Improvements in Submental Contour Up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials.

BACKGROUND ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week phase 3 studies (REFINE-1 and REFINE-2). OBJECTIVES To evaluate durability of effect and long-term safety of ATX-101. METHODS REFINE study patients with maintenance of ≥1-grade improvement on the Clinician-Reported SMF Rating Scale (CR-1 responders) 12 weeks after last REFINE treatment were eligible for enrollment in this multicenter, double-blind, nontreatment, long-term, follow-up study (NCT02163902). Primary endpoint was CR-1 response at years 1, 2, and 3. Patient-reported satisfaction, psychological impact, and adverse events were monitored. RESULTS 224 patients (ATX-101, n=113; placebo, n=111) were enrolled. Maintenance of CR-1 response was significantly better in the ATX-101 group versus placebo at year 1 (86.4%, 56.8%; P<.001), year 2 (90.6%, 73.8%; P=.014), and year 3 (82.4%, 65.0%; P=.03). Most (74%) ATX-101‒treated patients satisfied at 12 weeks remained satisfied at year 3. Significant reductions from baseline in psychological impact scores were sustained through year 3 (P<.001). No new treatment-related adverse events were reported. CONCLUSIONS Improvements in submental contour achieved with ATX-101 are maintained for 3 years in most patients. No new safety signals emerged.