N/A
N=246
Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities
Moderate to Severe Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01401452 ↗Enrolled (actual)
246
Serious AEs
5.3%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9 — 31.3; 52.8; 55.8; 57.5 percentage of participants
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 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9 |
31.3; 52.8; 55.8; 57.5 | — |
| SECONDARY Mean Dermatology Life Quality Index (DLQI) Scores |
12.4; 7.2; 5.4; 4.8; 4.3 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9 |
51.0; 66.8; 66.9; 72.5 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9 |
11.5; 38.9; 45.5; 43.7 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9 |
6.3; 22.3; 32.5; 30.4 | — |
| SECONDARY Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months |
46.33; 48.19; 49.54; 49.31; 50.48 | — |
| SECONDARY Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months |
41.35; 45.39; 47.01; 47.92; 48.32 | — |
| SECONDARY Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months |
38.3; 52.9; 48.0; 55.2 | — |
| SECONDARY Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months |
38.2; 49.7; 52.6; 61.9 | — |
Summary
This multicenter, post marketing observational study (PMOS) was designed to evaluate the effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct co-morbidities. Secondary objectives of this study were to measure changes in psychological health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect to gender; changes in quality of life using the Short Form Health Survey (SF-36); and evaluation of Minimal Clinically Important Differences (MCID).
Eligibility Criteria
Inclusion Criteria
Participants for whom adalimumab therapy is indicated and has been prescribed according to the product label and who meet the following criteria:
- Participant age ≥ 18 years
- Participants with moderate to severe plaque psoriasis participants who have at last one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression (diagnosed by a medical specialist for psychology, neurology, or psychiatry)
- Adalimumab naïve participants with moderate to severe plaque psoriasis after unsatisfactory response, non tolerability, or contraindication of systemic therapies such as ciclosporin, methotrexate or PUVA ( psoralen + UVA) or after biological disease modifying anti-rheumatic drugs (bDMARDs) failure (e.g.: infliximab, etanercept or ustekinumab)
- Participants of each country must fulfill any local treatment recommendation for use of bDMARD in psoriasis in their respective country. For Austria: participants must fulfill Austrian Treatment Recommendations for use of bDMARD in psoriasis (Chest X-ray and IGRA* interferon gamma release assay or PPD-skin test negative for tuberculosis)
- Participant is willing to give informed consent to anonymous data collection and their forwarding to AbbVie as well as to informed consent if required in different countries.
- Participant must be able and willing to self-administer adalimumab injections or have a qualified person available to administer Humira® syringe or Humira® Pen injections
Exclusion Criteria
The following participants will not be included in this observational study:
- Participants who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC
- Participants participating in another study program or clinical trial
- Participants who have been treated with Humira® before
Data sourced from ClinicalTrials.gov (NCT01401452). 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.