Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East

Table 2

Adverse events by system organ class.

	Tocilizumab
	Patients with AEs	43 (45.3)
Patients with treatment-related AEs	35 (36.8)
Investigations	21 (22.1)
Increased blood cholesterol level	10 (10.5)
Increase in hepatic enzymes	9 (9.5)
Metabolism and nutrition disorders	7 (7.4)
Infections and infestations	5 (5.3)
Upper respiratory tract infections	3 (3.2)
Influenza	1 (1.1)
Candidiasis	1 (1.1)
Patients with treatment-related SAEs	7 (7.4)
Metabolism and nutrition disorders	3 (3.2)
Hypercholesterolemia	3 (3.2)
Hypertriglyceridemia	1 (1.1)
Investigations	2 (2.1)
Prominent increase in ALT	1 (1.1)
Increased liver enzymes^a	1 (1.1)
Increased blood cholesterol and LDL levels^a	1 (1.1)
Infections and infestations	1 (1.1)
Mandibular infection with extension to cervicofacial soft tissue	1 (1.1)
Musculoskeletal and connective tissue disorders	1 (1.1)
Relapse of RA	1 (1.1)

AE, adverse event; ALT, alanine transaminase; LDL, low-density lipoprotein; RA, rheumatoid arthritis.
Data are presented as (%), where = number of patients reporting an event. Multiple occurrences of the same adverse event were counted only once.
One patient with hypercholesterolemia also had hypertriglyceridemia.
^aBoth SAEs occurred in the same patient.