Trial Outcomes & Findings for Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life (NCT NCT01169987)

Last Updated: 2016-07-13

Results Overview

Percentage of participants with an adalimumab treatment status of continuous, early intermittent, late intermittent, permanently discontinued, or other. Continuous=initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study. Early intermittent=initiated on adalimumab 40 mg, treated every other week (EOW) for \< 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study. Late intermittent=initiated on adalimumab 40 mg, treated EOW for ≥ 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study. Permanently discontinued=received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently. Other=participants not belonging to any of the previous groups.

Recruitment status

COMPLETED

Target enrollment

191 participants

Primary outcome timeframe

Month 24/ Early Termination visit

Results posted on

2016-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Treated With Adalimumab Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
Overall Study STARTED	191
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Treated With Adalimumab Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	24
Overall Study Other	4

Baseline Characteristics

Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Treated With Adalimumab n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
Age, Continuous	44.9 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	133 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 24/ Early Termination visit

Population: Intention to Treat (ITT) set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
Adalimumab Treatment Retention Status Continuous	44.0 percentage of participants	—	—	—	—	—
Adalimumab Treatment Retention Status Early intermittent	2.6 percentage of participants	—	—	—	—	—
Adalimumab Treatment Retention Status Late intermittent	8.4 percentage of participants	—	—	—	—	—
Adalimumab Treatment Retention Status Permanently discontinued	38.7 percentage of participants	—	—	—	—	—
Adalimumab Treatment Retention Status Other	6.3 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)

Population: ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at Baseline and given time point.

Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed with PASI for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100\*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months; n=76, 3, 16, 65, 9, 169	74.15 percentage improvement Standard Deviation 27.06	95.69 percentage improvement Standard Deviation 7.46	82.25 percentage improvement Standard Deviation 13.78	49.96 percentage improvement Standard Deviation 43.34	56.70 percentage improvement Standard Deviation 24.05	65.06 percentage improvement Standard Deviation 35.52
Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months; n=69, 2, 13, 54, 8, 146	89.28 percentage improvement Standard Deviation 13.73	33.00 percentage improvement Standard Deviation 65.69	67.55 percentage improvement Standard Deviation 26.79	52.35 percentage improvement Standard Deviation 62.07	77.39 percentage improvement Standard Deviation 12.15	72.26 percentage improvement Standard Deviation 43.62
Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months; n=77, 5, 15, 47, 3, 147	88.52 percentage improvement Standard Deviation 17.06	42.46 percentage improvement Standard Deviation 45.00	69.82 percentage improvement Standard Deviation 28.62	75.93 percentage improvement Standard Deviation 26.26	36.41 percentage improvement Standard Deviation 58.03	79.96 percentage improvement Standard Deviation 26.28
Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation; n=80, 5, 16, 72, 11, 184	88.27 percentage improvement Standard Deviation 17.06	42.46 percentage improvement Standard Deviation 45.00	69.99 percentage improvement Standard Deviation 27.66	67.63 percentage improvement Standard Deviation 32.36	57.46 percentage improvement Standard Deviation 38.94	75.52 percentage improvement Standard Deviation 29.48

