What is the best treatment for colitis caused by ipilimumab (Yervoy)?

From the Guidelines

The best treatment for ipilimumab-induced colitis is high-dose corticosteroids, typically starting with intravenous methylprednisolone 1-2 mg/kg/day or oral prednisone 1-2 mg/kg/day, as recommended by the most recent guidelines 1.

Treatment Approach

The treatment approach should be based on the severity of the colitis, which can be classified into different grades (G1-G4) based on the number of stools per day, presence of incontinence, hospitalization, and limiting self-care activities of daily living (ADL) 1.

• For mild cases (G1), symptomatic management with loperamide and fluid replacement may be sufficient while monitoring closely.
• For moderate to severe cases (G2-G4), ipilimumab should be withheld or permanently discontinued depending on severity, and steroid therapy initiated.

Steroid Therapy

Steroid therapy should be initiated promptly, with a dose of 1-2 mg/kg/day of prednisone or equivalent, and tapered over 4-6 weeks once symptoms improve to G1 1.

• If symptoms don't improve within 3-5 days of steroid treatment, additional immunosuppressive therapy such as infliximab (5 mg/kg as a single dose) should be considered 1.

Alternative Immunossuppressants

Alternative immunosuppressants like vedolizumab or mycophenolate mofetil may be required for steroid-refractory cases 1.

• Vedolizumab has been shown to be effective in treating ipilimumab-induced enterocolitis, with a response rate of 86% in a case series of seven patients 1.

Hospitalization and Surgery

Hospitalization should be considered for patients with dehydration or electrolyte imbalance, and surgery may be necessary for patients with colonic perforation or intra-abdominal abscess 1.

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From the FDA Drug Label

YERVOY can cause immune-mediated colitis, which may be fatal. In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

The best treatment for colitis caused by ipilimumab (Yervoy) is:

• Systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less.
• Corticosteroid taper over at least 1 month after improvement to Grade 1 or less.
• Consider other systemic immunosuppressants if colitis is not controlled with corticosteroid therapy 2.

From the Research

Treatment Options for Ipilimumab-Induced Colitis

• The treatment of ipilimumab-induced colitis typically involves the use of corticosteroids, such as prednisone, to reduce inflammation and manage symptoms 3, 4, 5.
• In cases where patients do not respond to corticosteroids, infliximab, an anti-tumor necrosis factor antibody, may be used as a rescue therapy 6, 7, 4, 5.
• Budesonide, a steroid-sparing agent, has also been used in some cases to manage ipilimumab-induced colitis, particularly in patients who are refractory to prednisone 5.
• Early and aggressive medical therapy is crucial in managing ipilimumab-induced colitis, and treatment should be tailored to the individual patient's needs and response to therapy 3, 4, 5.

Clinical Characteristics and Diagnosis

• Ipilimumab-induced colitis is characterized by diarrhea, which can range from mild to severe, and may be accompanied by rectal bleeding, abdominal pain, and other symptoms 3, 4, 5.
• Endoscopic and histologic features of ipilimumab-induced colitis may include colon erythema, ulcers, and inflammation, as well as cryptitis and crypt abscesses 4.
• Diagnosis is typically based on a combination of clinical, endoscopic, and histologic findings, as well as the patient's history of ipilimumab treatment 3, 4, 5.

Management and Outcomes

• Prompt identification and treatment of ipilimumab-induced colitis are essential to prevent complications, such as bowel perforation, and to improve outcomes 3, 4, 5.
• Treatment outcomes may vary depending on the severity of the colitis and the patient's response to therapy, but most patients can be successfully managed with corticosteroids and/or infliximab 6, 4, 5.
• In some cases, surgical intervention may be necessary to manage complications of ipilimumab-induced colitis, such as bowel perforation 3, 6.