Comparable long-term outcomes with biosimilar and originator adalimumab in juvenile idiopathic arthritis: a multicenter cohort study

Background Real-world evidence on biosimilar adalimumab in juvenile idiopathic arthritis (JIA) remains limited. We compared the effectiveness, treatment persistence, and safety of biosimilar and originator adalimumab.Methods This multicenter retrospective cohort study included children with JIA treated with biosimilar or originator adalimumab for ≥24 weeks. Disease activity was assessed using the Juvenile Arthritis Disease Activity Score-27 (JADAS-27) and, in enthesitis-related arthritis (ERA), the Juvenile Spondyloarthritis Disease Activity Index (JSpADA). Treatment persistence and adverse events were compared.Results 129 patients were analyzed (originator product [OP], n = 86; biosimilar product [BP], n = 43; ABP 501, n = 39; GP2017, n = 4). Prior biologic exposure was higher in OP (p = 0.007), and time to adalimumab initiation was longer in OP (p = 0.015). JADAS-27 scores were higher in BP at treatment initiation (T0) and month 3 (T3) (p = 0.029 and p = 0.027) but not thereafter. JSpADA scores were similar overall. Treatment persistence was similar between groups (p = 0.080). Remission ≥6 months was more frequent in OP (p = 0.039), whereas drug-free remission and adverse event rates were similar.Conclusions Biosimilar adalimumab demonstrated comparable long-term outcomes to the originator, although baseline differences between groups should be considered.

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Journal
Expert Opinion on Biological Therapy
Published
2026-08-26
DOI
https://doi.org/10.1080/14712598.2026.2723535
Primary Topic
Autoimmune and Inflammatory Disorders Research
Type
article
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article

Comparable long-term outcomes with biosimilar and originator adalimumab in juvenile idiopathic arthritis: a multicenter cohort study

Nuray Aktay Ayaz, Mustafa Çakan, Özlem Akgün, Ayşenur Doğru et al.
Expert Opinion on Biological Therapy
Autoimmune and Inflammatory Disorders Research
article

Comparable long-term outcomes with biosimilar and originator adalimumab in juvenile idiopathic arthritis: a multicenter cohort study

Nuray Aktay Ayaz, Mustafa Çakan, Özlem Akgün, Ayşenur Doğru, Fatma Gül Demirkan, Ayşe Tanatar, Figen Çakmak, Büşra Başer Taşkın, Buşra Çinpolat
article en

Abstract

Background Real-world evidence on biosimilar adalimumab in juvenile idiopathic arthritis (JIA) remains limited. We compared the effectiveness, treatment persistence, and safety of biosimilar and originator adalimumab.Methods This multicenter retrospective cohort study included children with JIA treated with biosimilar or originator adalimumab for ≥24 weeks. Disease activity was assessed using the Juvenile Arthritis Disease Activity Score-27 (JADAS-27) and, in enthesitis-related arthritis (ERA), the Juvenile Spondyloarthritis Disease Activity Index (JSpADA). Treatment persistence and adverse events were compared.Results 129 patients were analyzed (originator product [OP], n = 86; biosimilar product [BP], n = 43; ABP 501, n = 39; GP2017, n = 4). Prior biologic exposure was higher in OP (p = 0.007), and time to adalimumab initiation was longer in OP (p = 0.015). JADAS-27 scores were higher in BP at treatment initiation (T0) and month 3 (T3) (p = 0.029 and p = 0.027) but not thereafter. JSpADA scores were similar overall. Treatment persistence was similar between groups (p = 0.080). Remission ≥6 months was more frequent in OP (p = 0.039), whereas drug-free remission and adverse event rates were similar.Conclusions Biosimilar adalimumab demonstrated comparable long-term outcomes to the originator, although baseline differences between groups should be considered.

Expert Opinion on Biological Therapy
Zeynep Kamil Hospital (TR), İstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi (TR), İstanbul Başakşehir Çam ve Sakura Şehir Hastanesi, Istanbul University (TR), Marmara University (TR)
Good health and well-being
Openalex Percentile: Top 10%
Autoimmune and Inflammatory Disorders Research
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