Rituximab maintenance therapy for patients with antineutrophil cytoplasmic antibody-associated vasculitis in Japan

Abstract

Objectives

We examined the efficacy and safety of rituximab (RTX) maintenance therapy for patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) in Japan.

Methods

We conducted a retrospective study using a multi-center cohort database of vasculitis patients. All maintenance treatment courses were divided into three groups: a RTX group, a group treated with other immunosuppressant drugs (IS) and a group receiving glucocorticoid monotherapy (GC). The primary endpoint was the comparison of relapse-free survival after 1 year. We also analyzed the occurrence of severe adverse events (SAEs) to assess safety.

Results

We included 123 courses of 107 patients (RTX n = 14, IS n = 64, GC n = 45). Twelve of 14 in the RTX group patients were diagnosed with granulomatosis with polyangiitis (GPA). The relapse-free survival of RTX maintenance therapy was comparable to that in the other groups (p = .122). After 1 year of treatment, the RTX group was administered lower steroid doses and one-third of them could withdraw corticosteroid. The overall incidence of SAE was 0.54/patient-year in the RTX group, 0.39/patient-year in the IS group and 0.34/patient-year in the GC group.

Conclusion

RTX maintenance therapy could be effective and safe in Japanese GPA patients.

Keywords:

• ANCA-associated vasculitis
• maintenance therapy
• relapse
• rituximab
• safety

Conflict of interest

N. Ono received speaker’s fees from Chugai Pharmaceutical. Y. Tada received research grants and speaker’s fees from Chugai Pharmaceutical. All other authors have no conflicts of interest to report.