Real-World Effectiveness and Safety of Ustekinumab in Elderly Crohn’s Disease Patients

Rajat Garg, Manik Aggarwal, Robert Butler, Jean Paul Achkar, Bret Lashner, Jessica Philpott, Benjamin Cohen, Taha Qazi, Florian Rieder, Miguel Regueiro, Benjamin Click

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


Introduction: The efficacy and safety profile of ustekinumab (UST) in Crohn’s disease (CD) is favorable; however, data in elderly patients are lacking. We aimed to assess the safety and efficacy of UST in elderly CD. Methods: We performed a retrospective cohort study of CD patients classified as elderly (age ≥ 65 years at UST initiation) or nonelderly (<65 years) treated at a large, tertiary referral center. Outcomes assessed were clinical (measured by physician global assessment [PGA]) and steroid-free response, remission, adverse events, and postsurgical complications were compared by age category. Multivariable regression modeling and survival analysis was also performed. Results: In total, 117 patients (elderly n = 39, nonelderly n = 78) were included in the study. Elderly patients had predominantly moderate disease (87.2%), while nonelderly had a higher proportion of severe disease activity (44.9%) (p = 0.001), though no differences in baseline endoscopic activity, prior biologic use, or steroid or immunomodulator use at baseline existed (p > 0.05 all). While nearly 90% patients in both groups experienced clinical response to UST, compared to nonelderly, elderly patients were less likely to achieve complete clinical remission (28.2% vs. 52.6%, p = 0.01). On regression modeling, age was not associated with clinical outcomes (p > 0.05 all). Mucosal healing was achieved in 26% elderly and 30% nonelderly patients (p = 0.74). There were no significant differences in infusion reactions (2.6% vs. 6.4%, p = 0.77), infection (5.2% vs. 7.7%, p = 0.7), or postsurgical complications (p = 0.99) by age category. Conclusion: UST is safe and effective in elderly CD. Although limited by sample size and retrospective design, such real-world data can inform biologic positioning in this IBD population.

Original languageEnglish
Pages (from-to)3138-3147
Number of pages10
JournalDigestive Diseases and Sciences
Issue number7
StatePublished - Jul 2022
Externally publishedYes


  • Comparative effectiveness
  • Crohn’s disease
  • Elderly
  • IBD
  • Inflammatory bowel disease
  • Real world
  • Ustekinumab


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