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Background: Crohn's disease (CD) is a chronic inflammatory bowel disease characterized by relapsing and remitting inflammation that leads to progressive bowel damage. Despite advances in medical treatment for CD, many patients require surgical intervention. Most studies of surgery rates are from patients treated with anti-tumor necrosis factor alpha (anti-TNFα) treatments, with comparatively little data on the surgery rates of patients treated with vedolizumab and ustekinumab. SOJOURN aimed to estimate the hazard rate and incidence of the first CD-related surgery following initiation of treatment with vedolizumab or ustekinumab in biologic-naïve patients with CD. Methods: SOJOURN was a retrospective, observational cohort study examining administrative claims data from the Optum® Research Database between July 1, 2017 and March 31, 2020. Included participants were adults with a diagnosis of CD and a claim for vedolizumab or ustekinumab (defined as the index treatment) between January 1, 2018 and December 31, 2019, with no claims for a biologic in the 6 months before initiation of this treatment. The variable follow-up started on the day after the index date and continued until whichever came first of discontinuation of the index treatment, surgery event, switching of the index treatment, initiation of combination biologic treatment, disenrollment, or March 31, 2020. The time to the first CD-related surgery on biologic treatment was estimated by Kaplan–Meier analysis. The hazard ratio and incidence rate ratio of CD-related surgery for each treatment cohort was compared using a Cox proportional hazards model and a Poisson regression model, respectively. Results: Of the 1,122 included patients, 578 received vedolizumab and 544 received ustekinumab. After 1 year of the variable follow-up, 7.7% of patients receiving vedolizumab and 11.6% of patients receiving ustekinumab had undergone a CD-related surgery. Vedolizumab was associated with a 34.2% lower hazard rate of surgery (hazard ratio 0.658, 95% confidence interval [CI] 0.436–0.994, p = 0.047) and a 34.5% lower incidence of surgery (rate ratio 0.655, 95% CI 0.434–0.988, p = 0.044) than ustekinumab. Conclusions: This real-world analysis of biologic-naïve patients with CD suggests that vedolizumab is associated with greater effectiveness in reducing the rate of CD-related surgery than ustekinumab. [ABSTRACT FROM AUTHOR]

Introduction: Overactive bladder (OAB) management with pharmacotherapy is limited by low real-world adherence and persistence. This analysis compared real-world adherence and persistence of patients initiating vibegron, a 3-adrenergic receptor agonist approved in December 2020 for OAB, with mirabegron and anticholinergics. Methods: This retrospective study used pharmacy claims data from the Optum Research Database. Study criteria included patients ≥18 years old with ≥1 pharmacy claim for vibegron, mirabegron, or anticholinergic from April 1, 2021--December 31, 2021; continuous enrollment in a health plan with pharmacy and medical benefits for 3 months preindex (baseline) and ≥2 months postindex (follow-up); and no index medication during baseline. Two independent propensity-score models were used to match patients treated with (1) vibegron vs mirabegron and (2) vibegron vs anticholinergics. Adherence was measured by proportion of days covered (PDC) from index to end of follow-up and defined as PDC ≥80%. Persistence was defined as days to discontinuation of index medication or end of follow-up. Adherence and persistence were analyzed descriptively and by Kaplan-Meier analysis, respectively. Results: The matched vibegron and mirabegron cohorts included 1655 and 3310 patients, respectively; the matched vibegron and anticholinergic cohorts included 1595 and 3190 patients. Patients receiving vibegron had greater adherence vs patients receiving mirabegron (PDC=0.71 vs 0.68, respectively; P=0.004) or anticholinergics (0.71 vs 0.61; P<0.001). A greater percentage of patients receiving vibegron were adherent (ie, PDC ≥80%) vs those receiving mirabegron (53.4% vs 49.2%, respectively; P=0.005) or anticholinergics (53.7% vs 43.2%; P<0.001). Persistence was longer with vibegron vs mirabegron (median [95% CI]; 205 [162-246] vs 148 [126-162] days, respectively; P<0.001) and anticholinergics (207 [167-246] vs 91 [91- 95] days; P<0.001). Conclusions: In this retrospective analysis, real-world adherence and persistence was higher in patients initiating vibegron compared with patients initiating mirabegron or anticholinergic when matched on baseline characteristics. [ABSTRACT FROM AUTHOR]