Mirikizumab Maintains Efficacy, Safety in Ulcerative Colitis
Patients with moderately-to-severely active ulcerative colitis (UC) demonstrated durable treatment benefits with mirikizumab through 152 weeks of continuous therapy, according to results from the LUCENT-3 open-label extension study.
Sustained clinical, endoscopic, histologic, and symptomatic improvements were observed, with no new safety concerns reported.
The LUCENT-3 trial followed 316 patients who completed at least 52 weeks of mirikizumab maintenance therapy in prior LUCENT trials. Of these, 286 had achieved clinical response and 179 were in remission at week 52. The long-term extension evaluated outcomes through week 152, using modified nonresponder imputation (mNRI) and observed case analyses.
Among week 52 responders, 81.6% maintained clinical response at week 152. Remission rates at week 152 included clinical remission (56.1%), corticosteroid-free remission (54.5%), endoscopic remission (61.0%), and histologic-endoscopic mucosal remission (52.6%). Symptomatic remission was achieved in 74.9%, and 58.6% achieved bowel urgency (BU) remission.
For patients in remission at week 52, outcomes were even more robust: 85.4% retained clinical response and 70.1% sustained clinical remission, with corresponding improvements across histologic and endoscopic endpoints.
Clinical benefit was also reflected in patient-reported outcomes. “Stool frequency, rectal bleeding, BU, and abdominal pain score reductions from induction baseline to maintenance week 52 were sustained through week 152,” the authors noted.
Safety findings remained consistent with earlier reports; 7.4% of participants experienced severe adverse events (AEs), and 5.3% discontinued due to AEs. Events of special interest were rare, including opportunistic infections (1.8%) and malignancy (0.3%). Antidrug antibody rates declined over time, from 23.6% in year 1 to 3.2% by year 3.
These findings support the long-term use of mirikizumab in UC, including for patients with prior biologic failure, with a favorable safety profile and sustained therapeutic benefit.
Reference
Sands BE, D’Haens G, Clemow DB, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflamm Bowel Dis. 2025;31(7):1876–1890. https://doi.org/10.1093/ibd/izae253
