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
L. Bi1, Y. Li2, L. He3, H. Xu4, Z. Jiang5, Y. Wang6, X. Li7, W. Wei8, J. Gu9, G. Wang10, Z. Zhang11, B. Zhou12, Y. Liu13, Z. Wu14, H. Liu15, D. He16, Z. Lv17, Z. Li18, X. Zuo19, L. Dong20, H. Wu21, H. Zhang22, H. Chen23, C. Bao24, Z. Zhang25, M. Zhang26, H. Song27, Y. Zheng28, L. Jiang29, X. Liu30, M. Boehnlein31, J. Dunkel32, J. Shao33, K. Harris34, Z. Li35
- China-Japan Union Hospital of Jilin University, Changchun, China.
- Peking University People’s Hospital, Beijing, China.
- The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China.
- Shanghai Changzheng Hospital, Shanghai, China.
- Jilin University First Hospital, Changchun, China.
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, China.
- Anhui Medical University, Anhui Provincial Hospital, Hefei, China.
- Tianjin Medical University General Hospital, Tianjin, China.
- Sun Yat-sen University, The Third Affiliated Hospital, Guangzhou, China.
- China-Japan Friendship Hospital, Beijing, China.
- The First Affiliated Hospital of Harbin Medical University, Harbin, China.
- Sichuan Academy of Medical Sciences, Sichuan Provincial People’s Hospital, Chengdu, China.
- West China Hospital, Sichuan University, Chengdu, China.
- Xijing Hospital, Xi’an, China.
- Qilu Hospital of Shandong University, Jinan, China.
- Guanghua Hospital, Shanghai, China.
- First Affiliated Hospital of Kunming Medical University, Kunming, China.
- First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
- Xiangya Hospital, Central South University, Changsha, China.
- Tongji Hospital, Tongji Medical College, Huazhong University, Wuhan, China.
- Second Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China.
- The Third Xiangya Hospital of Central South University, Changsha, China.
- The Third Hospital of Hebei Medical University, Shijiazhuang, China.
- Shanghai Jiaotong University School of Medicine, Renji Hospital, Shanghai, China.
- Peking University First Hospital, Beijing, China.
- Jangsu Province Hospital, Nanjing, China.
- Beijing Ji Shui Tan Hospital, Beijing, China.
- Beijing Chao-Yang Hospital, Beijing, China.
- Zhong Shan Hospital, Fudan Universtiy, Shanghai, China.
- Peking University Third Hospital, Beijing, China.
- UCB Pharma, Monheim, Germany.
- UCB Pharma, Monheim, Germany.
- UCB Pharma, Tokyo, Japan.
- UCB Pharma, Slough, UK.
- Peking University People’s Hospital, Beijing, China. firstname.lastname@example.org
2019 Vol.37, N°2
PI 0227, PF 0234
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PMID: 30183595 [PubMed]
Accepted : 29/05/2018
In Press: 29/08/2018
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<0.001). CZP+MTX patients also achieved greater improvements in HAQ-DI, higher ACR50/70 responses and higher DAS28(ESR) remission rate at Week 24. Rapid onset of response to CZP+MTX was observed as early as Week 1 for most of the clinical, functional and patient-reported outcomes. Incidences of treatment-emergent adverse events (TEAEs) were similar between treatment arms. Serious TEAEs were reported by 6.3% of CZP+MTX patients and 2.7% of PBO+MTX patients. No new safety signals were observed.
CZP in combination with MTX showed an acceptable safety profile, a rapid onset of response and sustained effects in reducing the signs and symptoms of RA and improving physical function in Chinese patients with RA and an inadequate response to MTX.