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.

Comparative risk of infections among real-world users of biologics for juvenile idiopathic arthritis: data from the German BIKER registry

“…This is mainly due to methodical reasons, since younger age at baseline comes along with longer observation time in the BIKER registry. However, younger children are generally more susceptible to infectious diseases, as was also found in the STRIVE registry [ 39 ].…”

Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate

“…These findings were also consistent with data from the real-world STRIVE registry in patients with active polyarticular JIA. 23 24 In the 7-year interim analysis of STRIVE, the rate of serious AEs was 7.2/100 PY and the rate of serious infections was 2.0/100 PY with 1855.5 PY of adalimumab exposure (± methotrexate). Similar results were demonstrated in the German BiKeR registry in patients with polyarticular JIA (serious AEs, 11.0/100 PY; serious infections, 5.5/100 PY).…”

Biologics in Juvenile Idiopathic Arthritis-Main Advantages and Major Challenges: A Narrative Review

“…Moreover, the treatment with adalimumab is safe and efficient in patients with JIA. 2,[37][38][39][40] Apparently, adalimumab was well tolerated, efficient, and safe in young patients with pJIA aged two to four years and those older than four with <15 kg. 41 Seven-Year Interim Results from the STRIVE Registry showed that adalimumab was well tolerated and efficient in the majority of treated children with pJIA.…”

“…23,37,38 Combined usage of adalimumab with non-biological DMARDs (namely methotrexate) enhances the drug efficiency. [37][38][39] According to German Biologics Registry, adalimumab is highly effective in children and adolescents with inflammatory conditions. Moreover, the treatment with adalimumab is safe and efficient in patients with JIA.…”