*EMBARGOED All research presented at the 2021 ACG Annual Scientific Meeting and Postgraduate Course is strictly embargoed until Sunday, October 24, 2021, at 3:30 pm EDT.
P2613 Safety of Ustekinumab in Older IBD Patients (≥60 Years): Pooled Safety Analysis Through 5 Years in CD and 2 Years in UC and All Approved Indications
Author Insight from Maria T. Abreu, MD, University of Miami Miller School of Medicine
What’s new here and important for clinicians?
Inflammatory bowel disease (IBD) occurs in people of all ages and is a chronic condition that needs to be managed throughout a lifetime. Often clinicians taking care of older IBD patients are reluctant to start biologics fearing an increase in infections or cancer. Patients over 60 years old usually make up a small proportion of the study population in clinical trials. Now that multiple trials have been completed, there is a sufficient number of patients to examine the safety of ustekinumab in this older population.
Here, we evaluated the safety of ustekinumab in patients ≥60 years using pooled data from 13 Phase 2/3 studies across all approved indications (IBD [Crohn’s disease and ulcerative colitis], psoriasis, and psoriatic arthritis) for up to five years of follow-up. We found that overall rates for adverse events and infections, normalized for time of follow-up, were similar between ustekinumab and placebo in IBD, psoriatic diseases, and all approved indications in patients ≥60 years. Rates of serious adverse events and serious infections in ustekinumab-treated patients ≥60 years were small, had broad confidence intervals, and were generally similar to placebo. No increased risk of malignancy was observed in these data of older patients treated with ustekinumab compared with expected malignancies (SEER). The results suggest a favorable safety profile for ustekinumab in IBD patients ≥60 years, a high-risk population.
What do patients need to know?
Older adults with inflammatory bowel disease may be at higher risk of adverse events related to medications. This population is usually under-represented in clinical trials.
Among patients in ustekinumab clinical trials of Crohn’s disease, ulcerative colitis, psoriasis, or psoriatic arthritis who were 60 years or older, rates of adverse events were not higher with ustekinumab (with treatment of up to 5 years; 2 years on average) than they were with placebo, where follow-up was shorter.
The long-term safety profile of ustekinumab in older patients was favorable and consistent with the well-established overall safety profile.
Maria T. Abreu, MD, University of Miami Miller School of Medicine
mabreu1 [at] med [dot] miami [dot] edu
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