Upadacitinib (5) – Rinvoq®

• Clinical trials
  • The U-ACHIEVE and U-ACCOMPLISH studies were both double-blind RCTs comparing upadacitinib at various doses with placebo, which enrolled adult patients with moderate to severe ulcerative colitis who had not responded, or had not responded adequately, to conventional or biologic therapy, or who were intolerant to such treatments.
  • The UNIFI study is a double-blind RCT comparing ustekinumab with placebo in patients with moderate to severe ulcerative colitis who did not respond, or did not respond adequately, to conventional or biologic therapy, or who were intolerant to such therapy.

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

• 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 upadacitinib compared with the appropriate comparator therapy.
• Overall assessment
  • In the overall review, there is therefore no evidence of added benefit for upadacitinib compared with the appropriate comparator therapy in 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 upadacitinib compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.