Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis
To compare the efficacy and safety of infliximab-biosimilar with other biological drugs for the treatment of active ankylosing spondylitis (AS).
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.
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.
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.
- Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis
- Open Access
- Available under Open Access This content is freely available online to anyone, anywhere at any time.
The European Journal of Health Economics
Volume 15, Issue 1 Supplement, pp 45-52
- Cover Date
- Print ISSN
- Online ISSN
- Springer Berlin Heidelberg
- Additional Links
- Ankylosing spondylitis
- Biological drug
- Biosimilar pharmaceuticals
- Industry Sectors
- Author Affiliations
- 1. Department of Health Economics, Corvinus University of Budapest, Fővám tér 8, 1093, Budapest, Hungary
- 2. Department of Rheumatology, Flór Ferenc County Hospital, Semmelweis tér 1, 2143, Kistarcsa, Hungary
- 3. Division of Rheumatology, Institute of Medicine, University of Debrecen Medical and Health Sciences Center, Nagyerdei krt 98, 4032, Debrecen, Hungary
- 4. No. I. Department of Rheumatology, Budai Irgalmasrendi Hospital, Frankel Leó út 54, 1023, Budapest, Hungary