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Safety and efficacy of etanercept and adalimumab in children aged 2 to 4 years with juvenile idiopathic arthritis

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Abstract

The TNF inhibitors etanercept (ETA) and adalimumab (ADA) are approved for treating patients older than 2 years with polyarticular juvenile idiopathic arthritis (JIA). Because long-term experience of treating children younger than 4 years is limited, we evaluated the efficacy and safety of ETA or ADA in patients aged 2–4 years. This prospective, long-term, observational registry study documented baseline demographics, clinical characteristics, disease activity parameters, and safety of patients treated with ETA or ADA. Efficacy was determined using the JADAS-10, the JADAS criteria for minimal disease activity (MDA) and remission, and the PedACR response criteria after 3, 6, 12, 18, and 24 months. Between January 2001 and March 2015, 85 patients with polyarticular JIA aged 2–4 years started anti-TNF-α treatment. Seventy-four (54 girls) patients were treated with ETA and 11 (7 girls) with ADA. After 6/12/24 months of treatment, JADAS-MDA was reached by 55/58/58 % of ETA patients and 50/71/66 % of ADA patients. Furthermore, JADAS-Remission was achieved by 35/44/50 % of ETA patients and 16/28/66 % of ADA patients. PedACR 50/70/90 response was achieved by 64/54/41 % of ETA patients and 56/33/22 % of ADA patients at the last treatment observation. Discontinuation because of remission or inefficacy was recorded in 24 (29 %) and 28 (33 %) patients, respectively. Seventy-nine adverse events and four serious adverse events were reported. Administration of ETA and ADA in JIA patients younger than 4 years was efficacious, well tolerated, and safe. Patients younger than 4 years may show marked improvement following anti-TNF-alpha therapy.

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Acknowledgments

This study would not have been possible without the collaboration of numerous German and Austrian pediatric rheumatologists, patients, and their parents.

Collaborators

Michael Borte, Frank Dressler, Maria Fasshauer, Dirk Föll, Ivan Foeldvari, Toni Hospach, Christian Hümer, Markus Hufnagel, Jasmin Kümmerle-Deschner, Bernd-Ulrich Keck, Thomas Keller, Rolf Küster, Kirsten Minden, Thomas Müller, Martina Prelog, Betina Rogalski, Otto Schofer, Michaela Sailer-Höck, Frank Weller-Heinemann, and Olaf Zimmermann.

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Authors and Affiliations

  1. Department of Pediatrics, Asklepios Hospital Weissenfels, Naumburger-Strasse 76, 06667, Weissenfels, Germany

    D. Windschall

  2. Department of Pediatrics, Center for Pediatric Rheumatology, Asklepios Hospital Sankt Augustin, Arnold-Janssen-Strasse 29, 53757, St. Augustin, Germany

    G. Horneff

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  1. D. Windschall
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Correspondence to D. Windschall.

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Conflict of interest

D Windschall has received research grants from Roche and Pfizer and speaker’s fees from AbbVie, Novartis, and Pfizer. G Horneff has received research grants from AbbVie, Pfizer, and Roche, and speaker’s fees from AbbVie, Novartis, Pfizer, and Roche.

Funding

The registry is supported by an unrestricted grant from Pfizer, Germany; AbbVie, Germany; and Roche, Germany. The companies had no chance to influence the analysis of data or drafting of the manuscript.

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Windschall, D., Horneff, G. Safety and efficacy of etanercept and adalimumab in children aged 2 to 4 years with juvenile idiopathic arthritis. Clin Rheumatol 35, 2925–2931 (2016). https://doi.org/10.1007/s10067-016-3439-y

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  • DOI: https://doi.org/10.1007/s10067-016-3439-y

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