REAL-WORLD TREATMENT PERSISTENCE AMONG ADVANCED THERAPY-EXPERIENCED PATIENTS WITH ULCERATIVE COLITIS INITIATED ON USTEKINUMAB OR ADALIMUMAB

Abstract

Abstract BACKGROUND Prior exposure to advanced therapies (ADT) is associated with reduced response to future therapies in patients with ulcerative colitis (UC). Therapy persistence is a proxy of real-world treatment performance. This study compared persistence among ADT-experienced patients with UC initiated on ustekinumab (anti-interleukin 12/23 antibody), or adalimumab (anti-tumor necrosis factor biologic). METHODS Adults with UC initiated on ustekinumab or adalimumab (index date) between 10/21/2019 and 03/02/2022 were selected from the IQVIA PharMetrics® Plus database. Patients were ADT-experienced (i.e., ≥1 claim for a non-index UC-indicated ADT) in the 12-month baseline period before the index date. Patients with other auto-immune diseases during the baseline period were excluded. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence was defined as the absence of gaps between days of therapy supply of >120 days for ustekinumab or >60 days for adalimumab. Composite endpoints of being persistent while on monotherapy (no immunomodulators or index ADT) and persistent while corticosteroid-free (<14 consecutive days of corticosteroid supply after day 90 post-index) were also assessed. Persistence endpoints were described post-maintenance phase until the earlier of 12 months, end of insurance eligibility, or data using weighted Kaplan-Meier analyses and weighted Cox proportional hazards models adjusted for the use of ≥2 biologics and class of biologics used pre-index. RESULTS There were 693 and 254 patients in the weighted ustekinumab versus adalimumab cohorts, respectively (Fig. 1). At 12 months after the maintenance phase start, 78.1% of the ustekinumab cohort and 59.2% of the adalimumab cohort were persistent on the index biologic; persistence was 2.44 times higher in the ustekinumab cohort relative to the adalimumab cohort (p-value: <0.001; Fig. 2a). Moreover, 66.7% of the ustekinumab cohort and 40.5% of the adalimumab cohort persisted on the index biologic while on monotherapy; persistence while on monotherapy was 2.53 times higher in the ustekinumab cohort relative to the adalimumab cohort (p-value: <0.001; Fig. 2b). Finally, 48.0% of the ustekinumab cohort and 42.8% of the adalimumab cohort were persistent while corticosteroid-free; persistence while corticosteroid-free was 1.24 times higher in the ustekinumab cohort relative to the adalimumab cohort (p-value 0.0447; Fig. 2c). CONCLUSIONS ADT-experienced patients with UC treated with ustekinumab were more persistent, including persistent while on monotherapy and while corticosteroid-free than patients treated with adalimumab. These findings may aid healthcare providers in choosing a biologic for ADT-experienced patients with UC. Figure 1 Selected baseline characteristics in weighted ustekinumab and adalimumab cohorts Figure 2 Persistence in weighted ustekinumab and adalimumab cohorts: a) persistent on index biologic, b) persistent and on monotherapy, c) persistent and corticosteroid-free