Outcome of adult patients with JIA treated with the biosimilar Benepali ® : results of the biologic register JuMBO.

Autor: Vollbach K; Department of Pediatrics, RWTH Aachen University Hospital, Aachen, Germany., Tenbrock K; Department of Pediatrics, RWTH Aachen University Hospital, Aachen, Germany., Wagner N; Department of Pediatrics, RWTH Aachen University Hospital, Aachen, Germany., Horneff G; Centre for Pediatric Rheumatology, Department of Pediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.; Department of Pediatric and Adolescent Medicine, University Hospital of Cologne, Cologne, Germany., Klein A; Centre for Pediatric Rheumatology, Department of Pediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.; Department of Pediatric and Adolescent Medicine, University Hospital of Cologne, Cologne, Germany., Foeldvari I; Zentrum für Kinder- und Jugendrheumatologie, Hamburg, Germany., Haas JP; German Centre for Pediatric and Adolescent Rheumatology, Garmisch-Partenkirchen, Germany., Aries P; Rheumatologie im Struenseehaus, Hamburg, Germany., Gauler G; Rheumapraxis an der Hase, Osnabrück, Germany., Striesow F; Internistisch-Rheumatologische Praxis, Bonn, Germany., Hoff P; MVZ Endokrinologikum Berlin am Gendarmenmarkt, Berlin, Germany., Scholz C; Internistisch-Rheumatologische Praxis, Freiburg, Germany., Tatsis S; Marienkrankenhaus, Hamburg, Germany., Seipelt E; Immanuel Krankenhaus, Berlin Buch, Germany., Klotsche J; Deutsches Rheuma-Forschungszentrum Berlin, Leibniz Association, Berlin, Germany., Minden K; Deutsches Rheuma-Forschungszentrum Berlin, Leibniz Association, Berlin, Germany. minden@drfz.de.; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany. minden@drfz.de.
Jazyk: angličtina
Zdroj: Arthritis research & therapy [Arthritis Res Ther] 2022 Dec 13; Vol. 24 (1), pp. 271. Date of Electronic Publication: 2022 Dec 13.
DOI: 10.1186/s13075-022-02968-7
Abstrakt: Background: To analyze therapy adherence, safety, and outcome in adult patients with juvenile idiopathic arthritis (JIA) treated with the etanercept biosimilar Benepali ® (Biogen Inc, Cambridge, USA).
Methods: Data from the prospective registry, JuMBO (Juvenile arthritis MTX/Biologics long-term Observation), were used for the analysis. JuMBO is a long-term observational cohort study. It follows adult patients with JIA who were formerly included in the national JIA biologic register (BiKeR Registry). Both registries provide individual trajectories of clinical data and outcomes from childhood to adulthood in JIA patients treated with disease-modifying anti-rheumatic drugs (DMARDs).
Results: Eighty-three patients from the German JuMBO registry were treated with Benepali ® . Of these, 74% had switched from Enbrel ® (Pfizer Inc., NYC, USA) the originator of etanercept to Benepali ® for cost reasons. Therapy survival of patients treated with Benepali ® in comparison to Enbrel ® in patients matched by significant parameters was comparable. Adverse events (AE) were reported in 25.3% and serious adverse events (SAE) in 9.6% of patients. Physicians rated no SAE causative related to Benepali ® . The majority of SAEs were surgical/medical procedures and there was only one infection. All efficacy parameters (cJADAS-10, Physician Global Assessment, number of joints with active arthritis, patients' overall well-being, pain, and HAQ) demonstrated improvement over 24 months (p-values were not significant). 9.6% of patients permanently discontinued Benepali® because of an AE.
Conclusions: Tolerability and effectiveness of the biosimilar Benepali ® were satisfactory and therapy survival was comparable to the originator. Further data on therapy with biologics and biosimilars such as Benepali ® must be collected by registries such as BiKeR and JuMBO in order to optimize therapy and patient outcomes and to reduce costs in the health system in the long term.
(© 2022. The Author(s).)
Databáze: MEDLINE
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