P468 Analysis of international spontaneous reporting system databases for safety of corticosteroids in Inflammatory Bowel Disease: The Determinants, Incidence and consequences of Corticosteroid Excess (DICE)-impact study

Raine, T.(1);Bokemeyer, B.(2);Finney-Hayward, T.(3);Munsaka, M.(4);Liu, M.(4);Louis, E.(5);

(1)Addenbrooke’s Hospital University of Cambridge, Gastroenterology, Cambridge, United Kingdom;(2)Gastroenterology Practice Minden, Gastroenterology, Minden, Germany;(3)AbbVie Ltd, Gastroenterology, Maidenhead, United Kingdom;(4)AbbVie Inc., Safety Statistics, North Chicago IL, United States;(5)CHU Liège University Hospital, Gastroenterology, Liège, Belgium


Long-term use of corticosteroids (CS) may result in significant risk of adverse events (AEs), and the true incidence of AEs in patients with inflammatory bowel disease (IBD) receiving CS is unknown.1 Such AE data may be reported in spontaneous reporting systems (SRS). Using data-mining algorithms for disproportionality, we determined the frequency of AEs of special interest (AESIs) associated with CS in patients with IBD.


The FDA SRS database (FAERS) was examined for AE reports associated with prednisone/prednisolone (PRED) or budesonide (BUD) use for Crohn’s disease or ulcerative colitis from Q1 2008 to Q4 2019. The incidence of key predefined AESIs was determined and the association with CS therapy was assessed using the proportional reporting ratio (PRR) criteria.


Totals of 420,913 and 33,215 all-cause AEs were reported for PRED and BUD, respectively. The number of AE reports for each CS increased over time (Figure 1) and this was reflected in an increase in the proportion of reports of all AEs over time relating to CS. Common AEs reported with CS therapy included diarrhoea, abdominal pain, pyrexia and weight loss (Figure 2). Compared with other drugs and based on the PRR criteria, AESIs including osteonecrosis, adrenal insufficiency and Cushingoid complications were more frequently reported in patients treated with PRED; adrenal insufficiency, pancreatitis and Cushingoid complications were more frequently reported in patients treated with BUD (Table 1). There was no confounding effect from gender or disease type identified between CS and any of the AESIs in patients with IBD.


Analysis of FAERS demonstrated that steroid-treated patients with IBD report AEs that are consistent with the known safety profile for CS. Cushingoid complications and adrenal insufficiency were common signals for PRED and BUD. The increased reporting of AEs over time may reflect growth in CS prescribing, or growing awareness and reporting of CS AEs by prescribers. This analysis will be repeated in multiple international SRS systems to provide a global image of AEs for CS use in IBD.

1. Fardet L et al. Drug Saf 2007;30:861–81