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The European Journal of Health Economics

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01.05.2014 | Original Paper

Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison

verfasst von: Petra Baji, Márta Péntek, László Czirják, Zoltán Szekanecz, György Nagy, László Gulácsi, Valentin Brodszky

Erschienen in: The European Journal of Health Economics | Sonderheft 1/2014

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Abstract

Objective

The aim of this meta-analysis was to compare the efficacy and safety of infliximab-biosimilar and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab.

Methods

A systematic literature review of MEDLINE database until August 2013 was carried out to identify relevant randomized controlled trials (RCTs). Bayesian mixed treatment comparison method was applied for the pairwise comparison of treatments. Improvement rates by the American College of Rheumatology criteria (ACR20 and ACR50) at week 24 were used as efficacy endpoints, and the occurrence of serious adverse events was considered to assess the safety of the biologicals.

Results

Thirty-six RCTs were included in the meta-analysis. All the biological agents proved to be superior to placebo. For ACR20 response, certolizumab pegol showed the highest odds ratio (OR) compared to placebo, OR 7.69 [95 % CI 3.69–14.26], followed by abatacept OR 3.7 [95 % CI 2.17–6.06], tocilizumab OR 3.69 [95 % CI 1.87–6.62] and infliximab-biosimilar OR 3.47 [95 % CI 0.85–9.7]. For ACR50 response, certolizumab pegol showed the highest OR compared to placebo OR 8.46 [3.74–16.82], followed by tocilizumab OR 5.57 [95 % CI 2.77–10.09], and infliximab-biosimilar OR 4.06 [95 % CI 1.01–11.54]. Regarding the occurrence of serious adverse events, the results show no statistically significant difference between infliximab-biosimilar and placebo, OR 1.87 [95 % CI 0.74–3.84]. No significant difference regarding efficacy and safety was found between infliximab-biosimilar and the other biological treatments.

Conclusion

This is the first indirect meta-analysis in RA that compares the efficacy and safety of biosimilar-infliximab to the other biologicals indicated in RA. We found no significant difference between infliximab-biosimilar and other biological agents in terms of clinical efficacy and safety.

The product information details can be found at http://www.ema.europa.eu/ema/.

Also when the patient is intolerant to previous therapy with tumour-necrosis-factor (TNF) antagonists.

According to the definition of EMA, “A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorized (the ‘biological reference medicine’). The active substance of a biosimilar medicine is similar to that of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.”

Anakinra is also registered for the treatment of RA by the EMA; however, its utilization has not spread in the clinical practice of CEE countries where infliximab-biosimilar is marketed. Thus, anakinra was not included in the meta-analysis.

Adalimuab, certolizumab, etanercept and tocilizumab can be administered as monotherapy, in the case of intolerance to methotrexate.

(arthritis. rheumatoid"[MeSH Terms]) AND (abatacept OR adalimumab OR certolizumab pegol OR golimumab OR infliximab OR etanercept OR rituximab OR tocilizumab) AND ((randomized controlled trial[pt] OR controlled clinical trial[pt] OR randomized[tiab] OR placebo[tiab] OR "clinical trials as topic"[MeSH Terms:noexp] OR randomly[tiab] OR trial[ti]) NOT ("animals"[MeSH Terms] NOT "humans"[MeSH Terms])) AND ("2009/11/01"[PDAT]: "2013/08/20"[PDAT]).

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Titel: Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison
verfasst von: Petra Baji
Márta Péntek
László Czirják
Zoltán Szekanecz
György Nagy
László Gulácsi
Valentin Brodszky
Publikationsdatum: 01.05.2014
Verlag: Springer Berlin Heidelberg
Erschienen in: The European Journal of Health Economics / Ausgabe Sonderheft 1/2014
Print ISSN: 1618-7598
Elektronische ISSN: 1618-7601
DOI: https://doi.org/10.1007/s10198-014-0594-4

Springer Medizin

Abstract

Objective

Methods

Results

Conclusion

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