S1066 Sustained Improvement in Inflammatory Bowel Disease Questionnaire Outcomes in Moderately to Severely Active Ulcerative Colitis With Continued Mirikizumab Treatment in Phase 3 LUCENT-3 Study

Introduction: Mirikizumab (miri) significantly improved quality of life as evidenced by the Inflammatory Bowel Disease Questionnaire (IBDQ) scores in moderately to severely active ulcerative colitis (UC) during 12-week (W) induction (LUCENT-1) and 40-W maintenance (LUCENT-2) phase 3 studies.1 IBDQ response and remission rates were significantly higher with miri vs placebo in both studies.1 Here we report interim results of 104-W of continuous miri therapy on IBDQ outcomes from an ongoing open-label, single-arm, phase 3, multicenter, long-term extension study (LUCENT-3/NCT03519945). Methods: Patients who completed LUCENT-2 and achieved clinical response or remission after 52-W of continuous miri therapy entered LUCENT-3 and continued to receive miri 200 mg every 4 weeks subcutaneously. Least squares mean change from baseline in IBDQ total and domain scores were evaluated at W104 using an analysis of covariance model. IBDQ response (≥16-point improvement from baseline)1 and IBDQ remission (IBDQ total score ≥170)1 rates, stratified by prior biologic failure status, were assessed at W104. Missing data were imputed using modified baseline observation carried forward (IBDQ change from baseline) and non-responder imputation (IBDQ response and remission rates). Results: Among the 239 patients with clinical response at W52 who entered the LUCENT-3 study, 154 were in clinical remission. Improvements in IBDQ total and domain scores for these patients were sustained at W104 (Figure 1A). IBDQ response at W104 was seen in over 80% of patients and was comparable across ‘biologic failed’ and ‘not biologic failed’ subgroups (Figure 1B). IBDQ remission rates in the clinical response (78.2%) and clinical remission (80.5%) groups were sustained in ‘not biologic failed’ subgroup (80.1% and 83.2%) and were numerically lower in ‘biologic failed’ subgroup (74.0% and 74.5%), respectively (Figure 1C). Conclusion: In the LUCENT-3 extension study, treatment with mirikizumab showed sustained improvement in quality of life up to W104 in patients with moderately to severely active UC with or without prior biologic failure. 1Sands BE, et al. Mirikizumab improves quality of life in moderately to severely active ulcerative colitis: improvement in inflammatory bowel disease scores in participants of the LUCENT-1 and LUCENT-2 randomized, double-blind, placebo-controlled phase 3 induction and maintenance trials. United European Gastroenterol J. 2022;10(S8):778.Figure 1.: IBDQ outcomes at W104 of continuous mirikizumab treatment in patients who achieved clinical responsea or remissionb in LUCENT-2 – mITT population : A) LS mean change from baseline in IBDQ total and domain scores (ANCOVA with mBOCF) ; B) IBDQ response rates (≥16-point improvement from baseline) (NRI); and C) IBDQ remission rates (IBDQ total score ≥170) (NRI) Baseline was defined as the last nonmissing assessment recorded on or prior to the date of the first study drug administration at Week 0 in LUCENT-1 induction study. *Within-treatment change from baseline P<0.001 calculated using ANCOVA. aClinical Responders: Patients who achieved ≥2 points and ≥30% decrease from baseline in MMS and a decrease of ≥1 point in the RB subscore from baseline or an RB score of 0 or 1. bClinical Remitters: Patients who achieved SF subscore = 0 or 1 with ≥1 point decrease from baseline; RB = 0; ES = 0 or 1. cBiologic failed: Inadequate response, loss of response, or intolerant to a biologic therapy or Janus kinase inhibitors for UC. dNot biologic failed: Failed conventional treatments (i.e., immunomodulators/corticosteroids); may include some participants who were exposed to but did not fail biologic treatment. ANCOVA, analysis of covariance; ES, endoscopic subscore; IBDQ, Inflammatory Bowel Disease Questionnaire; LS, least squares; mBOCF, modified baseline observation carried forward; mITT, modified intent-to-treat; MMS, modified Mayo score; NRI, non-responder imputation; RB, rectal bleeding; SE, standard error; SF, stool frequency.

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