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Implications of Evolving Disease Classification for Drug Approval in Juvenile Idiopathic Arthritis

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Abstract

The classification of inflammatory arthritis incorporates a sharp divide between diseases of childhood onset, grouped together as juvenile idiopathic arthritis, and diseases such as rheumatoid arthritis that begin by definition in adulthood. An important consequence of this divide is that regulatory authorities and many rheumatologists regard pediatric and adult arthritides as truly different, with the implication that drugs should be evaluated separately for each category. However, it is now clear that most forms of arthritis transcend the pediatric/adult boundary and that agents generally exhibit comparable success irrespective of age of onset, offering new opportunities in drug development and regulation focused on pharmacology and safety rather than efficacy. This paradigm shift will enable advances in arthritis treatment, originating either with adults or children, to translate more rapidly across the age spectrum.

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Authors and Affiliations

  1. Division of Rheumatology, Inflammation, and Immunity, Brigham and Women’s Hospital, 60 Fenwood Road 3rd Floor, Boston, MA, 02115, USA

    Siobhan M. Case & Peter A. Nigrovic

  2. Division of Immunology, Boston Children’s Hospital, Karp 10210, One Blackfan Circle, Boston, MA, 02115, USA

    Siobhan M. Case & Peter A. Nigrovic

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  1. Siobhan M. Case
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  2. Peter A. Nigrovic
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Correspondence to Siobhan M. Case or Peter A. Nigrovic.

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Funding

PAN is funded by NIAMS awards 2R01AR065538, R01AR075906, R01AR073201, 2P30AR070253; the Fundación Bechara; and the Arbuckle Family Fund for Arthritis Research.

Conflicts of interest

PAN receives investigator-initiated research grants from Bristol-Myers Squibb and Pfizer; consulting from Bristol-Myers Squibb (BMS), Cerecor, Exo Therapeutics, Miach Orthopedics, Novartis, and Pfizer; royalties from UpToDate Inc.; and salary support from the Childhood Arthritis and Rheumatology Research Alliance.

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PAN and SC made substantial contributions to the conception/design of the work; drafted the work or revised it critically for important intellectual content; approved the version to be published; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Both authors read and approved the final version.

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Case, S.M., Nigrovic, P.A. Implications of Evolving Disease Classification for Drug Approval in Juvenile Idiopathic Arthritis. Pediatr Drugs 24, 185–191 (2022). https://doi.org/10.1007/s40272-022-00496-0

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