P3570 - Safety and Efficacy of Ustekinumab and Vedolizumab Among Older Adults with Inflammatory Bowel Disease

Moniyka Sachar, MD¹, Cristina Fernandez, MD, MPH¹, William Beaty, ², Pakdee Rojanasopondist, MD³, Olivia Delau, MS², Alice Li, BS⁴, Megan Murphy, MD⁵, Jordan Axelrad, MD, MPH², Simon J. Hong, MD¹, Ariela Holmer, MD⁵, Shannon Chang, MD, MBA¹, David Hudesman, MD⁶, Seymour Katz, MD⁶, Lisa Malter, MD², Adam S. Faye, MD, MS^7
1NYU Langone Health, New York, NY; ²NYU Grossman School of Medicine, New York, NY; ³University of Washington, Seattle, WA; ⁴NYU School of Public Health, New York, NY; ⁵NYU Langone, New York, NY; ⁶NYU, New York, NY; ⁷New York University Langone Health, New York, NY

Introduction: There is a lack of safety and efficacy data for newer biologic agents among adults 60 years old with inflammatory bowel disease (IBD) given their limited inclusion in clinical trials. We conducted a retrospective cohort study comparing the therapeutic efficacy and adverse events associated with ustekinumab (UST) or vedolizumab (VDZ) use in older adults as compared to younger adults with IBD.

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Methods: This single-center retrospective study compared adults 18 to 60 years old to individuals ≥60 years old with a confirmed diagnosis of IBD who began VDZ or UST treatment between 2014-2021. Endoscopic remission was the primary efficacy outcome, with endoscopic response and clinical remission secondary outcomes. The primary safety outcome was infection-related hospitalization, with secondary outcomes including non-severe side-effects. Chi-square, Fisher’s exact tests were used to compare outcomes by age, and multivariate regression to compare all predictors associated with safety and efficacy.

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Results: Of 953 participants: 783 (82%) were < 60 years old, 170 (18%) were ≥60 years old, 367 (39%) had ulcerative colitis and 552 (58%) had Crohn’s disease, 405 initiated VDZ whereas 548 initiated UST. Baseline characteristics were similar across age; however, prior treatment with an anti-TNF biologic and/or immunomodulator was more common in younger participants (p< 0.01). When assessing efficacy, younger and older participants had comparable rates of endoscopic remission (25.9% vs 27.7%, p=0.64) and clinical remission (26.6% vs 26.5%, p=0.98) (Figure 1). When assessing safety across age, infection-related hospitalization rates were comparable (8.9% vs 8.8%, p=0.96) and younger participants were more likely than older participants to have non-severe adverse events (19.8% vs 12.8%, p=0.04). Biologic dose escalation was more frequent in younger patients on VDZ than older patients (39% vs 25%; p≤0.05); there was no association between age and other secondary outcomes (Figure 1). In multivariate analysis, measures of disease severity (prior biologic use, prior steroid use, severe baseline disease) but not age, were associated with decreased clinical and endoscopic remission and increased infection risk (p< 0.05) (Table 1).

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Discussion: The use of UST and VDZ had similar efficacy and safety outcomes in older adults as compared to younger individuals with IBD. Decisions to utilize these biologics should be driven by overall disease burden, and not be deferred due to advanced chronological age alone.

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Disclosures:


Moniyka Sachar, MD¹, Cristina Fernandez, MD, MPH¹, William Beaty, ², Pakdee Rojanasopondist, MD³, Olivia Delau, MS², Alice Li, BS⁴, Megan Murphy, MD⁵, Jordan Axelrad, MD, MPH², Simon J. Hong, MD¹, Ariela Holmer, MD⁵, Shannon Chang, MD, MBA¹, David Hudesman, MD⁶, Seymour Katz, MD⁶, Lisa Malter, MD², Adam S. Faye, MD, MS⁷. P3570 - Safety and Efficacy of Ustekinumab and Vedolizumab Among Older Adults with Inflammatory Bowel Disease, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.