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irAE Workup Guidelines

Nov 5, 2019

Managing immune-related adverse events among patients who have received immune checkpoint inhibitors (ICI) can present many challenges for the multidisciplinary care team. Not only can irAEs be difficult to distinguish from other conditions, but knowing how and when to admit a patient, treat symptoms, or withhold ICI therapy can be difficult to navigate. However, in recent years, many organizations have published formal recommendations, or workup guidelines, for managing irAEs, including ASCO, ESMO, NCCN, and SITC.

The following can be used as a directory for the current irAE workup guidelines. Click to expand the organ system of interest to display the common irAEs for which guidelines are available, with details of where to find the condition-specific information in each set of guidelines. 

ASCO GUIDELINES (AS OF 2018):
Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018;36(17):1714-1768 doi.org/10.1200/JCO.2017.77.6385

ESMO GUIDELINES (AS OF 2017):
Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(S4): i119-i142. doi.org/10.1093/annonc/mdx225 

ESMO GUIDELINES CORRECTION (AS OF 2018):
Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S,  et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(S4): iv264-iv266. doi.org/10.1093/annonc/mdy162  

NCCN GUIDELINES (AS OF 2019):
Available on the NCCN website under NCCN Guidelines for Supportive Care, listed as Management of Immunotherapy-Related Toxicities. Login required; registration is free. https://www.nccn.org/ 

SITC GUIDELINES (AS OF 2017):
Puzanov I, Diab A, Abdallah K, Bingham CO 3rd, Brogdon C, et al. Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group. J ImmunoTher Cancer. 2017;5(95). DOI 10.1186/s40425-017-0300-z

Cardiovascular

Myocarditis, Pericarditis, Arrhythmias, Impaired Ventricular Function with Heart Failure and Vasculitis

Venous Thromboembolism

Dermatologic

Bulbous Dermatoses

Pruritis

Rash/Dermatitis

Severe Cutaneous Adverse Reactions (SCARS) (including SJS, TEN, Acute Generalized Exanthematous Pustulosis, and DRESS/DIHS)

Endocrine

Asymptomatic/Subclinical Hypothyroidism

Central Hypothyroidism

Hyperthyroidism

Hypophysitis

Primary Adrenal Insufficiency

Primary Hypothyroidism

Thyrotoxicosis

Gastrointestinal

Colitis/Diarrhea

Hematologic

Acquired Hemophilia

Acquired Thrombotic Thrombocytopenic Purpura (TTP)

Aplastic Anemia

Autoimmune Hemolytic Anemia

Hemolytic Uremic Syndrome

Immune Thrombocytopenia

Lymphopenia

Hepatic

Hepatitis

Musculoskeletal

Inflammatory Arthritis

Myositis

Polymyalgia-like Syndrome

Nervous System

Aseptic Meningitis

Autonomic Neuropathy

Encephalitis

Encephalopathy/PRES

Guillain Barré Syndrome

Myasthenia Gravis

Peripheral Neuropathy

Transverse Myelitis

Ocular

Blepharitis

Episcleritis

Uveitis/Iritris

Pancreatic

Acute Pancreatitis

Diabetes

Pulmonary

Pneumonitis

Sarcoidosis

Renal

Acute Renal Failure

Nephritis

Symptomatic Nephritis

Additional Resources

Symptoms & Grading: National Cancer Institute. (2017). Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Available here.

Routine Monitoring Recommendations:

Industry Toxicity Management Recommendations:

ACCC IO Wallet Card: Equip IO patients with a medical wallet card that includes the warning signs of common irAEs. Available here.