Efficacy and safety of certolizumab pegol in combination with methotrexate in methotrexate-inadequate responder Chinese patients with active rheumatoid arthritis: 24-week results from a randomised, double-blind, placebo-controlled phase 3 study

• Published in: Clinical and experimental rheumatology 2019-03, Vol.37 (2), p.227-234
• Main Authors: Bi, Liqi, Li, Yuhui, He, Lan, Xu, Huji, Jiang, Zhenyu, Wang, Yongfu, Li, Xiangpei, Wei, Wei, Gu, Jieruo, Wang, Guochun, Zhang, Zhiyi, Zhou, Bin, Liu, Yi, Wu, Zhenbiao, Liu, Huaxiang, He, Dongyi, Lv, Zhaoping, Li, Zhijun, Zuo, Xiaoxia, Dong, Lingli, Wu, Huaxiang, Zhang, Hao, Chen, Haiying, Bao, Chunde, Zhang, Zhuoli, Zhang, Miaojia, Song, Hui, Zheng, Yi, Jiang, Lindi, Liu, Xiangyuan, Boehnlein, Marion, Dunkel, Jochen, Shao, Jing, Harris, Kristina, Li, Zhanguo
• Format: Article
• Language: English
• ISSN: 0392-856X

To evaluate the efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) in Chinese patients with active rheumatoid arthritis (RA) and an inadequate response to MTX. This 24-week, phase 3, double-blind, placebo-controlled study was conducted in 30 centres across China. A total of 430 patients were randomised 3:1 to receive CZP 200 mg every 2 weeks (loading dose: 400 mg CZP at Weeks 0, 2 and 4) plus MTX or placebo (PBO) plus MTX. The primary endpoint was ACR20 response at Week 24, for which the superiority of CZP+MTX over PBO+MTX was evaluated. Additional parameters for clinical efficacy, health outcomes, immunogenicity and safety were assessed. At Week 24, 54.8% of CZP+MTX patients and 23.9% of PBO+MTX patients achieved ACR20 (odds ratio: 3.9, p