Efficacy and Safety of Risankizumab Compared with Apremilast in Patients with Moderate Plaque Psoriasis: Mean PASI and BSA Results From the Phase 4 IMMpulse Trial
Bibliographic record
Abstract
Introduction The IMMpulse study (NCT04908475) demonstrated superior efficacy of risankizumab (RZB) compared to apremilast (APR) in systemic-eligible patients with moderate plaque psoriasis (PsO). Material and Methods This phase 4, multi-center, randomized, open-label, assessor-blinded, active comparator study compared RZB to APR in adult systemic-eligible patients with moderate plaque PsO. In period A, patients were randomized 1:2 to receive RZB (150 mg) or APR (30 mg twice daily) for 16 weeks. In period B, all APR-treated patients were re-randomized 1:1 to RZB or APR stratified by their ≥ 75% improvement in psoriasis area and severity index (PASI75) response. All RZB patients in period A continued treatment till week 52. Pre-specified efficacy endpoints included change in PASI and body surface area (BSA) from baseline. Continuous endpoints were assessed using mixed-effect model repeat measures to handle missing data. Results Baseline characteristics were similar between the treatment arms. At week 16, PASI75 was achieved by 84.7% (RZB-treated) and 18.8% (APR-treated) patients. Mean PASI improved from 14.6 at baseline to 1.7 (RZB-treated), and from 14.5 at baseline to 8.8 (APR-treated) patients. Mean BSA improved from 13.1% to 2.6% with RZB, and from 13.1% to 10.6% for APR-treated patients. APR-treated patients not achieving PASI75 at week 16 who switched to RZB achieved a mean PASI of 0.7 at week 52, compared to 3.1 at week 52 in patients who continued with APR. In these same patients, those that switched to RZB achieved a mean BSA of 1.4% at week 52 compared to 6.3% for patients who continued APR. Most frequently observed treatment emergent adverse events were COVID-19 and nasopharyngitis for RZB, and diarrhea, nausea, and headache for APR. Conclusions These results demonstrate minimal residual disease observed with continuous RZB treatment and support the opportunity to elevate treatment outcomes with RZB in systemic-eligible patients with moderate plaque PsO.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".