title: Efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus and lupus nephritis who are refractory to conventional therapy.
abstract: OBJECTIVE
  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.
authors.affiliation: a The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health Japan , Kitakyushu , Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: b Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: c Department of Medicine and Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Miyasaka
authors.affiliation: d Division of Clinical Immunology, Doctoral Program in Clinical Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba , Ibaraki , Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Sumida
authors.affiliation: e Department of Rheumatology and Clinical Immunology , Graduate School of Medicine, Kyoto University , Kyoto , Japan.
authors.forename: Tsuneyo
authors.initials: T
authors.lastname: Mimori
authors.affiliation: f NTT-East Sapporo Medical Center , Sapporo , Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
authors.affiliation: g Zenyaku Kogyo Co., Ltd ., Tokyo Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Endo
authors.affiliation: g Zenyaku Kogyo Co., Ltd ., Tokyo Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Mashino
authors.affiliation: h Department of Allergy and Rheumatology , Graduate School of Medicine, The University of Tokyo , Tokyo , Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yamamoto
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008181:Lupus Nephritis / Q000188:drug therapy*; D008297:Male; D000069283:Rituximab / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007155:Immunologic Factors; D000069283:Rituximab
keywords: Efficacy; Lupus nephritis; Phase II study; Rituximab; Safety