Background In a previous systematic review (1), our group found no significant differences in most efficacy outcomes between low- (2x500 mg or 1x1,000mg) and high-dose (2x1,000 mg) rituximab (RTX) for the treatment of rheumatoid arthritis (RA).
Objectives To update a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing low- and high-dose RTX for the treatment of RA, considering the full publication of 2 important studies (2, 3).
Methods The systematic literature review searching for RCTs was updated to November 6, 2014 using the Embase, PubMed, Cochrane Library, and Web of Science databases, and hand searching. The primary outcomes were the American College of Rheumatology (ACR) criteria for 20% improvement (ACR20), ACR50, and ACR70 responses and the Disease Activity Score in 28 joints (DAS28) at 24 and 48 weeks. The secondary outcomes were the EULAR (European League against Rheumatism) moderate/good and good responses, the change in Health Assessment Questionnaire (HAQ) score, the change in the radiographic modified Total Sharp Score (mTSS), levels of immunoglobulin G (IgG), and safety outcomes.
Results In total, 7 RCTs (2-8) were identified; 5 RCTs (2,5-8) were included in the meta-analysis of efficacy and safety outcomes. There were no significant differences in the primary outcomes, EULAR responses, and change in HAQ. Mean change in mTSS was 0.25 units (95%CI: 0.01 to 0.49; P=0.04) higher in low-dose group at the end of week 52. Two RCTs (3, 4) did not demonstrate difference between the RTX regimens for maintaining clinical response (obtained initially using high-dose RTX) in anti-TNF-experienced patients. IgG levels were significantly lower in the high-dose group at week 24 (P=0.02). The low-dose RTX group presented a significantly lower incidence of first infusion reactions (P=0.02).
Conclusions Our updated results further support the similar efficacy of low- and high-dose RTX in different subsets of RA patients, despite a small difference in radiographic progression favoring high-dose RTX. The low-dose regimen demonstrated a better clinical and laboratory safety profile.
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Disclosure of Interest None declared