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Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.

Publication ,  Journal Article
Schanberg, LE; Mulugeta, LY; Akinlade, B; Brunner, HI; Chen, J; Colbert, RA; Delgaizo, V; Gastonguay, MR; Glaser, R; Imundo, L; Lovell, DJ ...
Published in: Arthritis Rheumatol
October 2023

OBJECTIVE: Stakeholders met to address persistent challenges facing the development of therapeutics for polyarticular juvenile idiopathic arthritis (pJIA), which result in fewer approved therapies for children with pJIA than adults with rheumatoid arthritis (RA) and long lag times from adult RA approval to pediatric labeling. Ensuring that new medications are authorized in a timely manner to meet the needs of JIA patients worldwide is critically important to multiple stakeholders. METHODS: The Food and Drug Administration in collaboration with the University of Maryland Center for Regulatory Science and Innovation held a public workshop entitled "Accelerating Drug Development for pJIA" on October 2, 2019, to address challenges surrounding access to new medications for children and adolescents with pJIA. Regulatory, academic, and industry stakeholders, as well as patient representatives, participated in the workshop, which consisted of 4 sessions, including panel discussions. RESULTS: The workshop facilitated broad public discussion of challenges facing the development of pJIA therapeutics, highlighting areas of need and outlining opportunities to expedite development, while underscoring the necessity of close collaboration between all stakeholders, including patients and families. CONCLUSION: This report summarizes key aspects of the workshop, including the appropriate application of innovative approaches to the development of pJIA therapeutics, including extrapolation, to address current challenges and provide timely access to newer safe and effective treatments. Long-term safety assessment is of pressing concern to stakeholders and cannot be fully extrapolated from adult studies but requires consistent postmarketing long-term follow-up.

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Published In

Arthritis Rheumatol

DOI

EISSN

2326-5205

Publication Date

October 2023

Volume

75

Issue

10

Start / End Page

1856 / 1866

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Humans
  • Drug Development
  • Clinical Trials as Topic
  • Child
  • Arthritis, Rheumatoid
  • Arthritis, Juvenile
  • Adult
  • Adolescent
  • 3204 Immunology
 

Citation

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Schanberg, L. E., Mulugeta, L. Y., Akinlade, B., Brunner, H. I., Chen, J., Colbert, R. A., … Yao, L. (2023). Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design. Arthritis Rheumatol, 75(10), 1856–1866. https://doi.org/10.1002/art.42534
Schanberg, Laura E., Lily Yeruk Mulugeta, Bolanle Akinlade, Hermine I. Brunner, Jianmeng Chen, Robert A. Colbert, Vincent Delgaizo, et al. “Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.Arthritis Rheumatol 75, no. 10 (October 2023): 1856–66. https://doi.org/10.1002/art.42534.
Schanberg LE, Mulugeta LY, Akinlade B, Brunner HI, Chen J, Colbert RA, et al. Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design. Arthritis Rheumatol. 2023 Oct;75(10):1856–66.
Schanberg, Laura E., et al. “Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.Arthritis Rheumatol, vol. 75, no. 10, Oct. 2023, pp. 1856–66. Pubmed, doi:10.1002/art.42534.
Schanberg LE, Mulugeta LY, Akinlade B, Brunner HI, Chen J, Colbert RA, Delgaizo V, Gastonguay MR, Glaser R, Imundo L, Lovell DJ, Leu JH, Mostafa NM, Nelson RM, Nigrovic PA, Nikolov NP, Rider LG, Rothwell R, Sahajwalla C, Singh R, Sinha V, Yancey CL, Yao L. Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design. Arthritis Rheumatol. 2023 Oct;75(10):1856–1866.
Journal cover image

Published In

Arthritis Rheumatol

DOI

EISSN

2326-5205

Publication Date

October 2023

Volume

75

Issue

10

Start / End Page

1856 / 1866

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Humans
  • Drug Development
  • Clinical Trials as Topic
  • Child
  • Arthritis, Rheumatoid
  • Arthritis, Juvenile
  • Adult
  • Adolescent
  • 3204 Immunology