Efficacy and safety of TNF inhibitors in the treatment of juvenile idiopathic arthritis: a systematic literature review

Table 2 Primary outcomes in RCTs, nRCTs, and open-label studies of adalimumab

JIA categories	Patients, n	Time point	JIA-ACR 30/50/70/90, % of patients	Exposure, PY	SAE, n	SAE/100PY
NCT00048542 (3-part RCT) [15, 45]
Multiple	ADA + MTX: 85	16 weeks lead-in	94/91/71/28	27.0	3	11.1
	ADA: 86	16 weeks lead-in	74/64/46/26	29.3	4	13.7
	PBO + MTX: 37	48 weeks randomized phase	38/38/27/27	15	1	6.7
	ADA + MTX: 38		63/63/63/42	18.3	0	0
	ADA: 30		57/53/47/30	14.4	0	0
	ADA + MTX: 71	104 weeks OLE	NR	127.4	7	5.5
	ADA: 57	104 weeks OLE	NR	102.6	2	2.0
	ADA + /– MTX: 171	312 weeks	NR	592.8	75	12.7
NCT00775437 (Open-label study) [39]
Multiple	ADA: 31	12 weeks	94/90/61/39	NR	X	X
	ADA: 30	24 weeks	90/83/73/37	NR	X	X
	ADA: 3	120 weeks	NR	45.1	5	11.1
NCT01166282 (RCT and OLE) [40]
ERA	ADA: 31	12 weeks randomized phase	71/68/55/42	NR	1	NR
ERA	ADA: 46	52 weeks OLE	> 80/ > 80/ > 75/ > 60	NR	5	NR

ACR American College of Rheumatology, ADA Adalimumab, JIA Juvenile idiopathic arthritis, MTX Methotrexate, n Number of patients included in the analysis at the indicated timepoint, NR Not reported, nRCT Nonrandomized controlled trial, OLE Open-label extension, PBO Placebo, PY Patient-years, RCT Randomized controlled trial, SAE Serious adverse event

ISSN: 1546-0096