Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations

Author:

Leu Jocelyn H.,Shiff Natalie J.,Clark Michael,Bensley Karen,Lomax Kathleen G.,Berezny Katherine,Nelson Robert M.,Zhou Honghui,Xu Zhenhua

Funder

Janssen Research and Development

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pediatrics, Perinatology and Child Health

Reference51 articles.

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2. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH E11A: Pediatric extrapolation. April 4, 2022. Available at: https://database.ich.org/sites/default/files/ICH_E11A_Document_Step2_Guideline_2022_0404_0.pdf. Accessed 6 Apr 2022.

3. Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, He X, Maldonado-Cocco J, Orozco-Alcala J, Prieur AM, Suarez-Almazor ME, Woo P, International League of Associations for Rheumatology. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004;31:390–2.

4. Ringold S, Angeles-Han ST, Beukelman T, Lovell DJ, Cuello CA, Becker ML, Colbert RA, Feldman BM, Ferguson PJ, Gewanter HL, Guzman J, Horonjeff J, Nigrovic PA, Ombrello M, Passo M, Stoll ML, Rabinovich CE, Schneider R, Halyabar O, Hays K, Shah AA, Sullivan N, Szymanski AM, Turgunbaev M, Turner A, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71:846–63. https://doi.org/10.1002/art.40884.

5. European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis. EMA/CHMP/239770/2014 Rev 2. November 19, 2015. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-juvenile-idiopathic-arthritis_en.pdf. Accessed 29 Mar 2022.

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4. Existing and Emerging Targeted Therapies in Juvenile Psoriatic Arthritis: Challenges and Unmet Needs;Pediatric Drugs;2024-02-04

5. Juvenile Psoriatic Arthritis: Myth or Reality? An Unending Debate;Journal of Clinical Medicine;2023-01-03

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