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Publication Detail
An open study of B lymphocyte depletion in systemic lupus erythematosus
  • Publication Type:
    Journal article
  • Publication Sub Type:
  • Authors:
    Leandro MJ, Edwards JC, Cambridge G, Ehrenstein MR, Isenberg DA
  • Publication date:
  • Pagination:
    2673, 2677
  • Journal:
    Arthritis and Rheumatism
  • Volume:
  • Issue:
  • Print ISSN:
  • Keywords:
    administration & dosage, adolescent, adult, ADVERSE, adverse effects, adverse events, AGENT, AGENTS, Anti-Inflammatory Agents, Steroidal, antibodies, Antibodies, Monoclonal, Antibody, Antineoplastic Agents, As, assessment, B Lymphocyte, B-lymphocyte, B-Lymphocytes, British, clinical, Clinical trial, CLINICAL-TRIAL, CONTROLLED TRIAL, corticosteroid, CORTICOSTEROIDS, Cyclophosphamide, DEPLETION, DNA, drug therapy, Drug Therapy, Combination, EFFICACY, EVENTS, fatigue, Female, Follow-Up Studies, global, IM, immunology, Immunosuppressive Agent, Immunosuppressive Agents, improved, IMPROVEMENT, INFUSION, LA, LEVEL, Low, Lupus, Lupus Erythematosus, Systemic, LYMPHOCYTE, Lymphocyte Depletion, MANIFESTATIONS, Methods, Open, Oral, Patient, patients, Prednisolone, Protocol, RANGE, RATIO, Result, rituximab, Safety, SCORES, sedimentation, SERA, serum, SLE, Standard, SYSTEMIC, SYSTEMIC LUPUS ERYTHEMATOSUS, SYSTEMIC-LUPUS-ERYTHEMATOSUS, THERAPIES, therapy, Treatment Outcome, TRIAL, URINARY, VALUES
  • Notes:
    UI - 22271014 DA - 20021017 IS - 0004-3591 LA - eng PT - Clinical Trial PT - Journal Article RN - 0 (Anti-Inflammatory Agents, Steroidal) RN - 0 (Antibodies, Monoclonal) RN - 0 (Antineoplastic Agents) RN - 0 (Immunosuppressive Agents) RN - 0 (rituximab) RN - 50-18-0 (Cyclophosphamide) RN - 50-24-8 (Prednisolone) SB - AIM SB - IM
OBJECTIVE: To gain preliminary evidence for the safety and efficacy of B lymphocyte depletion therapy in refractory systemic lupus erythematosus (SLE). METHODS: Six female patients with active SLE, resistant to standard immunosuppressive therapy, were treated on an open-label basis. During a 2-week period, each patient received two 500-mg infusions of rituximab, two 750-mg infusions of cyclophosphamide, and high-dose oral corticosteroids. RESULTS: No significant adverse events were observed during followup. Patient 1 had not improved at 3 months but was then lost to followup. At 6 months, all 5 remaining patients had improved, as evidenced by improvement in British Isles Lupus Assessment Group global scores, from a median of 14 (range 9-27) at baseline to a median of 6 (range 3-8) at 6 months. Manifestations of SLE such as fatigue, arthralgia/arthritis, and serositis responded particularly well to this protocol. Hemoglobulin levels increased in patients 2, 3, 5, and 6. The erythrocyte sedimentation rate decreased in patients 2, 3, 4, and 5 and was stable in patient 1. In patients 4 and 5, the urinary protein-to-creatinine ratio decreased significantly. C3 serum levels increased in all 5 patients who had low levels at baseline; in two of these patients, patients 2 and 5, C3 values were normal at 6 months. The variation in the level of anti-double-stranded DNA antibody was different in individual patients. CONCLUSION: This study provides sufficient evidence for the safety and possible efficacy of B lymphocyte depletion therapy in SLE to justify a formal controlled trial
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