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

Table 4 Primary outcomes in RCTs, nRCTs, and open-label studies of golimumab

JIA categories	Patients, n	Time point	JIA-ACR 30/50/70/90, % of patients	Exposure, PY	SAE, n	SAE/100PY
GO KIDS; NCT01230827 (3-part RCT) [20]
Multiple	GOL: 173	16 weeks OLE	89/79/66/36	53.7	8	16.8
	PBO: 76	48 weeks	NR	NR	10	32.5
	GOL: 78	48 weeks	53/51/47/39	NR	8	17.1
	PBO (to GOL): 76	96 weeks OLE	74/74/69/53	NR	7	10.4
	GOL: 78	96 weeks OLE	69/69/65/49	NR	13	24.3
	GOL: 173	160 weeks	NR	325.6	39	18.1
NCT02277444 (1-arm, open-label study) [47]
PA (RF −), PA (RF +), ERA, ExOA, PsA, sJIA	GOL: 127	28 weeks	84/80/70/47	NR	NR	NR
PA (RF −), PA (RF +), ERA, ExOA, PsA, sJIA	GOL: 127	52 weeks	76/74/65/49	NR	9	8.2

ACR American College of Rheumatology, ERA Enthesitis-related arthritis, ExOA Extended oligoarticular arthritis, GOL Golimumab, JIA Juvenile idiopathic arthritis, n Number of patients included in the analysis at the indicated timepoint, NR Not reported, nRCT Nonrandomized controlled trial, OLE Open-label extension, PA Polyarticular arthritis, PBO Placebo, PsA Psoriatic arthritis, PY Patient-years, RCT Randomized controlled trial, RF Rheumatoid factor, SAE Serious adverse event, sJIA Systemic juvenile idiopathic arthritis

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