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;


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.


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:


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.


In this large cohort, infections were one of the commonest AEs recorded during exposure to anti-TNF therapy.Bacterial infections were most frequent across all age groups requiring pause of anti-TNF in most cases and withdrawal in very few. Opportunistic infections were few and reported TB cases was as low as 0.5% of total cohort. Skin cancer was the most common malignancy and no lymphomas were reported in this cohort. Clinicians need to be aware of these risks in younger patients as anti-TNFs result in infections and malignancies across all age groups and not particularly limited to the elderly.