B0377 - Mirikizumab Significantly Improves Abdominal Pain in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies
Mayo Clinic College of Medicine and Science Rochester, Minnesota
Introduction: Abdominal pain (AP) is a frequent and burdensome symptom in patients (pts) with ulcerative colitis (UC).1 Mirikizumab (miri; IL-23p19 inhibitor) demonstrated efficacy vs placebo (PBO) in adult pts with moderately-to-severely active UC in randomized, double-blind, phase 3 LUCENT-1 (induction/NCT03518086) and LUCENT-2 (maintenance/NCT03524092) studies.2.3 Here, we report the effect of miri vs PBO on AP.
Methods: In the induction study, pts (N=1162) were randomized 3:1 to receive intravenous (IV) miri 300 mg or PBO every 4 weeks (Q4W). Pts who achieved clinical response with miri at W12 (N=544) of induction were re-randomized 2:1 to subcutaneous (SC) miri 200 mg or PBO Q4W through W40 in the maintenance study. Pts recorded “worst AP in the past 24 hours” each day using an 11-point AP Numeric Rating Scale (NRS; 0 = no pain; 10 = worst possible pain) on an electronic diary. AP improvement (AP NRS score ≥30% improvement from baseline [BL] in pts with BL AP NRS ≥3) was evaluated. The Cochran-Mantel-Haenszel test was used to compare the proportion of pts achieving AP improvement with missing data imputed as nonresponse.
Results: As early as W4 (miri 43.0% vs PBO 33.7%; risk difference [95% CI]: 9.7 [2.8–16.6], p=0.007) of the induction study, a significant reduction from BL of at least 30% in AP NRS score was observed in the miri-treated pts vs PBO through W12 (66.4% vs 49.2%; 17.4 [10.3–24.6], p< 0.001). In the maintenance study, a greater percentage of miri-treated pts maintained AP NRS improvement compared to PBO. The separation started at W16 (79.2% vs 69.2%; 9.0 [0.5–17.5], p=0.034) and sustained through W40 (76.2% vs 47.2%; 27.4 [18.3–36.4], p< 0.001; Figure).
Discussion: Miri provided early (W4) and sustained improvement (through W40) of AP compared with PBO in pts with moderately-to-severely active UC.
1Dulai PS, et al. Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis. Aliment Pharmacol Ther. 2020;51(11):1047–66.
2G D’Haens, et al. Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active Ulcerative Colitis: Results from the Phase 3 LUCENT-1 study. J Crohn's Colitis. 2022;16:i028–29.
3M Dubinsky, et al. Efficacy and safety of mirikizumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-2 study. Abs. 867e. Digestive Disease Week, May 21-24, 2022.
