S858 Corticosteroid-Sparing Effect in Patients With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab Maintenance Therapy
Why this work is in the frame
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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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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it