Trial Outcomes & Findings for Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet (NCT NCT00735787)

Results Overview

Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

81 participants

Primary outcome timeframe

Week 16

Results posted on

2010-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo/Adalimumab Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Period 1 STARTED	23	49
Period 1 COMPLETED	17	41
Period 1 NOT COMPLETED	6	8
Period 2 STARTED	18	41
Period 2 COMPLETED	13	40
Period 2 NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.	Total n=72 Participants Total of all reporting groups
Age Categorical < 40 years	1 subjects n=5 Participants	11 subjects n=7 Participants	12 subjects n=5 Participants
Age Categorical Between 40 and < 60 years	14 subjects n=5 Participants	29 subjects n=7 Participants	43 subjects n=5 Participants
Age Categorical >= 60 years	8 subjects n=5 Participants	9 subjects n=7 Participants	17 subjects n=5 Participants
Age Continuous	54.8 years STANDARD_DEVIATION 11.40 • n=5 Participants	49.0 years STANDARD_DEVIATION 11.41 • n=7 Participants	50.9 years STANDARD_DEVIATION 11.65 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	28 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	21 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	20 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Canada	14 participants n=5 Participants	29 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders.

Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16	1 subjects	15 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Population: Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method.

Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Week 2	-2.35 units on a scale Standard Deviation 4.074	-6.24 units on a scale Standard Deviation 7.685
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Week 4	-1.91 units on a scale Standard Deviation 7.019	-7.73 units on a scale Standard Deviation 9.064
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Week 8	-3.04 units on a scale Standard Deviation 7.327	-9.33 units on a scale Standard Deviation 9.335
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Week 12	-5.30 units on a scale Standard Deviation 6.825	-10.80 units on a scale Standard Deviation 11.175
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Week 16	-5.04 units on a scale Standard Deviation 6.568	-10.92 units on a scale Standard Deviation 12.460
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Week 20 (open-label)	-6.43 units on a scale Standard Deviation 8.805	-11.69 units on a scale Standard Deviation 11.353
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Week 24 (open-label)	-5.83 units on a scale Standard Deviation 9.267	-11.51 units on a scale Standard Deviation 11.502
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Week 28 (open-label)	-5.83 units on a scale Standard Deviation 8.574	-11.96 units on a scale Standard Deviation 10.261

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28

Population: Analysis was based on the ITT subject population and performed using the LOCF method.

Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Mean Change From Baseline in ESIF for Palms Week 2	-1.78 units on a scale Standard Deviation 3.464	-3.33 units on a scale Standard Deviation 4.095
Mean Change From Baseline in ESIF for Palms Week 4	-1.57 units on a scale Standard Deviation 4.326	-4.33 units on a scale Standard Deviation 4.543
Mean Change From Baseline in ESIF for Palms Week 8	-2.09 units on a scale Standard Deviation 4.889	-5.35 units on a scale Standard Deviation 4.829
Mean Change From Baseline in ESIF for Palms Week 12	-3.39 units on a scale Standard Deviation 4.639	-5.53 units on a scale Standard Deviation 5.934
Mean Change From Baseline in ESIF for Palms Week 16	-2.65 units on a scale Standard Deviation 4.914	-5.80 units on a scale Standard Deviation 6.285
Mean Change From Baseline in ESIF for Palms Week 20 (open-label)	-3.87 units on a scale Standard Deviation 5.810	-6.16 units on a scale Standard Deviation 5.669
Mean Change From Baseline in ESIF for Palms Week 24 (open-label)	-3.74 units on a scale Standard Deviation 5.387	-6.08 units on a scale Standard Deviation 5.947
Mean Change From Baseline in ESIF for Palms Week 28 (open-label)	-3.52 units on a scale Standard Deviation 4.870	-6.59 units on a scale Standard Deviation 5.244

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Population: Analysis was based on the ITT subject population and performed using the LOCF method.

Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Mean Change From Baseline in ESIF for Soles Week 20 (open-label)	-2.57 units on a scale Standard Deviation 5.358	-5.47 units on a scale Standard Deviation 6.959
Mean Change From Baseline in ESIF for Soles Week 2	-0.57 units on a scale Standard Deviation 1.619	-2.92 units on a scale Standard Deviation 4.650
Mean Change From Baseline in ESIF for Soles Week 4	-0.35 units on a scale Standard Deviation 3.915	-3.39 units on a scale Standard Deviation 5.553
Mean Change From Baseline in ESIF for Soles Week 8	-0.96 units on a scale Standard Deviation 4.017	-4.04 units on a scale Standard Deviation 5.972
Mean Change From Baseline in ESIF for Soles Week 12	-1.91 units on a scale Standard Deviation 3.965	-5.35 units on a scale Standard Deviation 6.515
Mean Change From Baseline in ESIF for Soles Week 16	-2.39 units on a scale Standard Deviation 4.620	-5.18 units on a scale Standard Deviation 7.132
Mean Change From Baseline in ESIF for Soles Week 24 (open-label)	-2.09 units on a scale Standard Deviation 5.608	-5.37 units on a scale Standard Deviation 7.082
Mean Change From Baseline in ESIF for Soles Week 28 (open-label)	-2.30 units on a scale Standard Deviation 5.431	-5.31 units on a scale Standard Deviation 6.378

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Population: Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).

Number of subjects that achieved \> 50% reduction from Baseline in ESIF.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With Moderate Improvement in ESIF From Baseline Week 2	1 subjects	8 subjects
Number of Subjects With Moderate Improvement in ESIF From Baseline Week 4	2 subjects	10 subjects
Number of Subjects With Moderate Improvement in ESIF From Baseline Week 8	3 subjects	17 subjects
Number of Subjects With Moderate Improvement in ESIF From Baseline Week 12	6 subjects	20 subjects
Number of Subjects With Moderate Improvement in ESIF From Baseline Week 16	4 subjects	21 subjects
Number of Subjects With Moderate Improvement in ESIF From Baseline Week 20 (open-label)	6 subjects	19 subjects
Number of Subjects With Moderate Improvement in ESIF From Baseline Week 24 (open-label)	6 subjects	21 subjects
Number of Subjects With Moderate Improvement in ESIF From Baseline Week 28 (open-label)	3 subjects	19 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Population: Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).

Number of subjects that achieved \> 75% reduction from Baseline in ESIF

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With Marked Improvement in ESIF From Baseline Week 2	0 subjects	3 subjects
Number of Subjects With Marked Improvement in ESIF From Baseline Week 4	0 subjects	5 subjects
Number of Subjects With Marked Improvement in ESIF From Baseline Week 8	0 subjects	7 subjects
Number of Subjects With Marked Improvement in ESIF From Baseline Week 12	0 subjects	11 subjects
Number of Subjects With Marked Improvement in ESIF From Baseline Week 16	1 subjects	14 subjects
Number of Subjects With Marked Improvement in ESIF From Baseline Week 20 (open-label)	5 subjects	13 subjects
Number of Subjects With Marked Improvement in ESIF From Baseline Week 24 (open-label)	4 subjects	12 subjects
Number of Subjects With Marked Improvement in ESIF From Baseline Week 28 (open-label)	2 subjects	11 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, and 28

Population: Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF.

For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=8 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=28 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Week 8	-0.63 units on a scale Standard Deviation 1.061	-0.88 units on a scale Standard Deviation 1.211
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Week 16	-0.13 units on a scale Standard Deviation 1.246	-1.67 units on a scale Standard Deviation 1.593
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Week 28 (open-label)	-1.00 units on a scale Standard Deviation 1.852	-2.00 units on a scale Standard Deviation 2.177

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28

Population: Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).

Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild Week 2	2 subjects	15 subjects
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild Week 4	3 subjects	21 subjects
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild Week 8	6 subjects	21 subjects
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild Week 12	8 subjects	24 subjects
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild Week 16	6 subjects	25 subjects
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild Week 20 (open-label)	8 subjects	23 subjects
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild Week 24 (open-label)	7 subjects	20 subjects
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild Week 28 (open-label)	4 subjects	23 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28

Population: Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).

Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With PGA of Clear or Almost Clear Week 2	1 subjects	4 subjects
Number of Subjects With PGA of Clear or Almost Clear Week 4	1 subjects	10 subjects
Number of Subjects With PGA of Clear or Almost Clear Week 8	2 subjects	12 subjects
Number of Subjects With PGA of Clear or Almost Clear Week 12	3 subjects	14 subjects
Number of Subjects With PGA of Clear or Almost Clear Week 20 (open-label)	5 subjects	11 subjects
Number of Subjects With PGA of Clear or Almost Clear Week 24 (open-label)	5 subjects	12 subjects
Number of Subjects With PGA of Clear or Almost Clear Week 28 (open-label)	2 subjects	12 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28

Population: Analysis was based on the ITT subject population and performed using NRI.

Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With PGA of Clear Week 2	0 subjects	1 subjects
Number of Subjects With PGA of Clear Week 4	0 subjects	2 subjects
Number of Subjects With PGA of Clear Week 8	0 subjects	3 subjects
Number of Subjects With PGA of Clear Week 12	0 subjects	6 subjects
Number of Subjects With PGA of Clear Week 16	1 subjects	6 subjects
Number of Subjects With PGA of Clear Week 20 (open-label)	2 subjects	8 subjects
Number of Subjects With PGA of Clear Week 24 (open-label)	3 subjects	7 subjects
Number of Subjects With PGA of Clear Week 28 (open-label)	2 subjects	7 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 16 and 28

Population: Analysis was based on the ITT subject population and performed using NRI.

Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 Week 16	5 subjects	21 subjects
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 Week 28 (open-label)	8 subjects	21 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 16 and 28

Population: Analysis was based on the ITT subject population and performed using NRI.

Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With PASI 75 Week 16	2 subjects	15 subjects
Number of Subjects With PASI 75 Week 28 (open-label)	4 subjects	11 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 16 and 28

Population: Analysis was based on the ITT subject population and performed using NRI.

Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With PASI 90 Week 16	0 subjects	10 subjects
Number of Subjects With PASI 90 Week 28 (open-label)	4 subjects	10 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 16 and 28

Population: Analysis was based on the ITT subject population and performed using NRI.

Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With PASI 100 Week 16	0 subjects	7 subjects
Number of Subjects With PASI 100 Week 28 (open-label)	1 subjects	8 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 8, 16, and 28

Population: Analysis was based on the ITT subject population and performed using LOCF.

The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Week 2	-3.43 units on a scale Standard Deviation 3.435	-4.35 units on a scale Standard Deviation 4.741
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Week 8	-3.09 units on a scale Standard Deviation 5.008	-4.08 units on a scale Standard Deviation 5.541
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Week 16	-4.22 units on a scale Standard Deviation 4.936	-4.78 units on a scale Standard Deviation 7.269
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Week 28 (open-label)	-4.74 units on a scale Standard Deviation 4.731	-5.18 units on a scale Standard Deviation 7.499

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 8, 16, and 28

Population: Analysis was based on the ITT subject population and performed using NRI.

Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects Achieving a DLQI of 0 Week 2	1 subjects	3 subjects
Number of Subjects Achieving a DLQI of 0 Week 8	1 subjects	3 subjects
Number of Subjects Achieving a DLQI of 0 Week 16	0 subjects	7 subjects
Number of Subjects Achieving a DLQI of 0 Week 28 (open-label)	1 subjects	6 subjects

SECONDARY outcome

Timeframe: Baseline and Weeks 16 and 28

Population: Analysis was based on the ITT subject population and performed using LOCF.

