SUPERIOR PERSISTENCE WHILE ON LABELED MAINTENANCE DOSE AMONG BIO-NAÏVE PATIENTS WITH CROHN'S DISEASE INITIATED ON USTEKINUMAB COMPARED TO ADALIMUMAB

Abstract

Abstract BACKGROUND Treatment of Crohn’s disease (CD) may require biologics. Dose escalation may be necessary to maintain efficacy, while adverse events or non-response may lead to treatment discontinuation. This analysis aimed to generate real-world evidence of persistence to ustekinumab versus adalimumab while on labeled maintenance dose (United States [US] prescribing information) among bio-naïve patients with CD in the US. METHODS Adults with CD initiated on ustekinumab or adalimumab from 09/23/2016 (approval of ustekinumab for CD in the US) to 08/01/2019 were selected from a de-identified health insurance claims database (IQVIA PharMetrics® Plus). Patients who used other biologics indicated for CD or had diagnoses for other autoimmune disorders in the 12 months before the initiation of the index agent (baseline) were excluded. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence to the index agent while on labeled maintenance dose was defined as (1) absence of gaps between days of therapy supply >120 days for ustekinumab (twice the 8-week on-label maintenance dosing interval) or >60 days for adalimumab (twice the mode of days of supply in claims) and (2) absence of any dose change during the maintenance phase relative to the dose per US label. It was assessed from the index date until the earliest of discontinuation (event), dose change during the maintenance phase (censoring), or the last day of index agent supply before the end of follow-up (censoring). Weighted Kaplan-Meier and Cox proportional hazards models were used to assess the outcome at 12 months post-index. RESULTS 948 bio-naïve patients with CD were included in the ustekinumab cohort (mean age 42.5 years old; 58.1% female) and 4,143 in the adalimumab cohort (mean age 42.3 years old; 56.7% female). During the baseline period, 8.4% and 9.2% previously had CD-related surgery, 66.6% and 67.7% used corticosteroids, and 25.9% and 26.3% used immunomodulators in the ustekinumab and adalimumab cohorts, respectively. At 12 months post-index, a higher proportion of patients in the ustekinumab cohort versus adalimumab cohort were persistent to the index biologic while on labeled maintenance dose (74.1% vs 65.4%; Fig. 1). Patients in the ustekinumab versus adalimumab cohort had a 47% higher rate of persistence while on labeled maintenance dose (hazard ratio [HR] 1.47; 95% confidence interval [CI]: 1.25-1.73; P-value: <0.001*). CONCLUSIONS Bio-naïve patients with CD initiated on ustekinumab were significantly more persistent while on labeled maintenance dose compared to patients initiated on adalimumab. These results are consistent with previous work, which demonstrated significantly higher persistence to the index agent and a trend of lower dose escalation rates among bio-naïve patients with CD initiating ustekinumab versus adalimumab.