SECONDARY outcome

Percentage of participants who achieved ≥ 50%, 75%, 90% or 100% reduction (improvement) from Baseline in PASI score (PASI50, PASI75, PASI90, PASI100). Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100\*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based on the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: ≥ 50%; n=76, 3, 16, 65, 9, 169	85.5 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	64.6 percentage of participants	55.6 percentage of participants	77.5 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: ≥ 75%; n=76, 3, 16, 65, 9, 169	64.5 percentage of participants	100.0 percentage of participants	75.0 percentage of participants	35.4 percentage of participants	33.3 percentage of participants	53.3 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: ≥ 90%; n=76, 3, 16, 65, 9, 169	26.3 percentage of participants	66.7 percentage of participants	31.3 percentage of participants	15.4 percentage of participants	0.0 percentage of participants	21.9 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: = 100%; n=76, 3, 16, 65, 9, 169	5.3 percentage of participants	66.7 percentage of participants	12.5 percentage of participants	7.7 percentage of participants	0.0 percentage of participants	7.7 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: ≥ 50%; n=69, 2, 13, 54, 8, 146	97.1 percentage of participants	50.0 percentage of participants	76.9 percentage of participants	68.5 percentage of participants	100.0 percentage of participants	84.2 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: ≥ 75%; n=69, 2, 13, 54, 8, 146	85.5 percentage of participants	50.0 percentage of participants	30.8 percentage of participants	40.7 percentage of participants	62.5 percentage of participants	62.3 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: ≥ 90%; n=69, 2, 13, 54, 8, 146	63.8 percentage of participants	0.0 percentage of participants	30.8 percentage of participants	24.1 percentage of participants	12.5 percentage of participants	42.5 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: = 100%; n=69, 2, 13, 54, 8, 146	31.9 percentage of participants	0.0 percentage of participants	23.1 percentage of participants	13.0 percentage of participants	0.0 percentage of participants	21.9 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: ≥ 50%; n=77, 5, 15, 47, 3, 147	94.8 percentage of participants	60.0 percentage of participants	73.3 percentage of participants	87.2 percentage of participants	66.7 percentage of participants	88.4 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: ≥ 75%; n=77, 5, 15, 47, 3, 147	84.4 percentage of participants	40.0 percentage of participants	53.3 percentage of participants	63.8 percentage of participants	33.3 percentage of participants	72.1 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: ≥ 90%; n=77, 5, 15, 47, 3, 147	66.2 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	34.0 percentage of participants	0.0 percentage of participants	49.0 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: = 100%; n=77, 5, 15, 47, 3, 147	39.0 percentage of participants	0.0 percentage of participants	13.3 percentage of participants	8.5 percentage of participants	0.0 percentage of participants	24.5 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: ≥ 50%; n=80, 5, 16, 72, 11, 184	95.0 percentage of participants	60.0 percentage of participants	75.0 percentage of participants	80.6 percentage of participants	72.7 percentage of participants	85.3 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: ≥ 75%; n=80, 5, 16, 72, 11, 184	83.8 percentage of participants	40.0 percentage of participants	50.0 percentage of participants	52.8 percentage of participants	45.5 percentage of participants	65.2 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: ≥ 90%; n=80, 5, 16, 72, 11, 184	65.0 percentage of participants	0.0 percentage of participants	31.3 percentage of participants	25.0 percentage of participants	9.1 percentage of participants	41.3 percentage of participants
PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: = 100%; n=80, 5, 16, 72, 11, 184	37.5 percentage of participants	0.0 percentage of participants	12.5 percentage of participants	6.9 percentage of participants	0.0 percentage of participants	20.1 percentage of participants

