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Outcome of adult patients with JIA treated with the biosimilar Benepali(®): results of the biologic register JuMBO
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 Obs...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9746218/ https://www.ncbi.nlm.nih.gov/pubmed/36514116 http://dx.doi.org/10.1186/s13075-022-02968-7 |
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author | Vollbach, Kristina Tenbrock, Klaus Wagner, Nobert Horneff, Gerd Klein, Ariane Foeldvari, Ivan Haas, Johannes-Peter Aries, Peer Gauler, Georg Striesow, Frank Hoff, Paula Scholz, Christine Tatsis, Stefanie Seipelt, Eva Klotsche, Jens Minden, Kirsten |
author_facet | Vollbach, Kristina Tenbrock, Klaus Wagner, Nobert Horneff, Gerd Klein, Ariane Foeldvari, Ivan Haas, Johannes-Peter Aries, Peer Gauler, Georg Striesow, Frank Hoff, Paula Scholz, Christine Tatsis, Stefanie Seipelt, Eva Klotsche, Jens Minden, Kirsten |
author_sort | Vollbach, Kristina |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9746218 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-97462182022-12-14 Outcome of adult patients with JIA treated with the biosimilar Benepali(®): results of the biologic register JuMBO Vollbach, Kristina Tenbrock, Klaus Wagner, Nobert Horneff, Gerd Klein, Ariane Foeldvari, Ivan Haas, Johannes-Peter Aries, Peer Gauler, Georg Striesow, Frank Hoff, Paula Scholz, Christine Tatsis, Stefanie Seipelt, Eva Klotsche, Jens Minden, Kirsten Arthritis Res Ther Research 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. BioMed Central 2022-12-13 2022 /pmc/articles/PMC9746218/ /pubmed/36514116 http://dx.doi.org/10.1186/s13075-022-02968-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Vollbach, Kristina Tenbrock, Klaus Wagner, Nobert Horneff, Gerd Klein, Ariane Foeldvari, Ivan Haas, Johannes-Peter Aries, Peer Gauler, Georg Striesow, Frank Hoff, Paula Scholz, Christine Tatsis, Stefanie Seipelt, Eva Klotsche, Jens Minden, Kirsten Outcome of adult patients with JIA treated with the biosimilar Benepali(®): results of the biologic register JuMBO |
title | Outcome of adult patients with JIA treated with the biosimilar Benepali(®): results of the biologic register JuMBO |
title_full | Outcome of adult patients with JIA treated with the biosimilar Benepali(®): results of the biologic register JuMBO |
title_fullStr | Outcome of adult patients with JIA treated with the biosimilar Benepali(®): results of the biologic register JuMBO |
title_full_unstemmed | Outcome of adult patients with JIA treated with the biosimilar Benepali(®): results of the biologic register JuMBO |
title_short | Outcome of adult patients with JIA treated with the biosimilar Benepali(®): results of the biologic register JuMBO |
title_sort | outcome of adult patients with jia treated with the biosimilar benepali(®): results of the biologic register jumbo |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9746218/ https://www.ncbi.nlm.nih.gov/pubmed/36514116 http://dx.doi.org/10.1186/s13075-022-02968-7 |
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