S1003 Safety of Ustekinumab in Patients 65 Years or Older With Inflammatory Bowel Disease: A Propensity-Based Match Analysis

Abstract

Introduction: Ustekinumab (UST) is a monoclonal antibody targeting both IL-12 and IL-23 receptors. Owing to its mechanism, there is always a concern for its adverse effects, including malignancy and opportunistic infections (OI). Our study aimed to study the risk of malignancy and OI in patients who were treated with UST and were 65 and older Methods: A retrospective cohort study was conducted using TriNetX, a multi-institutional database of more than 70 million patients from 49 healthcare organizations in the USA. We compared the 3-year risk of malignancy and opportunistic infections (OIs) in patients with inflammatory bowel disease (IBD) who were treated with UST who were 65 years and older compared with patients between the age of 18-65 years. Exclusion criteria included patients who were on the biologic agent for less than 3 months or had a prior history of any adverse event. 1:1 propensity-score matching was performed, gender, race, ethnicity, diabetes, nicotine dependence, obesity, PO and IV steroids, mean Hb, CRP, albumin, and calprotectin within 1 year before medication initiation. Adjusted odds ratios (aOR) with 95% confidence interval (CI) were calculated to express the risk of each adverse event Results: A total of 22,242 patients with IBD were identified who were 65 years or older. At the time of analysis, 147 patients received UST, 1,493 patients were on anti-TNF alpha (TNFi), 494 were on vedolizumab (VDZ), and 92 on tofacitinib, and 6040 patients were on a 5-ASA therapy. There was no difference in malignancy rates ( OR: 0.58, 95% CI; 0.29-1.15) and OI ( OR: 1.04, 95% CI; 0.50-2.1) in patients 65 years or older when treated with UST compared to 5-ASA therapy. There was also no difference seen in outcomes of malignancy and OI when UST was compared with other medications (TNFi, VDZ, tofacitinib) in the cohort Conclusion: In conclusion, Ustekinumab appears safe to be used in patients with IBD who are 65 years or older