A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy

Table 4 All-cause treatment-emergent adverse events (safety population)^a

	PF-06438179/GP1111 (n = 323)	Infliximab-EU (n = 326)
Number of AEs	486	492
Patients with events, n (%)
AEs	185 (57.3)	176 (54.0)
SAEs	16 (5.0)	20 (6.1)
Grade 3 AEs	34 (10.5)	34 (10.4)
Grade 4 AEs	1 (0.3)	6 (1.8)
Grade 5 AEs	2 (0.6)	1 (0.3)
Temporarily discontinued from treatment due to AEs	31 (9.6)	28 (8.6)
Permanently discontinued from treatment due to AEs	23 (7.1)	24 (7.4)
Discontinued from study due to AEs	16 (5.0)	14 (4.3)

Abbreviations: AE Adverse event, Infliximab-EU Infliximab sourced from the European Union, SAE Serious adverse event
^aIncludes all AEs collected from the first infusion through week 30 study visit for each patient. AEs were graded in accordance with National Cancer Institute Common Terminology Criteria for AEs (version 4.03). Grades 1–5 AEs are defined as mild, moderate, severe, and life-threatening AEs and death related to AEs, respectively

ISSN: 1478-6362