Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis

Authors: Ruperto N, Brunner H, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell JA, Nys M, Wong R, Martini A, Lovell DJ
Publication: J Rheumatol
Keywords: biological therapy, disease-modifying antirheumatic drugs, infection, juvenile idiopathic arthritis
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Abstract

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.

By, Nicolino Ruperto, Hermine I Brunner, Nikolay Tzaribachev, Gabriel Vega-Cornejo, Ingrid Louw, Rolando Cimaz, Jason Dare, Graciela Espada, Enrique Faugier, Manuel Ferrandiz, Valeria Gerloni, Pierre Quartier, Clovis Artur Silva, Linda Wagner-Weiner, Yash Gandhi, Julie A Passarell, Marleen Nys, Robert Wong, Alberto Martini, Daniel J Lovell.