Meaningful corticosteroid-sparing effect of mirikizumab in UC

A subgroup analysis of the phase 3 LUCENT-2 study demonstrated that the corticosteroid-sparing effect of mirikizumab was clinically meaningful among participants 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 an extended period of 12 weeks of induction therapy in the LUCENT-2 trial (NCT03524092). Subsequently, the responders (n=144) received subcutaneous mirikizumab 200 mg every 4 weeks up to week 52. Among 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 [1]. “If a clinical response was reached at week 24 or earlier, 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, i.e. patients who discontinued corticosteroids and did not discontinue study treatment or re-initiate corticosteroids use for the remainder of the study period. “At week 24, the response rates were 52.5% and 53.2% for participants receiving corticosteroids at baseline and for those not treated with these agents at baseline, respectively,” said Prof. Laharie. After 28 weeks of maintenance therapy, 89.6% (as observed) of baseline corticosteroid users had discontinued this therapy. Moreover, 36% of this subgroup had achieved clinical remission and were 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 participants who received extended induction therapy had mostly severe endoscopic subscores and had largely failed a prior advanced therapy,” according to Prof. Laharie. “Nonetheless, over half of the extended induction responders discontinued corticosteroids by week 6 of the tapering period and remained off corticosteroids throughout the study.”

1. 
   
   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. OP046, UEG Week 2024, 12–15 October, Vienna, Austria.

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Posted on 28 November 2024