A study of Etanar – an etanercept similar biotherapeutic product – has shown that it is as effective as adalimumab and infliximab in a cohort of patients with rheumatoid arthritis in a real-life setting [1].
Researchers from Biomab, Center For Rheumatoid Arthritis, Colombia carried out a descriptive cross-sectional study, which included patients who had at least six visits to a rheumatologist in the last 24 months in a specialized rheumatoid arthritis centre. Patients were divided into two groups: remission-low disease activity (Rem/LDA) patients and moderate-severe disease activity (MDA/SDA) patients and the aim of the study was to look at what percentage of patients who had MDA/SDA disease activity reached low disease activity or remission.
A total of 158 patients with rheumatoid arthritis and using adalimumab (61: 38.6%) infliximab (35: 22.2%) or Etanar (CP Guojian Pharmaceutical, China) (62: 39.2%) were included. Etanar has been approved for use in Colombia since 2007 [2].
The results of the study were presented at the European League against Rheumatism (EULAR) 2015 Congress held in Rome, Italy on 10–13 June 2015.
At 24 months a statistically significant increase was observed in the percentage of patients in remission and a decrease in the percentage of patients with MDA/SDA disease activity. In fact the Disease Activity Score for 28 joints (DAS28) decreased from 3.6 to 2.6 for all three biologicals, with no significant differences observed between the analysed biologicals. On the other hand, there were fewer adverse events (statistically significant) with Etanar than with adalimumab and infliximab.
Based on these results the authors concluded that Etanar ‘is as effective as 2 other traditional anti-TNF biologicals for disease activity control in patients with rheumatoid arthritis in a real-life setting with fewer adverse events, which could have implications in treatment decisions and health economics’.
Conflict of interest
The authors of the abstract [1] declared that there were no conflicts of interest.
Editor’s comment
It should be noted that similar biotherapeutic products approved in Colombia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
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References
1. Santos-Moreno P, et al. Etanar – a etanercept biosimilar is as effective as adalimumab and infliximab in a cohort of real-life of patients with rheumatoid arthritis. EULAR 2015; 10-13 June 2015; Rome, Italy.
2. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
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