Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis (NCT NCT02016482)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

217 participants

Primary outcome timeframe

Week 26

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 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.	Adalimumab EOW 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.
Period A STARTED	108	109
Period A COMPLETED	94	94
Period A NOT COMPLETED	14	15
Period B STARTED	94	94
Period B COMPLETED	81	87
Period B NOT COMPLETED	13	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 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.	Adalimumab EOW 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.
Period A Adverse Event	3	5
Period A Withdrawal by Subject	3	4
Period A Lost to Follow-up	3	3
Period A Lack of Efficacy	2	1
Period A Other	3	0
Period A Protocol Violation	0	1
Period A Required Alternative/Prohibited Therapy	0	1
Period B Withdrawal by Subject	1	1
Period B Lost to Follow-up	2	0
Period B Lack of Efficacy	6	4
Period B Other	4	0
Period B Required Alternative/Prohibited Therapy	0	2

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.	Total n=217 Participants Total of all reporting groups
Age, Continuous	46.16 years STANDARD_DEVIATION 12.134 • n=5 Participants	47.21 years STANDARD_DEVIATION 11.858 • n=7 Participants	46.69 years STANDARD_DEVIATION 11.980 • n=5 Participants
Age, Customized < 40 years	34 participants n=5 Participants	30 participants n=7 Participants	64 participants n=5 Participants
Age, Customized 40 to ≤ 64 years	65 participants n=5 Participants	70 participants n=7 Participants	135 participants n=5 Participants
Age, Customized ≥ 65 years	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	96 Participants n=7 Participants	183 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 26

Population: Intent-to-treat (ITT) Population in Period A: all participants who were randomized at Baseline.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26	3.4 percentage of participants	46.6 percentage of participants

PRIMARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
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	6.9 percentage of participants	48.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26	-11.5 percent change Standard Error 3.19	-56.2 percent change Standard Error 3.12

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26	0.0 percentage of participants	6.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26	-1.1 percent change Standard Error 0.24	-3.7 percent change Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26	-0.8 units on a scale Standard Error 0.24	-3.7 units on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Scalp psoriasis was assessed by B-SNIPI at Week 26 for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Period A: 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.	Adalimumab EOW n=18 Participants 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.
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	0.4 percentage of participants	58.3 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail bed component of "moderate" or "worse." Multiple imputation.

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."

Outcome measures

Outcome measures
Measure	Placebo n=101 Participants Period A: 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.	Adalimumab EOW n=98 Participants 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.
Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26	8.2 percentage of participants	51.4 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail matrix component of "moderate" or "worse." Multiple imputations.

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."

Outcome measures

Outcome measures
Measure	Placebo n=99 Participants Period A: 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.	Adalimumab EOW n=102 Participants 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.
Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26	8.5 percentage of participants	53.3 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26	1.3 percentage of participants	19.9 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26	7.3 percentage of participants	43.3 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26	0.2 percentage of participants	13.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Target Fingernail mNAPSI Score at Week 26	-2.1 units on a scale Standard Error 0.27	-5.7 units on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26	-23.0 percent change Standard Error 2.92	-61.9 percent change Standard Error 2.91

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Total Fingernail mNAPSI Score at Week 26	-7.5 units on a scale Standard Error 1.78	-36.1 units on a scale Standard Error 1.80

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26	-13.2 percent change Standard Error 3.06	-63.3 percent change Standard Error 3.02

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26	0.0 percentage of participants	7.5 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26	2.4 percentage of participants	20.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Target Fingernail NAPSI Score at Week 26	-1.1 units on a scale Standard Error 0.21	-3.6 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26	-14.4 percent change Standard Error 3.50	-54.6 percent change Standard Error 3.47

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Total Fingernail NAPSI Score at Week 26	-6.7 units on a scale Standard Error 1.51	-26.2 units on a scale Standard Error 1.47

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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. A decrease in PASI score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26	-0.9 units on a scale Standard Error 0.70	-9.0 units on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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. A decrease in PASI score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percent Change From Baseline in PASI Score at Week 26	2.4 percent change Standard Error 5.77	-68.7 percent change Standard Error 5.70

