title: Low-dose rituximab therapy for refractory thrombocytopenia in patients with systemic lupus erythematosus--a prospective pilot study.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of low-dose rituximab therapy for refractory thrombocytopenia in patients with SLE.
  
  
  METHODS
  Ten adult SLE patients with severe refractory thrombocytopenia (mean platelet count 10.4 × 10(9)/l) were enrolled in this prospective pilot study. All patients had failed traditional high-dose CSs and immunosuppressants including methylprednisolone pulse therapy. Patients were scheduled to receive i.v. rituximab at a dose of 100 mg once weekly for 4 weeks. Previous dose of CSs were gradually tapered, and immunosuppressants were withdrawn. Patients were followed at Weeks 4, 12, 24 and 36.
  
  
  RESULTS
  All patients completed four courses of low-dose rituximab infusion. At Week 4, two (20%) patients achieved complete responses (CRs, platelet count >100 × 10(9)/l). The CR rate increased to 60% (six patients) at Week 12, was maintained at Week 24 and began to drop at Week 36 (four patients, 40%). Overall response (OR, platelet count >50 × 10(9)/l) was achieved in 5/10, 6/10, 7/10 and 5/10 patients at Weeks 4, 12, 24 and 36, respectively. Peripheral CD19(+) B cells were depleted (<5 × 10(6)/l) in all patients at Week 4, and gradually increased at Weeks 24 and 36. Serum C3, IgG, IgA and IgM levels did not change significantly (P < 0.05). Infusion reaction was observed in two patients. One patient developed pulmonary thrombosis at Week 14 and active tuberculosis at Week 25.
  
  
  CONCLUSIONS
  Low-dose rituximab therapy is effective in treating severe thrombocytopenia in SLE patients who do not respond to vigorous glucocorticoid plus immunosuppressants, and in most cases is safe.
authors.affiliation: Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Chen
authors.forename: Wenjie
authors.initials: W
authors.lastname: Zheng
authors.forename: Jinmei
authors.initials: J
authors.lastname: Su
authors.forename: Dong
authors.initials: D
authors.lastname: Xu
authors.forename: Qian
authors.initials: Q
authors.lastname: Wang
authors.forename: Xiaomei
authors.initials: X
authors.lastname: Leng
authors.forename: Wen
authors.initials: W
authors.lastname: Zhang
authors.forename: Mengtao
authors.initials: M
authors.lastname: Li
authors.forename: Fulin
authors.initials: F
authors.lastname: Tang
authors.forename: Xuan
authors.initials: X
authors.lastname: Zhang
authors.forename: Xiaofeng
authors.initials: X
authors.lastname: Zeng
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhao
authors.forename: Fengchun
authors.initials: F
authors.lastname: Zhang
mesh_terms: D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage*; D001402:B-Lymphocytes / Q000187:drug effects / Q000378:metabolism; D005260:Female; D006801:Humans; D007132:Immunoglobulin Isotypes / Q000097:blood / Q000187:drug effects; D007155:Immunologic Factors / Q000008:administration & dosage*; D008180:Lupus Erythematosus, Systemic / Q000150:complications; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D000069283:Rituximab; D013921:Thrombocytopenia / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D007132:Immunoglobulin Isotypes; D007155:Immunologic Factors; D000069283:Rituximab