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

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. MET...

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Autores principales: Baji, Petra, Péntek, Márta, Czirják, László, Szekanecz, Zoltán, Nagy, György, Gulácsi, László, Brodszky, Valentin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4046078/
https://www.ncbi.nlm.nih.gov/pubmed/24832836
http://dx.doi.org/10.1007/s10198-014-0594-4
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author Baji, Petra
Péntek, Márta
Czirják, László
Szekanecz, Zoltán
Nagy, György
Gulácsi, László
Brodszky, Valentin
author_facet Baji, Petra
Péntek, Márta
Czirják, László
Szekanecz, Zoltán
Nagy, György
Gulácsi, László
Brodszky, Valentin
author_sort Baji, Petra
collection PubMed
description 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.
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spelling pubmed-40460782014-06-18 Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison Baji, Petra Péntek, Márta Czirják, László Szekanecz, Zoltán Nagy, György Gulácsi, László Brodszky, Valentin Eur J Health Econ Original Paper 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. Springer Berlin Heidelberg 2014-05-16 2014 /pmc/articles/PMC4046078/ /pubmed/24832836 http://dx.doi.org/10.1007/s10198-014-0594-4 Text en © Springer-Verlag Berlin Heidelberg 2014
spellingShingle Original Paper
Baji, Petra
Péntek, Márta
Czirják, László
Szekanecz, Zoltán
Nagy, György
Gulácsi, László
Brodszky, Valentin
Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison
title Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison
title_full Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison
title_fullStr Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison
title_full_unstemmed Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison
title_short Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison
title_sort efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4046078/
https://www.ncbi.nlm.nih.gov/pubmed/24832836
http://dx.doi.org/10.1007/s10198-014-0594-4
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