S1472 Efficacy of Risankizumab Maintenance Therapy by Clinical Remission and Endoscopic Improvement Status in Patients With Moderately to Severely Active Ulcerative Colitis: Post Hoc Analysis of the COMMAND Phase 3 Study
Bibliographic record
Abstract
Introduction: Risankizumab (RZB), an anti-interleukin-23 monoclonal antibody targeting p19, demonstrated efficacy vs placebo (PBO) and was well tolerated in the INSPIRE induction1 and COMMAND maintenance2 studies in patients (pts) with ulcerative colitis (UC). It is critical to understand if pts achieving outcomes (ie, clinical remission [CR] or endoscopic improvement [EI]) at the end of induction are better able to achieve long-term outcomes during maintenance. Here, we report endoscopic and histological outcomes by CR or EI status after 12 weeks (wks) of induction through 52wks of maintenance. Methods: Clinical responders per Adapted Mayo score (AMS) to RZB induction were randomized 1:1:1 in COMMAND to subcutaneous (SC) RZB 180 mg (RZB180), 360 mg (RZB360), or PBO (RZB withdrawal) for 52wks. Overall induction responders in the primary efficacy population included all randomized pts who received ≥1 dose of study drug in the maintenance period after receiving RZB 600 mg, 1200 mg, or 1800 mg intravenous (IV) induction for 12wks. RZB 1200 mg (RZB1200) induction responders included clinical responders to 12wks of RZB1200 IV. Achievement of EI, endoscopic remission (ER), or histological-endoscopic mucosal healing (HEMI) at wk52 were evaluated according to status (yes/no) of CR per AMS or EI at maintenance wk0. Results: Demographics and disease characteristics were balanced at induction baseline. Among overall induction responders with CR or EI at maintenance wk0, more pts treated with RZB vs PBO achieved EI, ER, or HEMI at wk52 (Figure 1A-B). Among RZB1200 induction responders with CR at maintenance wk0, more pts treated with RZB180 and RZB360 vs PBO achieved EI (80.5% and 66.7% vs 46.7%), ER (55.1% and 33.3% vs 23.3%), or HEMI (72.3% and 66.7% vs 40.0%) at wk52. RZB1200 induction responders with EI at maintenance wk0 achieved EI (74.8% and 59.4% vs 51.2%), ER (48.1% and 36.8% vs 23.3%), or HEMI (68.9% and 56.6% vs 39.5%) at wk52. The rates of each outcome were higher with RZB360 vs RZB180 in pts with inadequate disease activity (without CR or EI) at maintenance wk0. Conclusion: Regardless of CR or EI status after induction, RZB was more effective vs PBO in achieving EI, ER, and HEMI at maintenance wk52. In pts with UC who did not achieve CR or EI after induction, RZB360 demonstrated higher rates of improvement in endoscopic outcomes compared to RZB180 at maintenance wk52. References: 1. Louis E, Panaccione R, Parkes G, et al. S845 Risankizumab Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Efficacy and Safety in the Randomized Phase 3 INSPIRE Study. Am J Gastroenterol 2023;118(10S):S624–S625. 2. Louis E, Panaccione R, Parkes G, et al. OP06 Risankizumab Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Efficacy and Safety in the Randomised Phase 3 COMMAND Study. J Crohn’s Colitis 2024;18(Suppl_1):i10–i12Figure 1.: Summary of Key Secondary Endpoints at Week 52 According to Clinical Remission per Adapted Mayo Score or Endoscopic Improvement Status at Week 0 in Patients With Moderately to Severely Active UC. Status (yes/no) of A) CR per Adapted Mayo score or B) EI at maintenance week 0. Overall induction responder in the primary efficacy population includes all randomized patients who received at least 1 dose of study drug in the 52-week maintenance period after receiving RZB 600 mg IV, RZB 1200 mg IV, or RZB 1800 mg IV for 12 weeks in the induction study. Results for categorical endpoints are based on nonresponder imputation incorporating multiple imputation to handle missing data due to logistic restrictions (COVID-19 or the geo-political conflict in Ukraine and surrounding impacted regions) (NRI-MI). (a) EI is defined as an endoscopy subscore ≤ 1 without friability. (b) ER is defined as an endoscopy subscore = 0. (c) HEMI is defined as an endoscopy subscore = 0 or 1 without friability and Geboes score ≤ 3.1. (d) CR per Adapted Mayo score is defined as stool frequency score ≤ 1, and not greater than baseline, rectal bleeding score of 0, and endoscopy subscore ≤ 1. CI, confidence interval; CR, clinical remission; EI, endoscopic improvement; ER, endoscopic remission; HEMI, Histological-Endoscopic Mucosal Improvement; IV, intravenous; pts, patients; RZB, risankizumab; SC, subcutaneous; UC, ulcerative colitis; wk, week.
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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 | 0.007 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.005 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".