P1647 - Perianal Involvement and Cigarette Smoking Are Predictive of Need for Surgery Following Initiation of Ustekinumab for Treatment of Crohn’s Disease Refractory to Prior Biologic Therapies

Taaj Raasikh, MD¹, Abhijeet Yadav, MD², Alexys Nunn, BS³, Terrence A. Barrett, MD², Manreet Kaur, MD^3
1Baylor College of Medicine, Houston, TX; ²University of Kentucky, Lexington, KY; ³Baylor College of Medicine, Baylor, TX

Introduction: Ustekinumab (UST) has been shown effective for treatment of moderate to severe Crohn’s disease (CD). The aim of this study was to assess efficacy of UST in patients with CD that had previously failed treatment with a biologic therapy and identify factors predictive of loss of response and need for surgery following initiation of UST.

Methods: We performed a retrospective, observational c study of patients with CD initiated on UST between January 2016 and September 2019. Patients started on UST for treatment of CD, with at least 12 weeks of follow up were screened for eligibility. Exclusion criteria included history of indeterminate colitis. Primary outcome was loss of response defined by need for hospitalization, surgery, corticosteroids or discontinuation of UST. Clinical data were analyzed using R statistical software. Univariate associations of clinical variables were analyzed using chi-square tests for categorical variables and student t-test for continuous variables. Multivariable analyses were performed using step-wise logistic regression analyses, to identify variables associated with response to UST at 12, 24, 52 and 104 weeks. Survival analysis was performed using cox proportional hazard regression model.



Results: The study cohort comprised of 258 patients with a median follow up of 54.2 weeks. All patients had previously failed at least one biologic agent. Almost 62% of patients had complicated disease behavior and 59% had undergone prior abdominal surgery for CD at initiation of UST. Median disease duration in the study cohort was 12 years. Steroid free response was observed in 65% at 12 weeks, 71% at 24 weeks, 69% at 52 weeks and 89% of the cohort at 104 weeks. There were no clinical predictors of response to UST identified at any of these time points. Seventeen (45%) patients required surgery. Median time to surgery was 37 weeks (interquartile range: 17.7-63.3). On cox proportional hazards model, perianal involvement (p = 0.035) and cigarette smoking (p = 0.001) were associated with increased likelihood of abdominal surgery for CD (Table 1). Eighteen (7%) patients experienced serious adverse events that required discontinuation of UST.



Discussion: In this large cohort of 258 patients with CD refractory to prior biologic therapies, perianal CD and cigarette smoking were associated with increased risk of abdominal surgery, with 17% of patients requiring surgery, usually within first year of initiating therapy with UST.





Disclosures:


Taaj Raasikh, MD¹, Abhijeet Yadav, MD², Alexys Nunn, BS³, Terrence A. Barrett, MD², Manreet Kaur, MD³. P1647 - Perianal Involvement and Cigarette Smoking Are Predictive of Need for Surgery Following Initiation of Ustekinumab for Treatment of Crohn’s Disease Refractory to Prior Biologic Therapies, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.