On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain Week 28 (open-label)	-16.25 mm on scale Standard Deviation 24.950	-16.59 mm on scale Standard Deviation 34.430
Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain Week 16	-12.45 mm on scale Standard Deviation 28.637	-17.49 mm on scale Standard Deviation 34.451

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, and 28

Population: Analysis was based on the ITT subject population and performed using LOCF.

WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 \[psoriasis having no effect\] to 10 \[psoriasis completely prevented subject from working\]), % overall work impairment (on a scale from 0 \[psoriasis having no effect\] to 10 \[psoriasis completely prevented subject from working\]), and % activity impairment (on a scale from 0 \[psoriasis having no effect on daily activities\] to 10 \[psoriasis completely prevented subject from doing daily activities\]).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Work Time Missed due to Psoriasis Week 16	7.72 units on a scale Standard Deviation 33.299	5.34 units on a scale Standard Deviation 20.250
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Work Time Missed due to Psoriasis Week 8	6.32 units on a scale Standard Deviation 24.953	4.70 units on a scale Standard Deviation 12.778
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Work Time Missed due to Psoriasis Week 28 (OL)	2.60 units on a scale Standard Deviation 26.628	3.16 units on a scale Standard Deviation 18.198
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Impairment While Working Week 8	0.71 units on a scale Standard Deviation 29.733	-8.21 units on a scale Standard Deviation 27.087
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Impairment While Working Week 16	-4.67 units on a scale Standard Deviation 20.656	-5.94 units on a scale Standard Deviation 27.103
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Impairment While Working Week 28 (OL)	-5.33 units on a scale Standard Deviation 20.999	-8.44 units on a scale Standard Deviation 31.429
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Overall Work Impairment Week 8	-0.48 units on a scale Standard Deviation 29.988	-8.97 units on a scale Standard Deviation 27.355
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Overall Work Impairment Week 16	-5.45 units on a scale Standard Deviation 22.432	-7.19 units on a scale Standard Deviation 26.556
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Overall Work Impairment Week 28 (OL)	-5.79 units on a scale Standard Deviation 20.996	-9.88 units on a scale Standard Deviation 31.045
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Activity Impairment Week 8	-9.09 units on a scale Standard Deviation 32.500	-11.02 units on a scale Standard Deviation 23.562
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Activity Impairment Week 16	-9.09 units on a scale Standard Deviation 22.234	-13.88 units on a scale Standard Deviation 27.600
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) % Activity Impairment Week 28 (OL)	-15.91 units on a scale Standard Deviation 27.196	-14.69 units on a scale Standard Deviation 32.539

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 8, 16, and 28

Population: Analysis was based on the ITT subject population and performed using LOCF.

The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) Week 2	-2.85 units on a scale Standard Deviation 4.332	-2.86 units on a scale Standard Deviation 4.449
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) Week 8	-2.43 units on a scale Standard Deviation 4.057	-1.80 units on a scale Standard Deviation 4.796
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) Week 16	-2.64 units on a scale Standard Deviation 6.637	-2.14 units on a scale Standard Deviation 4.659
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) Week 28 (open-label)	-3.32 units on a scale Standard Deviation 5.719	-2.65 units on a scale Standard Deviation 5.031

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 8, 16, and 28

Population: Analysis was based on the ITT subject population. Missing values were imputed as "extremely difficult."

Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score \> 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).

