Abstract Background The use of immune checkpoint inhibitors (ICIs) in patients with cancer has expanded rapidly over the past decade. Consequently, the prevalence of immune-related adverse events (irAEs), including ICI (entero)colitis, is increasing. This study aimed to evaluate patient characteristics, use of selective immunosuppressive therapy (SIT), and temporal changes in ICI colitis management. Methods Patients with histologically confirmed ICI (entero)colitis between 2014 and 2024 were retrospectively identified. Clinical characteristics and treatment data were collected. Patients were stratified into cohorts by diagnosis date (before or after January 1st, 2022). Univariate logistic regression was performed to identify associations with early SIT use (i.e. within 3 weeks after starting first colitis treatment). Results A total of 279 patients were included in this cohort, of whom 125 were diagnosed between 2022 and 2024 (Table 1). CTCAE grade at onset and endoscopic severity were comparable between cohorts, and 65% of patients was hospitalized due to ICI colitis. Patients diagnosed with ICI colitis after 2022 were more often exposed to combination immunotherapy (53% vs 35%, p 0.001) rather than aCTLA-4 monotherapy (0.8% vs 10%, p 0.001), in line with current oncological practice. Overall, 40% of patients required SIT after first-line immunosuppression. Frequency of SIT use was similar between cohorts (37% vs 44%, p = 0.13), as well as time to initiation (median 13 vs 20 days, p = 0.2). Vedolizumab use as first SIT increased over time (16% vs 33%), although infliximab remained the predominant initial SIT overall (82% vs 65%). In both cohorts, 25% of patients treated with SIT required multiple sequential SITs. Switch to another SIT type was required in 11% of patients initially treated with infliximab and 23% of those treated with vedolizumab (p = 0.19). Early SIT initiation was associated with hospitalization (OR 16.4, p 0.0001), shorter time to symptom onset (OR 0.95, p = 0.0001), elevated CRP (OR 1.45, p = 0.002), decreased albumin (OR 0.93, p = 0.023) and an endoscopic Mayo score of 2 (OR 1.75, p = 0.004). Ulcerations on endoscopy were not associated with early SIT use. Conclusion In recent years, vedolizumab is increasingly used as first-line SIT after prednisone or topical treatment, although infliximab remains the predominantly used agent. Despite an increase in combination immunotherapy, which is associated with higher toxicity, the proportion of patients requiring SIT has remained stable. This may reflect a change in prescribing strategy, resulting from a growing body of evidence that both steroids and SIT use for irAEs limit overall survival through compromised antitumor immunity1,2. References: 1. Verheijden RJ, Burgers FH, Janssen JC, et al. Corticosteroids and other immunosuppressants for immune-related adverse events and checkpoint inhibitor effectiveness in melanoma. Eur J Cancer. 2024;207:114172. doi:10.1016/j.ejca.2024.114172 2. Verheijden RJ, van Eijs MJM, May AM, van Wijk F, Suijkerbuijk KPM. Immunosuppression for immune-related adverse events during checkpoint inhibition: an intricate balance. NPJ Precis Oncol. 2023;7(1):41. Published 2023 May 12. doi:10.1038/s41698-023-00380-1 Conflict of interest: Ms. Naber, Myrthe: No conflict of interest van Eijs, Mick: No conflict of interest Huitema, Jildou: No conflict of interest de Haan, Jacco: No conflict of interest Suijkerbuijk, Karijn: No conflict of interest Visschedijk, Marijn: Speakers fees from Jansen-Cilag, Abbvie, Ferring, Alfasigma, Takeda. van Schaik, Fiona: FDM van Schaik has received consultancy fees from Takeda, Galapagos and AbbVie, speaker’s honoraria from Galapagos, Lilly, AbbVie and Janssen-Cilag B.V., hospitality fees from Ferring and dr. Falk Farma and an unrestricted research grant from Takeda.
Naber et al. (Thu,) studied this question.