Introduction: Mirikizumab (miri) improved symptom control in a Phase 3, multicenter, randomized, double-blind, parallel, placebo-controlled induction study at Week (W)12, in patients (pts) with moderately-to-severely active ulcerative colitis (UC; LUCENT-1). This analysis assessed sustained symptom control during the maintenance phase through W40 (W52 of continuous therapy), among pts who were induced into clinical response with miri.
Methods: During the 40W maintenance study (LUCENT-2), pts (N=544) who achieved clinical response to miri 300mg Q4W by W12 of induction, were re-randomized 2:1 to subcutaneous (SC) miri 200mg (n=365) or PBO Q4W (n=179). We evaluated sustained control of stool frequency (SF), rectal bleeding (RB), bowel movement urgency (BU) and abdominal pain (AP). The proportion of pts achieving SF Remission (defined as SF=0, or SF=1 with a ≥1-point decrease from induction baseline [BL]), RB Remission (RB=0), Symptomatic Remission (both SF and RB Remission), Stable Maintenance of Symptomatic Remission (defined as pts in Symptomatic Remission for at least 7 out of 9 visits from W4 to W36 and also at Week 40 among pts in Symptomatic Remission and Clinical Response at the end of LUCENT-1), and AP Improvement (Numeric Rating Scale [NRS] pain score ≥30% improvement from BL in pts with baseline AP NRS ≥3) were assessed. BU NRS change from baseline, and the proportion of pts achieving BU Remission (NRS 0 or 1 in pts with BU NRS ≥3 at baseline) were evaluated.
Results: A greater proportion of miri-treated pts achieved SF Remission, RB Remission and Symptomatic Remission compared to PBO at W40 (Table), with significant differences observed from W8 of LUCENT-2 (p=0.042; p=0.004; p=0.036, respectively) and maintained through W40. Miri-treated pts had a significantly higher percentage of Stable Maintenance of Symptomatic Remission (p< 0.001). Pts in the miri-treatment group had a significantly greater mean reduction in BU NRS change from induction BL starting at W12 (p=0.034) onwards compared to PBO (Table). Pts assigned to miri accrued an additional 13.6 percentage-point benefit in BU Remission during the first 8W of maintenance therapy and achieved a significant greater improvement at W40 compared to PBO (p< 0.001, Table). Similarly, AP was significantly improved for the miri-treated group starting at W16 (p=0.034) onwards compared to PBO.
Discussion: Miri provides sustained control of UC symptoms including BU, RB, and SF compared to PBO in pts with moderately to severely active UC.
