurrences all number	0	6	3	1
General disorders and administration site conditions
INFLUENZA LIKE ILLNESS
subjects affected / exposed	0 / 108 (0.00%)	1 / 109 (0.92%)	2 / 94 (2.13%)	0 / 94 (0.00%)
occurrences all number	0	1	2	0
INJECTION SITE ERYTHEMA
subjects affected / exposed	0 / 108 (0.00%)	3 / 109 (2.75%)	0 / 94 (0.00%)	0 / 94 (0.00%)
occurrences all number	0	3	0	0
INJECTION SITE PAIN
subjects affected / exposed	2 / 108 (1.85%)	1 / 109 (0.92%)	2 / 94 (2.13%)	1 / 94 (1.06%)
occurrences all number	2	1	2	1
Gastrointestinal disorders
DIARRHOEA
subjects affected / exposed	2 / 108 (1.85%)	3 / 109 (2.75%)	1 / 94 (1.06%)	2 / 94 (2.13%)
occurrences all number	2	3	1	2
TOOTHACHE
subjects affected / exposed	0 / 108 (0.00%)	0 / 109 (0.00%)	0 / 94 (0.00%)	3 / 94 (3.19%)
occurrences all number	0	0	0	3
Respiratory, thoracic and mediastinal disorders
COUGH
subjects affected / exposed	3 / 108 (2.78%)	2 / 109 (1.83%)	1 / 94 (1.06%)	0 / 94 (0.00%)
occurrences all number	3	2	1	0
OROPHARYNGEAL PAIN
subjects affected / exposed	3 / 108 (2.78%)	2 / 109 (1.83%)	1 / 94 (1.06%)	1 / 94 (1.06%)
occurrences all number	3	2	1	1
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
subjects affected / exposed	0 / 108 (0.00%)	3 / 109 (2.75%)	0 / 94 (0.00%)	1 / 94 (1.06%)
occurrences all number	0	3	0	1
PSORIASIS
subjects affected / exposed	6 / 108 (5.56%)	1 / 109 (0.92%)	4 / 94 (4.26%)	1 / 94 (1.06%)
occurrences all number	7	1	4	1
Psychiatric disorders
DEPRESSION
subjects affected / exposed	1 / 108 (0.93%)	1 / 109 (0.92%)	0 / 94 (0.00%)	3 / 94 (3.19%)
occurrences all number	1	1	0	3
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	4 / 108 (3.70%)	5 / 109 (4.59%)	0 / 94 (0.00%)	1 / 94 (1.06%)
occurrences all number	5	5	0	1
BACK PAIN
subjects affected / exposed	4 / 108 (3.70%)	2 / 109 (1.83%)	1 / 94 (1.06%)	2 / 94 (2.13%)
occurrences all number	4	2	1	2
PSORIATIC ARTHROPATHY
subjects affected / exposed	1 / 108 (0.93%)	2 / 109 (1.83%)	0 / 94 (0.00%)	2 / 94 (2.13%)
occurrences all number	1	2	0	2
Infections and infestations
BRONCHITIS
subjects affected / exposed	0 / 108 (0.00%)	2 / 109 (1.83%)	3 / 94 (3.19%)	2 / 94 (2.13%)
occurrences all number	0	2	3	2
GASTROENTERITIS
subjects affected / exposed	1 / 108 (0.93%)	4 / 109 (3.67%)	3 / 94 (3.19%)	2 / 94 (2.13%)
occurrences all number	1	4	3	2
NASOPHARYNGITIS
subjects affected / exposed	10 / 108 (9.26%)	6 / 109 (5.50%)	9 / 94 (9.57%)	12 / 94 (12.77%)
occurrences all number	11	9	10	14
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	9 / 108 (8.33%)	9 / 109 (8.26%)	6 / 94 (6.38%)	4 / 94 (4.26%)
occurrences all number	11	11	7	4
URINARY TRACT INFECTION
subjects affected / exposed	1 / 108 (0.93%)	1 / 109 (0.92%)	2 / 94 (2.13%)	1 / 94 (1.06%)
occurrences all number	2	1	3	1
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
subjects affected / exposed	0 / 108 (0.00%)	3 / 109 (2.75%)	0 / 94 (0.00%)	1 / 94 (1.06%)
occurrences all number	0	3	0	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

08 Jan 2014

Key changes included in Amendment 1 included revision of the PGA-F from a 6-point scale to a 5-point scale to reduce the potential overlap among the levels of severity of fingernail Ps and addition of the B-SNIPI. Besides clarifying minor inconsistencies and making minor editorial changes within the protocol, the purpose of Amendment 1 was to incorporate changes to protocol section text and tables.

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.

Due to study design, a high percentage of participants randomized to the placebo arm early escaped from Period A and thus participated for a shorter duration than did participants in the active treatment arm.

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients with Chronic Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26

Primary: Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26

Primary: For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26

Primary: For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26

Secondary: Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26

Secondary: Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26

Secondary: Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26

Secondary: Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26

Secondary: Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26

Secondary: Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26

Secondary: Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

Secondary: Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

Secondary: Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26

Secondary: Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26

Secondary: Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26

Secondary: Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26

Secondary: Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26

Secondary: Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26

Secondary: Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26

Secondary: Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26

Secondary: Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26

Secondary: Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26

Secondary: Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26

Secondary: Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26

Secondary: Change From Baseline in Target Fingernail mNAPSI Score at Week 26

Secondary: Change From Baseline in Target Fingernail mNAPSI Score at Week 26

Secondary: Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26

Secondary: Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26

Secondary: Change From Baseline in Total Fingernail mNAPSI Score at Week 26

Secondary: Change From Baseline in Total Fingernail mNAPSI Score at Week 26

Secondary: Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26

Secondary: Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26

Secondary: Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26

Secondary: Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26

Secondary: Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26

Secondary: Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26

Secondary: Change from Baseline in Target Fingernail NAPSI Score at Week 26

Secondary: Change from Baseline in Target Fingernail NAPSI Score at Week 26

Secondary: Percent Change from Baseline in Target Fingernail NAPSI Score at Week 26

Secondary: Percent Change from Baseline in Target Fingernail NAPSI Score at Week 26

Secondary: Change from Baseline in Total Fingernail NAPSI Score at Week 26

Secondary: Change from Baseline in Total Fingernail NAPSI Score at Week 26

Secondary: Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26

Secondary: Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26

Secondary: Percent Change From Baseline in PASI Score at Week 26

Secondary: Percent Change From Baseline in PASI Score at Week 26

Secondary: Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26

Secondary: Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26

Secondary: Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26

Secondary: Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26

Secondary: Percentage of Participants Achieving PGA-S of "Clear" at Week 26

Secondary: Percentage of Participants Achieving PGA-S of "Clear" at Week 26

Secondary: Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26

Secondary: Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26

Secondary: Change From Baseline in Total Body Surface Area (BSA) at Week 26

Secondary: Change From Baseline in Total Body Surface Area (BSA) at Week 26

Secondary: Percent Change From Baseline in Total BSA at Week 26

Secondary: Percent Change From Baseline in Total BSA at Week 26

Secondary: Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26

Secondary: Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26

Secondary: Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

Secondary: Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

Secondary: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26

Secondary: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26

Secondary: Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26

Secondary: Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26

Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26

Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26

Secondary: Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26

Secondary: Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26

Clinical Trial Results:
A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients with Chronic Plaque Psoriasis