Nation-wide cohort study of remission induction therapy using rituximab in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis: Effectiveness and safety in the first 6 months

被引：4

作者：

Nagasaka, Kenji ^{[1
,2
]}

Amano, Koichi ^{[3
]}

Dobashi, Hiroaki ^{[4
]}

Nagafuchi, Hiroko ^{[5
]}

Sada, Ken-Ei ^{[6
,7
]}

Komagata, Yoshinori ^{[8
]}

Yamamura, Masahiro ^{[9
]}

Kato, Masaru ^{[10
,11
]}

Endo, Tomomi ^{[12
]}

Nakaya, Izaya ^{[13
]}

Takeuchi, Tsutomu ^{[14
]}

Murakawa, Yohko ^{[15
]}

Sugihara, Takahiko ^{[16
]}

Saito, Masaya ^{[17
]}

Hayashi, Taichi ^{[18
]}

Furuta, Shunsuke ^{[19
]}

Tamura, Naoto ^{[20
]}

Karasawa, Kazunori ^{[21
]}

Banno, Shogo ^{[22
]}

Endo, Shuichiro ^{[23
]}

Majima, Masako ^{[24
]}

Kaname, Shinya ^{[8
]}

Arimura, Yoshiriro ^{[8
,25
]}

Harigai, Masayoshi ^{[24
]}

机构：

[1] Ome Municipal Gen Hosp, Dept Rheumatol, Ome, Japan

[2] Tokyo Med & Dent Univ TMDU, Dept Rheumatol, Tokyo, Japan

[3] Saitama Med Univ, Saitama Med Ctr, Dept Rheumatol & Clin Immunol, Kawagoe, Saitama, Japan

[4] Kagawa Univ, Fac Med, Div Hematol Rheumatol & Resp Med, Dept Internal Med, Takamatsu, Kagawa, Japan

[5] St Marianna Univ, Div Rheumatol, Dept Internal Med, Sch Med, Kawasaki, Kanagawa, Japan

[6] Okayama Univ, Dept Nephrol Rheumatol Endocrinol & Metab, Grad Sch Med Dent & Pharmaceut Sci, Okayama, Japan

[7] Kochi Univ, Kochi Med Sch, Dept Clin Epidemiol, Nankoku, Kochi, Japan

[8] Kyorin Univ, Dept Nephrol & Rheumatol, Sch Med, Tokyo, Japan

[9] Okayama Saiseikai Gen Hosp, Ctr Rheumatol, Dept Internal Med, Okayama, Japan

[10] Hokkaido Univ, Grad Sch Med, Dept Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan

[11] Hokkaido Univ, Fac Med, Sapporo, Hokkaido, Japan

[12] Kitano Hosp, Tazuke Kofukai Med Res Inst, Div Nephrol & Dialysis, Osaka, Japan

[13] Iwate Prefectural Cent Hosp, Dept Nephrol & Rheumatol, Morioka, Iwate, Japan

[14] Keio Univ, Sch Med, Dept Internal Med, Div Rheumatol, Tokyo, Japan

[15] Shimane Univ, Internal Med 3, Fac Med, Izumo, Shimane, Japan

[16] Tokyo Metropolitan Geriatr Hosp, Dept Med & Rheumatol, Tokyo, Japan

[17] Akita Univ, Dept Hematol Nephrol & Rheumatol, Grad Sch Med, Akita, Japan

[18] Univ Tsukuba, Fac Med, Dept Internal Med, Ibaraki, Japan

[19] Chiba Univ Hosp, Dept Allergy & Clin Immunol, Chiba, Japan

[20] Juntendo Univ, Dept Internal Med & Rheumatol, Fac Med, Tokyo, Japan

[21] Tokyo Womens Med Univ, Sch Med, Dept Nephrol, Tokyo, Japan

[22] Aichi Med Univ, Dept Nephrol & Rheumatol, Nagakute, Aichi, Japan

[23] Shiga Gen Hosp, Dept Nephrol, Moriyama, Japan

[24] Tokyo Womens Med Univ, Dept Internal Med, Div Rheumatol, Sch Med, Tokyo, Japan

[25] Kichijoji Asahi Hosp, Dept Internal Med, Tokyo, Japan

来源：

MODERN RHEUMATOLOGY | 2023年 / 33卷 / 06期

关键词：

ANCA-associated vasculitis; rituximab; remission; serious infection; TREATMENT RESISTANCE; PREDICTORS; MANAGEMENT; RELAPSE; CYCLOPHOSPHAMIDE; POLYANGIITIS; PHENOTYPE;

D O I：

10.1093/mr/roac150

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objectives The aim of this article is to evaluate the effectiveness and safety of rituximab (RTX) for microscopic polyangiitis and granulomatosis with polyangiitis in Japan. Methods In this prospective observational study, all patients with microscopic polyangiitis and granulomatosis with polyangiitis administered RTX were enrolled at each institution. During the observation period of 2 years, data up to 6 months were analysed. Cox proportional hazards analysis was used to assess the factors associated with an outcome. Results Of the 75 patients who received RTX for remission induction therapy, 53 achieved remission by the sixth month and 50 were in remission at the sixth month. During therapy, 38 serious adverse events were observed in 24 patients, 21 serious infections in 16 patients, and 9 patients died. No factors were associated with remission; however, there was a significant difference between patients with and without remission in serious adverse events (22.6% vs. 54.5%), serious infections (11.3% vs. 45.4%), and death (1.9% vs. 36.4%). The hazard ratio (95% confidence interval) for serious infection 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. Conclusions The effectiveness and safety of RTX for microscopic polyangiitis and granulomatosis with polyangiitis for up to 6 months was demonstrated.

引用

页码：1117 / 1124

页数：8

共 23 条

[21] Comparative efficacy and safety of rituximab, mycophenolate, methotrexate, and cyclophosphamide versus azathioprine as maintenance therapy in antineutrophil cytoplasmic antibody-associated vasculitis: A Bayesian network meta-analysis of randomized controlled trials
Lee, Young Ho
Song, Gwan Gyu
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, 2022, 60 (02) : 97 - 105
[22] Extended versus standard azathioprine maintenance therapy in newly diagnosed proteinase-3 anti-neutrophil cytoplasmic antibody-associated vasculitis patients who remain cytoplasmic anti-neutrophil cytoplasmic antibody-positive after induction of remission: a randomized clinical trial
Sanders, Jan-Stephan F.
de Joode, Anoek A. E.
DeSevaux, Ruud G.
Broekroelofs, Jan
Voskuyl, Alexandre E.
van Paassen, Pieter
Kallenberg, Cees G. M.
Tervaert, Jan Willem Cohen
Stegeman, Coen A.
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2016, 31 (09) : 1453 - 1459
[23] Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial
Merkel, Peter A.
Jayne, David R.
Wang, Chao
Hillson, Jan
Bekker, Pirow
JMIR RESEARCH PROTOCOLS, 2020, 9 (04):

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