(P084) BIOLOGIC TREATMENT DE-ESCALATION IN PATIENTS WITH CROHN'S DISEASE IS COMMON IN THE UNITED STATES

Objectives: Chronic use of biologic agents is the mainstay for treating moderate to severe Crohn’s disease (CD), but many patients seek to stop biologics after achieving a sustained period of remission. European studies suggest that cycling biologic may be feasible, as selected patients regain remission with retreatment after relapse following biologic withdrawal. This study aimed to characterize and identify factors associated with biologic de-escalation in U.S. CD patients with stable disease.

METHODS: We performed a retrospective observational study using the Merative MarketScan Research Databases, a dataset of over 270 million patients, identifying adults with CD who were continuously treated with a biologic for ≥1 year and had stable disease (steroid-free, without CD-related hospitalizations, ER visits or surgeries) for ≥6 months from 2010-2020. After meeting eligibility, we started following for any biologic de-escalation, defined as a treatment gap >90 days between the last day of supply from the previous claim and the start of the next refill, with stable disease in the preceding 6 months. Patients were censored at biologic switching, disenrollment, or 12/31/2021, whichever occurred first. We used cause-specific hazard models to identify factors associated with de-escalation and assessed the cumulative incidence of re-treatment or switch among de-escalators.

RESULTS: The study included 8,393 patients with a mean age of 40.4 (SD: 15.8) years; females made up 48.9%. Adalimumab was the most common biologic (53%), followed by infliximab (37%), certolizumab (4%), vedolizumab (3%), ustekinumab (3%) and infliximab biosimilars (0.3%). Biologic de-escalation occurred in 17.4% (1,463) over a median follow-up of 14.1 months (IQR: 5.6, 26.6). The predictor of de-escalation was use of subcutaneous biologics (HR: 1.33; 95% CI: 1.19-1.49), while 1 year increase in age (HR: 0.99; 95% CI: 0.99-0.99), being enrolled into study since 2016 (HR: 0.65; 95% CI: 0.59-0.73), and prior IV steroid use (HR: 0.70; 95% CI: 0.61-0.80) reduced the likelihood. In a subgroup (n=2,327) of patients with available prescriber factors, prescriber being a gastroenterologist (HR: 1.35; 95% CI: 1.00-1.81) was the only positive predictor of de-escalation; older age as the only negative predictor. Among de-escalators, the cumulative incidence of re-treatment or switch was 48.1% at 1 year and 58.4% at 2 years post-biologic de-escalation.

CONCLUSIONS: Biologic de-escalation was not uncommon in CD patients with stable disease, and treatment outcomes among de-escalators were consistent with prior studies. Unlike smaller prospective studies focused on infliximab, this larger claims-based study included a diverse cohort, including non-infliximab-treated patients. Future comparative studies using this data will be valuable for U.S. providers and patients considering biologic de-escalation.