Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2014 May;15 Suppl 1(Suppl 1):S45-52.
doi: 10.1007/s10198-014-0593-5. Epub 2014 May 16.

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

Petra Baji  1 , Márta Péntek, Sándor Szántó, Pál Géher, László Gulácsi, Orsolya Balogh, Valentin Brodszky
Affiliations
Meta-Analysis

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

Petra Baji et al. Eur J Health Econ. 2014 May.

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.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Efficacy of infliximab-biosimilar compared to other biologicals in AS, results of mixed treatment comparison (ASAS20 response at weeks 12 and 24). Results for weeks 14 and 30 were available and considered for infliximab-biosimilar. Note: the Figure presents odds ratios (OR) between treatments. If the point estimate is greater than 1, then the biosimilar treatment is more effective (although not necessarily statistically significantly more effective) compared to the originator biologicals. Credibility intervals provide information on whether the difference between treatments is statistically significant. If the CI contains the value 1, the difference is not statistically significant
Fig. 2
Fig. 2
The safety of infliximab-biosimilar compared to other biologicals in AS: serious adverse events (AE). Results for week 30 were available and considered for infliximab-biosimilar. Note: the Figure presents odds ratios (OR) between treatments. If the point estimate is lower than 1 then the biosimilar treatment is safer (although not necessarily statistically significantly safer). Credibility intervals provide information on whether the difference between treatments is statistically significant. If the CI contains the value 1, the difference is not statistically significant
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Péntek, M., Poór, Gy., Wiland, P., Martina, O., Brzosko, M., Codrenau, C., Brodszky, N., Gulácsi, L.: Biologic therapy in inflammatory rheumatic diseases: issues in Central and Eastern European countries. Eur. J. Health Econ. (2014). doi:10.1007/s10198-014-0592-6 - PubMed
    1. Park, W., Hrycaj, P., Jeka, S., Kovalenko, V., Lysenko, G., Miranda, P., Mikazane, H., Gutierrez-Urena, S., Lim, M., Lee, Y.A., Lee, S.J., Kim, H., Yoo, D.H., Braun, J.: A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann. Rheum. Dis. 72(10), 1605–1612 (2013) - PMC - PubMed
    1. Sieper, J., Rudwaleit, M., Baraliakos, X., Brandt, J., Braun, J., Burgos-Vargas, R., Dougados, M., Hermann, K.G., Landewe, R., Maksymowych, W., van der Heijde, D.: The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann. Rheum. Dis. 68(Suppl 2), ii1–ii44 (2009) - PubMed
    1. Migliore, A., Broccoli, S., Bizzi, E., Lagana, B.: Indirect comparison of the effects of anti-TNF biological agents in patients with ankylosing spondylitis by means of a mixed treatment comparison performed on efficacy data from published randomised, controlled trials. J. Med. Econ. 15(3), 473–480 (2012) - PubMed
    1. Ades, A.E., Sculpher, M., Sutton, A., Abrams, K., Cooper, N., Welton, N., Lu, G.: Bayesian methods for evidence synthesis in cost-effectiveness analysis. Pharmacoeconomics 24(1), 1–19 (2006) - PubMed

MeSH terms