Avacopan (2) – Tavneos®

• Clinical trials
  • The ADVOCATE trial is a randomised, double-blind Phase 3 trial comparing avacopan with prednisone, each in combination with a rituximab or cyclophosphamide treatment regimen.

Adults with severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

• Overall, therefore, additional benefit from avacopan in combination with a cyclophosphamide or rituximab treatment regimen is not proven for adults with severe active GPA or MPA.
• Conclusion
  • The data from the ADVOCATE study are not suitable for establishing additional benefit, as not only the achievement of remission but also the maintenance of remission must be taken into account for the present benefit assessment.
  • With regard to maintenance therapy, however, the appropriate comparator therapy has not been implemented.
  • Apart from that, the data on remission induction at week 26 are subject to uncertainty due to the lack of treatment in the comparator arm after week 20.
• Overall assessment
  • On balance, there are no suitable data available to demonstrate the additional benefit of Avacopan compared with the appropriate comparator therapy for the treatment of adults with severe active GPA and MPA.
  • An additional benefit of Avacopan is therefore not proven.

Courtesy translation only, please refer to the German original.