Meaningful corticosteroid-sparing effect of mirikizumab in UC

A subgroup analysis of a phase 3 study demonstrated that the corticosteroid-sparing effect of mirikizumab was clinically meaningful among patients with moderately to severely active ulcerative colitis (UC).

In the LUCENT-1 trial (NCT03518086), participants with moderately to severely active UC (n=868) received mirikizumab (300 mg, intravenous, every 4 weeks) up to week 12. The 272 non-responders were exposed to another 12 weeks of induction therapy in the LUCENT-2 trial (NCT03524092). Subsequently, the responders (n=144) received 200 mg mirikizumab (subcutaneously, every 4 weeks) up to week 52. Of the 272 participants who received extended induction therapy, 118 used systemic corticosteroids at baseline. Prof. David Laharie (University of Bordeaux, France) investigated the steroid-sparing effect of mirikizumab in the subgroup of participants who received extended induction therapy. “If a clinical response was reached at week 24 or earlier, the start of a corticosteroid taper was initiated,” added Prof. Laharie.

At 6 weeks into the steroid-tapering phase, 63.5% (as observed) of the participants receiving corticosteroids at baseline had discontinued this treatment. “At week 24, the response rates were 52.5% and 53.2% for patients receiving corticosteroids at baseline and for those who were not treated with these agents at baseline, respectively,” said Prof. Laharie. After 28 weeks of maintenance therapy, 89.6% (as observed) of the participants receiving corticosteroids at baseline had discontinued this therapy. Moreover, 36.0% of the participants in this subgroup of corticosteroid users at baseline were in clinical remission and off corticosteroids after 28 weeks of maintenance therapy, 71.2% were in symptomatic remission and off corticosteroids, and 32.7% were in corticosteroid-free remission.

“The group of patients who received extended induction therapy had mostly severe endoscopic subscores and had largely failed a prior advanced therapy,” according to Prof. Laharie. “Nonetheless, more than half of the extended induction responders discontinued corticosteroids by week 6 of the taper period and remained off corticosteroids throughout the study.”

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   1. Laharie D, et al. Corticoid-sparing effect of mirikizumab for the treatment of moderately-to-severely active ulcerative colitis: extended induction subgroup analysis from phase 3 trial. Abstract OP046, UEG Week 2024, 12–15 October, Vienna, Austria.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 15 October 202417 October 2024