P475 Infections and malignancies during anti-TNF therapy in IBD patients affect all age groups – results from a 13-yr real-world retrospective study
Majumder, S.(1,2);Melanie , L.(2);Joanne , D.(2);Naveen, S.(2);Quraishi, M.N.(2);Cooney, R.(2);Ghosh, S.(3);Iacucci, M.(1,2,4);N Shivaji, U.(1,2,4)*;
(1)University of Birmingham, Institute of Immunology and Immunotherapy, Birmingham, United Kingdom;(2)University Hospitals Birmingham NHS Foundation Trust, Gastroenterology, Birmingham, United Kingdom;(3)University College Cork, College of Medicine and Health- University College Cork- APC Microbiome, Cork, United Kingdom;(4)National Institute for Health Research NIHR Birmingham Biomedical Research Centre- University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Institute of Immunology and Immunotherapy, Birmingham, United Kingdom;
Background
Anti-TNFα is the first class of biologics approved for treatment of moderate-to-severely active Inflammatory Bowel Disease (IBD). More than two decades on, anti-TNFs remain one of the most commonly used biologics for both Ulcerative Colitis (UC) and Crohn’s Disease (CD), and often as first-line therapy. Although effective, they cause several adverse events (AEs), sometimes requiring withdrawal of therapy. We aimed to report on AEs with a focus on risk of infections and malignancies in this large cohort.
Methods
All IBD patients exposed to anti-TNF therapy were identified from EMR at two centres of a large tertiary referral centre between January 2009 and June 2022. All relevant demographic and clinical data were collected for those patients with well recorded AEs and follow-up. Data on cumulative AEs directly attributed to anti-TNFs that ranged from mild reactions to serious AEs (defined as those requiring review/withdrawal of anti-TNF), were collected. The data were analysed and statistical analysis carried out using the IBM® SPSS® Statistics software package Version: 28.0.0.0.
Results
Total of 844 patients (M=408, 48%; median age 37years) were included, of which 61% were Caucasian. Majority had CD (608;72%) with mean age at diagnosis of 27y (SD 15y) and a median disease duration of 12years. About 50% of patients were on monotherapy and adalimumab was most frequently used (52%).There were 392 cumulative AEs recorded in this cohort with 78 infections (20% of all AEs). Among these, majority were bacterial infections, followed by Clostridium difficile. Tuberculosis(TB) was diagnosed in 5 patients. Infections were distributed evenly across all age groups with no significant difference between monotherapy or combination therapy. Majority of infections responded to anti-microbials and patients were able to resume anti-TNFs without major complications. One death recorded due to viral hepatitis. Detailed breakdown is given in Table 1. Malignancies were recorded in 16 (2%) patients and 6 were on combination therapy. Skin cancers were most common and there were no lymphomas noted. The details of malignancy are given in Table 1.
