Abstract: 680: Abatacept Treatment of Juvenile Idiopathic Arthritis (JIA): Safety Report
Sangeeta Sule, M.D.
Authors:
D. J. Lovell, N. Ruperto, A. M. Prieur, E. Paz, N. Rubio-Perez, C. A. Silva, C. Abud, R. Burgos-Vargas, V. Gerloni, J. A. Melo-Gomes, C. Saad Magalhaes, F. Sztajnbok, C. Goldenstein-Schainberg, M. Scheinberg, P. Hashkes, C. Hom1, L. H. Sigal, A. J. Block, A. Covucci, P. L. N Cornet, L. Pagliaro, E. H. Giannini, A. Martini.
Background:
Abatacept (ABA), a biological agent that blocks signaling required for antigen-specific T cell activation, has been shown to be effective in treatment of JIA in a previous double-blind, randomized withdrawal study. The authors report on the safety of patients enrolled in the study.
Methods:
190 patients enrolled and 170 patients completed the open-label lead-in period. The eligible patients who achieved the ACR Pedi 30 definition of improvement following the 4-month open-label lead in period were randomized to received either ABA or placebo infusion every 28 days for up to 6 months.
Results:
Of the 170 patients who completed the lead-in period, 123 patients achieved an ACR Pedi 30 response and 122 entered the double-blind withdrawal period study. In the open-label study, 6 patients reported serious adverse events (SAEs). These included 2 flares of disease, 1 joint replacement, 1 case of varicella, 1 case of ovarian cyst, an 1 case of acute lymphocytic leukemia. The patient with leukemia had anemia at enrollment and was diagnosed at day 89 (thought not related to study medication). 70% of patients reported some adverse events with 13.2% noting headache, 10% with nausea, 8.9% with cough, 8.9% with diarrhea, 7.4% with upper respiratory tract infection, and fever in 6.3%. There were no opportunistic infections reported. Eight patients (4.2%) had infusion reactions with headache and dizziness occurring in 4 and 2 patients, respectively. In the double-blind period, no SAE were reported in the ABA group; 3 SAE were reported in the placebo group (1 hematoma, 1 varicella, 1 encephalitis). AE were reported in 61.7% of ABA treated patients compared to 54.8% of placebo treated patients and included influenza (8.3% vs. 6.5%), bacteriuria (6.7% vs. 0%), nasopharyngitis (6.7% vs. 4.8%), URTI (6.7% vs. 8.1%), and pyrexia (6.7% vs. 8.1%). No serious infections or autoimmune phenomenon were reported.
Conclusions:
ABA seemed to be well tolerated during this open-label and double-blind study.
Editorial Comment:
This abstract shows the safety profile of ABA in children with JIA. The report is reassuring that no significant differences were noted in infection rate or autoimmune disease between treatment and placebo groups. Following these children longitudinally would be important to detect more long-term adverse events, such as rates of malignancy or disease relapse.
