Rodica Olteanu
Colentina Clinical Hospital, Romania
Title: Biosimilars in dermatology-clinical series of cases
Biography
Biography: Rodica Olteanu
Abstract
Introduction: Biosimilars represent a challenge in the daily clinical practice and they have demonstrated their effi cacy and good tolerance in a context of limited budget. Our health policy and Romanian protocols regarding the biosimilars does not recommend the pharmaceutical-nonmedical switch. Th e medical switch is permitted only by doctor’s prescription. Methods: In our hospital (Colentina Clinical Hospital, Bucharest, Dermatology Department), we treat patients with moderate to severe psoriasis with biologics according to the European and also Romanian Consensus (etanercept, adalimumab, infl iximab, ixekizumab, secukinumab, ustekinumab-originals or biosimilars) in a number of 290 patients on biologic therapy. From these 290 patients, 50 patients (17.24%) - are on biosimilars (Infl ectra, Remsima, Benepali) as they have been registered on the national program for psoriasis. Th e patients (23 women-46% and 27 men-54%) were studied for 12 months (January 2017-December 2017). Results: We compared the biosimilars patients with 50 patients on originals: etanercept (18 patients) and infl iximab (32 patients). From those 50 patients, fi ve dropped out from adverse reactions (tuberculosis, myocardial infarction etc.) and nine were switched because of ineffi cacy. As the remaining 36 patients, they were switched on other biologics (mainly on other biosimilars). For the patients on originals, at 12 months: 13 patients-26% (12 on Remicade and one on Enbrel) developed adverse reactions or lost PASI 50 (one dropped out and 18 were switched mainly on other originals: etanercept, adalimumab, ustekinumab, ixekizumab). Conclusions: Comparing the two groups, we did not fi nd any signifi cant diff erences (26% lost PASI 50 or had adverse reactions on originals and 28% on biosimilars) regarding maintaining the same therapy because of the adverse reactions or ineffi cacy at 12 months. In our study, the biosimilars demonstrated the same behavior as the originals.