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An updated systematic review and meta-analysis about the safety and efficacy of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease

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Abstract

Objective

We aimed to evaluate the efficacy and safety of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease.

Methods

We searched PubMed, Scopus, Ovid, and Web of Science for relevant clinical trials discussing CT-P31 administration for IBD patients either naïve to biological therapy or switched from IFX therapy. Data of the rates of clinical response, clinical remission, and adverse events were extracted and pooled in a random effect model meta-analysis using CMA version 2.

Results

Thirty-two studies with a total of 3464 IBD patients treated with CT-P13 were identified. The pooled rates of clinical response among Crohn’s disease (CD) and ulcerative colitis (UC) at 8–14 weeks were 0.81 (95% CI = 0.72 to 0.87) and 0.68 (95% CI = 0.63 to 0.72), respectively, and at 48–63 weeks were 0.69 (95% CI = 0.48 to 0.85) and 0.54 (95% CI = 0.45 to 0.63) respectively. After switching from IFX to CT-P13, the pooled rates of sustained clinical response among CD and UC at 30–32 weeks were 0.84 (95% CI = 0.57 to 0.96) and 0.96 (95% CI = 0.58 to 0.99), respectively, and at 48–63 weeks were 0.51 (95% CI = 0.22 to 0.79) and 0.83 (95% CI = 0.19 to 0.99) respectively. Moreover, adverse events were reported (CD = 0.10, 95% CI 0.04 to 0.22; UC = 0.18, 95% CI 0.05 to 0.15).

Conclusion

CT-P13 is effective and well tolerated in short and long-term periods. Switching to CT-P13 is recommended for the management of IBD.

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Acknowledgments

Special thanks are to be directed to the Medical Research Group of Egypt (MRGE) members, especially Dr. Ahmed Negida, for his support while revising this manuscript.

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Author notes

  1. Abdelmagid M. Elmatboly, Ahmed Said Ali and Ahmed Mohamed Ibrahim contributed equally to this work.

Authors and Affiliations

  1. Faculty of Medicine, Zagazig University, Zagazig, El-Sharkia, Egypt

    Mahmoud Ahmed Ebada, Notila Fayed & Souad Alkanj

  2. Medical Research Group of Egypt (MRGE), Zagazig, El-Sharkia, Egypt

    Mahmoud Ahmed Ebada, Abdelmagid M. Elmatboly, Ahmed Said Ali, Ahmed Mohamed Ibrahim, Notila Fayed, Ahmed Faisal Faisal & Souad Alkanj

  3. Zagazig University Hospitals, Zagazig University, Zagazig, El-Sharkia, Egypt

    Mahmoud Ahmed Ebada

  4. Faculty of Medicine, Al-Azhar University, Cairo, Egypt

    Abdelmagid M. Elmatboly, Ahmed Said Ali, Ahmed Mohamed Ibrahim & Ahmed Faisal Faisal

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  1. Mahmoud Ahmed Ebada
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Appendix S1

a shows a forest plot of mucosal healing in naïve UC patients. b shows the risk of bias summary according to the Cochrane Risk of Bias assessment tool (PDF 291 kb)

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Ebada, M.A., Elmatboly, A.M., Ali, A.S. et al. An updated systematic review and meta-analysis about the safety and efficacy of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease. Int J Colorectal Dis 34, 1633–1652 (2019). https://doi.org/10.1007/s00384-019-03354-7

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