Introduction: The aim of the systematic review was to evaluate the safety and efficacy of rituximab for the treatment of rheumatoid arthritis patients, as part of the Consensus on the use of rituximab in rheumatoid arthritis. A document with evidence based recommendations.
Methods: All papers published from January 2003 to September 2009 were reviewed in a systematic way in Medline, EMBASE and Cochrane Library database. The Mesh terms used were: "Rituximab", "Rheumatoid arthritis", "and Anti-CD20", "Biologics". The abstracts of the EULAR and ACR congress of 2003 to 2009 were also reviewed, as well data of Roche Pharma. Two rheumatologists (BHC y MGH) made the bibliographic review by title and summary of each work. Two authors (BHC y RAA) selected them by quality according the GRADE SCALE after they review. The data were collected in paper. The outcomes evaluated were of efficacy in agreement with OMERACT (Outcome Measurements in Rheumatoid Arthritis Clinical Trials) and The Musculoskeletal Cochrane Study Group. The outcomes of safety evaluated were: mortality, severe infections, severe adverse events, withdraw for any cause, for severe adverse events, and for infusion related reactions. The review was conducted with Cochrane methodology. The odds ratio and relative risk for dichotomist variables; and mean difference between baseline and final measurements for continuous variables, and risk differences were calculated with RevMan 5. The number of patients needed to treat was calculated with Cates' calculator.
Results: RTX is an effective drug in three groups of patients with RA: patients who fail to MTX, those who fail anti-TNF and in patients with no prior exposure to MTX. It is necessary to treat 7 (5-10) patients with RTX vs. placebo to obtain an ACR70 response; 9 (6-15) to achieve a DAS28 < 2.6; and 5 (4-8) to achieve a HAQ improvement > 0.2. Safety of the drug was similar to that of placebo except for infusion reactions where 12 (8-26) patients need to be treated with RTX vs. placebo to see a reaction to the first infusion with steroid premedication. Severe adverse events to the infusion had an incidence of 0.7% in patients of the RTX treated group. It was impossible to identify a larger increase in the number of severe infections, probably due to methodological problems, however, the risk of developing infections in patients treated with RTX seems to be comparable to that of other anti-TNF and biologics.
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