TY - JOUR T1 - Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis JF - The Journal of Rheumatology JO - J Rheumatol DO - 10.3899/jrheum.200154 SP - jrheum.200154 AU - Nicolino Ruperto AU - Hermine I. Brunner AU - Nikolay Tzaribachev AU - Gabriel Vega-Cornejo AU - Ingrid Louw AU - Rolando Cimaz AU - Jason Dare AU - Graciela Espada AU - Enrique Faugier AU - Manuel Ferrandiz AU - Valeria Gerloni AU - Pierre Quartier AU - Clovis Artur Silva AU - Linda Wagner-Weiner AU - Yash Gandhi AU - Julie Passarell AU - Marleen Nys AU - Robert Wong AU - Alberto Martini AU - Daniel J. Lovell Y1 - 2021/01/15 UR - http://www.jrheum.org/content/early/2021/04/27/jrheum.200154.abstract N2 - Objective To assess the relationship between infection risk and abatacept (ABA) exposure levels in patients with polyarticular-course juvenile idiopathic arthritis (pJIA) following treatment with subcutaneous (SC) and intravenous (IV) ABA. Methods Data from 2 published studies (ClinicalTrials.gov: NCT01844518, NCT00095173) of ABA treatment in pediatric patients were analyzed. One study treated patients aged 2–17 years with SC ABA and the other treated patients aged 6–17 years with IV ABA. Association between serum ABA exposure measures and infection was evaluated using Kaplan-Meier plots of probability of first infection vs time on treatment by ABA exposure quartiles and log-rank tests. Number of infections by ABA exposure quartiles was investigated. Results Overall, 343 patients were included in this analysis: 219 patients received SC ABA and 124 patients received IV ABA. Overall, 237/343 (69.1%) patients had ≥ 1 infection over 24 months. No significant difference in time to first infection across 4 quartiles of ABA exposure levels was observed in the pooled (P = 0.45), SC (2–5 yrs: P = 0.93; 6–17 yrs: P = 0.48), or IV (P = 0.50) analyses. Concomitant use of methotrexate and glucocorticoids (at baseline and throughout) with ABA did not increase infection risk across the ABA exposure quartiles. There was no evidence of association between number of infections and ABA exposure quartiles. No opportunistic infections related to ABA were reported. Conclusion In patients aged 2–17 years with pJIA, no evidence of association between higher levels of exposure to IV ABA or SC ABA and incidence of infection was observed. ER -