PERSISTENCE WHILE ON LABELED MAINTENANCE DOSE AMONG ADVANCED THERAPY-EXPERIENCED PATIENTS WITH ULCERATIVE COLITIS INITIATED ON USTEKINUMAB OR ADALIMUMAB
Authors: Boonmak Porpong , Kachroo Sumesh , Zhdanava Maryia , Burbage Sabree , Shah Aditi , Korsiak Jill , Lefebvre Patrick , Kerner Caroline , Pilon Dominic 
Published: January 2024

Abstract

BACKGROUND
Persistence on biologics in ulcerative colitis (UC) is a useful real-world treatment performance measure particularly important in advanced therapy (ADT)-experienced patients. Dose escalation on biologics is an indicator of suboptimal treatment response associated with higher biologic costs. This study compared persistence while on labeled maintenance dose among ADT-experienced patients with UC initiated 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-experienced (i.e., ≥1 claim for a non-index UC-indicated ADT agent) and without other auto-immune diseases in the 12-month baseline period. 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, &gt;120 days; adalimumab, &gt;60 days); (2) absence of any dose change relative to the maintenance dose per US label. Composite endpoints of being persistent while corticosteroid-free (&lt;14 consecutive days of corticosteroid supply after day 90 post-index) and persistent while on monotherapy (no immunomodulators or non-index ADT) were also assessed. Endpoints were assessed from the maintenance phase start until the earliest of discontinuation (event), corticosteroid use (event), immunomodulator, non-index advanced therapy use (event), dose change (censored), 12 months follow-up or data end (censored) using weighted Kaplan-Meier analyses and Cox proportional hazards models.

RESULTS
Weighted cohorts included 693 ustekinumab and 294 adalimumab patients (Fig. 1). At 12 months after the maintenance phase start, 88.7% and 65.8% of the ustekinumab versus adalimumab cohort were persistent while on the labeled maintenance dose with persistence 4.77 times higher in the ustekinumab cohort (p-value:&lt;0.001; Fig. 2a). Further, 55.7% and 44.6% of the ustekinumab versus adalimumab cohort were persistent and corticosteroid-free while on the labeled maintenance dose; persistence was 1.48 times higher in the ustekinumab cohort (p-value:0.002; Fig. 2b). Finally, 77.2% and 47.3% of the ustekinumab versus adalimumab cohort were persistent and on monotherapy while on the labeled maintenance dose; persistence was 3.29 times higher in the ustekinumab cohort (p-value:&lt;0.001; Fig. 2c).

CONCLUSIONS
ADT-experienced patients with UC treated with ustekinumab were significantly more persistent while on the labeled maintenance dose, including persistent while corticosteroid-free and while on monotherapy versus patients treated with adalimumab. Findings may help inform treatment strategies for ADT-experienced 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