S1449 Long-Term Endoscopic and Histological Outcomes of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis With up to 3 Years of Treatment
Bibliographic record
Abstract
Introduction: Mirikizumab (MIRI), achieved the primary endpoint of clinical remission (CR) and other key secondary outcomes, including endoscopic and histologic improvement and remission at week (W) 12 of LUCENT-1 induction trial (NCT03518086), W52 of LUCENT-2 maintenance trial (NCT03524092), and W104 of LUCENT-3 long-term (LT) extension study (NCT03519945) in patients (pts) with moderately to severely active ulcerative colitis (UC).1-4 Here we present the LT durable and sustained histological and endoscopic outcomes through 3 years and their association with quality of life. Methods: LUCENT-3 is an ongoing single-arm, open-label, LT extension phase 3 study evaluating the efficacy and safety of MIRI in pts who participated in LUCENT-1 and -2. For pts who achieved CR at W52 (clinical remitters), we evaluated the proportion who achieved histologic improvement or remission (HI or HR), endoscopic remission or normalization (ER or EN), histologic-endoscopic mucosal improvement or remission (HEMI or HEMR), alternate HEMR (aHEMR: Geboes score≤ 2B.0 plus Mayo ES=0) or CR at W152 and maintenance of these endpoints from W52 to W104, and W152. The relationship between clinical outcomes and Inflammatory Bowel Disease Questionnaire (IBDQ) remission (defined as IBDQ score ≥170) was assessed at W152. Results: With 3 years of continuous MIRI treatment, the proportion of pts achieving ER, HI, HR, HEMI, HEMR, EN, aHEMR, and CR at W152 were 82%, 75%, 71%, 71%, 70%, 47%, 44%, and 81%, respectively (observed data) (Figure 1A). Achieving these outcomes was associated with IBDQ remission (P < 0.001) (Figure 1B). The proportion of pts who maintained ER, HI, HR, HEMI, HEMR, and CR across W52, W104, and W152 were 75%, 58%, 48%, 54%, 45%, and 74% (observed data) (Figure 1C). Greater than 90% of patients who maintained these outcomes at all timepoints during 3 years with MIRI achieved IBDQ remission (Figure 1D). Conclusion: MIRI maintained endoscopic and histologic outcomes through an additional 2 years of continuous treatment among clinical remitters at W52 (3 years in total). The achievement of LT durable and sustained endoscopic and histologic outcomes with MIRI was strongly associated with IBDQ remission. References 1. D'Haens G, et al. Gastroenterology. 2022;162(Suppl_7):S214.2. Dubinsky MC, et al. Gastroenterology. 2022;162(7, Suppl_7):S1393-S1394.3. Magro F, et al. United European Gastroenterology J. 2023;11(Suppl_8).4. Sands BE, et al. Inflamm Bowel Dis. 2024;izae024.Figure 1.: Long-term durable and sustained histological and endoscopic outcomes through 3 years and their association with IBDQ remission. A. Proportion of patients on MIRI achieving ER, HI, HR, HEMI, HEMR, EN, aHEMR, and CR at W152 among clinical remitters at W52. B. Association between IBDQ remission and ER, HR, HEMR and ER at W152. C. Proportion of patients on MIRI maintaining ER, HI, HR, HEMI, HEMR and CR across W52, W104 and W152. D. Association between IBDQ remission at W152 and maintaining ER, HR, HEMR and CR with MIRI treatment across W52, W104 and W152. **P <0.01; ***P <0.001: Yes vs NO achieving the targeted endpoint. P-values on associations were estimated using the chi-squared test. Missing data were imputed using mNRI, in addition to the observed data. IBDQ remission was defined as IBDQ score ≥170. All time points refer to the total duration of continuous mirikizumab treatment. aHEMR=alternate HEMR (Geboes score≤ 2B.0 + Mayo ES=0); CI=confidence interval; CR=clinical remission (MMS SF=0 or SF=1 with ≥1-point decrease from baseline; RB=0; ES=0 or 1 [excluding friability]); EN=endoscopic normalization (Mayo ES=0); ER=endoscopic remission (Mayo ES = 0 or 1 [excluding friability]); ES= endoscopic score; HEMI=histologic-endoscopic mucosal improvement (Mayo ES=0 or 1 [excluding friability] + Geboes score≤ 3.1); HEMR=histologic-endoscopic mucosal remission (Mayo ES=0 or 1 [excluding friability] + Geboes score≤ 2B.0); HI=histologic improvement (Geboes score≤ 3.1); HR=histologic remission (Geboes score≤ 2B.0); IBDQ, Inflammatory Bowel Disease Questionnaire; MMS, Mayo Modified Score; mNRI, modified nonresponder imputation; N, number of participants in the analysis population; NA, not available; OC, observed case; RB, rectal bleeding; SF, stool frequency; W, 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 | 0.002 | 0.002 |
| 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 | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".