N/A
Completed N=191
Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life
Source: ClinicalTrials.gov NCT01169987 ↗Enrolled (actual)
191
Serious AEs
10.0%
Results posted
Jun 2016
Primary outcomePrimary: Adalimumab Treatment Retention Status — 44.0; 2.6; 8.4; 38.7 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adalimumab Treatment Retention Status |
44.0; 2.6; 8.4; 38.7; 6.3 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status |
74.15; 95.69; 82.25; 49.96; 56.70; 65.06 | — |
| SECONDARY PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status |
85.5; 100.0; 100.0; 64.6; 55.6; 77.5 | — |
| SECONDARY Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status |
21.92; 24.80; 18.25; 22.02; 23.95; 21.84 | — |
| SECONDARY Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status |
1.2; 0.0; 0.0; 0.0; 0.0; 0.5 | — |
| SECONDARY Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status |
12.48; 13.80; 12.27; 12.97; 12.08; 12.66 | — |
| SECONDARY DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status |
5.0; 0.0; 6.7; 2.9; 16.7; 4.9 | — |
| 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 |
3.05; 25.00; 0.00; 2.92; 1.00; 3.38 | — |
| SECONDARY WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status |
22.50; 0.00; 11.11; 18.51; 30.00; 20.32 | — |
| 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 |
21.29; 0.00; 11.11; 16.78; 30.64; 19.20 | — |
| SECONDARY WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status |
33.38; 28.00; 32.31; 34.92; 35.00; 33.83 | — |
Eligibility Criteria
Inclusion Criteria
- Patients > or = 18 years
- Patient with chronic plaque psoriasis
- Patient newly initiated on Humira
- Patient compliant with Humira Summary of Product Characteristics
- Patient compliant with Belgian reimbursement criteria of Humira in plaque psoriasis
- Patient has signed informed consent
Exclusion Criteria
- Patients having any of the contraindications mentioned in the Summary of Product Characteristics Humira
- Patients not willing to sign informed consent
Data sourced from ClinicalTrials.gov (NCT01169987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.