Efficacy and safety of three new biologics in the treatment of moderate to severe rheumatoid arthritis

ZHAO Zheng; ZHU Jian; ZHANG Jiang-lin; ZHANG Ya-mei; HUANG Feng; DENG Xiao-hu

Abstract：Objective: To observe the efficacy and safety of rituximab, tocilizumab and adalimumab combined with disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA). Methods:A total of 87 RA patients with a 28-joint Disease Activity Score (DAS28)> 3.2 were randomly given rituximab, tocilizumab, adalimumab combined with DMARDs respectively or DMARDs alone for 24 weeks. The primary end point was the proportion of patients achieving American College of Rheumatology criteria for 20%improvement (ACR20). The secondary end points included the proportion of patients achieving ACR50, ACR70, improvement of DAS28, C-reactive protein (CRP) and Health Assessment Questionnaire (HAQ). Safety was assessed by adverse event documentation. Results: At the end of the 24th week, 82 patients completed the treatment. The proportion of patients achieving ACR20 treated by rituximab + DMARDs, tocilizumab + DMARDs, adalimumab + DMARDs, DMARDs alone was 66.67%, 94.44%, 73.08% and 53.57% respectively. Results for other secondary efficacy endpoints showed that these three new biologics could provide substantial beneifts to patients with RA by reducing clinical signs, HAQ and DAS28. Efifcacy of tocilizumab and adalimumab were better than rituximab. Most treatment-related adverse events were mild to moderate. The most common adverse event was upper respiratory tract infection. Lymphocytes decreased and abnormal liver function was next. No serious infections were observed. Conclusion:These three new biologics have signiifcant efifcacy and good safety towards RA patients. The efifcacy of tocilizumab and adalimumab are better than rituximab.