Table 5.

Adverse events summarized by corticosteroid use at baseline in patients with RA, PsA, and AS*

Occurrence during placebo-controlled periods, n (%)
	RA trial				PsA trial				AS trial				Pooled
	PBO		Golimumab		PBO		Golimumab		PBO		Golimumab		PBO		Golimumab
Corticosteroid use at baseline	+	-	+	−	+	−	+	−	+	−	+	−	+	−	+	−
Treated patients, N	134	63	251	144	67	172	66	174	23	80	32	73	224	315	349	391
Mean follow-up, weeks	21.1	20.4	23.5	23.9	22.7	23.3	23.4	24.0	15.9	16.0	16.0	16.1	21.0	20.9	22.8	22.5
≥ 1 infection	34 (25.4)	14 (22.2)	79 (31.5)	40 (27.8)	9 (13.4)	28 (16.3)	13 (19.7)	32 (18.4)	0	8 (10.0)	2 (6.3)	10 (13.7)	43 (19.2)	50 (15.9)	94 (26.9)	82 (21.0)
≥ 1 SAE	5 (3.7)	0	16 (6.4)	3 (2.1)	3 (4.5)	5 (2.9)	1 (1.5)	6 (3.4)	0	0	0	2 (2.7)	8 (3.6)	5 (1.6)	17 (4.9)	11 (2.8)
≥ 1 serious infection	0	0	3 (1.2)	1 (0.7)	2 (3.0)	0	1 (1.5)	0	0	0	0	1 (1.4)	2 (0.9)	0	4 (1.1)	2 (0.5)
Events/100 patient-years through study completion**
	RA trial				PsA trial				AS trial				Pooled
	Golimumab				Golimumab				Golimumab				Golimumab
Corticosteroid use at baseline	+		−		+		−		+		−		+		−
Patients, N	381		203		126		334		55		149		562		686
Total PY of follow-up	697		379		112		306		57		146		865		832
SAE	16.4 (13.5, 19.6)		15.6 (11.8, 20.1)		4.5 (1.5, 10.5)		9.5 (6.4, 13.6)		0 (0.0, 5.3)		5.5 (2.4, 10.8)		13.8 (11.4, 16.5)		11.5 (9.4, 14.1)
Serious infections	3.6 (2.3, 5.3)		4.7 (2.8, 7.5)		3.6 (1.0, 9.2)		2.3 (0.9, 4.7)		0.0 (0.0, 5.3)		2.1 (0.4, 6.0)		3.4 (2.2, 4.8)		3.4 (2.2, 4.9)

“+” indicates with corticosteroids; “−” indicates without corticosteroids

AE adverse event, AS ankylosing spondylitis, CI confidence interval, PBO placebo, PsA psoriatic arthritis, PY patient-years, RA rheumatoid arthritis, SAE serious adverse event

*Data presented as n (%) or events/100 PY (95% CI), unless otherwise noted

**The three trials ranged from 60 to 112 weeks in duration (Fig. 1). Time-adjusted incidence of AEs (events/100 PY) is shown