Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry 7-Year Interim Results

To evaluate safety and effectiveness of adalimumab (ADA) in polyarticular-course juvenile idiopathic arthritis (pcJIA) in the STRIVE registry (NCT00783510). STRIVE enrolled patients with pcJIA into 2 arms based on treatment with methotrexate (MTX) alone or ADA with/without MTX (ADA±MTX). Adverse events (AEs) per 100 patient-years (PY) 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 C-reactive protein-based 27-joint Juvenile Arthritis Disease Activity Score (JADAS27 ). At the 7-year cut-off 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 PY in the MTX-arm and 2.0 events/100 PY 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 JADAS27 compared with new users in the MTX-arm in the first year of STRIVE. The STRIVE registry 7-year interim results support that ADA±MTX is well tolerated by most children. Registry median (interquartile range) ADA exposure was 2.47 (1.0-3.6) years, with 42% of patients continuing ADA at the 7-year cut-off date.