A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48)

Table 2 Summary of TEAEs by preferred term during TP2 and up to week 52 (safety set)

Participants with TEAE, n (%)	TCZ (N = 145)	TCZ→BAT1806/BIIB800 (N = 142)	BAT1806/BIIB800 (N = 290)
TEAE	90 (62.1)	92 (64.8)	162 (55.9)
Upper respiratory tract infection	15 (10.3)	6 (4.2)	20 (6.9)
Leukopenia	15 (10.3)	10 (7.0)	15 (5.2)
ALT increased	7 (4.8)	15 (10.6)	13 (4.5)
Hyperlipidemia	6 (4.1)	7 (4.9)	21 (7.2)
Hepatic function abnormal	9 (6.2)	10 (7.0)	10 (3.4)
Neutropenia	7 (4.8)	9 (6.3)	12 (4.1)
Anemia	4 (2.8)	8 (5.6)	5 (1.7)
Related TEAE	59 (40.7)	64 (45.1)	112 (38.6)
Leukopenia	15 (10.3)	9 (6.3)	12 (4.1)
ALT increased	6 (4.1)	13 (9.2)	11 (3.8)
Upper respiratory tract infection	9 (6.2)	5 (3.5)	14 (4.8)
Neutropenia	7 (4.8)	9 (6.3)	12 (4.1)
Hepatic function abnormal	9 (6.2)	10 (7.0)	9 (3.1)
Serious TEAE^a	4 (2.8)	5 (3.5)	8 (2.8)
Related serious TEAE^a	1 (0.7)	1 (0.7)	2 (0.7)
Fatal TEAEs	0	0	0

^aNo serious TEAE occurred in more than two participants (≥ 1.5%) in any treatment group. Only TEAEs that occurred in ≥ 5% of participants are listed
Safety set included all randomized participants who had received ≥ 1 dose of study drug
N represents the number of participants who received study treatment in TP2
ALT Alanine aminotransferase, TCZ Tocilizumab reference product, TEAE Treatment-emergent adverse event, TP2 Treatment period 2

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