Risankizumab (4) – Skyrizi®

• Clinical trials
  • In the dossier, the pharmaceutical manufacturer presents data from the randomised INSPIRE (induction study) and COMMAND (maintenance study) trials comparing risankizumab 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 to it, the additional benefit is not proven.
• For both patient group a) and patient group b), there are no direct comparative data available for risankizumab versus the appropriate comparator therapy.
• Overall, therefore, both for patient group 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 – and for patient group b) adults with moderate to severe active ulcerative colitis who have responded inadequately to, no longer respond to, or are intolerant of a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it, or are intolerant to it, additional benefit is not proven for risankizumab compared with the appropriate comparator therapy.

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 to it, the additional benefit is not proven.
• For both patient group a) and patient group b), there are no direct comparative data available for risankizumab versus the appropriate comparator therapy.
• Overall, therefore, for both patient group 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 – and for patient group b) adults with moderate to severe active ulcerative colitis who have responded inadequately to, no longer respond to, or are intolerant of 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 risankizumab compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.