REAL-WORLD USTEKINUMAB PERSISTENCE IN PATIENTS WITH ULCERATIVE COLITIS ATTAINING THE MAINTENANCE PHASE

Abstract

Abstract BACKGROUND Sustained use of biologics and small molecule/advanced therapy has proven to be effective for controlling disease activity in ulcerative colitis (UC). The anti-interleukin agent ustekinumab was recently approved for UC in 2019. This study aimed to describe real-world ustekinumab persistence among patients with UC attaining the maintenance phase. METHODS Adults with UC selected from the Komodo Health’s comprehensive dataset had the first claim for ustekinumab (index date) between 10/21/2019 and 08/13/2021. Patients had ≥12 months of continuous insurance eligibility pre-index (baseline period), ≥1 claim with a diagnosis of UC at baseline or on the index date and persisted to their first subcutaneous ustekinumab claim (maintenance phase). Patients with diagnoses for other immune disorders at baseline or diagnoses for Crohn’s disease at any time were excluded. Persistence to ustekinumab was defined as absence of a therapy exposure gap of >120 days between days of supply or end of follow-up. Composite endpoints were persistence while being corticosteroid-free (no corticosteroids with ≥14 days of supply after day 90 post-index), and persistence while on monotherapy (no immunomodulators/non-index biologics or advanced therapies). Persistence endpoints were described post-maintenance phase until the earlier of 12 months, end of insurance eligibility, or data. Kaplan-Meier curves were used to assess persistence outcomes in all patients and among patients without prior biologic/advanced therapy exposure pre-index (bio-naïve). RESULTS 778 patients attaining the ustekinumab maintenance phase were selected, 236 (30.3%) were bio-naïve (Fig. 1). Mean follow-up time post-index was 13.5 months overall and 12.7 months for bio-naïve patients. By 12 months post-maintenance, 73.2% of all patients and 75.5% of bio-naïve patients were persistent to ustekinumab (Fig. 2). Additionally, amongst patients who were persistent and corticosteroid-free between the index date and the start of maintenance phase, 47.0% of all patients and 55.1% of bio-naïve patients remained persistent and corticosteroid-free 12 months after their first maintenance claim. Further, among patients who were persistent on monotherapy at the start of maintenance phase, 63.6% of all patients and 68.1% of bio-naïve patients remained persistent on monotherapy at 12 months. CONCLUSIONS In this study, 12 months after their first ustekinumab maintenance claim for UC, most patients who attained the maintenance phase were persistent to treatment, around half of patients who were also corticosteroid-free at the start of the maintenance phase remained persistent and corticosteroid-free, and most patients who were persistent on monotherapy at the start of the maintenance phase remained persistent on monotherapy.