P15 Evaluating risankizumab for moderate-to-severe plaque psoriasis: real-world outcomes from an international study
Bibliographic record
Abstract
Abstract Risankizumab has shown high efficacy in Phase III randomized controlled trials (RCTs) for treating moderate-to-severe plaque psoriasis, outperforming ustekinumab and adalimumab in terms of skin clearance. However, there is limited data on its long-term effectiveness and safety in real-world settings. This study aims to bridge this gap by evaluating the 1-year real-world outcomes of risankizumab in adult patients with moderate-to-severe plaque psoriasis, focusing on both its efficacy and safety. We conducted an international, multicentre retrospective study involving five tertiary academic dermatology clinics in Canada and Portugal. The study included adult patients aged 18 years or older diagnosed with moderate-to-severe plaque psoriasis, characterized by a Physician’s Global Assessment (PGA) score of 3 or 4. One year after initiating risankizumab treatment, we assessed efficacy based on achieving a psoriasis area and severity index (PASI90) or PGA score of 0 (clear) or 1 (almost clear). Safety evaluations were based on the frequency and nature of adverse events reported by the patients. The study included 291 participants, with a mean age of 50.7 ± 15.0 years, of whom 62.5% were male. Of these, 56.4% (164/291) had not previously been treated with systemic biologic therapy, and the group had previously failed an average of 0.79 systemic biologics. After 1 year of treatment, 264 patients (90.7%) achieved PASI90 or a PGA score of 0/1. Furthermore, 90.7% attained a PASI ≤2, 56.4% achieved a PASI <1, and 72% reported a body surface area <1%. Adverse events were noted in 4.5% of the cohort (13/291), with fatigue being the most frequently reported, affecting 23% (3/13) of those with adverse events. None of the adverse events were considered severe, and all patients experiencing adverse events continued with the treatment. Treatment discontinuation occurred in 7.9% (23/291) of the patients, primarily due to insufficient efficacy (15/23, 65.2%). The findings from this study indicate that risankizumab provides substantial real-world efficacy and maintains a strong safety profile for treating moderate-to-severe plaque psoriasis, supporting the results seen in Phase III clinical trials. The treatment resulted in high levels of skin clearance over 1 year. However, further validation through larger real-world cohort studies with control groups is essential to confirm these results.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.010 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".