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Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis

Author

Listed:
  • Petra Baji

    (Corvinus University of Budapest)

  • Márta Péntek

    (Corvinus University of Budapest
    Flór Ferenc County Hospital)

  • Sándor Szántó

    (University of Debrecen Medical and Health Sciences Center)

  • Pál Géher

    (Budai Irgalmasrendi Hospital)

  • László Gulácsi

    (Corvinus University of Budapest)

  • Orsolya Balogh

    (Corvinus University of Budapest)

  • Valentin Brodszky

    (Corvinus University of Budapest)

Abstract

Objectives To compare the efficacy and safety of infliximab-biosimilar with other biological drugs for the treatment of active ankylosing spondylitis (AS). Methods Systematic literature review for randomized controlled trials (RCTs) with adalimumab, etanercept, golimumab, infliximab and infliximab-biosimilar in AS was performed and indirect meta-analysis (Bayesian mixed treatment comparison) was carried out. The proportion of patients reaching 20 % improvement by the assessment of Spondyloarthritis International Society response criteria (ASAS20) at weeks 12 and 24 was used as efficacy endpoints, and the occurrence of serious adverse events at week 24 was applied to compare the safety of the biologicals. Results Altogether, 13 RCTs, identified by the systematic literature search, were included in the analysis. Results on the ASAS20 efficacy endpoint were reported for week 12 in 12 RCTs involving 2,395 patients, and for week 24 in 5 RCTs comprising 1,337 patients. All the five biological agents proved to be significantly superior to placebo. Infliximab showed the highest odds ratio (OR) of 7.2 (95 % CI 3.68–13.19) compared to placebo, followed by infliximab-biosimilar with OR 6.25 (95 % CI 2.55–13.14), both assessed at week 24. No significant difference was found between infliximab-biosimilar and other biological treatments regarding their efficacy and safety. Conclusions This is the first study which includes a biosimilar drug in the meta-analysis of biological treatments in AS. The results have proven the similar efficacy and safety profile of infliximab-biosimilar treatment compared to other biologicals.

Suggested Citation

  • Petra Baji & Márta Péntek & Sándor Szántó & Pál Géher & László Gulácsi & Orsolya Balogh & Valentin Brodszky, 2014. "Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 15(1), pages 45-52, May.
    • Handle: RePEc:spr:eujhec:v:15:y:2014:i:1:d:10.1007_s10198-014-0593-5
    DOI: 10.1007/s10198-014-0593-5
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    Keywords

    Ankylosing spondylitis; Biological drug; Biosimilar pharmaceuticals; Meta-analysis; Efficacy; Safety;
    All these keywords.

    JEL classification:

    • I10 - Health, Education, and Welfare - - Health - - - General
    • I19 - Health, Education, and Welfare - - Health - - - Other

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