Etrasimod (1) – Velsipity®

• Clinical trials
  • In the dossier, the pharmaceutical manufacturer presents data from the randomised ELEVATE UC 52 trial comparing etrasimod with placebo.

a) Adults and adolescents aged 16 years and over 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 and adolescents aged 16 years and over 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.
• For both patient group a) and patient group b), there are no direct comparative data available for etrasimod versus the appropriate comparator therapy.
• In the dossier, the pharmaceutical manufacturer presents data from the randomised ELEVATE UC 52 trial comparing etrasimod with placebo. The study included adults and adolescents aged 16 years and over with moderate to severe active ulcerative colitis who had responded inadequately to at least one conventional therapy or at least one therapy with a biologic or a JAK inhibitor, no longer responded to such treatments, or who were intolerant to them. Throughout the entire 52-week study period, the use of all active ingredients (INNs) listed in the G-BA’s appropriate comparator therapy was prohibited in accordance with the study protocol. The study is therefore not suitable for determining any additional benefit of etrasmiod compared with the appropriate comparator therapy.
• Overall, this means that for both patient group a) adults and adolescents aged 16 years and over with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it or have shown intolerance, as well as for patient group b) adults and adolescents aged 16 years and over 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; an additional benefit of etrasimod over the appropriate comparator therapy is not proven.

b) Adults and adolescents aged 16 years and over 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

• For adults and adolescents aged 16 years and over 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.
• For both patient group a) and patient group b), there are no direct comparative data available for etrasimod against the appropriate comparator therapy.
• In the dossier, the pharmaceutical manufacturer presents data from the randomised ELEVATE UC 52 trial comparing etrasimod with placebo. The study included adults and adolescents aged 16 years and over with moderate to severe active ulcerative colitis who had responded inadequately to at least one conventional therapy or at least one therapy with a biologic or a JAK inhibitor, no longer responded to such treatments, or who were intolerant to them. Throughout the entire 52-week study period, the use of all active ingredients listed in the G-BA’s appropriate comparator therapy was prohibited in accordance with the study protocol. The study is therefore not suitable for determining any additional benefit of etrasmiod compared with the appropriate comparator therapy.
• Overall, this means that for patient group a) adults and adolescents aged 16 years and over with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it or have shown intolerance, as well as for patient group b) adults and adolescents aged 16 years and over 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), the additional benefit of etrasimod over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.