Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study

Table 3 Treatment-emergent adverse events (safety population)

	CT-P17 (N = 324)	EU-adalimumab (N = 324)
Subjects with ≥ 1 TEAE, n (%)	169 (52.2)	184 (56.8)
Study drug-related	88 (27.2)	99 (30.6)
TEAEs reported in ≥ 5% of subjects in either treatment group
ISR	16 (4.9)	22 (6.8)
Nasopharyngitis	17 (5.2)	20 (6.2)
Upper respiratory tract infection	17 (5.2)	20 (6.2)
Neutropenia	14 (4.3)	17 (5.2)
Subjects with ≥ 1 TESAE, n (%)	10 (3.1)	16 (4.9)
Subjects with ≥ 1 TEAE leading to study drug discontinuation, n (%)	5 (1.5)	8 (2.5)
Subjects with ≥ 1 TEAE classified as hypersensitivity/allergic reactions, n (%)	2 (0.6)	4 (1.2)
Subjects with ≥ 1 TEAE classified as ISR, n (%)	16 (4.9)	22 (6.8)
Subjects with ≥ 1 TEAE classified as infection, n (%)	97 (29.9)	103 (31.8)
Subjects with ≥ 1 TEAE classified as malignancy, n (%)	1 (0.3)^a	0
Total number of TEAEs leading to death	0	0

Note: There were no significant differences between the CT-P17 and EU-adalimumab groups for any parameter (p > 0.05)
^aBreast cancer that was considered unrelated to study drug; the subject’s family history of breast cancer was considered a risk factor by the investigator
TEAE treatment-emergent adverse event, EU-adalimumab European Union-approved adalimumab, ISR injection-site reaction, TESAE treatment-emergent serious adverse event

ISSN: 1478-6362