Abstract Background Immune checkpoint inhibitors (ICIs) have become a cornerstone in cancer therapy but are often limited by gastrointestinal immune-related adverse events (GI-irAEs), especially in patients with pre-existing inflammatory bowel disease (IBD). Evidence on how to manage IBD during ICI therapy is scarce, and most patients stop immunosuppressive or biologic drugs at cancer diagnosis. We present a series of patients with IBD and cancer who received ICIs together with biologic therapy as a pre-emptive strategy. Methods We reviewed five cases of IBD patients treated in our centre who started ICI therapy for different malignancies while receiving, or after switching to, biologic agents with lower infection and malignancy risk. We collected data on IBD activity, biologic/ICI regimen, adverse events and oncologic outcomes, and performed a brief review of the literature. Results The series includes IBD patients with hepatocellular carcinoma, renal cell carcinoma, melanoma and breast cancer. In all cases, biologic therapy (vedolizumab or ustekinumab) was continued or introduced concomitantly with ICIs. Over follow-up up to three years, patients maintained IBD remission with normal biomarkers and/or endoscopic findings, no life-threatening GI-irAEs were observed, and oncologic responses were maintained (complete or partial remission or stable disease). One patient successfully resumed ICI after toxicity under vedolizumab cover Conclusion Our experience suggests that, in selected IBD patients, starting or maintaining a biologic agent with a safer profile at the time of ICI therapy may help prevent IBD relapse and GI-irAEs without compromising antitumor efficacy. This cotreatment approach, although not included in current guidelines, deserves further evaluation in prospective studies References: 1. Abu-Sbeih H, Faleck DM, Ricciuti B, Mendelsohn RB, Naqash AR, Cohen J V, et al. Immune Checkpoint Inhibitor Therapy in Patients With Preexisting Inflammatory Bowel Disease. J Clin Oncol. 2020 Feb 20;38(6):576–83. 2. Pauwels RWM, van der Woude CJ, Nieboer D, Steyerberg EW, Casanova MJ, Gisbert JP, et al. Prediction of Relapse After Anti-Tumor Necrosis Factor Cessation in Crohn’s Disease: Individual Participant Data Meta-analysis of 1317 Patients From 14 Studies. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1671-1686.e16. 3. Haanen J, Ernstoff M, Wang Y, Menzies A, Puzanov I, Grivas P, et al. Rechallenge patients with immune checkpoint inhibitors following severe immune-related adverse events: review of the literature and suggested prophylactic strategy. J Immunother Cancer. 2020 Jun;8(1). 4. Badran YR, Zou F, Durbin SM, Dutra BE, Abu-Sbeih H, Thomas AS, et al. Concurrent immune checkpoint inhibition and selective immunosuppressive therapy in patients with immune-related enterocolitis. J Immunother Cancer. 2023 Jun;11(6). 5. Perez-Ruiz E, Minute L, Otano I, Alvarez M, Ochoa MC, Belsue V, et al. Prophylactic TNF blockade uncouples efficacy and toxicity in dual CTLA-4 and PD-1 immunotherapy. Nature. 2019 May;569(7756):428–32. 6. Ju M, Zhang J, Deng Z, Wei M, Ma L, Chen T, et al. Prophylactic IL-23 blockade uncouples efficacy and toxicity in dual CTLA-4 and PD-1 immunotherapy. J Immunother Cancer. 2024 Jul 31;12(7). 7. Montfort A, Filleron T, Virazels M, Dufau C, Milhès J, Pagès C, et al. Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial. Clin Cancer Res. 2021 Feb 15;27(4):1037–47. 8. Olivera PA, Lasa JS, Bonovas S, Danese S, Peyrin-Biroulet L. Safety of Janus Kinase Inhibitors in Patients With Inflammatory Bowel Diseases or Other Immune-mediated Diseases: A Systematic Review and Meta-Analysis. Gastroenterology. 2020 May;158(6):1554-1573.e12. Conflict of interest: Robles Alonso, Virginia: No conflict of interest Serra-Ruiz, Xavier: No conflicts. Lastiri, Ernesto: No conflict of interest Mayorga Ayala, Luis Fernando: No conflict of interest Herrera De Guise, Claudia Maria: No conflict of interest Céspedes Martínez, Elena: No conflict of interest Oller, Elena: No conflict of interest Pérez Martínez, Zahira: Grant: NECCO Grant award 2023 Personal Fees: Honoraria from Janssen and Takeda (symposio speechs from that year and last year) Borruel, Natalia: No conflict of interest
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