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Publication Detail
Clinical outcome in 22 patients with rheumatoid arthritis treated with B lymphocyte depletion
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Article
  • Authors:
    Leandro MJ, Edwards JC, Cambridge G
  • Publication date:
    10/2002
  • Pagination:
    883, 888
  • Journal:
    Annals of the Rheumatic Diseases
  • Volume:
    61
  • Issue:
    10
  • Print ISSN:
    0003-4967
  • Keywords:
    1200, activity, adult, ADVERSE, adverse events, Aged, Aged, 80 and over, AGENT, AGENTS, American, antibodies, Antibodies, Monoclonal, Antibody, Antirheumatic Agents, Arthritis, Arthritis, Rheumatoid, As, B CELL, B Lymphocyte, B-cell, B-lymphocyte, B-Lymphocytes, cell, chosen, clinical, Clinical trial, CLINICAL-TRIAL, COHORT, COMBINATION, Combined Modality Therapy, CONTROLLED TRIAL, CP, CRITERIA, Cyclophosphamide, DEPLETION, design, disease, dose, Dose Response, DOSE-RESPONSE, Drug Administration Schedule, drug effects, drug therapy, Drug Therapy, Combination, DURATION, EFFICACY, EVENTS, Female, FOLLOW, Follow-Up Studies, GRADE, IM, IMPROVEMENT, IV, LA, LYMPHOCYTE, Lymphocyte Depletion, Male, Methods, Middle Age, Observation, Open, Other, outcome, Patient, patients, phase, PHASE II, PHASE-II, PR, Prednisolone, PROGRESS, Protocol, response, Result, Rheumatoid arthritis, RHEUMATOID-ARTHRITIS, Rheumatology, rituximab, SAFE, Safety, SCORES, Severity of Illness Index, therapeutic use, therapy, treatment, Treatment Outcome, Treatments, TRIAL, TRIALS
  • Notes:
    UI - 22215432 DA - 20020913 IS - 0003-4967 LA - eng PT - Clinical Trial PT - Journal Article RN - 0 (Antibodies, Monoclonal) RN - 0 (Antirheumatic Agents) RN - 0 (rituximab) RN - 50-18-0 (Cyclophosphamide) RN - 50-24-8 (Prednisolone) SB - IM
Abstract
OBJECTIVES: To obtain evidence for dose response and to extend evidence of safety and efficacy for B lymphocyte depletion in rheumatoid arthritis. METHODS: Twenty two patients with rheumatoid arthritis received a total of 29 treatments with five different combinations of rituximab (RTX), cyclophosphamide (CP), and/or high dose prednisolone (PR) on an open basis as follows; cohort I: RTX 1400 mg/m(2), CP 750x2+PR; cohort II: RTX 300-700 mg/m(2), -CP+/-PR); cohort III: RTX 600-700 mg/m(2), CP 750x2+PR; cohort IV: RTX 1200 mg/m(2), CP 750x2-PR; cohort V: RTX 500 mg/m(2), CP 750x2+PR. American College of Rheumatology (ACR) criteria of improvement at six months were chosen as the primary outcome measure. Disease activity scores and total duration of improvement and of B cytopenia were also recorded. RESULTS: No major adverse events attributable to treatment were seen. ACR grades of improvement at six months were as follows: cohort I: ACR70x3, ACR50x2; cohort II: ACR20x1, ACR0x3; cohort III: ACR70x6, ACR50x2, ACR20x2; cohort IV: ACR70x2, ACR50x2, ACR20x1, ACR0x1; cohort V: ACR0x4. CONCLUSIONS: B lymphocyte depletion in rheumatoid arthritis has so far proved to be safe and associated with major improvement with protocols including RTX 600 mg/m(2) or more and CP, but not with more limited protocols. These observations provide an initial basis for the design of formal trials of B cell depletion and other B cell directed treatments, including a phase II controlled trial now in progress
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