Infliximab Effective, Safe for Ipilimumab-Induced Colitis in Patients with Melanoma

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(ChemotherapyAdvisor) – Use of infliximab for corticosteroid-refractory ipilimumab-induced colitis in patients with melanoma is safe and effective and does not appear to alter response rate or median overall survival (OS), according to data from a small series of patients presented during the Society for Melanoma Research 2012 Congress in Hollywood, CA.

Noting limited evidence exists to support the practice of using infliximab in this setting, Paul B. Chapman, MD, of Memorial Sloan-Kettering Cancer Center, New York, NY, and colleagues reviewed data from patients with melanoma treated at their institution from January 2008 through June 2012 to characterize responsiveness of ipilimumab-induced colitis to infliximab.

Among the 397 patients treated with ipilimumab, 36 had received infliximab 5mg/kg intravenously for colitis unresponsive to corticosteroids. Patients were symptomatic while on therapy for a median of 16 days (range, 2-71 days); 27 (75%) received 1 dose of infliximab and 9 (25%) received >2 doses.

After treatment with infliximab, median time to symptom resolution was 4 days (range, 1-114 days). In 26 of 35 patients (1 patient was not evaluable), 74.3% had diarrhea resolved within 14 days. In 9 patients, symptoms continued for more than 2 weeks; in 6 of these patients, symptoms abated after more than 2 doses of infliximab and extended corticosteroid therapy. In 2 of the 9 patients, Clostridium difficile was identified and symptoms subsided with antibiotics. At the last evaluation, 108 days after the first dose of infliximab, 1 patient had mild ongoing diarrhea.

Of the 36 patients, 3 were retreated with ipilimumab after resolution of colitis and their symptoms returned, which were successfully treated with corticosteroids or infliximab.

Investigator-assessed response rate to ipilimumab by immune-related response criteria was 8.6% (95% CI 2.6% to 27.0%), Dr. Chapman reported. Median OS among the 29 evaluable patients who received infliximab was similar to that of those treated only with ipilimumab, 14.3 months vs 12.0 months, respectively (log-rank P=0.25).

Infliximab-related adverse events comprised drug hypersensitivity reactions in 2 patients and a fungal pneumonia in 1 patient.

“Infliximab is an effective and safe therapy for ipilimumab-induced colitis, although a second dose may be needed,” they stated. “Approximately 25% of patients will have persistent symptoms, despite infliximab. In such cases, a thorough diagnostic evaluation is required to exclude other potential causes of diarrhea.”

Abstract (search using “infliximab” as the key word):

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