Outcome measures

Outcome measures
Measure	Placebo/Adalimumab n=23 Participants Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 Participants 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Number of Subjects With Difficulties According to PHQ-9 Very difficult - Week 2	2 subjects	3 subjects
Number of Subjects With Difficulties According to PHQ-9 Very difficult - Week 8	2 subjects	5 subjects
Number of Subjects With Difficulties According to PHQ-9 Extremely difficult - Week 8	9 subjects	11 subjects
Number of Subjects With Difficulties According to PHQ-9 Not difficult at all - Baseline	4 subjects	20 subjects
Number of Subjects With Difficulties According to PHQ-9 Somewhat difficult - Baseline	9 subjects	19 subjects
Number of Subjects With Difficulties According to PHQ-9 Very difficult - Baseline	3 subjects	5 subjects
Number of Subjects With Difficulties According to PHQ-9 Extremely difficult - Baseline	7 subjects	5 subjects
Number of Subjects With Difficulties According to PHQ-9 Not difficult at all - Week 2	5 subjects	21 subjects
Number of Subjects With Difficulties According to PHQ-9 Somewhat difficult - Week 2	9 subjects	16 subjects
Number of Subjects With Difficulties According to PHQ-9 Extremely difficult - Week 2	7 subjects	9 subjects
Number of Subjects With Difficulties According to PHQ-9 Not difficult at all - Week 8	4 subjects	18 subjects
Number of Subjects With Difficulties According to PHQ-9 Somewhat difficult - Week 8	8 subjects	15 subjects
Number of Subjects With Difficulties According to PHQ-9 Not difficult at all - Week 16	3 subjects	19 subjects
Number of Subjects With Difficulties According to PHQ-9 Somewhat difficult - Week 16	8 subjects	10 subjects
Number of Subjects With Difficulties According to PHQ-9 Very difficult - Week 16	2 subjects	1 subjects
Number of Subjects With Difficulties According to PHQ-9 Extremely difficult - Week 16	10 subjects	19 subjects
Number of Subjects With Difficulties According to PHQ-9 Not difficult at all - Week 28 (OL)	4 subjects	21 subjects
Number of Subjects With Difficulties According to PHQ-9 Somewhat difficult - Week 28 (OL)	5 subjects	6 subjects
Number of Subjects With Difficulties According to PHQ-9 Very difficult - Week 28 (OL)	2 subjects	1 subjects
Number of Subjects With Difficulties According to PHQ-9 Extremely difficult - Week 28 (OL)	12 subjects	21 subjects

Adverse Events

Placebo/Adalimumab

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Adalimumab

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo/Adalimumab n=23 participants at risk Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 participants at risk 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Cardiac disorders Acute myocardial infarction	0.00% 0/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	2.0% 1/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	2.0% 1/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	4.3% 1/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	0.00% 0/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Reproductive system and breast disorders Breast mass	4.3% 1/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	0.00% 0/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.

Other adverse events

Additional Information

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Phone: 1-800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott 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. Abbott requests that no presentation/publication 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 Abbott needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo/Adalimumab n=23 participants at risk Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Adalimumab n=49 participants at risk 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Gastrointestinal disorders Diarrhoea	13.0% 3/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	2.0% 1/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	0.00% 0/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Gastrointestinal disorders Nausea	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	0.00% 0/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Gastrointestinal disorders Toothache	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	0.00% 0/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
General disorders Injection site reaction	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	4.1% 2/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
General disorders Oedema peripheral	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	4.1% 2/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Infections and infestations Bronchitis	13.0% 3/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	2.0% 1/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Infections and infestations Gastroenteritis	4.3% 1/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	6.1% 3/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Infections and infestations Nasopharyngitis	13.0% 3/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	26.5% 13/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Infections and infestations Pharyngitis	4.3% 1/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	6.1% 3/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Infections and infestations Sinusitis	4.3% 1/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	6.1% 3/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Infections and infestations Upper respiratory tract infection	0.00% 0/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	8.2% 4/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Infections and infestations Urinary tract infection	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	0.00% 0/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	6.1% 3/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 1/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	6.1% 3/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Nervous system disorders Headache	4.3% 1/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	14.3% 7/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Psychiatric disorders Insomnia	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	0.00% 0/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	8.2% 4/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Skin and subcutaneous tissue disorders Pruritus	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	2.0% 1/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Skin and subcutaneous tissue disorders Psoriasis	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	4.1% 2/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Skin and subcutaneous tissue disorders Urticaria	8.7% 2/23 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.	6.1% 3/49 • All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration. For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.