Trial Outcomes & Findings for Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis (NCT NCT01646073)

Last Updated: 2015-01-19

Results Overview

The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

425 participants

Primary outcome timeframe

Week 12

Results posted on

2015-01-19

Participant Flow

Participants were randomized at Week 0 (Day 1) in a 4:1 ratio to receive either adalimumab every other week (eow) or matching placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B	Adalimumab Eow Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
Period A (12 Weeks) STARTED	87	338
Period A (12 Weeks) COMPLETED	85	333
Period A (12 Weeks) NOT COMPLETED	2	5
Period B (12 Weeks) STARTED	85	333
Period B (12 Weeks) COMPLETED	84	320
Period B (12 Weeks) NOT COMPLETED	1	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B	Adalimumab Eow Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
Period A (12 Weeks) Adverse Event	0	2
Period A (12 Weeks) Withdrawal by Subject	1	1
Period A (12 Weeks) Lack of Efficacy	1	0
Period A (12 Weeks) Protocol Violation	0	1
Period A (12 Weeks) Other	0	1
Period B (12 Weeks) Adverse Event	0	7
Period B (12 Weeks) Withdrawal by Subject	1	5
Period B (12 Weeks) Lost to Follow-up	0	1

Baseline Characteristics

Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=87 Participants Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B	Adalimumab Eow n=338 Participants Participants were started on adalimumab 40 mg every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B	Total n=425 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 12.45 • n=5 Participants	43.1 years STANDARD_DEVIATION 11.91 • n=7 Participants	43.2 years STANDARD_DEVIATION 12.01 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	84 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	254 Participants n=7 Participants	312 Participants n=5 Participants
Duration of Psoriasis	15.79 years STANDARD_DEVIATION 10.309 • n=5 Participants	14.84 years STANDARD_DEVIATION 10.114 • n=7 Participants	15.03 years STANDARD_DEVIATION 10.149 • n=5 Participants
Body Surface Area with Psoriasis	39.30 Percentage of Body Surface Area STANDARD_DEVIATION 22.502 • n=5 Participants	42.62 Percentage of Body Surface Area STANDARD_DEVIATION 21.748 • n=7 Participants	41.94 Percentage of Body Surface Area STANDARD_DEVIATION 21.918 • n=5 Participants
Psoriasis Area and Severity Index	25.60 units on a scale STANDARD_DEVIATION 10.978 • n=5 Participants	28.19 units on a scale STANDARD_DEVIATION 11.999 • n=7 Participants	27.66 units on a scale STANDARD_DEVIATION 11.831 • n=5 Participants
Physician's Global Assessment of Psoriasis Clear	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Physician's Global Assessment of Psoriasis Minimal	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Physician's Global Assessment of Psoriasis Mild	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Physician's Global Assessment of Psoriasis Moderate	57 participants n=5 Participants	214 participants n=7 Participants	271 participants n=5 Participants
Physician's Global Assessment of Psoriasis Marked	28 participants n=5 Participants	110 participants n=7 Participants	138 participants n=5 Participants
Physician's Global Assessment of Psoriasis Severe	2 participants n=5 Participants	14 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent to Treat Population A (ITT\_A): all participants who were randomized at Week 0 (Baseline); Non-responder imputation (NRI): any participant who had a missing value at a specific visit as non-responder for that visit.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=338 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12	11.5 percentage of participants	77.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 3 and 7

Population: ITT\_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=338 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A] Week 3	0 percentage of participants	9.8 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A] Week 7	2.3 percentage of participants	45.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16, 19, and 24

Population: Intent to Treat Population B (ITT\_B): all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=333 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B] Week 16	51.8 percentage of participants	87.4 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B] Week 19	80.0 percentage of participants	87.1 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B] Week 24	90.6 percentage of participants	87.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT\_A: all participants that were randomized in Week 0 (Baseline); Last observation carried forward (LOCF): used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.

Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=336 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]	-20.44 Percent change Standard Error 3.049	-82.20 Percent change Standard Error 1.548

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT\_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.

PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=333 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]	-91.39 percent change Standard Deviation 14.423	-91.07 percent change Standard Deviation 19.028

SECONDARY outcome

Timeframe: Weeks 3, 7, and 12

Population: ITT\_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=338 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 50 [Week 3]	1.1 percentage of participants	31.7 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 90 [Week 3]	0 percentage of participants	2.7 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 100 [Week 3]	0 percentage of participants	0 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 50 [Week 7]	11.5 percentage of participants	77.2 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 90 [Week 7]	0 percentage of participants	23.4 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 100 [Week 7]	0 percentage of participants	3.8 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 50 [Week 12]	23.0 percentage of participants	88.8 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 90 [Week 12]	3.4 percentage of participants	55.6 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] PASI 100 [Week 12]	1.1 percentage of participants	13.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16, 19, and 24

Population: ITT\_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=333 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 50 [Week 16]	71.8 percentage of participants	93.4 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 90 [Week 16]	28.2 percentage of participants	70.0 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 100 [Week 16]	8.2 percentage of participants	20.4 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 50 [Week 19]	92.9 percentage of participants	94.3 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 90 [Week 19]	56.5 percentage of participants	74.2 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 100 [Week 19]	22.4 percentage of participants	28.8 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 50 [Week 24]	94.1 percentage of participants	91.9 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 90 [Week 24]	75.3 percentage of participants	76.3 percentage of participants
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] PASI 100 [Week 24]	34.1 percentage of participants	35.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 7, and 12

Population: ITT\_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=338 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A] Baseline	0 percentage of participants	0 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A] Week 3	0 percentage of participants	0.6 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A] Week 7	0 percentage of participants	12.1 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A] Week 12	1.1 percentage of participants	25.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16, 19, and 24

Population: ITT\_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=333 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B] Week 16	14.1 percentage of participants	39.3 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B] Week 19	29.4 percentage of participants	42.9 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B] Week 24	41.2 percentage of participants	45.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 3, 7, and 12

Population: ITT\_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=338 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A] Baseline	0 percentage of participants	0 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A] Week 3	0 percentage of participants	20.1 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A] Week 7	4.6 percentage of participants	57.4 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A] Week 12	14.9 percentage of participants	80.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 16, 19, and 24

Population: ITT\_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=333 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B] Week 16	61.2 percentage of participants	85.6 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B] Week 19	84.7 percentage of participants	84.4 percentage of participants
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B] Week 24	89.4 percentage of participants	83.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 3, and Week 12

Population: ITT\_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=338 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A] Baseline	0 percentage of participants	0.9 percentage of participants
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A] Week 3	1.1 percentage of participants	3.3 percentage of participants
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A] Week 12	0 percentage of participants	13.0 percentage of participants

SECONDARY outcome

Timeframe: Week 16 and Week 24

Population: ITT\_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=333 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B] Week 16	12.9 percentage of participants	15.0 percentage of participants
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B] Week 24	23.5 percentage of participants	19.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 3, and Week 12

Population: ITT\_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=338 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A] Baseline	1.1 percentage of participants	2.4 percentage of participants
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A] Week 3	3.4 percentage of participants	9.2 percentage of participants
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A] Week 12	10.3 percentage of participants	28.4 percentage of participants

SECONDARY outcome

Timeframe: Week 16 and Week 24

Population: ITT\_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=333 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B] Week 16	27.1 percentage of participants	30.0 percentage of participants
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B] Week 24	44.7 percentage of participants	37.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT\_A: all participants that were randomized in Week 0 (Baseline); LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.

Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=335 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A] Physical Component Summary	1.13 scores on a scale Standard Error 0.665	4.22 scores on a scale Standard Error 0.332
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A] Mental Component Summary	1.91 scores on a scale Standard Error 0.913	7.02 scores on a scale Standard Error 0.456

SECONDARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Participants were started on placebo in Period A (Week 0 to Week 12).	Adalimumab Eow n=332 Participants Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B] Physical Component Summary	4.20 scores on a scale Standard Deviation 8.351	4.73 scores on a scale Standard Deviation 8.260
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B] Mental Component Summary	5.74 scores on a scale Standard Deviation 12.661	7.76 scores on a scale Standard Deviation 11.652

Adverse Events

Double-blind Placebo

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Double-blind Adalimumab Eow

Serious events: 4 serious events

Other events: 64 other events

Deaths: 0 deaths

Any Adalimumab

Serious events: 15 serious events

Other events: 137 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Double-blind Placebo n=87 participants at risk Participants were started on placebo in Period A (Week 0 to Week 12)	Double-blind Adalimumab Eow n=338 participants at risk Participants were started on adalimumab eow in Period A (Week 0 to Week 12)	Any Adalimumab n=423 participants at risk Participants that received at least one dose of adalimumab during Period A or Period B
Infections and infestations NASOPHARYNGITIS	5.7% 5/87 • Baseline up to 70 days after last dose (week 24).	3.8% 13/338 • Baseline up to 70 days after last dose (week 24).	9.0% 38/423 • Baseline up to 70 days after last dose (week 24).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	6.9% 6/87 • Baseline up to 70 days after last dose (week 24).	10.1% 34/338 • Baseline up to 70 days after last dose (week 24).	16.1% 68/423 • Baseline up to 70 days after last dose (week 24).
Respiratory, thoracic and mediastinal disorders COUGH	4.6% 4/87 • Baseline up to 70 days after last dose (week 24).	3.3% 11/338 • Baseline up to 70 days after last dose (week 24).	6.4% 27/423 • Baseline up to 70 days after last dose (week 24).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	1.1% 1/87 • Baseline up to 70 days after last dose (week 24).	4.1% 14/338 • Baseline up to 70 days after last dose (week 24).	7.1% 30/423 • Baseline up to 70 days after last dose (week 24).

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

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

Measure	Double-blind Placebo n=87 participants at risk Participants were started on placebo in Period A (Week 0 to Week 12)	Double-blind Adalimumab Eow n=338 participants at risk Participants were started on adalimumab eow in Period A (Week 0 to Week 12)	Any Adalimumab n=423 participants at risk Participants that received at least one dose of adalimumab during Period A or Period B
Cardiac disorders ARRHYTHMIA	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.30% 1/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Cardiac disorders MYOCARDITIS	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Congenital, familial and genetic disorders PYLORIC STENOSIS	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Eye disorders RETINAL DETACHMENT	1.1% 1/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.00% 0/423 • Baseline up to 70 days after last dose (week 24).
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Infections and infestations LUNG INFECTION	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.47% 2/423 • Baseline up to 70 days after last dose (week 24).
Infections and infestations LYMPH NODE TUBERCULOSIS	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Infections and infestations PNEUMONIA	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.47% 2/423 • Baseline up to 70 days after last dose (week 24).
Infections and infestations TUBERCULOSIS	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.30% 1/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Injury, poisoning and procedural complications SKIN INJURY	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Injury, poisoning and procedural complications TIBIA FRACTURE	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Musculoskeletal and connective tissue disorders PSORIATIC ARTHROPATHY	1.1% 1/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.00% 0/423 • Baseline up to 70 days after last dose (week 24).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.30% 1/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Renal and urinary disorders HAEMATURIA	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.30% 1/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Respiratory, thoracic and mediastinal disorders PLEURAL FIBROSIS	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Skin and subcutaneous tissue disorders ERYTHEMA MULTIFORME	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).
Skin and subcutaneous tissue disorders PSORIASIS	1.1% 1/87 • Baseline up to 70 days after last dose (week 24).	0.00% 0/338 • Baseline up to 70 days after last dose (week 24).	0.00% 0/423 • Baseline up to 70 days after last dose (week 24).
Vascular disorders HYPERTENSION	0.00% 0/87 • Baseline up to 70 days after last dose (week 24).	0.30% 1/338 • Baseline up to 70 days after last dose (week 24).	0.24% 1/423 • Baseline up to 70 days after last dose (week 24).