Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis
Abstract
Objective To assess the relationship between infection risk and abatacept exposure levels in patients with polyarticular-course juvenile idiopathic arthritis (pJIA) following treatment with subcutaneous and intravenous abatacept.
Methods Data from two published studies (NCT01844518, NCT00095173) of abatacept treatment in pediatric patients were analyzed. One study treated patients aged 2–17 years with subcutaneous abatacept and the other treated patients aged 6–17 years with intravenous abatacept. Association between serum abatacept exposure measures and infection was evaluated using Kaplan–Meier plots of probability of first infection versus time on treatment by abatacept exposure quartiles and log-rank tests. Number of infections by abatacept exposure quartiles was investigated.
Results Overall, 343 patients were included in this analysis: 219 patients received subcutaneous abatacept and 124 patients received intravenous abatacept. Overall, 237/343 (69.1%) patients had ≥1 infection over 24 months. No significant difference in time to first infection across four quartiles of abatacept exposure levels was observed in the pooled (p = 0.4458), subcutaneous (2–5 years p = 0.9305; 6–17 years p = 0.4787), or intravenous (p = 0.4999) analyses. Concomitant use of methotrexate and glucocorticoids (at baseline and throughout) with abatacept did not increase infection risk across the abatacept exposure quartiles. There was no evidence of association between number of infections and abatacept exposure quartiles. No opportunistic infections related to abatacept were reported.
Conclusion In patients aged 2–17 years with pJIA, no evidence of association between higher levels of exposure to intravenous or subcutaneous abatacept and incidence of infection was observed.