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| Name | Class |
|---|---|
| Veeda Clinical Research | INDUSTRY |
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This observational study will document to what extent in daily clinical practice Humira (adalimumab) therapy is continued, interrupted or permanently discontinued during a follow-up period of 2 years. Reasons for interrupting or permanently discontinuing Humira therapy and reasons for restarting Humira therapy will be noted. An evaluation will be performed of the effect of the disease on quality of life and work productivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Treated with Adalimumab | Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment is initiated. All medications will be prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adalimumab Treatment Retention Status | 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. | Month 24/ Early Termination visit |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with psoriasis followed in university or peripheral hospitals or peripheral private practices with experience in psoriasis patient care.
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| Name | Affiliation | Role |
|---|---|---|
| Simonne Lens, MD | AbbVie sa | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adalimumab Treatment Retention Status | 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. | 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. | Posted | Number | percentage of participants | Month 24/ Early Termination visit |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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) |
| PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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) |
| Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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) |
| Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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 (obs.; up to 24 months) |
| Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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) |
| DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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) |
| 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 | 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). | 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) |
| WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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) |
| WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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) |
| WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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) |
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| Sex: Female, Male | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
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| Secondary | Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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. | Posted | Mean | Standard Deviation | percentage improvement | 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) |
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| Secondary | PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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 given time point. | Posted | Number | percentage of participants | 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) |
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| Secondary | Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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 given time point. | Posted | Mean | Standard Deviation | percentage of affected BSA | 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) |
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| Secondary | Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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 given time point. | Posted | Number | percentage of participants | 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 (obs.; up to 24 months) |
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| Secondary | Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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 given time point. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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 given time point. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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 | 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). | 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 assessment at given time point. | Posted | Mean | Standard Deviation | percentage of work time missed | 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) |
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| Secondary | WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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. | Posted | Mean | Standard Deviation | percentage of impairment while working | 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) |
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| Secondary | WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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. | Posted | Mean | Standard Deviation | percentage of TWPI | 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) |
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| Secondary | WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status | 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). | 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 given time point. | Posted | Mean | Standard Deviation | percentage of activity impairment | 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) |
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| 19 |
| 191 |
| 67 |
| 191 |
| Aortic valve incompetence | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Aplasia | Congenital, familial and genetic disorders | MedDRA 16.1 | Systematic Assessment |
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| Meniere's disease | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
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| Ocular icterus | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Drug ineffective | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Hepatic fibrosis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
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| Immunodeficiency | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Double stranded DNA antibody positive | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Back disorder | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Nasal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Mental disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Activities of daily living impaired | Social circumstances | MedDRA 16.1 | Systematic Assessment |
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| Treatment noncompliance | Social circumstances | MedDRA 16.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Foetal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| Inappropriate schedule of drug administration | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Guttate psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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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.
| TW 12 months; n=69, 2, 13, 54, 8, 146 |
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| TW 24 months; n=77, 5, 15, 47, 3, 147 |
