N/A
N=506
Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
Moderate to Severe Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01202565 ↗Enrolled (actual)
506
Serious AEs
1.0%
Results posted
Aug 2014
Primary outcome: Primary: Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12 — -74.6 percent change
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
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12 |
-74.6 | — |
| PRIMARY Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12 |
-89.7 | — |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) |
-4.6; -7.6; -9.1; -10.5; -9.6 | — |
| SECONDARY Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis |
33.1; 68.1; 85.3; 90.4; 84.0 | — |
| SECONDARY Percentage of Participants Achieving Complete Clearing of Nails |
1.9; 11.8; 22.1; 40.0; 33.3 | — |
| SECONDARY Change From Baseline in Psoriasis Scalp Severity Index (PSSI) |
-17.2; -22.2; -24.2; -25.8; -24.3 | — |
| SECONDARY Percentage of Participants Achieving Good Clinical Response on Scalp |
67.0; 92.8; 97.5; 98.3; 93.8 | — |
| SECONDARY Percentage of Participants Achieving Complete Clearing of Scalp |
27.0; 39.5; 47.9; 71.7; 66.7 | — |
| SECONDARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
-83.3 | — |
| SECONDARY Change From Baseline in PASI Score |
-14.5; -17.9; -19.6; -20.6; -19.1 | — |
| SECONDARY Percentage of Participants Achieving a PASI 90 Response |
25.1; 38.0; 51.4; 72.0; 65.3 | — |
| SECONDARY Percentage of Participants Achieving a PASI 75 Response |
43.5; 66.7; 84.6; 91.8; 84.0 | — |
| SECONDARY Percentage of Participants Achieving a PASI 50 Response |
69.2; 92.5; 95.5; 97.2; 91.1 | — |
| SECONDARY Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score |
-83.6 | — |
| SECONDARY Change From Baseline in DLQI Score |
-12.6; -16.1; -17.9; -18.9; -17.4 | — |
| SECONDARY Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis |
0.61 | — |
| SECONDARY Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis |
0.65 | — |
| SECONDARY Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis |
0.60 | — |
| SECONDARY Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis |
0.59 | — |
| SECONDARY Associations Between General Improvement in Psoriasis With Improvement in Quality of Life |
0.78 | — |
Summary
There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice.
The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.
Eligibility Criteria
Inclusion Criteria
Patients will be enrolled in this PMOS if they fulfill all of the below criteria:
- Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines
- Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI score of hands and feet ≥ 10) and/or significant psoriatic scalp affection (Psoriasis Scalp Severity Index PSSI score ≥ 10)
- Adult (≥18 years of age)
- Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines
- Willing to provide informed consent if requested by the local law regulations
Exclusion Criteria
Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS:
- Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
- Participate in another clinical/observational study
Data sourced from ClinicalTrials.gov (NCT01202565). 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.