Low‐ Versus High‐Dose Rituximab for Rheumatoid Arthritis: A Systematic Review and Meta‐Analysis. Issue 2 (February 2014)

• Record Type: Journal Article
• Authors: Bredemeier, Markus; de, Fernando K.; Rocha, Cláudia M.
• Is Part Of: Arthritis care & research. Volume 66:Issue 2(2014:Feb.)
• Page Start: 228
• Page End: 235
• Publication Date: 2014-02
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/acr.22116
• Languages: English
• ISSNs: 2151-464X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="acr22116-sec-0001" sec-type="section"> <title>Objective</title> <p>The approved dose of rituximab (RTX) for rheumatoid arthritis (RA) is 2 × 1, 000 mg infusions given 2 weeks apart. There is contradictory evidence regarding the effectiveness of a lower‐dose regimen (2 × 500 mg) of RTX. Our aim was to compare the efficacy and safety of low‐ and high‐dose RTX and to test the noninferiority of the low‐dose regimen.</p> </sec> <sec id="acr22116-sec-0002" sec-type="section"> <title>Methods</title> <p>A systematic literature review searching for randomized controlled trials (RCTs) and cohort studies comparing low‐ and high‐dose RTX for RA was conducted using the Embase, PubMed, Cochrane Library, and Web of Science databases. The primary end points were the American College of Rheumatology 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 end points were patient‐reported outcomes (PROs; Health Assessment Questionnaire, Short Form 36, and Functional Assessment of Chronic Illness Therapy–Fatigue scores) and adverse events. Noninferiority of low‐dose RTX was tested using different approaches, one of which was based on the fixed margin method.</p> </sec> <sec id="acr22116-sec-0003" sec-type="section"> <title>Results</title> <p>In total, 6 RCTs and 2 cohort studies were identified. Four RCTs were included in the meta‐analysis of efficacy outcomes, which showed no significant differences in the primary outcomes between low‐ and high‐dose RTX. Noninferiority criteria of low‐dose RTX were met for the ACR20, ACR50, DAS28, and PROs (at 24 and 48 weeks). Serious adverse events did not differ significantly. The results of 2 additional RCTs and a meta‐analysis of 2 cohort studies corroborated the results of the meta‐analysis of RCTs.</p> </sec> <sec id="acr22116-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Low‐dose RTX has similar effectiveness and met noninferiority criteria for most primary outcomes. Considering the lower cost, it should be the standard RTX regimen for RA.</p> </sec> </abstract>