Backhaus Marina, Kaufmann Jörg, Richter Constanze, Wassenberg Siegfried, Roske Anne-Eve, Hellmann Peter, Gaubitz Markus
Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany,
Clin Rheumatol. 2015 Apr;34(4):673-81. doi: 10.1007/s10067-015-2879-0. Epub 2015 Jan 29.
Tocilizumab (TCZ) and tumour necrosis factor inhibitors (TNFi) are recommended for the treatment of rheumatoid arthritis (RA) in patients with inadequate response (IR) to prior disease-modifying antirheumatic drugs (DMARDs). This retrospective analysis assessed the efficacy of TCZ and TNFi, alone or in combination with DMARDs, in 1603 patients with IR to previous treatment with either DMARDs (DMARD-IR) and/or TNFi (TNFi-IR), initiating treatment with TCZ or a TNFi, managed in routine clinical practice. Patients were grouped according to treatment history and treatment initiated: DMARD-IR patients initiating treatment with TCZ + DMARD (DMARD-IR TCZ) or TNFi + DMARD (DMARD-IR TNFi), DMARD-IR and/or TNFi-IR patients initiating treatment with TCZ monotherapy (TCZ mono) or TNFi monotherapy (TNFi mono), and TNFi-IR patients initiating treatment with TCZ + DMARD (TNFi-IR TCZ) or TNFi + DMARD (TNFi-IR TNFi). Patients initiating treatment with TCZ generally had more severe disease and longer disease duration compared with the corresponding TNFi group. Significantly more patients achieved remission (DAS28 ESR <2.6) in the TCZ groups compared with corresponding TNFi groups (DMARD-IR, TCZ 44.0 % vs. TNFi 29.6 %; monotherapy, TCZ 37.2 % vs. TNFi 30.2 %; TNF-IR, TCZ 41.3 % vs. TNFi 19.2 %; p < 0.001 for all comparisons). More patients achieved moderate-good responses (EULAR criteria) in the TCZ treatment groups (79-85 %) compared with TNFi treatment groups (65-81 %). Patient-reported outcomes showed greater improvements in TCZ compared with TNFi groups. In patients with inadequate response to DMARDs and/or TNFi treated in routine clinical practice, TCZ in combination with DMARDs or as monotherapy resulted in significantly more patients achieving remission and more marked improvements in patient-reported outcomes compared with TNF inhibitors.
托珠单抗（TCZ）和肿瘤坏死因子抑制剂（TNFi）被推荐用于治疗对既往改善病情抗风湿药物（DMARDs）反应不足（IR）的类风湿关节炎（RA）患者。这项回顾性分析评估了TCZ和TNFi单独或与DMARDs联合使用，在1603例对既往DMARDs治疗（DMARD-IR）和/或TNFi治疗（TNFi-IR）反应不足、开始使用TCZ或TNFi治疗且在常规临床实践中接受管理的患者中的疗效。患者根据治疗史和起始治疗进行分组：开始使用TCZ + DMARD（DMARD-IR TCZ）或TNFi + DMARD（DMARD-IR TNFi）治疗的DMARD-IR患者，开始使用TCZ单药治疗（TCZ mono）或TNFi单药治疗（TNFi mono）的DMARD-IR和/或TNFi-IR患者，以及开始使用TCZ + DMARD（TNFi-IR TCZ）或TNFi + DMARD（TNFi-IR TNFi）治疗的TNFi-IR患者。与相应的TNFi组相比，开始使用TCZ治疗的患者通常疾病更严重且病程更长。与相应的TNFi组相比，TCZ组中达到缓解（DAS28 ESR <2.6）的患者明显更多（DMARD-IR，TCZ为44.0%，TNFi为29.6%；单药治疗，TCZ为37.2%，TNFi为30.2%；TNF-IR，TCZ为41.3%，TNFi为19.2%；所有比较p < 0.001）。与TNFi治疗组（65 - 81%）相比，TCZ治疗组中更多患者达到中度 - 良好反应（依欧洲抗风湿病联盟标准）（79 - 85%）。患者报告的结果显示，与TNFi组相比，TCZ组有更大改善。在常规临床实践中对DMARDs和/或TNFi反应不足的患者中，与肿瘤坏死因子抑制剂相比，TCZ联合DMARDs或作为单药治疗可使更多患者达到缓解，且患者报告的结果有更显著改善。
