A Phase 3b Study Evaluating Safety and Efficacy of Risankizumab in Adult Patients with Moderate-to-Severe Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement
Bibliographic record
Abstract
Introduction: We evaluate safety and efficacy of risankizumab (RZB) vs. placebo (PBO) in adult patients with moderate-to-severe non-pustular palmoplantar psoriasis (PPPsO). Method: IMMprint, a Ph3b study evaluated safety and efficacy of RZB vs. PBO in moderate-to-severe PPPsO patients with a static physician’s global assessment(sPGA) of moderate or severe ≥3, palmoplantar psoriasis area and severity index(PPASI) ≥8 and at least 1 additional PsO plaque. The 52-week treatment was split into period A, patients randomized (1:1) to RZB 150-mg or PBO, and period B, patients continuing RZB or switching from PBO to RZB (PBO/RZB). Primary endpoint was achievement of palmoplantar investigator’s global assessment (ppIGA) 0/1 with at least 2-point reduction from baseline at Wk16. Ranked secondary endpoints include ≥75% & 90% improvement in PPASI (PPASI75, PPASI90), sPGA 0/1 and 100% improvement in PPASI(PPASI100) at Wk16. Results: Of 174 enrolled, 87(mean age[SD]: 56.9[12.9] years) were randomized to RZB and 87(mean age[SD]: 53.9[14.3] years) were randomized to PBO. Baseline characteristics were similar except for numerical difference in PsA (RZB vs. PBO: 11.5% vs 4.6%, respectively). At Wk16, a significantly higher proportion receiving RZB achieved ppIGA 0/1 than PBO(33.3% vs. 16.1%, p = 0.006). Patients receiving RZB also demonstrated significantly higher responses than patients receiving PBO in all ranked secondary endpoints: PPASI75 (42.5% vs 14.9%, P < 0.001); PPASI90 (27.6% vs 5.7%, p<0.001); sPGA 0/1 (32.2% vs 11.5%, p < 0.001); and PPASI100 (17.2% vs. 1.1%, p < 0.001). Four patients (3 RZB: 1 PBO) discontinued drug in period A. At Wk52, ppIGA 0/1 was achieved by 50.6% of RZB patients and 61.7% of PBO/RZB group. Proportion of patients achieving PPASI75 at Wk52 was 57.5%(RZB) vs. 65.4% (PBO/RZB). Achievement of sPGA 0/1 (%RZB vs. %PBO/RZB) was 43.7% vs. 66.7%; PPASI100 was achieved by 26.4% (RZB) and 37.0% (PBO/RZB) patients at Wk52. Proportion of patients with adverse events were 29.1%(RZB) and 23.0%(PBO) in period A, and 49.4%(RZB) and 35.8% (PBO/RZB) in period B. One RZB patient with prior cardiovascular risk factors had an adjudicated myocardial infarction and subsequently died after 140-day follow-up period. The number of patients with COVID-19 were 3 (RZB; 1 serious infection) and 2(PBO) in period A and 11 (RZB) and 7 (PBO/RZB) in period B. Conclusion: This study demonstrates RZB can provide effective improvement compared to PBO by Wk16 with continuous improvement until Wk52 with no new safety signals in patients with moderate-to-severe PPPsO.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".