Immune Related Adverse Events (irAEs) and Serious irAEs Reported

IrAEs related to Interleukin-2
 1. 70% low level requiring no to minimal intervention
  a. Vitiligo in mM patients
  b. Thyroid dysfunction: 3 times more common in mRCC than mM
 2. <5% irAEs reported requiring intervention (holding IL-2)
  a. joint pain
  b. Neuropathy
  c. Hepatitis by enzyme elevation
15 Serious irAEs reported in overall Data Base among 152 irAEsa
  6 in patients with mRCC – all during IL-2
  9 in mM patients – 4 during IL-2; 5 after IL-2
9 patients - Myocarditis – all during IL-2
  7 patients, only enzyme release; no clinical, electrocardiogram or echocardiogram findings
  2 patients – elevated enzymes; 1- abnormal electrocardiogram and symptoms; 1 – elevated enzymes and asymptomatic ventricular arrhythmia.
1 patient each - Myasthenia Gravis, Guillain Barre - both related to IL-2
4 serious irAEs reported related to CPIa: 1 each: colitis, encephalopathy, neuropathy, uveitis

airAEs related to CPI were not required to be reported