SECONDARY outcome

Clinical psoriasis evaluations by the investigator of percentage of affected BSA. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline; n=84, 5, 16, 71, 11, 187	21.92 percentage of affected BSA Standard Deviation 15.02	24.80 percentage of affected BSA Standard Deviation 23.19	18.25 percentage of affected BSA Standard Deviation 10.46	22.02 percentage of affected BSA Standard Deviation 15.54	23.95 percentage of affected BSA Standard Deviation 18.25	21.84 percentage of affected BSA Standard Deviation 15.21
Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 3 months; n=79, 3, 15, 66, 10, 173	7.67 percentage of affected BSA Standard Deviation 9.33	1.67 percentage of affected BSA Standard Deviation 2.89	4.34 percentage of affected BSA Standard Deviation 4.75	11.33 percentage of affected BSA Standard Deviation 13.57	15.16 percentage of affected BSA Standard Deviation 20.73	9.11 percentage of affected BSA Standard Deviation 11.89
Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 12 months; n=73, 1, 12, 54, 9, 149	2.83 percentage of affected BSA Standard Deviation 3.56	31.00 percentage of affected BSA Standard Deviation NA Only 1 participant was assessed at this time point.	2.25 percentage of affected BSA Standard Deviation 2.14	9.09 percentage of affected BSA Standard Deviation 13.44	4.44 percentage of affected BSA Standard Deviation 4.93	5.34 percentage of affected BSA Standard Deviation 9.27
Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 24 months; n=78, 5, 15, 45, 1, 144	1.71 percentage of affected BSA Standard Deviation 2.39	9.80 percentage of affected BSA Standard Deviation 6.61	4.88 percentage of affected BSA Standard Deviation 5.48	4.82 percentage of affected BSA Standard Deviation 6.73	1.00 percentage of affected BSA Standard Deviation NA Only 1 participant was assessed at this time point.	3.29 percentage of affected BSA Standard Deviation 5.01
Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status Last Observation; n=84, 5, 16, 74, 12, 191	2.03 percentage of affected BSA Standard Deviation 3.06	9.80 percentage of affected BSA Standard Deviation 6.61	4.89 percentage of affected BSA Standard Deviation 5.29	6.42 percentage of affected BSA Standard Deviation 7.50	5.51 percentage of affected BSA Standard Deviation 5.27	4.39 percentage of affected BSA Standard Deviation 5.95

SECONDARY outcome

The PGA was an evaluation of a participant's psoriasis on a 6-point scale: clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5), which were then regrouped into the 2 categories "Clear/Minimal" or "Mild/Moderate/Severe/Very Severe (M/Md/S/VS)," and presented as the percentage of participants in each. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline: Clear/Minimal; n=82,5,16,73,12,188	1.2 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.5 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline: M/Md/S/VS; n=82,5,16,73,12,188	98.8 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	99.5 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: Clear/Minimal; n=78,3,16,66,10,173	59.0 percentage of participants	66.7 percentage of participants	43.8 percentage of participants	28.8 percentage of participants	40.0 percentage of participants	45.1 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: M/Md/S/VS; n=78,3,16,66,10,173	41.0 percentage of participants	33.3 percentage of participants	56.3 percentage of participants	71.2 percentage of participants	60.0 percentage of participants	54.9 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: Clear/Minimal; n=73,1,12,54,9,149	78.1 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	35.2 percentage of participants	22.2 percentage of participants	55.0 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: M/Md/S/VS; n=73,1,12,54,9,149	21.9 percentage of participants	100.0 percentage of participants	66.7 percentage of participants	64.8 percentage of participants	77.8 percentage of participants	45.0 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: Clear/Minimal; n=81,5,15,47,1,149	77.8 percentage of participants	0.0 percentage of participants	46.7 percentage of participants	36.2 percentage of participants	0.0 percentage of participants	58.4 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: M/Md/S/VS; n=81,5,15,47,1,149	22.2 percentage of participants	100.0 percentage of participants	53.3 percentage of participants	63.8 percentage of participants	100.0 percentage of participants	41.6 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Last obs.: Clear/Minimal; n=84,5,16,74,12,191	77.4 percentage of participants	0.0 percentage of participants	43.8 percentage of participants	32.4 percentage of participants	16.7 percentage of participants	51.3 percentage of participants
Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Last obs.: M/Md/S/VS; n=84,5,16,74,12,191	22.6 percentage of participants	100.0 percentage of participants	56.3 percentage of participants	67.6 percentage of participants	83.3 percentage of participants	48.7 percentage of participants

