Immune-Mediated Adverse Events Associated with Ipilimumab CTLA-4 Blockade Therapy: The Underlying Mechanisms and Clinical Management

Table 3

Time to onset and resolution of irAEs in phase III and pooled phase II trials [25].

	Phase III MDX010-20; Ipilimumab 3 mg/kg (𝑛 = 131)	Pooled phase II data; Ipilimumab 3 mg/kg (𝑛 = 111)
irAE time to onset
Grade 2–5, 𝑛	45	38
Median, weeks (95% CI)	6.14 (3.71–8.14)	6.93 (4.86–7.57)
% of patients experiencing irAE within
0–1 month	42	32
>1–3 months	44	63
>3–5 months	7	5
>5 months	7	0
irAE time to resolution
Grade 2–4, 𝑛	44	38
Resolved, 𝑛	33	23
Median, weeks (95% CI)	6.86 (4.14–8.43)	5.71 (2.14–NR)
% of patients whose irAE resolved within
0–1 month	52	74
>1–3 months	36	17
>3–5 months	9	9
>5 months	3	0

CI: confidence interval; irAE: immune-related adverse event; NR: not reached.