Universität zu Köln

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 and Minden, Kirsten (2022). Outcome of adult patients with JIA treated with the biosimilar Benepali (R): results of the biologic register JuMBO. Arthritis Res. Ther., 24 (1). LONDON: BMC. ISSN 1478-6362

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Abstract

Background: To analyze therapy adherence, safety, and outcome in adult patients with juvenile idiopathic arthritis (JIA) treated with the etanercept biosimilar Benepali (R) (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 (R). Of these, 74% had switched from Enbrel (R) (Pfizer Inc., NYC, USA) the originator of etanercept to Benepali (R) for cost reasons. Therapy survival of patients treated with Benepali (R) in comparison to Enbrel (R) 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 (R). 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 (R) because of an AE. Conclusions: Tolerability and effectiveness of the biosimilar Benepali (R) were satisfactory and therapy survival was comparable to the originator. Further data on therapy with biologics and biosimilars such as Benepali (R) 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Vollbach, Kristina UNSPECIFIED UNSPECIFIED UNSPECIFIED Tenbrock, Klaus UNSPECIFIED UNSPECIFIED UNSPECIFIED Wagner, Nobert UNSPECIFIED UNSPECIFIED UNSPECIFIED Horneff, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Klein, Ariane UNSPECIFIED UNSPECIFIED UNSPECIFIED Foeldvari, Ivan UNSPECIFIED UNSPECIFIED UNSPECIFIED Haas, Johannes-Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Aries, Peer UNSPECIFIED UNSPECIFIED UNSPECIFIED Gauler, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Striesow, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoff, Paula UNSPECIFIED UNSPECIFIED UNSPECIFIED Scholz, Christine UNSPECIFIED UNSPECIFIED UNSPECIFIED Tatsis, Stefanie UNSPECIFIED UNSPECIFIED UNSPECIFIED Seipelt, Eva UNSPECIFIED UNSPECIFIED UNSPECIFIED Klotsche, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Minden, Kirsten UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-691413
DOI:	10.1186/s13075-022-02968-7
Journal or Publication Title:	Arthritis Res. Ther.
Volume:	24
Number:	1
Date:	2022
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1478-6362
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language JUVENILE IDIOPATHIC ARTHRITIS; DISEASE-ACTIVITY; RHEUMATOLOGY; ETANERCEPT Multiple languages Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69141