SECONDARY outcome

DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (3), a lot (2), a little (1), or not at all (0). The total DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows, based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline; n=80, 5, 15, 70, 12, 182	12.48 units on a scale Standard Deviation 7.18	13.80 units on a scale Standard Deviation 6.72	12.27 units on a scale Standard Deviation 6.13	12.97 units on a scale Standard Deviation 7.02	12.08 units on a scale Standard Deviation 7.35	12.66 units on a scale Standard Deviation 6.97
Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 3 months; n=73, 3, 15, 61, 8, 160	3.41 units on a scale Standard Deviation 4.69	0.33 units on a scale Standard Deviation 0.58	3.53 units on a scale Standard Deviation 5.80	5.38 units on a scale Standard Deviation 5.89	7.13 units on a scale Standard Deviation 9.51	4.30 units on a scale Standard Deviation 5.62
Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 12 months; n=68, 1, 12, 47, 6, 134	1.51 units on a scale Standard Deviation 2.33	18.00 units on a scale Standard Deviation NA Only 1 participant was assessed at this time point.	3.42 units on a scale Standard Deviation 3.03	6.94 units on a scale Standard Deviation 6.54	3.33 units on a scale Standard Deviation 6.31	3.79 units on a scale Standard Deviation 5.24
Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 24 months; n=71, 5, 14, 44, 3, 137	1.44 units on a scale Standard Deviation 3.21	7.40 units on a scale Standard Deviation 3.51	5.50 units on a scale Standard Deviation 5.17	4.32 units on a scale Standard Deviation 5.42	10.00 units on a scale Standard Deviation 9.00	3.18 units on a scale Standard Deviation 4.79
Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status Last Observation; n=82, 5, 15, 74, 12, 188	1.56 units on a scale Standard Deviation 3.19	7.40 units on a scale Standard Deviation 3.51	5.13 units on a scale Standard Deviation 5.18	6.08 units on a scale Standard Deviation 6.74	8.25 units on a scale Standard Deviation 8.40	4.21 units on a scale Standard Deviation 5.87

