• Fabiola Atzeni, Elisabetta Gerratana, Sara Bongiovanni, Rossella Talotta, Gianfranco Miceli, Fausto Salaffi, and Piercarlo Sarzi-Puttini.
• Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
• Isr Med Assoc J. 2021 Jun 1; 23 (6): 344-349.

BackgroundThere is a lack of real-life clinical data for biosimilar etanercept, an anti-TNF blocking fusion protein. We describe the comparable efficacy and safety of originator and biosimilar etanercept in rheumatoid arthritis (RA) patients in a real-life clinical setting. Our data confirm that a biosimilar etanercept can be safely used as first-line treatment as well as in patients switched from a previous originator compound.ObjectivesTo compare the efficacy and safety of originator and biosimilar etanercept in a cohort of RA patients attending two Italian hospitals.MethodsThe study involved 81 consecutive adult RA patients treated for at least 6 months with originator or biosimilar etanercept and considered their clinical and laboratory data, concomitant medications, and adverse events at baseline, and after 3 and 6 months of treatment.ResultsGroup 1 included 51 patients taking originator etanercept; group 2 included 30 taking biosimilar etanercept, including 19 who had been switched from the reference product. Despite a significant baseline difference in clinical disease activity, one-way analysis of variance showed that the two groups were clinically comparable after 6 months of treatment, and the same was true when only those receiving etanercept as first-line biological treatment were considered. Nine patients discontinued the treatment due to inefficacy or adverse events, which were never serious and were only reported in group 1.ConclusionsThe efficacy and safety profiles of originator and biosimilar etanercept are comparable in RA patients in a real-life clinical setting. Further studies are needed to confirm these preliminary findings.

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