Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven‐Year Interim Results. Issue 10 (29th September 2020)

• Record Type: Journal Article
• Authors: Brunner, Hermine I.; Nanda, Kabita; Toth, Mary; Foeldvari, Ivan; Bohnsack, John; Milojevic, Diana; Rabinovich, C. Egla; Kingsbury, Daniel J.; Marzan, Katherine; Chalom, Elizabeth; Horneff, Gerd; Kuester, Rolf‐Michael; Dare, Jason A.; Trachana, Maria; Jung, Lawrence K.; Olson, Judyann; Minden, Kirsten; Quartier, Pierre; Bereswill, Mareike; Kalabic, Jasmina; Kupper, Hartmut; Lovell, Daniel J.; Martini, Alberto; Ruperto, Nicolino
• Is Part Of: Arthritis care & research. Volume 72:Issue 10(2020)
• Page Start: 1420
• Page End: 1430
• Publication Date: 2020-09-29
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/acr.24044
• Languages: English
• ISSNs: 2151-464X

Abstract

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.