N/A
Completed N=547
Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)
Moderate-to-severe Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT01076192 ↗
Enrolled (actual)
547
Serious AEs
4.4%
Results posted
Jan 2016
Primary outcomePrimary: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) — 8.39; 11.30; 11.52; 11.32 units on a scale
Summary
The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) |
8.39; 11.30; 11.52; 11.32; 11.21; 10.93 | — |
| PRIMARY Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) |
58.4; 80.6; 80.8; 80.6; 79.5; 76.8 | — |
| PRIMARY Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) |
29.8; 64.8; 66.9; 65.8; 64.6; 63.7 | — |
| PRIMARY Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) |
11.4; 43.3; 49.8; 47.5; 48.3; 46.4 | — |
| PRIMARY Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) |
6.1; 29.3; 33.1; 33.5; 33.8; 32.7 | — |
| PRIMARY Mean Change From Baseline in Body Surface Area (BSA) Affected |
11.24; 17.86; 18.86; 18.75; 18.62; 18.04 | — |
| PRIMARY Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) |
71.9; 85.3; 82.6; 83.0; 81.3; 79.4 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) |
5.83; 6.17; 6.05; 5.99 | — |
| SECONDARY Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) |
-10.79; -12.27; -12.91; -12.71 | — |
| SECONDARY Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) |
10.61; 9.86; 12.63; 12.89 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESIs) |
2; 1; 1; 1; 30; 1 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
24 | — |
Eligibility Criteria
Inclusion Criteria
- Patient 18 years of age or older.
- Patient diagnosed with moderate to severe chronic plaque PS beginning treatment with adalimumab in accordance with the authorized conditions of use.
- Patient gives informed consent in writing.
Exclusion Criteria
- Patients who cannot be treated in accordance with the local product label
- Patient participating or going to participate in a clinical trial during the study follow-up
- Patient with difficulties for adequately reading, understanding and completing a questionnaire
Data sourced from ClinicalTrials.gov (NCT01076192). 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.