Table 2.

Adverse events in juvenile idiopathic arthritis ( JIA) patients treated with either abatacept or placebo

	4-month open-label period	6-month double-blind period
	Abatacept (N = 190)	Abatacept (N = 60)	Placcbo (N = 62)	p value*
Total serious adverse events	6 (3%)	0	2 (3%)	0.50
Total adverse events†	133 (70%)	37 (62%)	34 (55%)	0.47
Infections and infestations	68 (36%)	27 (45%)	27 (44%)	1.00
Influenza	7 (4%)	5 (8%)	4 (7%)	0.74
Bacteriuria	3 (2%)	4 (7%)	0	0.06
Nasopharyngitis	11 (6%)	4 (7%)	3 (5%)	0.72
Upper respiratory tract infection	14 (7%)	4 (7%)	5 (8%)	1.00
Gastroenteritis	1 (0.5%)	3 (5%)	1 (2%)	0.36
Sinusitis	6 (3%)	3 (5%)	2 (3%)	0.68
Rhinitis	8 (4%)	1 (2%)	4 (7%)	0.36
Gastrointestinal disorders	66 (35%)	10 (14%)	9 (15%)	0.81
Abdominal pain	9 (5%)	3 (5%)	1 (2%)	0.36
Nausea	19 (10%)	2 (3%)	4 (7%)	0.68
Diarrhea	17 (9%)	1 (2%)	1 (2%)	1.00
Upper abdominal pain	10 (5%)	1 (2%)	0	0.49
General disorders and administration site conditions	26 (14%)	4 (7%)	9 (15%)	0.24
Pyrexia	12 (6%)	4 (7%)	5 (8%)	1.00
Nervous system disorders	30 (16%)	3 (5%)	2 (3%)	0.68
Headache	25 (13%)	3 (5%)	1 (2%)	0.36
Respiratory, thoracic and mediastinal disorders	32 (17%)	6 (10%)	3 (5%)	0.50
Cough	17 (9%)	0	2 (3%)	0.50

^*Fisher’s test used to test the difference between groups given abatacept and placebo in the double-blind phase.

^†Adverse events that occurred in at least 5% of patients in the open-label and double-blind phases.

Adapted from The Lancet, 372, Ruperto N, Lovell DJ, Quartier P, et al; Paediatric Rheumatology International Trials Organization; Pediatric Rheumatology Collaborative Study Group. 2008. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial, 383–91, Copyright © 2008 with permission from Elsevier.