Mirikizumab (1) – Omvoh®

• Clinical trials
  • In the dossier, the pharmaceutical manufacturer presents data from the randomised, sequential studies LUCENT 1 and LUCENT 2 comparing mirikizumab with placebo.

a) Adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or are intolerant of it

• For adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, they no longer respond to it, or are intolerant of it, the additional benefit is not proven.

b) Adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it, or are intolerant to it

• For adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, the additional benefit is not proven.
• Overall, therefore, for b) adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, additional benefit is not proven for mirikizumab compared with the appropriate comparator therapy.
• Overall assessment
  • In summary, therefore, for b) adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, additional benefit is not proven for mirikizumab compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.