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

Abstract

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.

• Authors: Hermine I Brunner, Kabita Nanda, Mary Toth, Ivan Foeldvari, John Bohnsack, Diana Milojevic, C Egla Rabinovich, Daniel J Kingsbury, Katherine Marzan, Elizabeth Chalom, Gerd Horneff, Rolf-Michael Kuester, Jason A Dare, Maria Trachana, Lawrence K Jung, Judyann Olson, Kirsten Minden, Pierre Quartier, Mareike Bereswill, Jasmina Kalabic, Hartmut Kupper, Daniel J Lovell, Alberto Martini, Nicolino Ruperto, Paediatric Rheumatology International Trials Organisation, and the Pediatric Rheumatology Collaborative Study Group
• Journal: Arthritis care & research (Arthritis Care Res (Hoboken)) Vol. 72 Issue 10 Pg. 1420-1430 (10 2020) ISSN: 2151-4658 [Electronic] United States
• PMID: 31421019 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2019 AbbVie Inc. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

Chemical References

• Antirheumatic Agents
• Adalimumab
• Methotrexate

Topics

• Adalimumab (therapeutic use)
• Adolescent
• Antirheumatic Agents (therapeutic use)
• Arthritis, Juvenile (complications, drug therapy)
• Child
• Child, Preschool
• Drug Therapy, Combination
• Female
• Humans
• Male
• Methotrexate (therapeutic use)
• Registries
• Uveitis (drug therapy, etiology)