Dose-escalation of human anti-interferon-α receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study

Goldberg, Avram; Geppert, Thomas; Schiopu, Elena; Frech, Tracy; Hsu, Vivien; Simms, Robert W; Peng, Stanford L; Yao, Yihong; Elgeioushi, Nairouz; Chang, Linda; Wang, Bing; Yoo, Stephen

doi:10.1186/ar4492

Table 2 Frequently reported (>10% overall and >1 subject in any group) treatment-emergent adverse events and laboratory abnormalities

From: Dose-escalation of human anti-interferon-α receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study

	MEDI-546
	0.1 mg/kg single dose	0.3 mg/kg single dose	1.0 mg/kg single dose	3.0 mg/kg single dose	10.0 mg/kg single dose	20.0 mg/kg single dose	0.3 mg/kg/week multiple dose	1.0 mg/kg/week multiple dose	5.0 mg/kg/week multiple dose	Total
	(n = 1)	(n = 4)	(n = 4)	(n = 4)	(n = 4)	(n = 4)	(n = 4)	(n = 4)	(n = 5)	(N = 34)
TEAEs
Total number of TEAEs	1	10	15	15	18	11	20	20	38	148
Total subjects reporting ≥1 TEAEs, n (%)	1 (100.0)	4 (100.0)	4 (100.0)	4 (100.0)	4 (100.0)	4 (100.0)	4 (100.0)	4 (100.0)	5 (100.0)	34 (100.0)
Upper respiratory tract infection, n (%)^a	0 (0.0)	2 (50.0)	1 (25.0)	2 (50.0)	0 (0.0)	2 (50.0)	0 (0.0)	3 (75.0)	0 (0.0)	10 (29.4)
Headache, n (%)^a	0 (0.0)	1 (25.0)	0 (0.0)	0 (0.0)	2 (50.0)	1 (25.0)	2 (50.0)	1 (25.0)	0 (0.0)	7 (20.6)
Diarrhea, n (%)^a	0 (0.0)	0 (0.0)	3 (75.0)	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	1 (25.0)	1 (20.0)	6 (17.6)
Nausea, n (%)^a	0 (0.0)	0 (0.0)	0 (0.0)	1 (25.0)	2 (50.0)	1 (25.0)	0 (0.0)	1 (25.0)	1 (20.0)	6 (17.6)
Arthralgia, n (%)^a	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	1 (25.0)	0 (0.0)	1 (25.0)	1 (25.0)	0 (0.0)	4 (11.8)
Fatigue, n (%)^a	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	1 (25.0)	0 (0.0)	1 (25.0)	1 (25.0)	0 (0.0)	4 (11.8)
Pruritus, n (%)^a	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	1 (25.0)	0 (0.0)	0 (0.0)	1 (25.0)	1 (20.0)	4 (11.8)
Dizziness, n (%)^a	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (40.0)	3 ( 8.8)
Musculoskeletal chest pain, n (%)^a	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (40.0)	3 ( 8.8)
Urticaria, n (%)^a	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	2 (40.0)	3 ( 8.8)
Constipation, n (%)^a	0 (0.0)	2 (50.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (5.9)
Depression, n (%)^a	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (40.0)	2 (5.9)
Laboratory abnormalities
Anemia^b,c, n (%)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (20.0)	1 (2.9)
Decreased hemoglobin^d, n (%)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (20.0)	1 (2.9)
Decreased absolute lymphocyte count^d, n (%)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (20.0)	1 (2.9)
Elevated aspartate aminotransferase value^e, n (%)	0 (0.0)	1 (25.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (2.9)
Hyperglycemia^b, n (%)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (2.9)
Hematuria^b, n (%)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (25.0)	0 (0.0)	0 (0.0)	1 (2.9)

^aPreferred term according to the Medical Dictionary for Regulatory Activities version 14.0.
^bLaboratory abnormality reported as a TEAE.
^cGrade 1 in severity.
^dGrade 3 in severity.
^eGrade 2 in severity.
TEAE treatment-emergent adverse event.
Note: Subjects were counted only once for each preferred term, regardless of how many events the subject reported.

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