SECONDARY outcome

DLQI is a participant-reported outcome consisting of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect. Follow-up visits were classified into time windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline: score 0-1; n=80,5,15,70,12,182	5.0 percentage of participants	0.0 percentage of participants	6.7 percentage of participants	2.9 percentage of participants	16.7 percentage of participants	4.9 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline: score 2-5; n=80,5,15,70,12,182	12.5 percentage of participants	0.0 percentage of participants	6.7 percentage of participants	15.7 percentage of participants	0.0 percentage of participants	12.1 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline: score 6-10; n=80,5,15,70,12,182	27.5 percentage of participants	40.0 percentage of participants	20.0 percentage of participants	15.7 percentage of participants	25.0 percentage of participants	22.5 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline: score 11-20; n=80,5,15,70,12,182	41.3 percentage of participants	40.0 percentage of participants	46.7 percentage of participants	51.4 percentage of participants	50.0 percentage of participants	46.2 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline: score 21-30; n=80,5,15,70,12,182	13.8 percentage of participants	20.0 percentage of participants	20.0 percentage of participants	14.3 percentage of participants	8.3 percentage of participants	14.3 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: score 0-1; n=73,3,15,61,8,160	50.7 percentage of participants	100.0 percentage of participants	46.7 percentage of participants	27.9 percentage of participants	50.0 percentage of participants	42.5 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: score 2-5; n=73,3,15,61,8,160	26.0 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	34.4 percentage of participants	12.5 percentage of participants	28.8 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: score 6-10; n=73,3,15,61,8,160	16.4 percentage of participants	0.0 percentage of participants	6.7 percentage of participants	19.7 percentage of participants	12.5 percentage of participants	16.3 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: score 11-20; n=73,3,15,61,8,160	5.5 percentage of participants	0.0 percentage of participants	6.7 percentage of participants	16.4 percentage of participants	12.5 percentage of participants	10.0 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 3 months: score 21-30; n=73,3,15,61,8,160	1.4 percentage of participants	0.0 percentage of participants	6.7 percentage of participants	1.6 percentage of participants	12.5 percentage of participants	2.5 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: score 0-1; n=68,1,12,47,6,134	69.1 percentage of participants	0.0 percentage of participants	41.7 percentage of participants	31.9 percentage of participants	66.7 percentage of participants	53.0 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: score 2-5; n=68,1,12,47,6,134	26.5 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	17.0 percentage of participants	16.7 percentage of participants	23.1 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: score 6-10; n=68,1,12,47,6,134	2.9 percentage of participants	0.0 percentage of participants	25.0 percentage of participants	19.1 percentage of participants	0.0 percentage of participants	10.4 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: score 11-20; n=68,1,12,47,6,134	1.5 percentage of participants	100.0 percentage of participants	0.0 percentage of participants	27.7 percentage of participants	16.7 percentage of participants	11.9 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 12 months: score 21-30; n=68,1,12,47,6,134	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	4.3 percentage of participants	0.0 percentage of participants	1.5 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: score 0-1; n=71,5,14,44,3,137	76.1 percentage of participants	0.0 percentage of participants	35.7 percentage of participants	47.7 percentage of participants	33.3 percentage of participants	59.1 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: score 2-5; n=71,5,14,44,3,137	16.9 percentage of participants	40.0 percentage of participants	21.4 percentage of participants	15.9 percentage of participants	0.0 percentage of participants	17.5 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: score 6-10; n=71,5,14,44,3,137	4.2 percentage of participants	40.0 percentage of participants	21.4 percentage of participants	27.3 percentage of participants	33.3 percentage of participants	15.3 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: score 11-20; n=71,5,14,44,3,137	2.8 percentage of participants	20.0 percentage of participants	21.4 percentage of participants	6.8 percentage of participants	33.3 percentage of participants	7.3 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status TW 24 months: score 21-30; n=71,5,14,44,3,137	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	2.3 percentage of participants	0.0 percentage of participants	0.7 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: score 0-1; n=82,5,15,74,12,188	73.2 percentage of participants	0.0 percentage of participants	40.0 percentage of participants	37.8 percentage of participants	41.7 percentage of participants	52.7 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: score 2-5; n=82,5,15,74,12,188	18.3 percentage of participants	40.0 percentage of participants	20.0 percentage of participants	14.9 percentage of participants	0.0 percentage of participants	16.5 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: score 6-10; n=82,5,15,74,12,188	6.1 percentage of participants	40.0 percentage of participants	20.0 percentage of participants	27.0 percentage of participants	25.0 percentage of participants	17.6 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: score 11-20; n=82,5,15,74,12,188	2.4 percentage of participants	20.0 percentage of participants	20.0 percentage of participants	16.2 percentage of participants	25.0 percentage of participants	11.2 percentage of participants
DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation: score 21-30; n=82,5,15,74,12,188	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	4.1 percentage of participants	8.3 percentage of participants	2.1 percentage of participants

SECONDARY outcome

Absenteeism, presented as the mean percentage of work time missed due to psoriasis (as reported on the WPAI), and calculated as: 100\*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline; n=48, 4, 9, 35, 10, 106	3.05 percentage of work time missed Standard Deviation 14.92	25.00 percentage of work time missed Standard Deviation 50.00	0.00 percentage of work time missed Standard Deviation 0.00	2.92 percentage of work time missed Standard Deviation 16.90	1.00 percentage of work time missed Standard Deviation 2.27	3.38 percentage of work time missed Standard Deviation 16.83
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 3 months; n=43, 2, 7, 31, 6, 89	0.21 percentage of work time missed Standard Deviation 1.39	0.00 percentage of work time missed Standard Deviation 0.00	0.00 percentage of work time missed Standard Deviation 0.00	0.81 percentage of work time missed Standard Deviation 4.49	0.86 percentage of work time missed Standard Deviation 2.11	0.44 percentage of work time missed Standard Deviation 2.85
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 12 months; n=39, 1, 5, 26, 3, 74	0.00 percentage of work time missed Standard Deviation 0.00	0.00 percentage of work time missed Standard Deviation NA Only 1 participant had an assessment at this time point.	0.00 percentage of work time missed Standard Deviation 0.00	0.00 percentage of work time missed Standard Deviation 0.00	17.78 percentage of work time missed Standard Deviation 30.79	0.72 percentage of work time missed Standard Deviation 6.20
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 24 months; n=41, 4, 11, 22, 0, 78	0.00 percentage of work time missed Standard Deviation 0.00	0.00 percentage of work time missed Standard Deviation 0.00	0.00 percentage of work time missed Standard Deviation 0.00	2.27 percentage of work time missed Standard Deviation 10.66	NA percentage of work time missed Standard Deviation NA No participants had an assessment at this time point.	0.64 percentage of work time missed Standard Deviation 5.66
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation; n=60, 4, 11, 47, 11, 133	0.00 percentage of work time missed Standard Deviation 0.00	0.00 percentage of work time missed Standard Deviation 0.00	0.00 percentage of work time missed Standard Deviation 0.00	2.66 percentage of work time missed Standard Deviation 10.73	6.62 percentage of work time missed Standard Deviation 16.10	1.49 percentage of work time missed Standard Deviation 7.98

