S1062 Effect of 104 Weeks of Mirikizumab Treatment on Inflammatory Bowel Disease Questionnaire Scores Among Patients With Moderately to Severely Active Crohn’s Disease
Bibliographic record
Abstract
Introduction: Mirikizumab (miri) is an anti-IL23p19 antibody that has shown efficacy in Crohn’s disease (CD). We have previously shown that miri improves health-related quality of life (HRQoL) by 12 weeks as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) in a Phase 2, multicenter, randomized, double-blind, placebo (PBO)-controlled study (NCT02891226) conducted in patients (pts) with moderately-to-severely active CD. This analysis assesses IBDQ scores through Week 104 (W104). Methods: At baseline, pts (N=191) were randomized 2:1:1:2 allocation amongst 4 treatment arms (PBO, and 200, 600, 1000mg miri, respectively, administered intravenously (IV) every 4 weeks (Q4W) at Weeks 0, 4, and 8). Pts who received miri and achieved ≥1 point improvement at W12 in Simple Endoscopic Score for Crohn’s Disease (SES-CD) were re-randomized 1:1 into double-blind maintenance to either continue IV treatment assignment Q4W (combined arms of 200, 600, and 1000mg miri IV treatment; IV-C; N=41) or to 300mg miri subcutaneous (SC; N=46) Q4W up to W52. Subjects who had clinical benefit from the maintenance period received 300mg SC Q4W from W52 to W104. For analysis purposes, all IV and all SC arms were pooled. IBDQ score change from baseline (BL), IBDQ response (improvement ≥16 points), and IBDQ remission (score ≥170 points) were assessed up to W104 in pts who achieved endoscopic improvement at W12. Results: Out of the 127 pts randomized to miri for induction, 68.5% (87/127) achieved endoscopic improvement at W12 and were rerandomized into maintenance. Among the W12 miri induction endoscopic improvers, IBDQ response rates at W52 were 75.6% (31/41) and 80.4% (37/46) and IBDQ remission rates were 65.9% (27/41) and 67.4% (31/46) in the IV-C and SC groups, respectively. Of the W12 endoscopic improvers, 74 finished W52 in the maintenance and entered period 3 (W52-W104) where 68 went on to complete treatment through W104. At W104, the IBDQ response rates were 81.8% (27/33) and 78.0% (32/41) and IBDQ remission rates were 69.7% (23/33) and 56.1% (23/41) in the IV-C and SC groups, respectively. W52 and W104 IBDQ outcomes and domain scores are reported in Table 1. Conclusion: Treatment with miri produced clinically meaningful improvement in HRQoL as measured by IBDQ at W52 and W104 in pts who achieved endoscopic improvement after miri induction with moderately-to-severely active CD. Table 1. - Week 52 and Week 104 IBDQ Outcomes in miri induction Week 12 Endoscopic Improvers Week 12 Endoscopic Improverse Week 52 Week 104 Week 52 Week 104 Miri IV-CN=41 Miri IV-CN=33 Miri SCN=46 Miri SCN=41 Total IBDQ scorea, mean (SD) 188.5 (26.6) 187.4 (21.8) 180.8 (25.4) 173.7 (32.1) IBDQ responseb, n (%) 31 (75.6) 27 (81.8) 37 (80.4) 32 (78.0) IBDQ remissionc, n (%) 27 (65.9) 23 (69.7) 31 (67.4) 23 (56.1) IBDQ score change from baseline a d mean 64.3 67.1 66.4 57.9 IBDQ Domain Scoresa, mean (SD) Bowel symptoms 58.6 (8.8) 58.8 (6.5) 57.3 (8.0) 54.3 (9.8) Systemic symptoms 27.7 (5.4) 26.8 (5.1) 25.8 (5.4) 24.7 (6.6) Emotional function 70.5 (11.1) 70.0 (9.9) 67.1 (11.0) 65.0 (13.1) Social function 31.8 (3.9) 31.8 (3.34) 30.6 (4.2) 29.7 (5.3) aMean and (SD) for scores and changes in scores do not utilize imputation and therefore are based on patients with observed data at the indicated timepoint (IV week 52 N=35; IV week 104 N=29; SC week 52 N=41; SC week 104 N=33).bIBDQ response: ≥16-point improvement in IBDQ score.cIBDQ remission: total IBDQ score ≥170.dChange from baseline.eEndoscopic improvement: ≥1 point improvement in SES-CD at Week 12.Abbreviations: IBDQ = Inflammatory Bowel Disease Questionnaire; IV-C = Intravenous arms combined; SC = subcutaneous; SD = standard deviation.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 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 | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".