N/A
Completed 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
Source: ClinicalTrials.gov NCT01202565 ↗
Enrolled (actual)
506
Serious AEs
1.0%
Results posted
Aug 2014
Primary outcomePrimary: Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12 — -74.6 percent change
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.
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 | — |
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. Informational only — not medical advice.