Tanaka Yoshiya, Yamamoto Kazuhiko, Takeuchi Tsutomu, Yamanaka Hisashi, Ishiguro Naoki, Eguchi Katsumi, Watanabe Akira, Origasa Hideki, Shoji Toshiharu, Miyasaka Nobuyuki, Koike Takao
First Department of Internal Medicine, University of Occupational and Environmental Health , Japan, Kitakyushu , Japan.
Mod Rheumatol. 2014 Sep;24(5):734-43. doi: 10.3109/14397595.2014.881709. Epub 2014 Mar 4.
To evaluate the long-term efficacy and safety of certolizumab pegol (CZP) plus methotrexate treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis (RA) patients with an inadequate response to methotrexate.
J-RAPID double-blind patients were entered into an open-label extension (OLE) study. Patients withdrawn due to lack of efficacy at 16 weeks and double-blind completers without a week-24 American College of Rheumatology (ACR) 20 response received CZP 200 mg every other week (Q2W) plus methotrexate. Double-blind completers with week-24 ACR20 responses were randomized to CZP 200 mg Q2W plus methotrexate or CZP 400 mg every 4 weeks plus methotrexate.
The ACR20/ACR50/ACR70 response rates of double-blind completers (n = 204) were 89.7%/67.2%/36.3% at OLE entry and 95.6%/84.8%/58.3% at 52 weeks, respectively. Other clinical, functional and radiographic outcomes were sustained with long-term CZP plus methotrexate. Long-term treatment with CZP was well-tolerated with no new unexpected adverse events observed. The efficacy and safety of CZP treatment were similar between the two dosing schedules.
Continued CZP administration with methotrexate maintained efficacy over 52 weeks and was well-tolerated for Japanese RA patients. No obvious differences in clinical efficacy and safety were observed between the two dosing schedules, giving flexibility in maintenance administration schedules.
评估聚乙二醇化赛妥珠单抗（CZP）联合甲氨蝶呤治疗的长期疗效和安全性，并评估两种 CZP 维持给药方案对甲氨蝶呤反应不足的日本类风湿关节炎（RA）患者的疗效。
J-RAPID 双盲试验患者进入开放标签扩展（OLE）研究。因 16 周时缺乏疗效而退出的患者以及双盲试验完成但未达到第 24 周美国风湿病学会（ACR）20 反应标准的患者，接受每两周一次（Q2W）200mg CZP 联合甲氨蝶呤治疗。双盲试验完成且达到第 24 周 ACR20 反应标准的患者被随机分为每两周一次 200mg CZP 联合甲氨蝶呤组或每四周一次 400mg CZP 联合甲氨蝶呤组。
双盲试验完成者（n = 204）在 OLE 入组时的 ACR20/ACR50/ACR70 反应率分别为 89.7%/67.2%/36.3%，在 52 周时分别为 95.6%/84.8%/58.3%。其他临床、功能和影像学结果在长期 CZP 联合甲氨蝶呤治疗中得以维持。长期使用 CZP 治疗耐受性良好，未观察到新的意外不良事件。两种给药方案的 CZP 治疗疗效和安全性相似。
持续给予 CZP 联合甲氨蝶呤在 52 周内维持疗效，且日本 RA 患者耐受性良好。两种给药方案在临床疗效和安全性方面未观察到明显差异，在维持给药方案上提供了灵活性。
