Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients

Table 3 Summary of safety events related to blood parameters and hematology: shift from CTCAE grade 0 at baseline through week 52 (safety analysis set)

Parameter	Total (N)	Grade 0 at baseline	Grade 0	Grade 1	Grade 2	Grade 3	Grade 4
Neutrophils decreased
Sirukumab 50 mg q4w	61	61 (100.0)	33 (54.1)	17 (27.9)	8 (13.1)	3 (4.9)	0
Sirukumab 100 mg q2w	61	61 (100.0)	34 (55.7)	14 (23.0)	11 (18.0)	2 (3.3)	0
Platelets decreased
Sirukumab 50 mg q4w	61	61 (100.0)	44 (72.1)	17 (27.9)	0	0	0
Sirukumab 100 mg q2w	61	61 (100.0)	54 (88.5)	6 (9.8)	0	0	1 (1.6)^a
Leukocytes decreased
Sirukumab 50 mg q4w	61	61 (100.0)	34 (55.7)	21 (34.4)	6 (9.8)	0	0
Sirukumab 100 mg q2w	61	61 (100.0)	42 (68.9)	11 (18.0)	6 (9.8)	2 (3.3)	0
Lymphocytes decreased
Sirukumab 50 mg q4w	61	58 (95.1)	51 (83.6)	3 (4.9)	4 (6.6)	0	0
Sirukumab 100 mg q2w	61	58 (95.1)	50 (82.0)	1 (1.6)	7 (11.5)	0	0
Alanine aminotransferase increased
Sirukumab 50 mg q4w	61	58 (95.1)	30 (49.2)	26 (42.6)	2(3.3)	0	0
Sirukumab 100 mg q2w	61	56 (91.8)	31 (50.8)	24 (39.3)	1 (1.6)	0	0
Aspartate aminotransferase increased
Sirukumab 50 mg q4w	61	59 (96.7)	33 (54.1)	25 (41.0)	1 (1.6)	0	0
Sirukumab 100 mg q2w	61	55 (90.2)	32 (52.5)	23 (37.7)	0	0	0
Bilirubin increased
Sirukumab 50 mg q4w	61	61 (100.0)	48 (78.7)	10 (16.4)	3 (4.9)	0	0
Sirukumab 100 mg q2w	61	61 (100.0)	47 (77.0)	10 (16.4)	4 (6.6)	0	0
Cholesterol increased
Sirukumab 50 mg q4w	59	59 (100.0)	51 (83.6)	5 (8.2)	3 (4.9)	0	0
Sirukumab 100 mg q2w	60	60 (100.0)	54 (88.5)	5 (8.2)	1 (1.6)	0	0
Triglycerides increased
Sirukumab 50 mg q4w	59	55 (93.2)	34 (55.7)	20 (32.8)	0	1 (1.6)	0
Sirukumab 100 mg q2w	60	54 (90.0)	33 (54.1)	20 (32.8)	0	1 (1.6)	0

Data presented as n (%) unless stated otherwise
CTCAE Common Terminology Criteria For Adverse Events, q4w once in 4 weeks, q2w once in 2 weeks
^aErroneously reported

ISSN: 1478-6362