Intravenous dosing of tocilizumab in patients younger than two years of age with systemic juvenile idiopathic arthritis: results from an open-label phase 1 clinical trial

Table 3 Safety

Adverse events	Patients < 2 years of age < 30 kg n = 11		Patients 2–17 years of age^a < 30 kg n = 38
Adverse events	12-week MEP	Entire study	First 12 weeks
Patients with ≥1 AE
AE	10 (90.9)	10 (90.9)	33 (86.8)
SAE	3 (27.3)	5 (45.5)	2 (5.3)
AE with fatal outcome	0	0	0
AE leading to withdrawal	4 (36.4)	5 (45.5)	1 (2.6)
AE leading to dose interruption	1 (9.1)	5 (45.5)	4 (10.5)
Infection
AE	9 (81.8)	9 (81.8)	23 (60.5)
SAE	1 (9.1)	1 (9.1)	1 (2.6)
Hypersensitivity reactions^b
Clinically confirmed	4 (36.4)	4 (36.4)	1 (2.6)
Serious	3 (27.3)	3 (27.3)	1 (2.6)
Low neutrophil count (grade ≥ 3)	1 (9.1)	3 (27.3)	3 (7.9)
Low platelet count (grade ≥ 3)	1 (9.1)	0	0

All data are number (%) of patients with event
AE adverse event, IV intravenously, MEP main evaluation period, Q2W every 2 weeks, SAE serious adverse event, TCZ tocilizumab
^aPatients weighing < 30 kg and receiving TCZ 12 mg/kg IV Q2W
^bSee Additional file 1: Appendix 3 for full details of patients with hypersensitivity reactions

ISSN: 1546-0096