Treatment of rheumatoid arthritis with rituximab and methotrexate: a multicenter, randomized, double blind, placebo-controlled trial / 中华风湿病学杂志

ABSTRACT

Objective To evaluate the therapeutic effect and safety of the rituximab in the treatment of severe rheumatoid arthritis (RA). Methods A total 22 severe RA patients with DAS28＞5.1 were treated with rituximab 500～1000 mg/24week, or placebo/24 week, along with methotrexate (MTX) 10～25 mg/week.Chi-square test was adapted for statistical analysis if the results met the data criteria for the analysis. Rank conversion analysis was used to test the results if the data did not satisfy the Chi-square test. Results Twenty-two patients (93% were females with the median age of 50 yd and the average MTX dosage was 17.6 mg/week ) completed the treatment. The proportion of ACR 20 responders at 72 week was 80%, 60%,57% respectively. Other secondary efficacy endpoints showed that rituximab could provide substantial benefits to patients with RA by reducing clinical signs and disease activity score. The most frequently occurred adverse event was upper respiratory tract infection. Tne second most frequent adverse events were reduction of lymphocytes and elevation of liver enzymes. Most treatment-related adverse events were mild to moderate in severity. Conclusion Rituximab has demonstrated to be effective and is well tolerated by patients in the treatment of active RA.