A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis

Table 2 Adverse events ^a

				Brodalumab
	Placebo			SC			IV
Adverse events	SC	IV	All	50 mg	140 mg	210 mg	420 mg	700 mg	All	Total
Adverse events	(N = 6)	(N = 4)	(N=10)	(N = 6)	(N = 6)	(N = 6)	(N = 6)	(N = 6)	(N = 30)	(N = 40)
Adverse events, n (%)
Any	3 (50)	4 (100)	7 (70)	5 (83)	5 (83)	4 (67)	5 (83)	4 (67)	23 (77)	30 (75)
Serious^b	0 (0)	1 (25)	1 (10)	0 (0)	0 (0)	0 (0)	1 (17)	0 (0)	1 (4)	2 (5)
Fatal	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Leading to study discontinuation	0 (0)	1 (25)	1 (10)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (3)
Leading to IP discontinuation	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (17)	0 (0)	0 (0)
Common adverse events^c
Headache	2 (33)	2 (50)	4 (40)	1 (17)	1 (17)	2 (33)	2 (33)	2 (33)	8 (27)	12 (30)
Cough	2 (33)	0 (0)	2 (20)	1 (17)	0 (0)	0 (0)	1 (17)	0 (0)	3 (10)	5 (13)
Abdominal pain	0 (0)	0 (0)	0 (0)	0 (0)	2 (33)	1 (17)	1 (17)	1 (17)	4 (13)	4 (10)
Constipation	1 (17)	1 (25)	2 (20)	0 (0)	0 (0)	2 (33)	0 (0)	0 (0)	2 (7)	4 (10)
Diarrhea	0 (0)	0 (0)	0 (0)	0 (0)	2 (33)	2 (33)	0 (0)	0 (0)	4 (13)	4 (10)
Upper respiratory tract infection	0 (0)	1 (25)	1 (10)	1 (17)	1 (17)	0 (0)	0 (0)	1 (17)	3 (10)	4 (10)
Rash	0 (0)	1 (0)	1 (10)	0 (0)	2 (33)	0 (0)	0 (0)	0 (0)	2 (7)	3 (8)

^aIP investigational product; IV, intravenous; SC subcutaneous. ^bA serious adverse event was defined as an event that was fatal or life-threatening, either required or prolonged hospitalization or caused persistent or substantial disability or incapacity or congenital anomaly or birth defect or an event that was considered by the investigator to be a medically important event. ^cCommon adverse events were those that were reported in at least three patients from all brodalumab-treated groups combined.

ISSN: 1478-6362