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Effectiveness and safety of mirikizumab as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis?
Published online: May 8, 2024


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Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies
Intest Res. 2023;22(2):172-185

Ulcerative colitis (UC) is a chronic relapsing disease characterized by mucosal inflammation of the colon. The goal of UC treatment is to induce and maintain remission. Despite significant therapeutic advances, current treatments have limited or lose clinical efficacy over time. Mirikizumab is a humanized immunoglobulin G4–variant monoclonal antibody that specifically binds to the p19 subunit of IL23. LUCENT-1 and LUCENT-2 demonstrated mirikizumab was more effective compared with placebo in inducing and maintaining clinical remission in patients with moderately to severely active UC. Would mirikizumab actually be effective in Far East Asian UC patients?
The present study evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies. A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC and no new safety issues have been identified.

  1. At week 12 of LUCENT-1, the proportion of Japanese patients with clinical remission was numerically greater in the mirikizumab group compared with placebo (32.4% [n = 33] vs. 2.9% [n = 1])
  2. At week 40 of LUCENT-2 (52 weeks of treatment), the proportion of Japanese patients in clinical remission was numerically greater in the mirikizumab group compared with the placebo group (48.9% [n = 23] vs. 28.0% [n = 7])
  3. The proportion of Japanese patients with treatment-emergent adverse events (TEAEs) was similar between the mirikizumab and placebo groups during both the induction and maintenance studies.
  4. The most common TEAEs reported during mirikizumab treatment were nasopharyngitis, headache, and arthralgia during induction; and nasopharyngitis, arthralgia, injection site pain, headache, rash, and pyrexia during maintenance.
  5. Overall infections occurred with similar frequency in Japanese patients in the mirikizumab and placebo groups during both induction and maintenance and the severity of all infections was predominantly mild.
Read more about the effectiveness and safety of mirikizumab as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis.

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