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• W4381113209 abstract "<h3>Background</h3> Here we report the efficacy and safety of the Phase (Ph)3 LUCENT-2 study, a double-blind, randomized withdrawal maintenance study, in patients who responded to mirikizumab (miri) induction therapy. <h3>Methods</h3> Miri induction clinical responders (primary efficacy population N=544) were re-randomized in a 2:1 ratio to receive blinded miri 200 mg or PBO subcutaneously (SC) every four weeks (Q4W) for 40 weeks. Randomization was stratified by biologic-failed status, induction remission status, baseline (BL) corticosteroid (CS) use, and geographic region (North America/Europe/other). The primary objective was to determine if miri was superior to PBO in achieving clinical remission at Week 40. Key secondary objectives were multiplicity controlled and included CS-free remission, endoscopic remission, histologic-endoscopic mucosal remission (HEMR), improvement in bowel urgency, bowel urgency remission, and maintenance of clinical remission. <h3>Results</h3> Baseline demographic and disease characteristics were balanced across the two treatment groups, including BL corticosteroid use (miri 37.0%, PBO 38.0%) and biologic failure status (miri 35.1%, PBO 35.8%). A significantly greater proportion of patients treated with miri achieved clinical remission at Week 40 (miri 49.9%, PBO 25.1%; Δ=23.2 [95%CI 15.2, 31.2]; p<0.001). Among miri treated patients who achieved clinical remission at Week 40, approximately 90% were in CS-free remission. All key secondary endpoints were achieved (each: p<0.001), including a significantly greater proportion of patients who maintained clinical remission, and who achieved bowel urgency remission and HEMR compared to PBO. The frequency of treatment-emergent adverse events (TEAEs) in miri patients was similar to PBO. There were fewer serious adverse events and discontinuations due to adverse events in miri patients compared to PBO. The most common TEAEs were nasopharyngitis and arthralgia with miri and ulcerative colitis with PBO. <h3>Conclusions</h3> In patients responding to miri induction therapy, the miri 200 mg SC Q4W maintenance regimen demonstrated an acceptable safety profile and clinically meaningful and statistically significant improvements across clinical, symptomatic, endoscopic, and histologic endpoints. The safety profile was consistent with previous miri studies in UC. These results confirm miri’s Ph2 efficacy and build on the Ph3 induction efficacy demonstrated in LUCENT-1." @default.
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• W4381113209 date "2023-06-01" @default.
• W4381113209 modified "2023-09-27" @default.
• W4381113209 title "P72 Efficacy and safety of mirikizumab as maintenance therapy in patients with moderate-severe active ulcerative colitis: phase 3 LUCENT-2 study results" @default.
• W4381113209 doi "https://doi.org/10.1136/gutjnl-2023-bsg.144" @default.
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