EFFICACY OF INFLIXIMAB DOSE ESCALATION IN PATIENTS WITH REFRACTORY IMMUNOTHERAPY-RELATED COLITIS: A CASE SERIES
Abstract Introduction Immune checkpoint inhibitor (ICI)-related colitis (irColitis) is a frequent complication of ICI use in cancer. Treatment algorithms have been adapted from the treatment of inflammatory bowel disease (IBD), including the use of infliximab (IFX) for patients with irColitis refractory to corticosteroids. The efficacy of IFX dose-escalation in patients not responding to standard dose IFX, a common practice in patients with severe IBD, has not been reported in irColitis. Methods We describe a retrospective study of patients treated with IFX dose escalation (i.e. 10mg/kg dose) after failure of standard dose IFX (5mg/kg) for irColitis at a tertiary care center in New York City between 2016–2020. Clinical response was defined as improvement in diarrhea to CTCAE Grade ≤1. Results Ten patients were treated with high dose IFX for refractory irColitis. High dose IFX was started after a median of 2 (IQR 2-2) doses of standard dose IFX for non-response (n=2) or incomplete response (n=8). Five (50%) patients had a clinical response to high dose IFX after a median of 4 (IQR 3–6) days. Five (50%) patients were refractory to high dose IFX and were treated with Vedolizumab (n= 5) and/or fecal microbiota transplantation (n=2). Patients were followed for a median 457 (IQR 325–567) days from initiation of ICI therapy. No adverse events attributed to IFX were observed in any of the patients. Discussion In this series of patients with irColitis refractory to standard dose IFX, high dose IFX was successful in inducing response in 50% of patients. Prospective studies are needed to further elucidate the role and optimal dosing of IFX in irColitis.