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

Abstract BACKGROUND In Crohn’s disease (CD), dose escalation on biologic therapy may be required to maintain effectiveness, while adverse events or non-response, among other factors, lead lack of persistence. Understanding persistence labeled maintenance is particularly important in bio-experienced patients with CD, as they have reduced response subsequent lines therapy. This analysis compared ustekinumab versus adalimumab the United States (US). METHODS Adults CD initiated (index date) between 09/23/2016 (ustekinumab approval for US) and 08/01/2019 were selected from IBM® MarketScan® Commercial Database. Patients (≥1 claim another CD-indicated 12 months baseline period pre-index date). auto-immune diseases at excluded. Cohorts balanced characteristics using inverse probability treatment weights. Persistence index agent was defined (1) no gaps days supply >120 (2 x 8-week on-label interval) >60 mode) (2) change relative US label dose. It assessed date until earliest discontinuation (event), during phase (censoring), last day (censoring). Weighted Kaplan-Meier Cox proportional hazards models adjusted classes biologics used assess outcome post-index. RESULTS 903 included cohort (mean age 40.9 years old; 57.1% female) 525 41.3; 56.3% female). During period, 71.1% 72.6% corticosteroids, 41.2% 40.8% immunomodulators, 11.1% 12.6% had a prior CD-related surgery, cohorts, respectively. At post-index, persisting higher (78.8% vs. 67.8%; Fig. 1). 71% rate (hazard ratio [HR] 1.71; 95% confidence interval: 1.31-2.23; P-value: <0.001*). CONCLUSIONS Bio-experienced significantly more persistent adalimumab. These results confirm study.