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 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..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:24 |
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| Enthalten in: |
Arthritis Research & Therapy - 24(2022), 1 vom: 13. Dez. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Vollbach, Kristina [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
Benepali |
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| Anmerkungen: |
© The Author(s) 2022 |
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| doi: |
10.1186/s13075-022-02968-7 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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OLC2133073167 |
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| 245 | 1 | 0 | |a Outcome of adult patients with JIA treated with the biosimilar $ Benepali^{®} $: results of the biologic register JuMBO |
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| 520 | |a 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. | ||
| 650 | 4 | |a Juvenile idiopathic arthritis | |
| 650 | 4 | |a Biosimilar | |
| 650 | 4 | |a Etanercept | |
| 650 | 4 | |a Enbrel | |
| 650 | 4 | |a Benepali | |
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| 700 | 1 | |a Scholz, Christine |4 aut | |
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| 700 | 1 | |a Seipelt, Eva |4 aut | |
| 700 | 1 | |a Klotsche, Jens |4 aut | |
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