SECONDARY outcome

Population: ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.

Presenteeism (the extent to which psoriasis decreased productivity) is presented as the mean percentage of impairment while working due to psoriasis, and calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline; n=52, 3, 9, 37, 10, 111	22.50 percentage of impairment while working Standard Deviation 25.81	0.00 percentage of impairment while working Standard Deviation 0.00	11.11 percentage of impairment while working Standard Deviation 11.67	18.51 percentage of impairment while working Standard Deviation 19.82	30.00 percentage of impairment while working Standard Deviation 19.44	20.32 percentage of impairment while working Standard Deviation 22.55
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 3 months; n=46, 2, 8, 34, 6, 96	6.74 percentage of impairment while working Standard Deviation 18.26	0.00 percentage of impairment while working Standard Deviation 0.00	0.00 percentage of impairment while working Standard Deviation 0.00	6.18 percentage of impairment while working Standard Deviation 13.71	28.33 percentage of impairment while working Standard Deviation 38.17	7.19 percentage of impairment while working Standard Deviation 18.28
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 12 months; n=45, 1, 6, 27, 3, 82	4.22 percentage of impairment while working Standard Deviation 12.34	60.00 percentage of impairment while working Standard Deviation NA Only 1 participant had an assessment at this time point.	5.00 percentage of impairment while working Standard Deviation 8.37	9.26 percentage of impairment while working Standard Deviation 17.30	10.00 percentage of impairment while working Standard Deviation 17.32	6.83 percentage of impairment while working Standard Deviation 15.22
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 24 months; n=46, 4, 11, 24, 0, 85	2.61 percentage of impairment while working Standard Deviation 8.01	12.50 percentage of impairment while working Standard Deviation 25.00	16.36 percentage of impairment while working Standard Deviation 21.57	5.42 percentage of impairment while working Standard Deviation 10.21	NA percentage of impairment while working Standard Deviation NA No participants had an assessment at this time point.	5.65 percentage of impairment while working Standard Deviation 12.77
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation; n=60, 4, 11, 49, 11, 135	3.33 percentage of impairment while working Standard Deviation 8.77	12.50 percentage of impairment while working Standard Deviation 25.00	16.36 percentage of impairment while working Standard Deviation 21.57	9.08 percentage of impairment while working Standard Deviation 19.03	20.91 percentage of impairment while working Standard Deviation 27.37	8.19 percentage of impairment while working Standard Deviation 17.27

SECONDARY outcome

Population: ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any data follow-up were available; n=number of participants with an assessment at given time point.

