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

Baji, Petra and Péntek, Márta and Szántó, Sándor and Géher, Pál and Gulácsi, László and Brodszky, Valentin (2014) Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis. European Journal of Health Economics . DOI 10.1007/s10198-014-0593-5

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Official URL: http://link.springer.com/article/10.1007%2Fs10198-014-0593-5


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.

Item Type:Article
Series Number / Identification Number:MTMT:2589953; doi:10.1007/s10198-014-0593-5
Uncontrolled Keywords:Ankylosing spondylitis, Biological drug, Biosimilar pharmaceuticals, Meta-analysis, Efficacy Safety
JEL classification:I10 - Health: General
I19 - Health: Other
Subjects:Social welfare, insurance, health care
Funders:Center for Public Affairs Studies Foundation, EGIS Pharmaceuticals
DOI:10.1007/s10198-014-0593-5
ID Code:1588
Deposited By: MTMT SWORD
Deposited On:02 Jun 2014 14:25
Last Modified:02 Jun 2014 14:25

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