Immune-Mediated Adverse Events

Article 2

IMMUNE-MEDIATED ADVERSE EVENTS

Immunotherapy may cause inflammation or increased or decreased activity of various systems within the body. As the immune system is the target and the immune system is ubiquitous within the body, basically any organ may be impacted by immunotherapy. Typically, immune-related adverse events (AEs) are relatively rare. Often, they can be treated by steroids and/or discontinuation of the drug, but the AE must be identified early.

Importantly, failure to identify and treat immune-related adverse events effectively may require stopping treatment either temporarily or permanently, which for some patients may occur before they have achieved an optimal response to therapy.

Management of some immune-related adverse events is illustrated in the table below. Healthcare professional understanding of adverse events and their management is essential for successfully treating patients with immunotherapy.

Site Signs/Symptoms Treatment
Gastrointestinal
  • Abdominal pain
  • Dehydration
  • Fever
  • Diarrhea
  • Possible hospitalization required for severe cases
  • Dietary modification
  • Loperamide
  • Oral corticosteroids (eg, prednisone 1 mg/kg daily)
  • For severe cases, high-dose IV corticosteroids (eg, methylprednisone 2 mg/kg once or twice daily)
  • Abdominal pain with diarrhea should be evaluated for perforation or peritonitis
Skin
  • Itching
  • Rash
  • Symptoms can become intense/widespread and interfere with activities of daily living
  • Over-the-counter moisturizers, antihistamines, or topical corticosteroids
  • Oral corticosteroids (eg, methylprednisone 2 mg/kg once or twice daily)
  • For severe cases, high-dose IV corticosteroids (eg, methylprednisone 2 mg/kg once or twice daily)
Liver
  • Elevated levels of aminotransferases
  • Elevated total bilirubin
  • Frequent monitoring of liver enzymes
  • Oral corticosteroids (eg, prednisone 1 mg/kg once or twice daily
  • For severe cases, high-dose IV corticosteroid (eg, methylprednisone 2 mg/kg once or twice daily)
Endocrine
  • Low blood pressure
  • Adrenal crisis
  • Severe dehydration
  • Shock
  • IV corticosteroids (eg, hydrocortisone)
  • Once symptoms or laboratory abnormalities are controlled, taper corticosteroid over 1 month or longer; avoid abrupt discontinuation
  • Relevant hormone replacement (eg, sex hormones), as needed
  • Evaluate patients for sepsis or infection