Colon to Rectum
Clin Gastroenterol Hepatol. 2025;23(5):855-865.e5
Safety of immunosuppression in a prospective cohort of inflammatory bowel disease patients with a history of cancer: SAPPHIRE Registry
Background and aims: In patients with inflammatory bowel disease (IBD) and a history of cancer, retrospective studies have suggested that exposure to immunosuppressive agents does not increase the risk of incident (recurrent or new) cancer compared with unexposed patients. Safety of immunosuppression in A Prospective cohort of inflammatory bowel disease Patients and a HIstoRy of cancEr (SAPPHIRE) is a prospective registry aimed at addressing this issue.
Methods: Since 2016, patients with IBD and confirmed index cancer before enrollment were followed up annually. Patients receiving chemotherapy or radiation at enrollment, or recurrent cancer within 5 years, were excluded. The primary outcome was development of incident cancer related to exposure to immunosuppressive medications.
Results: Among 305 patients (47% male, 88% white), the median age at IBD diagnosis and cancer were 32 and 52 years, respectively. Index cancers were solid organ (46%), dermatologic (32%), gastrointestinal (13%), and hematologic (9%). During a median follow-up period of 4.8 years, 210 patients (69%) were exposed to immunosuppressive therapy and 46 patients (15%) developed incident cancers (25 new, 21 recurrent). In unadjusted analysis, the crude rate of incident cancer in unexposed patients was 2.58 per 100 person-years versus 4.78 per 100 person-years (relative risk = 1.85; 95% confidence interval [CI]: 0.92–3.73) for immunosuppression-exposed patients. In a time-varying proportional hazards model adjusting for sex, smoking history, age and stage at index malignancy, and non-melanoma skin cancer, no significant association was found between receipt of immunosuppression and incident cancer (adjusted hazard ratio = 1.41; 95% CI: 0.69–2.90), or with any major drug class.
Conclusions: In this interim analysis of patients with inflammatory bowel disease and a history of cancer, despite numerically increased adjusted hazard ratios, the authors did not find a statistically significant association between subsequent exposure to immunosuppressive therapies and development of incident cancers.