P0716Safety of biologic and small molecule therapies in IBD patients with previous cancer: risk of recurrence or new neoplasia

Abstract Background Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, often requires long-term immunosuppressive therapy, demanding a careful balance between disease control and overall patient safety. In individuals with a prior cancer, therapeutic decisions are particularly complex, as the risk of cancer recurrence must be weighed against the need to maintain IBD remission. While the safety of anti-TNF agents is well established, evidence on newer biologics and small molecules remains limited. Our main aim was to evaluate the risk of new or recurrent malignancy in IBD patients treated with biologics or small molecules after extracolonic cancer. Methods This was a real-world, multicentre Spanish study based on a prospectively maintained database (ENEIDA registry), promoted by GETECCU, including 66,486 patients with IBD as of January 2024. Eligible participants were adults with IBD and a history of extracolonic cancer who received biologics or small molecules after cancer diagnosis. Variables collected included demographic, clinical, oncological, and therapeutic data. Only drug exposure after cancer diagnosis was computed. Incidence rates of cancer by drug exposure were compared using random-effects Poisson regression models for panel data, adjusted for the accumulated prior exposure to treatments, risk of cancer recurrence according to the Penn classification, type of initial cancer, sex, smoking and age at cancer diagnosis. Anti-TNF group constituted the reference category. Results A total of 961 patients were included. The mean age at cancer diagnosis was 52 years. Index cancers were mostly solid organ malignancies (61%), and 41% were categorized as high recurrence risk. Baseline demographic and oncologic characteristics are detailed in table 1. Accumulated exposure time of treatments and total number of patients that received the treatments are included in table 2. During follow-up, 155 patients developed either cancer recurrence (69) or a new cancer (86). Incidence rates are detailed for each treatment group in table 3. In comparison with anti-TNF exposure as the reference category, the adjusted Incidence rate ratios of cancer recurrence or new onset cancer was 0.63 for vedolizumab (95% CI, 0.37–1.08), 0.58 for ustekinumab (0.32–1.06), 0.90 for small molecules (0.23–3.55), and 0.58 for off-treatment periods (0.34–0.99). Conclusion Data from this large real-world registry show that the incidence of cancer recurrence or new-onset malignancy in IBD patients with a prior history of cancer treated with vedolizumab, ustekinumab, or small molecules was not higher than with anti-TNF therapy. These findings strongly support that these newer agents are associated with a low risk of cancer recurrence in this population. Conflict of interest: Mr. Calvo, Mario: No conflict of interest Fernández-Felix, Borja M.: No conflict of interest Ordás Jiménez, Ingrid: I have received financial support for travel and educational activities, and have served as a speaker or advisory board member for the following companies AbbVie, MSD, Pfizer, Takeda, Janssen, Kern Pharma, Chiesi, Falk Pharma, and Faes Farma. I have also received research funding from AbbVie, Faes Farma, and Takeda. Llao Guardia, Jordina: I have received financial support from AbbVie, Tillots, Adacyte, Jansen, Alfasigma and Lilly for educational activities. Riestra Menéndez, Sabino: No conflict of interest Mesonero Gismero, Francisco: I ve served as a speaker for and received consulting fees from MSD, AbbVie, Takeda, Janssen, Pfizer, Ferring Pharmaceuticals, Kern Pharma, Dr. Falk Pharma, Galapagos, Lilly, Chiesi Farmaceutici, and Faes Farma. De Castro Parga, Maria Luisa: I declare that I have acted as a speaker for Abbvie, Johnson & Johnson, Takeda, Tillots Pharma and Dr. Falk Pharma. I have received travel or conference attendance grants from Abbvie, Faes, Dr. Falk Pharma, Pfizer, Johnson & Johnson, Takeda, Tillots Pharma and Ferring. Varela Trastoy, Pilar: No conflict of interest Vela, Milagros: No conflict of interest Marcos Carrasco, Natalia: No conflict of interest Gargallo-Puyuelo, Carla: No conflict of interest Roig Ramos, Cristina: CR has received support for conference attendance and education funding from Kern Pharma, Ferring, Alfasigma, Faes Farma, Pfizer and Takeda. Martin Arranz, Maria Dolores: No conflict of interest Rivas, Coral: No conflict of interest Guardiola Capón, Jordi: Grant: MSD, Abbvie, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Galapagos, Sandoz, Celltrion and GE Healthcare. Personal Fees: Roche, MSD, Abbvie, Kern Pharma, Takeda, Janssen, Pfizer, Galapagos, Celltrion, Goodgut and GE Healthcare. Non-financial Support: MSD, Abbvie, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Galapagos, Sandoz, Celltrion and GE Healthcare. Arias Garcia, Lara: Support for travel for meetings to support study Abbvie, FAES Pharma, Kern Pharma, Ferring y MSD Gutiérrez Casbas, Ana: No conflict of interest Bermejo San Jose, Fernando: No conflict of interest Gonzalez, Sheila: No conflict of interest Lucia, Marquez: No conflict of interest Elorza, Ainara: No conflict of interest Garcia Sepulcre, Mariana Fe: No conflict of interest Fernández-Salazar, Luis: My institution has been granted by Johnosn & Johnson for investigation. I have been financed to attend IBD meetings by Ferring, Lilly and Sandoz. Mínguez, Alejandro: No conflict of interest Quiñones, Marta: No conflict of interest Taxonera, Carlos: No conflict of interest Barreiro-de Acosta, Manuel: MBA has been speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Alphasigma, Lilly, Pfizer, Sandoz, Biocon, Abivax, Fresenius, Faes Farma, Ferring, Tillots, Chiesi, Adacyte, Diasorin, Oncostellae and SunRock. Ponferrada Diaz, Angel: financial support for travelling and educational activities from Johnsson and Johnsson, AbbVie, Takeda, Alfasigma, Lilly, Faes Farma and Ferring. Iglesias Flores, Eva: has served as a speaker, consultant and advisory member for or has received research funding from AbbVie, Janssen, Takeda, Gillead, Celgene, Pfizer, Lilly, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, and Adacyte, Piqueras Cano, Marta: No conflict of interest Sese, Eva: No conflict of interest Busquets Casals, David: No conflict of interest Bas-Cutrina, Francesc: No conflict of interest Betoré Glaría, Elena: No conflict of interest Gómez Moreno, Ana Zaida: No conflict of interest Castro Poceiro, Jesus: J. Castro-Poceiro has served as a speaker or received funding for training from Ferring, Tillots, Abbvie, Pfizer, Galapagos, Lilly, Takeda, Kern and Chiesi. Ramos Lopez, Laura: L.R. has acted as a speaker or received funding for training from MSD, Abbvie, Adacyte, Takeda, Pfizer, Janssen, and Ferring. Domènech Moral, Eugeni: Personal Fees: I have served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Biogen, Celltrion, Gilead, Janssen, Kern Pharma, MSD, Pfizer, Roche, Samsung, Takeda, Tillots. Other: I have served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Alfasigma/Galapagos Biogen, Celltrion, Ferring, Gilead, GoodGut, Imidomics, Janssen, Kern Pharma, Lilly, MSD, Pfizer, Roche, Takeda, Tillots. Chaparro, María: Grants: Pfizer, Janssen, Biogen, Abbvie, Lilly Personal Fees: Pfizer, Faes, Lilly, Abbvie, Janssen Gisbert, Javier: Grant: MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos/Alfasigma, Lilly, Sanofi, STADA, Teva, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine, Italfarmaco, and Vifor Pharma. Personal Fees: MSD, Abbvie, Pfizer, Ke