Evaluation of the Long-Term Safety of Avacopan in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis in the Real World (AvacoStar): Protocol for a Noninterventional Prospective Cohort Study - P
3 hours ago
- #ANCA-associated vasculitis
- #Avacopan
- #Real-world evidence
- Avacopan is approved for treating severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in combination with rituximab or cyclophosphamide.
- The AvacoStar study aims to evaluate the long-term safety and real-world effectiveness of avacopan in patients with antineutrophil cytoplasmic antibody-associated vasculitis.
- Primary objectives include assessing the incidence of medical events of special interest such as liver injury, cardiac safety, serious infections, and malignancy.
- The study is a noninterventional, multinational, prospective postauthorization safety study enrolling up to 500 patients in Germany and the UK.
- Patients will be followed for up to 7 years, with the final report expected in 2031 and interim reports every 24 months.
- AvacoStar is expected to be the largest European prospective real-world evidence study on avacopan's long-term safety in severe, active GPA or MPA.