A randomized, double-blind study of AMG 108 (a fully human monoclonal antibody to IL-1R1) in patients with osteoarthritis of the knee

Table 2 Summary of adverse events

	IV Administration				SC Administration
Number (%) of patients with	Placebo (n= 8)	100 mg (n= 12)	300 mg (n= 12)	All AMG 108 (n= 24)	Placebo (n= 88)	75 mg (n= 12)	300 mg (n= 94)
Any adverse event	8 (100)	12 (100)	12 (100)	24 (100)	74 (84)	12 (100)	77 (82)
Most common AE
Headache	4 (50)	9 (75)	7 (58)	16 (57)	22 (25)	4 (33)	15 (16)
Upper respiratory tract infection	1 (13)	2 (17)	5 (42)	7 (29)	7 (8)	6 (50)	9 (10)
Infection	3 (38)	4 (33)	8 (67)	12 (50)	18 (21)	7 (58)	25 (27)
Injection-site reaction	1 (13)	1 (8)	2 (17)	3 (13)	3 (3)	0	7 (7)
Treatment-related AE	5 (63)	8 (67)	6 (50)	14 (58)	10 (11)	0	28 (30)
AE leading to study discontinuation	0	0	0	0	1 (1)	0	1 (1)
Serious AE	0	0	2 (17)	2 (8)	3 (3)	0	2 (2)
Treatment-related SAE	0	0	1 (8)	1 (4)	0	0	1 (1)
Serious infectious AE	0	0	1 (8)	1 (4)	2 (2)	0	1 (1)
Death	0	0	1 (8)	1 (4)	0	0	0

AE, adverse event; IV, intravenous; SAE, serious adverse event; SC, subcutaneous. SAEs were reported by two patients in the 300-mg IV group (hemorrhagic diarrhea and unstable angina in one; and lobar pneumonia, respiratory failure, multiorgan failure, sepsis, neutropenia, and leukopenia in the other); two patients in the 300-mg SC group (pancreatitis in one; and pneumonia and supraventricular tachycardia in the other); and three patients in the placebo SC group (arthropod bite and Staphylococcus infection in one; abdominal pain in the second; and coronary artery disease in the third). All serious infectious AEs have been listed as SAEs above and include one patient in the 300-mg IV group (lobar pneumonia and sepsis); one patient in the 300-mg SC group (pneumonia); and two patients in the placebo SC group (Staphylococcus infection in one and abdominal pain in the other).

ISSN: 1478-6362