N/A
N=153
Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01328366 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Dermatology Life Quality Index (DLQI) Scores — 17.25; 8.65; 4.51; 3.65 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dermatology Life Quality Index (DLQI) Scores |
17.25; 8.65; 4.51; 3.65 | — |
| PRIMARY Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline |
-9.95; -13.03; -13.63 | — |
| SECONDARY Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores |
21.02; 7.37; 4.42; 4.41 | — |
| SECONDARY Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline |
-16.41; -18.79; -17.34 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Scores |
16.98; 5.52; 3.42; 2.38 | — |
| SECONDARY Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline |
-10.90; -13.93; -13.99 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Scores |
9.63; 8.21; 6.65; 6.00; 7.08; 6.19 | — |
| SECONDARY Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline |
-1.56; -2.81; -3.32; -1.58; -2.68; -3.14 | — |
| SECONDARY Cutaneous Body Image Scale (CBI) Scores |
2.73; 4.38; 5.58; 6.16 | — |
| SECONDARY Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline |
2.05; 2.83; 3.45 | — |
| SECONDARY 12-item Short Form Survey (SF-12) Score |
43.08; 46.38; 50.53; 49.53; 41.23; 45.50 | — |
| SECONDARY Change in 12-item Short Form Survey (SF-12) Score From Baseline |
4.60; 6.84; 6.46; 4.96; 6.10; 6.47 | — |
| SECONDARY Female Sexual Function Index (FSFI) Score |
15.77; 18.65; 20.73 | — |
| SECONDARY Mean Change in Female Sexual Function Index (FSFI) Score From Baseline |
3.78; 0.53; 4.72 | — |
| SECONDARY International Index of Erectile Function Score |
56.05; 58.33; 60.61; 54.43 | — |
Summary
The impact of psoriasis on an individual's emotional and social well-being goes beyond skin symptoms of the disease. Data suggests patients with severe psoriasis experience a greater prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation. Given the nature of the disease and the treatment failures which are required before a patient commences a biologic therapy such as adalimumab, the patient's mental health at initiation of biologics is an important consideration for clinicians. This study seeks to explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial factors and disease-related quality of life.
Eligibility Criteria
Inclusion Criteria
- Participants were eligible for adalimumab as determined by the National Institute for Health and Clinical Excellence (NICE) criteria
- Participants had severe psoriasis as defined by a Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10
- Participant's psoriasis did not respond to standard systemic therapies, to include: ciclosporin, methotrexate, and psoralen and long-wave ultraviolet radiation; or the participant was intolerant of or had a contraindication to these treatments
Exclusion Criteria
- Participants were previously treated with another biologic therapy
- Participants were unable or unwilling to complete the study questionnaires
Data sourced from ClinicalTrials.gov (NCT01328366). 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.