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline PASI score ≥ 5. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Period A: 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.	Adalimumab EOW n=97 Participants 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.
Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26 PASI 75	13.8 percentage of participants	64.8 percentage of participants
Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26 PASI 50	25.3 percentage of participants	77.8 percentage of participants
Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26 PASI 90	7.1 percentage of participants	48.0 percentage of participants
Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26 PASI 100	2.9 percentage of participants	29.3 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26	11.2 percentage of participants	63.4 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percentage of Participants Achieving PGA-S of "Clear" at Week 26	4.0 percentage of participants	28.8 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had Baseline inverse psoriasis score ≥ 6. Inverse psoriasis was assessed for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Period A: 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.	Adalimumab EOW n=12 Participants 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.
Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26	0.5 percentage of participants	90.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Total Body Surface Area (BSA) at Week 26	0.4 percentage of affected BSA Standard Error 1.00	-10.7 percentage of affected BSA Standard Error 1.00

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percent Change From Baseline in Total BSA at Week 26	12.8 percent change Standard Error 6.08	-67.8 percent change Standard Error 6.01

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value \>0). Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants Period A: 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.	Adalimumab EOW n=103 Participants 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.
Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26	-18.0 percent change Standard Error 4.80	-68.9 percent change Standard Error 4.70

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value \>0). Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=105 Participants Period A: 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.	Adalimumab EOW n=104 Participants 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.
Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26	-9.9 percent change Standard Error 5.51	-67.6 percent change Standard Error 5.63

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26	-0.4 units on a scale Standard Error 0.07	-1.3 units on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26	-11.7 percent change Standard Error 2.24	-39.5 percent change Standard Error 2.23

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Period A: 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.	Adalimumab EOW n=94 Participants 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26	-1.9 units on a scale Standard Error 0.60	-8.0 units on a scale Standard Error 0.60

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.

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. Data presents the percentage of participants with a score of 0 (no effect) or 1 (little effect) at Week 26.

Outcome measures

Outcome measures
Measure	Placebo n=93 Participants Period A: 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.	Adalimumab EOW n=94 Participants 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.
Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26 DLQI = 0	2.5 percentage of participants	18.2 percentage of participants
Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26 DLQI = 0/1	3.7 percentage of participants	30.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with given assessment. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26 Absenteeism; n=65, 74	-1.0 units on a scale Standard Error 0.73	-0.3 units on a scale Standard Error 0.65
Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26 Presenteeism; n=70, 77	-3.4 units on a scale Standard Error 2.08	-20.7 units on a scale Standard Error 2.06
Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26 Overall Work impairment; n=65, 74	-6.2 units on a scale Standard Error 2.20	-21.3 units on a scale Standard Error 2.05
Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26 Activity impairment; n=106, 108	-1.8 units on a scale Standard Error 2.09	-23.1 units on a scale Standard Error 2.18

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26	0.0 units on a scale Standard Error 0.01	0.1 units on a scale Standard Error 0.01

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26	-0.1 units on a scale Standard Error 1.53	5.5 units on a scale Standard Error 1.53

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with a given assessment. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=108 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26 HADS anxiety score; n=106, 109	-0.1 units on a scale Standard Error 0.33	-1.1 units on a scale Standard Error 0.33
Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26 HADS depression score; n=106, 108	0.0 units on a scale Standard Error 0.33	-1.4 units on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: up to Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and did not have PsA at Baseline. Observed cases.

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.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Period A: 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.	Adalimumab EOW n=79 Participants 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.
Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study	0 percentage of participants	2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.

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.

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants Period A: 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.	Adalimumab EOW n=109 Participants 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.
Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26	-0.6 units on a scale Standard Error 0.23	-3.3 units on a scale Standard Error 0.23

Adverse Events

Placebo (Period A)

Serious events: 5 serious events

Other events: 43 other events

Deaths: 0 deaths

Adalimumab EOW (Period A)

Serious events: 8 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo/Adalimumab EOW (Period B)

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Adalimumab EOW/Adalimumab EOW (Period B)

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER