Abstract

Abstract Background All available biologics have demonstrated efficacy and safety as first-line treatment options for bio-naive Crohn’s disease (CD) patients. Real-world data about persistence with biologic treatment in patients with CD are lacking. The aim of this study was to assess and to identify potential factors affecting treatment persistence with index biologic medication in our tertiary center. Methods A single-center, noninterventional, retrospective chart review study (January 2015-October 2020) was performed on real-life data of adult bio-naïve CD patients who were treated with infliximab, adalimumab, vedolizumab or ustekinumab for >12 months duration of drug exposure. Treatment persistence was assessed using Kaplan-Meier analysis for a 36 month period and t-test for independent samples was used to identify predictors of long-term biologic persistence rates. Results Out of 84 patients (51.7% female; median age 33) included in the study 38.4% were smokers, 34.5% had history of intestinal resection and 25.6% had extraintestinal manifestations of CD. At the start of the biologic-induction regime 35.7% of patients were treated with corticosteroids and 43.4% with concomitant immunomodulator (81.8 % azathioprine, 18.2 % methotrexate). The median of CD duration was 47 months and the mean duration of treatment persistence was 29 months. After 36 months of treatment duration, the persistence rates for ustekinumab, adalimumab and infliximab were 61.9%, 56% and 48.1% respectively. Vedolizumab results were omitted from final analysis due to the small number of patients treated with the drug (N=3). Factor associated with higher persistence was body mass index (BMI) > 25 kg/m2 at the time of biologic therapy induction (p=0.05). Concomitant therapy with immunomodulator numerically significantly prolongs the therapy persistence (33.6 vs. 24.5 months). No other patient or disease-related factors (including disease duration) were found to be associated with treatment persistence for studied biologics. Conclusion These real-world data suggest that infliximab, adalimumab and ustekinumab are effective and efficient therapeutic options for bio-naive patients with moderate to severe long-standing Crohn′s disease. Concomitant immunomodulatory therapy and BMI >25 kg/m2 at the time of therapy induction were factors associated with higher biologic treatment persistence in those patients.

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