Efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus and lupus nephritis who are refractory to conventional therapy

被引:35
作者
Tanaka, Yoshiya [1 ]
Takeuchi, Tsutomu [2 ]
Miyasaka, Nobuyuki [3 ]
Sumida, Takayuki [4 ]
Mimori, Tsuneyo [5 ]
Koike, Takao [6 ]
Endo, Kazuhiro [7 ]
Mashino, Naomi [7 ]
Yamamoto, Kazuhiko [8 ]
机构
[1] Univ Occupat & Environm Hlth, Sch Med, Dept Internal Med 1, 1-1 Iseigaoka, Kitakyushu, Fukuoka 8078555, Japan
[2] Keio Univ, Sch Med, Dept Internal Med, Div Rheumatol, Tokyo, Japan
[3] Tokyo Med & Dent Univ, Grad Sch Med & Dent Sci, Dept Med & Rheumatol, Tokyo, Japan
[4] Univ Tsukuba, Div Clin Immunol, Doctoral Program Clin Sci, Grad Sch Comprehens Human Sci, Ibaraki, Japan
[5] Kyoto Univ, Dept Rheumatol & Clin Immunol, Grad Sch Med, Kyoto, Japan
[6] NTT East Sapporo Med Ctr, Sapporo, Hokkaido, Japan
[7] Zenyaku Kogyo Co Ltd, Tokyo, Japan
[8] Univ Tokyo, Grad Sch Med, Dept Allergy & Rheumatol, Tokyo, Japan
关键词
Efficacy; Lupus nephritis; Phase II study; Rituximab; Safety; NEPHROTIC SYNDROME; DOUBLE-BLIND; DEPLETION; CLASSIFICATION; MANAGEMENT; REDUCTION; MORBIDITY; CRITERIA; COHORT;
D O I
10.3109/14397595.2015.1060665
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives. To evaluate the efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN) who are refractory to conventional immunosuppressive therapy.Methods. Eligible patients received rituximab at a dose of 1,000 mg at days 1, 15, 169, and 183, and were followed for 53 weeks after the first dose of rituximab. Overall disease activity was assessed monthly using a British Isles Lupus Assessment Group activity index. Patients with LN (Upr/Ucr 1.0 at study entry) were identified and their renal responses were evaluated according to the criteria proposed by the American College of Rheumatology (ACR) and the Lupus Nephritis Assessment with Rituximab (LUNAR) study.Results. A total of 34 patients were enrolled and received at least one dose of rituximab. Decrease in disease activity was achieved in 16 (76.5%) out of 34 patients. In 17 patients with LN, response rates of 58.8% and 52.9% by ACR and LUNAR criteria, respectively, were seen. Successful steroid tapering was achieved in association with disease remission. Rituximab was well tolerated, and most adverse drug reactions were grade 1-2 in severity.Conclusions. Rituximab is effective for treatment of Japanese patients with SLE and LN refractory to conventional therapy.
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页码:80 / 86
页数:7
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