Certolizumab pegol plus methotrexate for active rheumatoid arthritis: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

CUI Saisai ^1,2 , FU Lingyu ¹ , YAN Lei ³ , ZHANG Yao ¹ ,  LIU Haina ⁴

1. Department of Clinical Epidemiology, the First Affiliated Hospital, China Medical University, Shenyang, 110001, P.R.China;
2. Health Management Center, the General Hospital of Shenyang Military Region, Shenyang, 110005, P.R.China;
3. Department of Medical Informatics, China Medical University, Shenyang, 110001, P.R.China;
4. Department of Rheumatology, the First Affiliated Hospital, China Medical University, Shenyang, 110001, P.R.China;

Corresponding author：

LIU Haina, Email: liuhaina@hotmail.com

Keywords：

Certolizumab pegol; Methotrxate; Rheumatoid arthritis; Randomized controlled trial; Meta-analysis

DOI：

10.7507/1672-2531.201707098

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Objectives To systematically review the efficacy and safety of certolizumab pegol (CZP) plus methotrexate (MTX) for active rheumatoid arthritis. Methods The Cochrane Library, PubMed, EMbase, CBM, CNKI, VIP and WanFang Data were searched to collect randomized controlled trials (RCTs) on CZP plus MTX vs. MTX plus placebo for active rheumatoid arthritis from inception to May, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, data were analyzed by using Stata 11.0 software. Results Seven RCTs were included. The results of meta-analysis showed the CZP plus MTX group was superior to MTX plus placebo group in ACR20 (CZP_{400 mg}: RR=2.86, 95%CI 1.70 to 4.79, P<0.001; CZP_{200 mg}: RR=3.76, 95%CI 2.59, 5.46, P<0.001), ACR50 (CZP_{400 mg}: RR=3.91, 95%CI 2.10 to 7.27, P<0.001; CZP_{200 mg}: RR=4.86, 95%CI 3.20 to 7.39, P<0.001), and ACR70 (CZP_{400 mg}: RR=5.65, 95%CI 1.99 to 16.06, P=0.001; CZP_{200 mg}: RR=10.08, 95%CI 5.11 to 19.89, P<0.001). The CZP plus MTX group was also superior to MTX plus placebo group in swollen joint counts (SMD=–12.72, 95%CI –15.39 to –10.06,P<0.001), tender joint counts (SMD=–11.54, 95%CI –13.97 to –9.11,P<0.001), doctor's global assessment of disease activity (SMD=–11.78, 95%CI –13.81 to –9.75,P<0.001), patient's global assessment of disease activity (SMD=–9.62, 95%CI –11.09 to –8.15,P<0.001), and patient's assessment of pain (SMD=–9.10, 95%CI –10.91 to –7.30,P<0.001) and HAQ (SMD=–7.74, 95%CI –8.99, –6.49,P<0.001), respectively. However, the incidence of adverse events in CZP plus MTX group was higher than that in MTX plus placebo group. Conclusions CZP plus MTX is superior to MTX plus placebo for treatment of active rheumatoid arthritis but with higher adverse events. Due to limited quantity and quality of the included studies, the above conclusions are still needed to be verified by more high-quality studies.

Citation： CUI Saisai, FU Lingyu, YAN Lei, ZHANG Yao, LIU Haina. Certolizumab pegol plus methotrexate for active rheumatoid arthritis: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2018, 18(2): 172-177. doi: 10.7507/1672-2531.201707098 Copy

1.	中华医学会类风湿分会. 类风湿关节炎诊断治疗指南(草案). 中华风湿病学杂志, 2003, 7(4): 145.
2.	Gabriel SE. The epidemiology of rheumatoid arthritis. Rheum Dis Clin Norht Am, 2001, 27(2): 269-281.
3.	陈亚飞, 谭海燕. 类风湿关节炎治疗新进展. 中国综合临床, 2011, 27(8): 890-892.
4.	Jani M, Barton A, Warren RB, et al. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases. Rheumatology (Oxford), 2014, 53(2): 213-222．.
5.	Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum, 1988, 31(3): 315-324.
6.	Keystone E, Heijde DV, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum, 2008, 58(11): 3319-3329.
7.	Smolen J, Landewé RB, Mease P, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis, 2009, 68(6): 797-804.
8.	Fleischmann R, Vencovsky J, van Vollenhoven RF, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis, 2009, 68(6): 805-811.
9.	Choy E, McKenna F, Vencovsky J, et al. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford), 2012, 51(7): 1226-1234.
10.	Weinblatt ME, Fleischmann R, Huizinga TW, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford), 2012, 51(12): 2204-2214.
11.	Yamamoto K, Takeuchi T, Yamanaka H, et al. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo controlled trial. Mod Rheumatol, 2014, 24(5): 715-724.
12.	Atsumi T, Yamamoto K, Takeuchi T, et al. The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression. Ann Rheum Dis, 2015, 75(1): 75-83.
13.	Choy EH, Panayi GS. Cytokine Pathway and joint inflammation in rheumatoid arthritis. N Engl J Med, 2001, 344: 907-916.
14.	Neabitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol(CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis, 2007, 13(11): 1323-1332.

1. 中华医学会类风湿分会. 类风湿关节炎诊断治疗指南(草案). 中华风湿病学杂志, 2003, 7(4): 145.
2. Gabriel SE. The epidemiology of rheumatoid arthritis. Rheum Dis Clin Norht Am, 2001, 27(2): 269-281.
3. 陈亚飞, 谭海燕. 类风湿关节炎治疗新进展. 中国综合临床, 2011, 27(8): 890-892.
4. Jani M, Barton A, Warren RB, et al. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases. Rheumatology (Oxford), 2014, 53(2): 213-222．.
5. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum, 1988, 31(3): 315-324.
6. Keystone E, Heijde DV, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum, 2008, 58(11): 3319-3329.
7. Smolen J, Landewé RB, Mease P, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis, 2009, 68(6): 797-804.
8. Fleischmann R, Vencovsky J, van Vollenhoven RF, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis, 2009, 68(6): 805-811.
9. Choy E, McKenna F, Vencovsky J, et al. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford), 2012, 51(7): 1226-1234.
10. Weinblatt ME, Fleischmann R, Huizinga TW, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford), 2012, 51(12): 2204-2214.
11. Yamamoto K, Takeuchi T, Yamanaka H, et al. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo controlled trial. Mod Rheumatol, 2014, 24(5): 715-724.
12. Atsumi T, Yamamoto K, Takeuchi T, et al. The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression. Ann Rheum Dis, 2015, 75(1): 75-83.
13. Choy EH, Panayi GS. Cytokine Pathway and joint inflammation in rheumatoid arthritis. N Engl J Med, 2001, 344: 907-916.
14. Neabitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol(CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis, 2007, 13(11): 1323-1332.

Chinese Journal of Evidence-Based Medicine

Certolizumab pegol plus methotrexate for active rheumatoid arthritis: a meta-analysis

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