Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study

Table 2 Week 52 database lock safety results

	IV golimumab + methotrexate	IV golimumab without methotrexate
Patients, N	420	265
Mean duration of follow-up (weeks)	71.4	61.9
Mean duration of exposure (weeks)	61.4	52.9
Median (IQR) duration of exposure (weeks)	57 (21, 97)	44 (12, 86)
Total patient-years of follow up	574.6	314.3
Patients with ≥ 1 AE	233 (55.5)	146 (55.1)
Events/100 PY (95% CI)¹	155.6 (145.6, 166.1)	191.2 (176.2, 207.1)
Patients with ≥ 1 infection and infestation	121 (28.8)	77 (29.1)
Upper respiratory tract infection	26 (6.2)	11 (4.2)
Urinary tract infection	24 (5.7)	10 (3.8)
Sinusitis	16 (3.8)	20 (7.5)
Bronchitis	17 (4.0)	11 (4.2)
Events/100 PY (95% CI)	37.1 (32.3, 42.4)	50.0 (42.4, 58.4)
Patients with ≥ 1 infusion reaction	12 (2.9)	15 (5.7)
Events/100 PY (95% CI)	2.1 (1.1, 3.6)	5.1 (2.9, 8.3)
Patients with ≥ 1 SAE	50 (11.9)	33 (12.5)
Events/100 PY (95% CI)	14.1 (11.2, 17.5)	17.8 (13.5, 23.1)
AEs of special interest
Serious infections	12 (2.9)	13 (4.9)
Events/100 PY(95% CI)	2.6 (1.5, 4.3)	7.0 (4.4, 10.6)
Latent tuberculosis	0	1 (0.4)
Events/100 PY (95% CI)	0.0 (0.0, 0.5)	0.3 (0.0, 1.8)
Opportunistic infections	5 (1.2)	6 (2.3)
Events/100 PY (95% CI)	0.9 (0.3, 2.0)	2.6 (1.1, 5.0)
Malignancies²	15 (3.6)	3 (1.1)
Events/100 PY (95% CI)	3.0 (1.7, 4.7)	1.0 (0.2, 2.8)
Deaths³	7 (1.7)	2 (0.1)
Events/100 PY (95% CI)	1.2 (0.5, 2.5)	0.6 (0.1, 2.3)

Data presented as n (%) unless otherwise noted
AE adverse event, CI confidence interval, IQR interquartile range, IV intravenous, MTX methotrexate, SAE serious adverse event, PY patient-years
¹Incidence rates could include multiple AEs per patient
²Among 15 patients with a total of 17 events in the golimumab + MTX group: squamous cell carcinoma (n = 2; 1 patient had 2 events), lymphoma (n = 1), melanoma (n = 1), ovarian cancer (n = 1), and vulvar cancer (n = 1) occurred in biologic-naïve patients; basal cell carcinoma (n = 2), squamous cell carcinoma (n = 3; 1 patient had 2 events), breast cancer (n = 1), lung adenocarcinoma (n = 1), melanoma (n = 1), and stage IV lung cancer (n = 1) occurred in biologic-experienced patients. Among 3 patients in the golimumab without MTX group, squamous cell carcinoma occurred in a biologic-naïve patient, and basal cell carcinoma (n = 1) and Non-Hodgkin's lymphoma (n = 1) occurred in the biologic-experienced patients
³Of the 9 patients who died, 7 received golimumab + MTX (one each due to congestive heart failure [biologic-naïve], acute myocardial infarction, vulvar cancer [biologic-naïve], acute respiratory failure [biologic-naïve], septic shock, stage IV lung cancer, and unknown reason), and 2 received golimumab without MTX (one each congestive heart failure [biologic-naïve] and motor vehicle accident)

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