比较三种新型生物制剂治疗中重度活动性类风湿关节炎的疗效与安全性

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

目的:观察利妥昔单抗、托珠单抗及阿达木单抗联合慢作用抗风湿药物(DMARDs)治疗中重度活动性类风湿关节炎24周后的疗效和安全性。方法:共入组87例DAS28>3.2的活动性类风湿关节炎患者,给予利妥昔单抗或托珠单抗或阿达木单抗同时联合DMARDs,或仅用DMARDs药物治疗,主要疗效指标为达到ACR20的患者比例,次要疗效指标为达到ACR50、ACR70的比例及DAS28-CRP的改善情况。结果:在24周时,利妥昔单抗、托珠单抗及阿达木单抗达到ACR20的比例分别为66.67%、94.44%和73.08%,而单用DMARDs组则为53.57%,同时各治疗组患者DAS28-CRP亦较基线及仅用DMARDs组显著下降,且托珠单抗及阿达木单抗组优于利妥昔单抗组。最常见的不良事件为上呼吸道感染,其次是淋巴细胞下降及肝功能异常。结论:利妥昔单抗、托珠单抗及阿达木单抗对类风湿关节炎均具有显著的疗效和良好的安全性,阿达木单抗及托珠单抗的疗效优于利妥昔单抗。

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.