The mean percentage of TWPI due to psoriasis (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which psoriasis decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to psoriasis + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation; n=60, 4, 11, 47, 11, 133	3.83 percentage of TWPI Standard Deviation 10.10	12.50 percentage of TWPI Standard Deviation 25.00	16.36 percentage of TWPI Standard Deviation 21.57	9.95 percentage of TWPI Standard Deviation 19.14	26.58 percentage of TWPI Standard Deviation 28.68	9.17 percentage of TWPI Standard Deviation 18.11
WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline; n=47, 3, 9, 34, 10, 103	21.29 percentage of TWPI Standard Deviation 25.24	0.00 percentage of TWPI Standard Deviation 0.00	11.11 percentage of TWPI Standard Deviation 11.67	16.78 percentage of TWPI Standard Deviation 16.71	30.64 percentage of TWPI Standard Deviation 19.42	19.20 percentage of TWPI Standard Deviation 21.33
WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 3 months; n=42, 2, 7, 31, 6, 88	6.65 percentage of TWPI Standard Deviation 18.82	0.00 percentage of TWPI Standard Deviation 0.00	0.00 percentage of TWPI Standard Deviation 0.00	6.69 percentage of TWPI Standard Deviation 15.40	28.42 percentage of TWPI Standard Deviation 38.33	7.47 percentage of TWPI Standard Deviation 19.23
WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 12 months; n=39, 1, 5, 26, 3, 74	3.85 percentage of TWPI Standard Deviation 11.84	60.00 percentage of TWPI Standard Deviation NA 1 participant had an assessment at this time point.	2.00 percentage of TWPI Standard Deviation 4.47	9.62 percentage of TWPI Standard Deviation 17.55	27.78 percentage of TWPI Standard Deviation 26.74	7.48 percentage of TWPI Standard Deviation 16.26
WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 24 months; n=41, 4, 11, 22, 0, 78	2.20 percentage of TWPI Standard Deviation 7.25	12.50 percentage of TWPI Standard Deviation 25.00	16.36 percentage of TWPI Standard Deviation 21.57	7.27 percentage of TWPI Standard Deviation 13.86	NA percentage of TWPI Standard Deviation NA No participants had an assessment at this time point.	6.15 percentage of TWPI Standard Deviation 13.79

SECONDARY outcome

Activity impairment due to psoriasis (the extent to which psoriasis affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).

Outcome measures

Outcome measures
Measure	Participants Treated With Adalimumab n=84 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.	Participants Treated With Adalimumab: Early Intermittent n=5 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for \< 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Late Intermittent n=16 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days \[16 weeks\] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).	Participants Treated With Adalimumab: Permanently Discontinued n=74 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).	Participants Treated With Adalimumab: Other n=12 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).	Participants Treated With Adalimumab: All Participants n=191 Participants Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Baseline; n=74, 5, 13, 65, 10, 167	33.38 percentage of activity impairment Standard Deviation 28.05	28.00 percentage of activity impairment Standard Deviation 31.14	32.31 percentage of activity impairment Standard Deviation 23.86	34.92 percentage of activity impairment Standard Deviation 26.35	35.00 percentage of activity impairment Standard Deviation 20.68	33.83 percentage of activity impairment Standard Deviation 26.52
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 3 months; n=61, 3, 13, 57, 7, 141	8.36 percentage of activity impairment Standard Deviation 16.35	0.00 percentage of activity impairment Standard Deviation 0.00	8.46 percentage of activity impairment Standard Deviation 14.05	20.53 percentage of activity impairment Standard Deviation 28.37	40.00 percentage of activity impairment Standard Deviation 41.63	14.68 percentage of activity impairment Standard Deviation 24.48
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 12 months; n=63, 1, 11, 43, 5, 123	5.56 percentage of activity impairment Standard Deviation 13.65	40.00 percentage of activity impairment Standard Deviation NA Only 1 participant had an assessment at this time point.	12.73 percentage of activity impairment Standard Deviation 16.18	17.91 percentage of activity impairment Standard Deviation 24.35	10.00 percentage of activity impairment Standard Deviation 14.14	10.98 percentage of activity impairment Standard Deviation 19.14
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Time-window 24 months; n=64, 5, 14, 40, 2, 125	4.53 percentage of activity impairment Standard Deviation 13.68	32.00 percentage of activity impairment Standard Deviation 39.62	18.57 percentage of activity impairment Standard Deviation 19.94	12.00 percentage of activity impairment Standard Deviation 18.43	25.00 percentage of activity impairment Standard Deviation 35.36	9.92 percentage of activity impairment Standard Deviation 18.77
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status Last observation; n=82, 5, 15, 73, 10, 185	4.02 percentage of activity impairment Standard Deviation 12.26	32.00 percentage of activity impairment Standard Deviation 39.62	17.33 percentage of activity impairment Standard Deviation 19.81	17.40 percentage of activity impairment Standard Deviation 25.61	21.00 percentage of activity impairment Standard Deviation 29.98	12.05 percentage of activity impairment Standard Deviation 22.09

