p19-Directed IL-23 antibody mirikizumab

Mirikizumab is a p19-directed IL-23 antibody. It has demonstrated efficacy and was well-tolerated during 12 weeks of induction treatment in a phase 2 randomised clinical trial [1]. Results through week 52 from this trial demonstrated durable efficacy, with no unexpected safety signals and few discontinuations due to AEs throughout the maintenance period [2].

Patients who achieved clinical response to mirikizumab at week 12, were re-randomised to receive mirikizumab 200 mg subcutaneously every 4 (n=47) or every 12 weeks (n=46) through week 52. At baseline, 52.7% had previously received a biologic. The main results at week 52 for the respective groups were as follows:

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  • 46.8% and 37.0% were in clinical remission;
  • 80.9% and 76.1% had a clinical response;
  • 57.4% and 47.8% had an ES 0/1;
  • 61.1% and 38.5% of those in clinical remission at week 12 remained in clinical remission at week 52; and
  • 37.9% and 36.4% of those with clinical response, but not in remission, at week 12 achieved clinical remission at week 52.

During the maintenance period, 1 patient discontinued the study due to an adverse event, and similar frequencies of treatment-emergent adverse events and serious adverse events were reported across both treatment groups. This is the first data demonstrating that a p19-directed IL-23 antibody may be an effective maintenance therapy in patients with moderately to severely active ulcerative colitis.

1. 
   
   1. Reich K, et al. Br J Dermatol. 2019 Feb 7. Doi: 10.1111/bjd.17628. [Epub ahead of print]
   2. Geert G, et al. ECCO 2019, OP38.

Posted on 9 May, 20199 April, 2024