Mirikizumab demonstrates efficacy up to 52 weeks in Crohn’s disease
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Phase 2 data support the safety and efficacy of mirikizumab in patients with Crohn’s disease, according to results presented at UEG Week.
“At UEG Week, Lilly presented the first disclosure of new 52-week efficacy and safety data from the phase 2 SERENITY study evaluating mirikizumab in patients with moderately to severely active Crohn’s disease, and results showed continued symptom improvement and endoscopic response and remission,” Lotus Mallbris, MD, PhD, vice president and global head of immunology product development at Lilly, told Healio Gastroenterology. “These encouraging phase 2 results continue to provide evidence of the efficacy and safety of mirikizumab in [inflammatory bowel disease] indications, and we look forward to continuing our clinical program for mirikizumab and hope to help those living with Crohn’s disease.”
Researchers randomly assigned patients with moderate-to-severe CD to placebo, 200 mg mirikizumab, 600 mg mirikizumab, 1,000 mg mirikizumab or administered IV every 4 weeks at 0, 4 and 8 weeks. At week 12, patients who received mirikizumab and achieved 1 point or more improvement in Endoscopic Score for Crohn’s Disease were additionally randomly assigned to continue IV treatment (n = 41) or subcutaneous 300 mg mirikizumab every 4 weeks (n = 46). Investigators assessed clinical and endoscopic endpoints at 52 weeks.
Results showed at 52 weeks, the endoscopic response rate was 58.5% in the IV group and 58.7% in the subcutaneous mirikizumab group. The patient-reported remission rate in the IV group was 46.3% and 66.7% in the subcutaneous group.
According to researchers, those in the IV group and subcutaneous group who had an endoscopic response at week 12 also had an endoscopic response at week 52 (69.6% and 66.7%, respectively). At 12 weeks, 50% of those in the IV group and 64.3% in the subcutaneous group who had endoscopic remission also had endoscopic remission at 52 weeks. Because of an adverse event, one patient from each group discontinued.
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Sands BE, et al. OP108. Estimated effects of screening delays due to SARS-CoV-2 pandemic on colorectal cancer mortality. Presented at: UEG Week; Oct. 11-13, 2020.
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