Adverse Events

Participants Treated With Adalimumab

Serious events: 19 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants Treated With Adalimumab n=191 participants at risk Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
Blood and lymphatic system disorders Thrombocytopenia	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Cardiac disorders Aortic valve incompetence	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Cardiac disorders Mitral valve incompetence	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Congenital, familial and genetic disorders Aplasia	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Ear and labyrinth disorders Meniere's disease	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Eye disorders Ocular icterus	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Gastrointestinal disorders Ascites	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Gastrointestinal disorders Haematemesis	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Gastrointestinal disorders Nausea	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Gastrointestinal disorders Vomiting	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
General disorders Drug ineffective	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
General disorders Fatigue	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
General disorders General physical health deterioration	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
General disorders Malaise	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Hepatobiliary disorders Hepatic cirrhosis	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Hepatobiliary disorders Hepatic fibrosis	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Immune system disorders Hypersensitivity	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Immune system disorders Immunodeficiency	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Infections and infestations Lung infection	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Injury, poisoning and procedural complications Excoriation	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Injury, poisoning and procedural complications Multiple fractures	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Injury, poisoning and procedural complications Road traffic accident	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Injury, poisoning and procedural complications Wound	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Investigations Double stranded DNA antibody positive	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Investigations Weight increased	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Metabolism and nutrition disorders Decreased appetite	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Metabolism and nutrition disorders Ketoacidosis	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 3/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Musculoskeletal and connective tissue disorders Back disorder	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Musculoskeletal and connective tissue disorders Back pain	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Musculoskeletal and connective tissue disorders Myalgia	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal neoplasm	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Nervous system disorders Cerebrovascular accident	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Psychiatric disorders Alcoholism	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Psychiatric disorders Depressed mood	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Psychiatric disorders Depression	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Psychiatric disorders Insomnia	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Psychiatric disorders Mania	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Psychiatric disorders Mental disorder	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Psychiatric disorders Suicidal ideation	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Respiratory, thoracic and mediastinal disorders Rales	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Skin and subcutaneous tissue disorders Dermatitis contact	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Skin and subcutaneous tissue disorders Eczema	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Skin and subcutaneous tissue disorders Psoriasis	2.1% 4/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Skin and subcutaneous tissue disorders Rash	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Social circumstances Activities of daily living impaired	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Social circumstances Treatment noncompliance	0.52% 1/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.

Other adverse events

Other adverse events
Measure	Participants Treated With Adalimumab n=191 participants at risk Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
General disorders Drug ineffective	18.8% 36/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
General disorders Injection site pain	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Injury, poisoning and procedural complications Foetal exposure during pregnancy	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Injury, poisoning and procedural complications Inappropriate schedule of drug administration	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Skin and subcutaneous tissue disorders Dermatitis	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Skin and subcutaneous tissue disorders Guttate psoriasis	1.6% 3/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Skin and subcutaneous tissue disorders Pruritus	1.0% 2/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.
Skin and subcutaneous tissue disorders Psoriasis	12.0% 23/191 • From informed consent through Month 24 (or early termination) + 70 days after the date of last administration of adalimumab. Mean (SD) study duration: 23.18 (5.64) months.

Additional Information

Global Medical Information

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