Mirikizumab induces, maintains remission among nearly 50% of patients with UC at 40 weeks
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Key takeaways:
- Mirikizumab induced remission among 24.3% and 49.9% at weeks 12 and 40.
- Opportunistic infections or cancer developed in a few mirikizumab-treated patients.
In two phase 3 trials, mirikizumab induced and maintained remission at a higher rate compared with placebo among patients with moderate to severely active ulcerative colitis, according to data in The New England Journal of Medicine.
“Current therapies [for UC] are limited by increased risks of infection or cancer, nonresponse to primary therapy or loss of clinical benefit over time,” Geert D’Haens, MD, PhD, of the department of gastroenterology and hepatology at Amsterdam University Medical Center, and colleagues wrote. “Mirikizumab, a humanized IgG4-variant monoclonal antibody that specifically binds to subunit p19 of interleukin-23, showed efficacy in a phase 2 trial involving patients with ulcerative colitis.”
The phase 3 LUCENT-1 induction and LUCENT-2 maintenance trials were randomized, double-blind, placebo-controlled studies aimed to report the safety and efficacy of mirikizumab among patients with moderate to severe UC. In the modified intention-to-treat induction trial, 1,162 patients received either IV mirikizumab 300 mg (n = 868) or placebo (n = 294) every 4 weeks for 12 weeks. In the maintenance trial, 544 responders crossed over into maintenance and received either subcutaneous mirikizumab 200 mg (n = 365) or placebo (n = 179) every 4 weeks for 40 weeks.
The primary outcome was clinical remission at weeks 12 and 40. Secondary endpoints included clinical response, endoscopic remission and bowel movement urgency.
At week 12, 24.2% of patients in the treatment group and 13.3% of patients in the placebo group achieved clinical remission (difference, 11.1 percentage points; 95% CI, 3.2-19.1). At week 40, 49.9% and 25.1%, respectively, achieved clinical remission (difference, 23.2 percentage points; 95% CI, 15.2-31.2). Patients in the treatment group also had a “significantly greater” rate of glucocorticoid-free clinical remission, maintenance of clinical remission, endoscopic remission, histologic-endoscopic mucosal remission and bowel urgency remission.
Researchers observed 15 cases of opportunistic infection and eight cases of opportunistic cancer.
“In these two phase 3 trials, we found that, over periods of 12 weeks and 24 weeks, mirikizumab therapy had efficacy in both induction and maintenance phases across clinical, symptomatic, endoscopic and histologic measures of disease, even after treatment failure with conventional immunosuppressive agents, biologic therapies or tofacitinib,” D’Haens and colleagues concluded. “Opportunistic infections or cancer developed in a small number of mirikizumab-treated patients. Additional and longer trials are ongoing to further assess the efficacy and safety of mirikizumab therapy in patients with ulcerative colitis.”
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D’Haens G, et al. N Engl J Med. 2023;doi:10.1056/NEJMoa2207940.
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