PERSISTENCE WHILE ON LABELED MAINTENANCE DOSE AMONG ADVANCED THERAPY-NAÏVE PATIENTS WITH ULCERATIVE COLITIS INITIATED ON USTEKINUMAB OR ADALIMUMAB

Abstract

Abstract BACKGROUND In the real-world setting, biologic therapy in patients with ulcerative colitis (UC) may require dose escalation if initial response is limited or due to loss of response. Dose escalation leads to higher treatment costs and may cause difficulties obtaining prior authorization and approvals from health plans. This study compared treatment persistence while on labeled maintenance dose among advanced therapy (ADT)-naïve patients with UC on ustekinumab or adalimumab. METHODS Adults with UC initiated on ustekinumab or adalimumab (index date: 10/21/2019 - 03/02/2022) were selected from the IQVIA PharMetrics® Plus database. Patients were ADT-naïve (i.e., no claim for UC-indicated ADT) and had no other autoimmune diseases in the 12-month baseline period before the index date. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence while on the labeled maintenance dose was defined as (1) no gaps between days of therapy supply (ustekinumab, >120 days; adalimumab, >60 days), and (2) absence of any dose change from the maintenance dose per US label. Composite endpoints of being persistent while corticosteroid-free (<14 consecutive days of corticosteroid supply after day 90 post-index) and persistent while on monotherapy (no immunomodulators or ADT) were also evaluated. Endpoints were assessed from the maintenance phase start until the earliest of discontinuation (event), corticosteroid use (event), immunomodulator or ADT use (event), dose change (censored), 12 months follow-up, or data end (censored) using weighted Kaplan-Meier and Cox proportional hazards model analyses. RESULTS There were 371 and 1,726 patients in the weighted ustekinumab versus adalimumab cohort, respectively (Fig. 1). At 12 months after the maintenance phase start, 88.6% and 61.7% of the ustekinumab versus adalimumab cohort were persistent while on the labeled maintenance dose; persistence was 4.21 times higher in the ustekinumab cohort (p-value: <0.001; Fig 2a). Further, 70.0% and 43.9% of the ustekinumab versus adalimumab cohorts were persistent and corticosteroid-free while on the labeled maintenance dose; persistence was 2.31 times higher in the ustekinumab cohort (p-value: <0.001; Fig 2b). Finally, 84.4% and 55.1% of the ustekinumab versus adalimumab cohorts were persistent while on monotherapy and on the labeled maintenance dose; persistence was 3.38 times higher in the ustekinumab cohort (p-value: <0.001; Fig 2c). CONCLUSIONS ADT-naïve patients with UC initiated on ustekinumab were significantly more persistent while on the labeled maintenance dose, including persistent while corticosteroid-free and while on monotherapy, compared to patients initiated on adalimumab. Results may help with selecting a biologic for ADT-naive patients with UC. Figure 1 Selected baseline characteristics in weighted ustekinumab and adalimumab cohorts Figure 2 Persistence while on US labelled dose among weighted ustekinumab and adalimumab cohorts: a) persistent on index biologic, b) persistent and corticosteroid-free, c) persistent and on monotherapy