Abstract

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

Dig Dis Sci. 2021 Jun 23. doi: 10.1007/s10620-021-07117-9. Online ahead of print.

Rajat Garg 1, Manik Aggarwal 1, Robert Butler 2, Jean Paul Achkar 3, Bret Lashner 3, Jessica Philpott 3, Benjamin Cohen 3, Taha Qazi 3, Florian Rieder 3, Miguel Regueiro 1 2 3, Benjamin Click

 
     

Author information

  • 1Department of Internal Medicine, Cleveland Clinic, Cleveland, OH, USA.
  • 2Quantitative Health Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
  • 3Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
  • 4Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH, 44195, USA. clickb@ccf.org.

Abstract

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.

 

 

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