The study, published in Arthritis Care & Research, published seven-year results for patients enrolled in the STRIVE registry. Eligible patients were between ages two and 17 years and had moderate to severe disease. Patients were stratified into two groups: methotrexate alone or adalimumab plus methotrexate. New users were defined as patients who entered the study within four weeks of initiating either treatment; these patients underwent assessment for disease activity change per the C‐reactive protein–based 27‐joint Juvenile Arthritis Disease Activity Score (JADAS27CRP). Researchers analyzed adverse events per 100 patient years.
Final analysis included 838 patients: 301 methotrexate alone and 537 adalimumab plus methotrexate patients. In the methotrexate arm, the most common AEs were nausea (10.3%), sinusitis (4.7%), and vomiting (4.3%). In the adalimumab plus methotrexate arm, the most common AEs were arthritis (3.9%); upper respiratory tract infection (3.5%); and sinusitis, tonsillitis, and injection site pain (3.0% each). Serious infection rates were 1.5 events/100 person years and 2.0 events/100 person years in the methotrexate alone and adalimumab plus methotrexate groups, respectively. Rates of AEs and serious AEs were similar between the groups, and there were no reports of deaths or malignancies. New users in the adalimumab plus methotrexate cohort had lower mean JADAS27CRP compared to the new methotrexate users in the first year of the study.
The authors wrote in summary, “The STRIVE registry 7‐year interim results support that [adalimumab plus methotrexate] is well tolerated by most children. Registry median (interquartile range) [adalimumab] exposure was 2.47 (1.0–3.6) years, with 42% of patients continuing [adalimumab] at the 7‐year cut‐off date.”