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| Last observation; n=80, 5, 16, 72, 11, 184 |
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| TW 3 months: ≥ 75%; n=76, 3, 16, 65, 9, 169 |
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| TW 3 months: ≥ 90%; n=76, 3, 16, 65, 9, 169 |
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| TW 3 months: = 100%; n=76, 3, 16, 65, 9, 169 |
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| TW 12 months: ≥ 50%; n=69, 2, 13, 54, 8, 146 |
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| TW 12 months: ≥ 75%; n=69, 2, 13, 54, 8, 146 |
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| TW 12 months: ≥ 90%; n=69, 2, 13, 54, 8, 146 |
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| TW 12 months: = 100%; n=69, 2, 13, 54, 8, 146 |
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| TW 24 months: ≥ 50%; n=77, 5, 15, 47, 3, 147 |
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| TW 24 months: ≥ 75%; n=77, 5, 15, 47, 3, 147 |
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| TW 24 months: ≥ 90%; n=77, 5, 15, 47, 3, 147 |
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| TW 24 months: = 100%; n=77, 5, 15, 47, 3, 147 |
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| Last observation: ≥ 50%; n=80, 5, 16, 72, 11, 184 |
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| Last observation: ≥ 75%; n=80, 5, 16, 72, 11, 184 |
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| Last observation: ≥ 90%; n=80, 5, 16, 72, 11, 184 |
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| Last observation: = 100%; n=80, 5, 16, 72, 11, 184 |
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| Time-window 3 months; n=79, 3, 15, 66, 10, 173 |
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| Time-window 12 months; n=73, 1, 12, 54, 9, 149 |
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| Time-window 24 months; n=78, 5, 15, 45, 1, 144 |
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| Last Observation; n=84, 5, 16, 74, 12, 191 |
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| Baseline: M/Md/S/VS; n=82,5,16,73,12,188 |
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| TW 3 months: Clear/Minimal; n=78,3,16,66,10,173 |
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| TW 3 months: M/Md/S/VS; n=78,3,16,66,10,173 |
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| TW 12 months: Clear/Minimal; n=73,1,12,54,9,149 |
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| TW 12 months: M/Md/S/VS; n=73,1,12,54,9,149 |
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| TW 24 months: Clear/Minimal; n=81,5,15,47,1,149 |
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| TW 24 months: M/Md/S/VS; n=81,5,15,47,1,149 |
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| Last obs.: Clear/Minimal; n=84,5,16,74,12,191 |
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| Last obs.: M/Md/S/VS; n=84,5,16,74,12,191 |
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| Time-window 3 months; n=73, 3, 15, 61, 8, 160 |
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| Time-window 12 months; n=68, 1, 12, 47, 6, 134 |
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| Time-window 24 months; n=71, 5, 14, 44, 3, 137 |
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| Last Observation; n=82, 5, 15, 74, 12, 188 |
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| Baseline: score 2-5; n=80,5,15,70,12,182 |
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| Baseline: score 6-10; n=80,5,15,70,12,182 |
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| Baseline: score 11-20; n=80,5,15,70,12,182 |
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| Baseline: score 21-30; n=80,5,15,70,12,182 |
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| TW 3 months: score 0-1; n=73,3,15,61,8,160 |
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| TW 3 months: score 2-5; n=73,3,15,61,8,160 |
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| TW 3 months: score 6-10; n=73,3,15,61,8,160 |
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| TW 3 months: score 11-20; n=73,3,15,61,8,160 |
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| TW 3 months: score 21-30; n=73,3,15,61,8,160 |
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| TW 12 months: score 0-1; n=68,1,12,47,6,134 |
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| TW 12 months: score 2-5; n=68,1,12,47,6,134 |
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| TW 12 months: score 6-10; n=68,1,12,47,6,134 |
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| TW 12 months: score 11-20; n=68,1,12,47,6,134 |
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| TW 12 months: score 21-30; n=68,1,12,47,6,134 |
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| TW 24 months: score 0-1; n=71,5,14,44,3,137 |
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| TW 24 months: score 2-5; n=71,5,14,44,3,137 |
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| TW 24 months: score 6-10; n=71,5,14,44,3,137 |
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| TW 24 months: score 11-20; n=71,5,14,44,3,137 |
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| TW 24 months: score 21-30; n=71,5,14,44,3,137 |
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| Last observation: score 0-1; n=82,5,15,74,12,188 |
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| Last observation: score 2-5; n=82,5,15,74,12,188 |
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| Last observation: score 6-10; n=82,5,15,74,12,188 |
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| Last observation: score 11-20; n=82,5,15,74,12,188 |
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| Last observation: score 21-30; n=82,5,15,74,12,188 |
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| Time-window 3 months; n=43, 2, 7, 31, 6, 89 |
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| Time-window 12 months; n=39, 1, 5, 26, 3, 74 |
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| Time-window 24 months; n=41, 4, 11, 22, 0, 78 |
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| Last observation; n=60, 4, 11, 47, 11, 133 |
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| Time-window 3 months; n=46, 2, 8, 34, 6, 96 |
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| Time-window 12 months; n=45, 1, 6, 27, 3, 82 |
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| Time-window 24 months; n=46, 4, 11, 24, 0, 85 |
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| Last observation; n=60, 4, 11, 49, 11, 135 |
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| Time-window 3 months; n=42, 2, 7, 31, 6, 88 |
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| Time-window 12 months; n=39, 1, 5, 26, 3, 74 |
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| Time-window 24 months; n=41, 4, 11, 22, 0, 78 |
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| Last observation; n=60, 4, 11, 47, 11, 133 |
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| Time-window 3 months; n=61, 3, 13, 57, 7, 141 |
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| Time-window 12 months; n=63, 1, 11, 43, 5, 123 |
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| Time-window 24 months; n=64, 5, 14, 40, 2, 125 |
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| Last observation; n=82, 5, 15, 73, 10, 185 |
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