Kobayakawa Tomonori, Kojima Toshihisa, Takahashi Nobunori, Hayashi Masatoshi, Yabe Yuichiro, Kaneko Atsushi, Shioura Tomone, Saito Kiwamu, Hirano Yuji, Kanayama Yasuhide, Miyake Hiroyuki, Asai Nobuyuki, Funahashi Koji, Hirabara Shinya, Hanabayashi Masahiro, Asai Shuji, Ishiguro Naoki
Department of Orthopedic Surgery and Rheumatology,Nagoya University Hospital , Nagoya Japan.
Mod Rheumatol. 2015 Mar;25(2):251-6. doi: 10.3109/14397595.2014.953668. Epub 2014 Sep 11.
The purpose of this study was to explore drug retention rates of second biologic agents after switching from tumor necrosis factor inhibitors (TNFi) in clinical practice in patients with rheumatoid arthritis (RA) on low-dose methotrexate (MTX) or without MTX.
A total of 169 RA patients who had been withdrawn from first-course TNFi therapy and received a different TNFi or tocilizumab (TCZ) as a second biologic agent were selected from the Tsurumai Biologics Communication Registry, an observational cohort database. Retention rates of second biologic treatment were compared by the type of first TNFi and second biologic agents.
Eighty-six patients received first-course infliximab (IFX) or adalimumab (ADA) therapy, and 83 patients received first-course etanercept (ETN) therapy. The former group had a significantly higher retention rate (IFX, 81.1%; ADA, 83.3%) of the second biologic therapy compared to the latter (56.6%, p < 0.001, log-rank test). Drug retention rates of the second biologic agent after switching from IFX/ADA were significantly higher with ETN (90.0%) and TCZ (94.7%) than with ADA/IFX (59.3%). Drug retention rates of the second biologic agent after switching from ETN were significantly higher with TCZ (75.9%) than with ADA/IFX (46.3%). The differences were significant even after adjusting for baseline clinical variables using the Cox proportional hazards model.
Drug retention rates of IFX and ADA after switching from the first TNFi were significantly lower compared to those of ETN and TCZ in patients on low-dose MTX or without MTX.
本研究旨在探讨类风湿关节炎(RA)患者在临床实践中从肿瘤坏死因子抑制剂(TNFi)转换为第二种生物制剂后的药物留存率,这些患者使用低剂量甲氨蝶呤(MTX)或未使用MTX。
从鹤舞生物制剂交流登记处(一个观察性队列数据库)中选取了169例已停用首个疗程TNFi治疗并接受不同TNFi或托珠单抗(TCZ)作为第二种生物制剂的RA患者。根据首个TNFi和第二种生物制剂的类型比较第二种生物治疗的留存率。
86例患者接受了首个疗程的英夫利昔单抗(IFX)或阿达木单抗(ADA)治疗,83例患者接受了首个疗程的依那西普(ETN)治疗。与后者(56.6%,p<0.001,对数秩检验)相比,前一组第二种生物治疗的留存率显著更高(IFX为81.1%;ADA为83.3%)。从IFX/ADA转换后,第二种生物制剂与ETN(90.0%)和TCZ(94.7%)的药物留存率显著高于ADA/IFX(59.3%)。从ETN转换后,第二种生物制剂与TCZ(75.9%)的药物留存率显著高于ADA/IFX(46.3%)。即使使用Cox比例风险模型对基线临床变量进行调整后,差异仍具有统计学意义。
在使用低剂量MTX或未使用MTX的患者中,从首个TNFi转换后,IFX和ADA的药物留存率显著低于ETN和TCZ。