S858 Corticosteroid-Sparing Effect in Patients With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab Maintenance Therapy
Bibliographic record
Abstract
Introduction: Corticosteroid (CS)-free remission is a treatment goal for patients with ulcerative colitis (UC). Mirikizumab’s (miri) CS-sparing effect was assessed in the LUCENT-2 maintenance trial among patients receiving CS at baseline (BL). Methods: In LUCENT-1, patients on miri or placebo (PBO) who entered the study on CS remained on their stable BL dose (≤20mg/day prednisone equivalent) during induction (Week [W] 0 to W12). Patients randomized to miri induction and achieving clinical response (N=365) at W12 were re-randomized 2:1 in LUCENT-2 to miri (200mg/4 weeks) or PBO for maintenance (W12-52). LUCENT-1 responders began a CS taper upon entering LUCENT-2 by tapering the >10mg daily dose by 5mg/week until receiving 10mg/day, and then 2.5mg/week until 0mg/day. For those receiving ≤10mg/day, the daily dose was tapered by 2.5 mg/week until 0mg/day. Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 with ≥1-point decrease from W0 BL, a rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1 (excluding friability). Descriptive statistics were calculated with non-responder imputation used for missing data. The common risk difference between miri and PBO was calculated and adjusted for the following stratification factors: prior biologic/tofacitinib failure, region, and W12 clinical remission status. Results: Of the miri induction responders who were re-randomized in LUCENT-2, 33% (59/179) of PBO patients were BL CS users compared with 34% (125/365) of miri patients. The median BL CS dose was 20 mg/day. At W52, a significantly greater proportion of patients treated with maintenance miri vs PBO, achieved clinical remission while off CS, clinical remission + off CS for ≥12 weeks, and clinical remission + symptomatic remission at W40 +off CS for ≥12 weeks (Table 1; all p≤0.01). A significantly greater proportion of patients treated with miri permanently discontinued CS by W24, W40, and W52 vs PBO (Table 1; all P< 0.001) and among patients who completed W52 of miri treatment, 95.2% permanently discontinued CS by W52. Conclusion: Among patients on CS at BL, miri induction responders who were re-randomized to miri maintenance achieved CS-free clinical remission at W52 at higher rates than miri induction responders who were re-randomized to PBO maintenance. Mirikizumab’s CS-sparing effect in patients with moderately to severely active UC is clinically meaningful and aligned with long-term treatment goals of CS discontinuation. Table 1. - Corticosteroid-Sparing Effects in Patients on Baseline Systemic Corticosteroids Treated with Mirikizumab vs Placebo MirikizumabN=125 PlaceboN=59 Common risk difference (95% CI) P-value Patients achieving clinical remission Clinical remission and off CS at Week 52 52 (41.6%) 9 (15.3%) 22.3 (9.9–34.6) P=0.002 Clinical remission at Week 52 and off CS for ≥12 weeks 51 (40.8%) 9 (15.3%) 21.2 (8.9–33.4) P=0.003 Clinical remission at Week 52 with symptomatic remission at Week 40 and off CS for ≥12 weeks 48 (38.4%) 7 (11.9%) 21.9 (10.7–33.2) P=0.002 Patients permanently off CS by week* Off CS at Week 52 among treatment completers 99/104 (95.2%) 26/30 (86.7%) NA** NA** Off CS at Week 52 99 (79.2%) 26 (44.1%) 34.2 (19.2–49.2) P< 0.001 Off CS at Week 40 96 (76.8%) 25 (42.4%) 33.1 (18.0–48.3) P< 0.001 Off CS at Week 24 88 (70.4%) 23 (39.0%) 30.5 (15.2–45.8) P< 0.001 Abbreviations: CI = confidence interval; CS = corticosteroid; N = number of patients in group.Risk difference CI were calculated with the Mantel-Haenszel-Sato method. P-values were calculated with the Cochran-Mantel-Haenszel test adjusted by prior biologic/tofacitinib failure and Week 0 CS use. Non-responder imputation was used for missing data. Patients who discontinued study treatment or received rescue treatment were defined as treatment failures (i.e., remaining on CS).*Patients were off CS and did not discontinue study treatment or re-initiate CS use for the remainder of the study period.**NA = not available. Formal treatment comparison for this endpoint not performed because this is an observed analysis.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 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".