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Improving efficacy with longer mirikizumab treatment in CD

Presented by
Prof. Séverine Vermeire, KU Leuven, Belgium
Conference
ECCO 2025
Trial
Phase 3, VIVID-2
Doi
https://doi.org/10.55788/dc61fde9
Mirikizumab displayed excellent maintenance rates after 2 years of therapy in patients with moderately to severely active Crohn’s disease (CD). Moreover, a substantial proportion of participants reached an endoscopic response in the second year of mirikizumab treatment after not showing an endoscopic response after 1 year of therapy.

“Recently, the anti-IL23p19 antibody mirikizumab was approved for the treatment of moderately to severely active CD,” said Prof. Séverine Vermeire (KU Leuven, Belgium) [1]. Prof. Vermeire presented the efficacy and safety data of participants who had received up to 2 years of treatment with mirikizumab. In the VIVID-1 study, participants received mirikizumab for 52 weeks. Subsequently, endoscopic responders (n=251) received the maintenance dose of 300 mg, subcutaneously administered every 4 weeks in the VIVID-2 study. Endoscopic non-responders (n=179) first received re-induction therapy, after which they continued on the maintenance dose. Prof. Vermeire presented the findings per modified non-responder imputation at week 52 of the VIVID-2 study.

Maintained endoscopic response (81.8%) and maintained endoscopic remission (72.5%) rates were high. Next to this, 33.3% of the participants who had an endoscopic response at week 0 of the VIVID-2 study gained endoscopic remission at week 52 of the VIVID-2 study. In the endoscopic non-responder group of participants, 30.9% had gained an endoscopic response, and 12.1% had gained endoscopic remission at 52 weeks of follow-up. Prof. Vermeire further emphasised that the safety profile of mirikizumab was consistent with previously reported data. The discontinuation rate due to adverse events was 0.8% in the endoscopic responders arm and 5.0% in the endoscopic non-responders arm.

In short, mirikizumab was associated with high maintenance rates, with more participants achieving an endoscopic response at 2 years of treatment than after 1 year of treatment. The safety profile was consistent with the known safety profile of mirikizumab in this population of patients with CD.

  1. Vermeire S, et al. Long-term efficacy and safety of mirikizumab treatment for Crohn’s disease: results from the VIVID-2 open-label extension study. DOP05, 20th Congress of ECCO, 19–22 February 2025, Berlin, Germany.

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