Real-world effectiveness of rituximab or intravenous cyclophosphamide versus non-use in patients with severe microscopic polyangiitis and granulomatosis with polyangiitis: a retrospective cohort study of J-CANVAS.
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Omura Satoshi, Kida Takashi, Kitai Junya, Yanagida Takuya, Nakagomi Daiki, Abe Yoshiyuki, Wada Makoto, Takizawa Naoho, Nomura Atsushi, Kukida Yuji, Kondo Naoya, Takagi Hirosuke, Endo Koji, Hirata Shintaro, Azuma Naoto, Takeuchi Tohru, Fukui Shoichi, Kamada Kazuro, Yanai Ryo, Matsuo Yusuke, Shimojima Yasuhiro, Nishioka Ryo, Okazaki Ryota, Takata Tomoaki, Moriyama Mayuko, Takatani Ayuko, Miyawaki Yoshia, Shirai Tsuyoshi, Dobashi Hiroaki, Ito Takafumi, Matsumoto Isao, Takada Toshihiko, Ito-Ihara Toshiko, Yajima Nobuyuki, Kawaguchi Takashi, Seno Takahiro, Kawahito Yutaka
Аннотация
METHODS: This observational study emulated a target trial using data from the Japan Collaborative Registry of ANCA-associated Vasculitis. Patients aged ≥20 years with newly diagnosed or relapsing MPA or GPA (2017-23) were included. RTX or IVCY use within 4 weeks defined the treatment group; others formed the control group. The primary outcome was failure to achieve remission at week 24 (Birmingham Vasculitis Activity Score = 0 and prednisolone ≤ 10 mg/day). Secondary outcomes included a composite of death, kidney failure, and relapse, and serious infection. In inverse probability weighted population, risk ratios were estimated using modified Poisson regression.
RESULTS: Among 544 patients (MPA: 413, GPA: 131), 63.6% received RTX or IVCY. The risk ratio for failure to achieve remission was 0.72 (95% CI: 0.61-0.85), and for the composite outcome was 0.57 (95% CI: 0.33-0.97), and for serious infection was 1.03 (95% CI: 0.47-2.25). Results were robust in sensitivity analyses.
CONCLUSIONS: RTX and IVCY improved short-term outcomes in MPA and GPA without increasing infection risk, supporting their recommendation as standard therapy.