S759 Efficacy and Safety of Mirikizumab in Patients With Ulcerative Colitis: 104-Week Results From a Phase 2 Randomized Controlled Trial
Bibliographic record
Abstract
Introduction: Mirikizumab (miri)showed efficacy and a positive safety profile in patients (pts) with moderate-to-severely active ulcerative colitis (UC) during 52 week (W) phase2 trial (NCT02589665). We conducted post-hoc analysis of persistence of efficacy and safety of miri in pts with UC through W104. Methods: Pts responding to miri after 12W induction (clinical response: decrease in 9-pt Mayo subscore [rectal bleeding (RB), stool frequency (SF), endoscopy] inclusive of ≥2 pt and ≥35% from baseline (BL) with either decrease of RB subscore of ≥1 or RB subscore = 0 or 1, were re-randomised (1:1, double-blind maintenance period) to miri 200 mg SC every 4W (Q4W; n = 47)or 12W (Q12W; n = 46). Pts completing W52 without loss of response either continued in maintenance to W104 or moved to long-term extension study(NCT03519945) and received miri open label 200 mg Q4W. Patient-reported efficacy outcomes assessed through W104: symptomatic remission (SF subscore = 0 or 1;RB subscore = 0), SF remission (SF = 0 or 1) and RB remission (RB = 0). Analyses of symptomatic remission, RB and SF over time included all pts randomised to miri in maintenance and evaluation of biologic-naïve (BN) and biologic-experienced (BE) subpopulations. Results: Ninety-three pts (mean age = 40.1 years, average diagnosis with UC = 7.6 years) responded to miri at W12 and moved to maintenance. At BL, 40.9% pts had total Mayo score between 6-8, 59.1% pts between 9-12; median fCLP level: 1668 µg/g, median CRP level: 4.80mg/L. Similar no. of pts were BN (n = 44) and BE (n = 49). Of 93 pts who responded to miri at W12, 86 (92.5%) reached W52 in maintenance and continued with miri. At W52, 70.9 % (66/93) pts were in symptomatic remission. Among them, 83.9% (78/93) continued treatment through W104 (n = 37 BN; n = 41 BE). At W104, 75.6% (59/78) were in symptomatic remission, 85.9% (67/78) in RB remission, 84.6% (66/78) in SF remission. No differences in remission rates were observed between BN and BE pts. One (1.3%) SAE (C. difficile infection) and one (1.3%) AE of UC worsening lead to discontinuation were reported. No deaths occurred. No new safety signals were observed between W52–W104. Conclusion: Pts with moderate-to-severely active UC responding to miri at W52 showed durable efficacy with continued miri dosing up to W104 with no unexpected safety events. Symptomatic remission, RB and SF remission were sustained through W104, with no differences between BN and BE pts. The data demonstrates the continued benefit of miri in treatment of UC.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| 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) | 0.008 | 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".