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Multicenter Study
. 2024 Oct;43(10):3195-3204.
doi: 10.1007/s10067-024-07096-y. Epub 2024 Aug 12.

Effectiveness and safety of rituximab in severely relapsed antineutrophil cytoplasmic antibody-associated vasculitis: a retrospective analysis of a Japanese multicentre cohort from the J-CANVAS

Genki Kidoguchi  1 , Yusuke Yoshida  2 , Hirofumi Watanabe  2 , Tomohiro Sugimoto  2 , Sho Mokuda  2 , Takashi Kida  3 , Nobuyuki Yajima  4 , Satoshi Omura  3 , Daiki Nakagomi  5 , Yoshiyuki Abe  6 , Masatoshi Kadoya  7 , Naoho Takizawa  8 , Atsushi Nomura  9 , Yuji Kukida  10 , Naoya Kondo  11 , Yasuhiko Yamano  12 , Takuya Yanagida  3   13 , Koji Endo  14   15 , Kiyoshi Matsui  16 , Tohru Takeuchi  17 , Kunihiro Ichinose  18   19 , Masaru Kato  20 , Ryo Yanai  4 , Yusuke Matsuo  21   22 , Yasuhiro Shimojima  23 , Ryo Nishioka  24 , Ryota Okazaki  25 , Tomoaki Takata  26 , Takafumi Ito  27 , Mayuko Moriyama  19 , Ayuko Takatani  28 , Yoshia Miyawaki  29 , Toshiko Ito-Ihara  30 , Takashi Kawaguchi  31 , Yutaka Kawahito  3 , Shintaro Hirata  2 ; Japan Collaborative Registry of ANCA-Associated Vasculitis (J-CANVAS)
Affiliations
Multicenter Study

Effectiveness and safety of rituximab in severely relapsed antineutrophil cytoplasmic antibody-associated vasculitis: a retrospective analysis of a Japanese multicentre cohort from the J-CANVAS

Genki Kidoguchi et al. Clin Rheumatol. 2024 Oct.

Abstract

We aimed to clarify the long-term safety and efficacy of rituximab (RTX) as a remission induction therapy following severe relapse in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). We retrospectively collected the data of patients with severely relapsed AAV from a Japanese multicentre cohort. The primary exposure was RTX use; the primary outcome was complete remission (CR) proportions at week 24. Baseline characteristics were compared between the RTX and non-RTX groups. We performed multivariate logistic regression analysis and one-to-one propensity score matching analysis as a sensitivity analysis. Totally, 100 patients were enrolled: 52 in the RTX group and 48 in the non-RTX group. Baseline characteristics were comparable between the two groups, except for age, AAV subtype and ANCA serotype. The median age was 71 vs. 75 years, and the PR3-ANCA positivity rate was 44.2% vs. 18.8% in the RTX and non-RTX groups, respectively. No significant difference was observed in CR proportions at week 24 between the two groups (79.2% vs. 68.1%, p = 0.321), with an adjusted odds ratio of 1.27 (95% confidence interval [CI] 0.47-3.51). At week 48, CR proportions were significantly higher in the RTX group (91.7% vs. 64.9%, p = 0.005), with an adjusted odds ratio of 2.95 (95% CI 0.97-9.91). Serious infection rates were lower in the RTX group than in the non-RTX group, with no statistically significant difference. RTX was not superior to conventional immunosuppressive therapies at week 24 but showed significantly favourable results at week 48 for severely relapsed AAV.

Keywords: ANCA-associated vasculitis; Granulomatosis with polyangiitis; Microscopic polyangiitis; Relapse; Rituximab.

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Conflict of interest statement

We disclose the following conflicts of interest with pharmaceutical companies promoting RTX or RTX biosimilars as outlined below. Yusuke Yoshida: speaker fees — Chugai. Takashi Kida: speaker fees — Chugai. Daiki Nakagomi: scholarship donations, speaker fees — Chugai. Naoho Takizawa: speaker fees — Chugai, Kyowa Hakko Kirin, Pfizer. Yuji Kukida: speaker fees — Chugai, Pfizer. Kiyoshi Matsui: research grants — Chugai. Masaru Kato: speaker fees — Chugai, Pfizer. Tomoaki Takata: speaker fees — Chugai; scholarship donations, speaker fees — Kyowa Hakko Kirin. Takafumi Ito: speaker fees — Chugai, Kyowa Hakko Kirin. Takashi Kawaguchi: speaker fees, consultancy — Chugai; speaker fees — Kyowa Hakko Kirin. Yutaka Kawahito: speaker fees, research grants — Chugai; speaker fees — Pfizer. Shintaro Hirata: speaker fees, consultancy fees, research grants — Chugai, Pfizer and additional relationships, including speaker fees, consultancy fees, research grants and honoraria with AbbVie; Asahi — Kasei Pharma; Astellas; AstraZeneca; Ayumi; Bristol Myers Squibb; Boehringer Ingelheim; Daiichi — Sankyo; Eisai; Gilead Sciences; GlaxoSmithKline; Eli Lilly; Janssen; Nippon Shinyaku; Novartis; Otsuka; Taisho; Tanabe — Mitsubishi; and UCB.

Figures

Fig. 1
Fig. 1
Prednisolone dosage at different time points. This box-and-whisker plot diagram illustrates the prednisolone dosage up to 144 weeks in the RTX and non-RTX groups. RTX, rituximab
Fig. 2
Fig. 2
Sankey diagram illustrating proportions of complete remission, non-complete remission, missing/withdrawal and death at baseline, 24 weeks and 48 weeks in the RTX (left) and non-RTX groups (right). Patients who achieved CR are classified as “complete remission”, those who did not achieve CR as “non-remission”, those with missing data or who withdrew from the registry as “missing/withdrawn” and those who passed away as “death”. The values in the figure represent the number of individuals and their proportions at each time point. RTX, rituximab; CR, complete remission
Fig. 3
Fig. 3
Subgroup analysis by ANCA serotype and AAV subtype on the association between RTX use and complete remission. The forest plot describes the results of the subgroup analysis by ANCA serotype and AAV subtype on the association between RTX use and complete remission. We depict the odds ratio for achieving remission with RTX use. ANCA, antineutrophil cytoplasmic antibody; AAV, ANCA-associated vasculitis; RTX, rituximab
See this image and copyright information in PMC

References

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