Filgotinib (2) – Jyseleca®

• Clinical trials
  • Instead, the pU presents the results of the SELECTION trial, which is a randomised, double-blind trial comparing filgotinib with placebo.

a) Adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or have an intolerance or contraindication.

• An additional benefit is not proven.
• To assess the additional benefit of filgotinib compared with the appropriate comparator therapy in adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy or to a biologic, no longer respond to such treatment, or who are intolerant to such treatment, there are no suitable data available for comparing filgotinib with the appropriate comparator therapy (ZVT) specified by the G-BA.
• Instead, the pharmaceutical company presents the results of the SELECTION study, which is a randomised, double-blind trial comparing filgotinib with placebo.
• In line with the pharmaceutical manufacturer’s assessment, the SELECTION study is therefore not suitable for evaluating the additional benefit of filgotinib compared with the appropriate comparator therapy.
• Overall assessment
  • Consequently, for both patient populations, there is no hint of additional benefit from filgotinib compared with the appropriate comparator therapy; additional benefit is therefore not proven in either case.

b) Adults with moderate to severe active ulcerative colitis who have had an inadequate response to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it, or are intolerant to such treatment.

• 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 to such treatment, additional benefit for filgotinib compared with the appropriate comparator therapy is not proven.
• There are no suitable data available to assess the additional benefit of filgotinib compared with the appropriate comparator therapy in adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy or to a biologic, no longer respond to such treatment or are intolerant of it, there are no suitable data available for comparing filgotinib with the appropriate comparator therapy (ZVT) as determined by the G-BA.
• Instead, the pharmaceutical company presents the results of the SELECTION study, which is a randomised, double-blind trial comparing filgotinib with placebo.
• In line with the pharmaceutical manufacturer’s assessment, the SELECTION study is therefore not suitable for evaluating the additional benefit of filgotinib compared with the appropriate comparator therapy.
• Overall assessment
  • Consequently, for both patient populations, there is no hint of additional benefit from filgotinib compared with the appropriate comparator therapy; additional benefit is therefore not proven in either case.

Courtesy translation only, please refer to the German original.