Extended Mirikizumab Induction Benefits Slower Responders in UC Trials

An extended induction of mirikizumab led to clinical response in more than half of patients with moderately to severely active ulcerative colitis who had failed to achieve clinical response with 12 weeks of mirikizumab induction in the phase 3 LUCENT trials. Researchers reported their findings online ahead of print in Inflammatory Bowel Diseases.

“Our results from the LUCENT trials demonstrated that an extended induction strategy with mirikizumab induced response in about half of the patients, so at the end only approximately 19.7% were true primary nonresponders to mirikizumab. In this study, adding the benefit of ‘extended induction,’ a total of 697 of 868 (80.3%) mirikizumab-treated patients achieved clinical response by week 24,” wrote corresponding author Geert D’Haens, MD, PhD, of the Amsterdam University Medical Center, the Netherlands, and study coauthors.

The analysis focused on participants who did not respond to 300 mg of intravenous (IV) mirikizumab every 4 weeks by week 12. Those participants went on to receive 3 additional 300-mg IV doses every 4 weeks.

Among them, 53.7% achieved clinical response after the extended induction at week 24, according to the study. By week 52, 36.1% achieved clinical remission.

The study also looked at induction responders who subsequently lost response while receiving mirikizumab maintenance therapy. After receiving rescue therapy with 3 more 300-mg IV mirikizumab doses every 4 weeks, 63.2% of the “reinduction population” achieved symptomatic response and 36.8% achieved remission.

Patient factors positively associated with clinical response to extended induction included no prior treatment with a biologic or tofacitinib, no immunomodulators at baseline, older than 40 years, and modified Mayo Score improvement at week 12, the study found. Additionally, the safety profile with extended induction was similar to initial induction.

“In conclusion, the results suggest that some patients with active ulcerative colitis respond slower to induction treatment and may benefit from an extended course of induction treatment with mirikizumab to achieve clinical response or remission…” researchers wrote. “This information could be helpful in clinical management decisions for extended and reinduction in patients with moderately to severely active ulcerative colitis.”

Reference:
D'Haens G, Higgins PDR, Peyrin-Biroulet L, et al. Extended induction and prognostic indicators of response in patients treated with mirikizumab with moderately to severely active ulcerative colitis in the LUCENT Trials. Inflamm Bowel Dis. Published online January 25, 2024. doi: 10.1093/ibd/izae004