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Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven‐Year Interim Results
Author(s) -
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 RolfMichael,
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
Publication year - 2020
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.24044
Subject(s) - medicine , adalimumab , nausea , arthritis , methotrexate , vomiting , adverse effect , meddra , interim analysis , surgery , disease , clinical trial , pharmacovigilance
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‐27 CRP ). 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‐27 CRP 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.