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Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results.

Publication ,  Journal Article
Brunner, HI; Nanda, K; Toth, M; Foeldvari, I; Bohnsack, J; Milojevic, D; Rabinovich, CE; Kingsbury, DJ; Marzan, K; Chalom, E; Horneff, G ...
Published in: Arthritis Care Res (Hoboken)
October 2020

OBJECTIVE: To evaluate safety and effectiveness of adalimumab (ADA) in polyarticular-course juvenile idiopathic arthritis (JIA) in the STRIVE registry. METHODS: STRIVE enrolled patients with polyarticular-course JIA into 2 arms based on treatment with methotrexate (MTX) alone or ADA with/without MTX (ADA ± MTX). Adverse events (AEs) per 100 patient-years of observation time were analyzed by registry arm. Patients who entered the registry within 4 weeks of starting MTX or ADA ± MTX, defined as new users, were evaluated for change in disease activity assessed by the 27-joint Juvenile Arthritis Disease Activity Score with the C-reactive protein level (JADAS-27CRP ). RESULTS: At the 7-year cutoff date (June 1, 2016), data from 838 patients were available (MTX arm n = 301, ADA ± MTX arm n = 537). The most common AEs were nausea (10.3%), sinusitis (4.7%), and vomiting (4.3%) in the MTX arm and arthritis (3.9%), upper respiratory tract infection (3.5%), sinusitis, tonsillitis, and injection site pain (3.0% each) in the ADA ± MTX arm. Rates of serious infection were 1.5 events/100 patient-years in the MTX arm and 2.0 events/100 patient-years in the ADA ± MTX arm. AE and serious AE rates were similar in patients receiving ADA with versus without MTX. No deaths or malignancies were reported. New users in the ADA ± MTX arm showed a trend toward lower mean JADAS-27CRP compared with new users in the MTX arm in the first year of STRIVE. CONCLUSION: The STRIVE registry 7-year interim results support the idea that ADA ± MTX is well tolerated by most children. Registry median ADA exposure was 2.47 (interquartile range 1.0-3.6) years, with 42% of patients continuing ADA at the 7-year cutoff date.

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Published In

Arthritis Care Res (Hoboken)

DOI

EISSN

2151-4658

Publication Date

October 2020

Volume

72

Issue

10

Start / End Page

1420 / 1430

Location

United States

Related Subject Headings

  • Uveitis
  • Registries
  • Methotrexate
  • Male
  • Humans
  • Female
  • Drug Therapy, Combination
  • Child, Preschool
  • Child
  • Arthritis, Juvenile
 

Citation

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Brunner, H. I., Nanda, K., Toth, M., Foeldvari, I., Bohnsack, J., Milojevic, D., … Paediatric Rheumatology International Trials Organisation, and the Pediatric Rheumatology Collaborative Study Group, . (2020). Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results. Arthritis Care Res (Hoboken), 72(10), 1420–1430. https://doi.org/10.1002/acr.24044
Brunner, Hermine I., Kabita Nanda, Mary Toth, Ivan Foeldvari, John Bohnsack, Diana Milojevic, C Egla Rabinovich, et al. “Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results.Arthritis Care Res (Hoboken) 72, no. 10 (October 2020): 1420–30. https://doi.org/10.1002/acr.24044.
Brunner HI, Nanda K, Toth M, Foeldvari I, Bohnsack J, Milojevic D, et al. Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results. Arthritis Care Res (Hoboken). 2020 Oct;72(10):1420–30.
Brunner, Hermine I., et al. “Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results.Arthritis Care Res (Hoboken), vol. 72, no. 10, Oct. 2020, pp. 1420–30. Pubmed, doi:10.1002/acr.24044.
Brunner HI, Nanda K, Toth M, Foeldvari I, Bohnsack J, Milojevic D, Rabinovich CE, Kingsbury DJ, Marzan K, Chalom E, Horneff G, Kuester R-M, Dare JA, Trachana M, Jung LK, Olson J, Minden K, Quartier P, Bereswill M, Kalabic J, Kupper H, Lovell DJ, Martini A, Ruperto N, Paediatric Rheumatology International Trials Organisation, and the Pediatric Rheumatology Collaborative Study Group. Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results. Arthritis Care Res (Hoboken). 2020 Oct;72(10):1420–1430.
Journal cover image

Published In

Arthritis Care Res (Hoboken)

DOI

EISSN

2151-4658

Publication Date

October 2020

Volume

72

Issue

10

Start / End Page

1420 / 1430

Location

United States

Related Subject Headings

  • Uveitis
  • Registries
  • Methotrexate
  • Male
  • Humans
  • Female
  • Drug Therapy, Combination
  • Child, Preschool
  • Child
  • Arthritis, Juvenile