Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

Husni, M. Elaine; Deodhar, Atul; Schwartzman, Sergio; Chakravarty, Soumya D.; Hsia, Elizabeth C.; Leu, Jocelyn H.; Zhou, Yiying; Lo, Kim H.; Kavanaugh, Arthur

doi:10.1186/s13075-022-02753-6

Table 4 Adverse events, including clinical laboratory abnormalities, summarized by methotrexate use at baseline in patients with RA, PsA, and AS*

From: Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

Occurrence during placebo-controlled periods, n (%)
	RA trial		PsA trial				AS trial				Pooled
	PBO	Golimumab	PBO		Golimumab		PBO		Golimumab		PBO		Golimumab
Methotrexate use at baseline	+	+	+	−	+	−	+	−	+	−	+	−	+	−
Treated patients, N	197	395	173	66	163	77	21	82	16	89	391	148	574	166
Mean follow-up, weeks	20.9	23.6	23.2	23.1	23.8	24.0	15.9	16.0	16.1	16.1	21.6	19.2	23.5	19.7
≥ 1 infection	48 (24.4)	119 (30.1)	26 (15.0)	11 (16.7)	26 (16.0)	19 (24.7)	2 (9.5)	6 (7.3)	2 (12.5)	10 (11.2)	76 (19.4)	17 (11.5)	147 (25.6)	29 (17.5)
≥ 1 SAE	5 (2.5)	19 (4.8)	4 (2.3)	4 (6.1)	5 (3.1)	2 (2.6)	0	0	0	2 (2.2)	9 (2.3)	4 (2.7)	24 (4.2)	4 (2.4)
≥ 1 serious infection	0	4 (1.0)	1 (0.6)	1 (1.5)	1 (0.6)	0	0	0	0	1 (1.1)	1 (0.3)	1 (0.7)	5 (0.9)	1 (0.6)
Baseline ALT ≤ ULN, n	182	357	144	60	135	74	18	76	15	83	344	136	507	157
ALT ≥ 3 to < 5× ULN	2 (1.1)	4 (1.1)	1 (0.7)	0	2 (1.5)	1 (1.4)	0	0	0	1 (1.2)	3 (0.9)	0	6 (1.2)	2 (1.3)
ALT ≥ 5× ULN	0	3 (0.8)	0	1 (1.7)	0	1 (1.4)	0	1 (1.3)	0	0	0	2 (1.5)	3 (0.6)	1 (0.6)
Baseline ALT > ULN, n	14	34	25	4	27	3	3	4	1	6	42	8	62	9
ALT ≥ 3 to < 5× ULN	3 (21.4)	4 (11.8)	0	0	3 (11.1)	1 (33.3)	0	0	0	0	3 (7.1)	0	7 (11.3)	1 (11.1)
ALT ≥ 5× ULN	0	0	0	0	3 (11.1)	0	0	0	0	0	0	0	3 (4.8)	0
Events/100 patient-years through study completion**
	RA trial		PsA trial				AS trial				Pooled
	Golimumab		Golimumab				Golimumab				Golimumab
Methotrexate use at baseline	+		+		−		+		−		+		−
Patients, N	584		323		137		36		168		943		305
Total PY of follow-up	1077		290		127		35		168		1402		295
Serious infections	4.0 (2.9, 5.4)		3.8 (1.9, 6.8)		0 (0.0, 2.4)		0 (0.0, 8.5)		1.8 (0.4, 5.2)		3.9 (2.9, 5.0)		1.0 (0.2, 3.0)
ALT ≥ 3 to < 5× ULN	3.5 (2.5, 4.8)		21.0 (16.1, 27.0)		7.9 (3.8, 14.5)		2.8 (0.1, 15.8)		2.4 (0.7, 6.1)		7.1 (5.8, 8.7)		4.8 (2.6, 8.0)
ALT ≥ 5× ULN	2.0 (1.3 ,3.1)		3.1 (1.4, 5.9)		3.2 (0.9, 8.1)		0 (0.0, 8.5)		1.2 (0.1, 4.3)		2.2 (1.5, 3.1)		2.0 (0.8, 4.4)
Patients positive for antibodies to golimumab***, n/N (%)	129/552 (23.4)		60/316 (19.0)		39/134 (29.1)		4/36 (11.1)		37/167 (22.2)		193/904 (21.3)		76/301 (25.2)

“+” indicates with methotrexate; “−” indicates without methotrexate
AE adverse event, ALT alanine aminotransferase, AS ankylosing spondylitis, CI confidence interval, PBO placebo, PsA psoriatic arthritis, PY patient-years, RA rheumatoid arthritis, SAE serious adverse event, ULN upper limit of normal
*Data presented as n (%), n/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) are shown
***Antibodies to golimumab were assessed using a drug-tolerant enzyme immunoassay at 52 weeks for all three trials

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