A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

Table 2 All-causality treatment-emergent adverse events (safety population)

	PF-06410293 n = 297	Adalimumab-EU n = 299
Number of AEs	343	379
Patients with events, n (%)
AEs	143 (48.1)	143 (47.8)
SAEs	12 (4.0)	13 (4.3)
Grade 3 AEs	15 (5.1)	16 (5.4)^a
Grade 4 AEs	2 (0.7)	4 (1.3)
Grade 5 AEs	0	1 (0.3)
Patients with temporary treatment discontinuation due to AEs, n (%)	17 (5.7)	29 (9.7)
Patients discontinued from treatment due to AEs^c, n (%)	11 (3.7)^b	14 (4.7)
Patients discontinued from the study due to AEs, n (%)	8 (2.7)	9 (3.0)

AEs were graded in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Grade 1–5 AEs are defined as mild, moderate, severe, life-threatening AEs, and death related to AE, respectively.
Abbreviations: Adalimumab-EU adalimumab sourced from the European Union, AE adverse event, SAE serious adverse event
^aOne patient had an AE of neutropenia incorrectly recorded as grade 2; the correct severity was grade 3 (not corrected in this table)
^bOne patient was incorrectly recorded as treatment discontinuation due to an AE; the correct reason was insufficient clinical response (not corrected in this table)
^cThe System Organ Class with the highest proportion of subjects who had AEs leading to permanent treatment discontinuation was infections and infestations (8 [2.7%] subjects on PF-06410293 and 3 [1.0%] subjects on adalimumab-EU)

ISSN: 1478-6362