Nation-wide Cohort Study of Remission Induction Therapy using Rituximab in Japanese patients with ANCA-Associated Vasculitis: effectiveness and safety in the first six months.

Abstract

To evaluate effectiveness and safety of rituximab (RTX) for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) in Japan. In this prospective observational study, all patients with MPA and GPA administered RTX were enrolled at each institution. During observation period of two years, data up to six months was analysed. Cox proportional hazards analysis was used to assess the factors associated with an outcome. Of the 75 patients who received RTX for remission induction therapy, 53 achieved remission by 6th month and 50 were in remission at 6th month. During therapy, 38 serious adverse events (SAE) were observed in 24 patients, 21 serious infections (SI) in 16 patients, and nine patients died. No factors were associated with remission; however, there was a significant difference between patients with and without remission in SAE (22.6 vs. 54.5 %), SI (11.3 vs. 45.4 %), and death (1.9 vs. 36.4 %). The hazard ratio (95 % CI) for SI was 3.49 (1.29-9.74) for patients aged ≥ 75 years and 3.53 (1.31-9.53) for pulmonary complications. Four patients maintained remission for 6 months. Effectiveness and safety of RTX for MPA and GPA for up to 6 months was demonstrated.