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

Shannon Humphrey, Joel L Cohen, Ashish C Bhatia, Lawrence J Green, Jeremy B Green, Beta Bowen, Shannon Humphrey, Joel L Cohen, Ashish C Bhatia, Lawrence J Green, Jeremy B Green, Beta Bowen

Abstract

Background: ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week Phase 3 studies (REFINE-1 and REFINE-2).

Objectives: The aim of this study was to evaluate the durability of effect and long-term safety of ATX-101.

Methods: REFINE study patients who maintained ≥1-grade improvement on the Clinician-Reported SMF Rating Scale (CR-1 responders) 12 weeks after their last REFINE treatment were eligible for enrollment in this multicenter, double-blind, nontreatment, long-term, follow-up study (NCT02163902). The primary endpoint was CR-1 response at Years 1, 2, and 3. Patient-reported satisfaction, psychological impact, and adverse events were monitored.

Results: In total, 224 patients (ATX-101, n = 113; placebo, n = 111) were enrolled. Maintenance of CR-1 response was significantly better in the ATX-101 group than in the placebo group at Year 1 (86.4% vs 56.8%; P < 0.001), Year 2 (90.6% vs 73.8%; P = 0.014), and Year 3 (82.4% vs 65.0%; P = 0.03). 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 < 0.001). 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.

© 2021 The Aesthetic Society.

Figures

Figure 1.
Figure 1.
Three-year durability of REFINE study response. Percentage of patients who had achieved a ≥1-grade improvement in SMF from baseline at 12 weeks after their last REFINE treatment and the percentage of responders who maintained the response for up to 3 years (long term) are shown: (A) clinician assessment via the CR-SMFRS (CR-1 response) at 12 weeks and long term; (B) patient assessment via the 5-point PR-SMFRS (PR-1 response) at 12 weeks and long term; and (C) composite CR-1/PR-1 response at 12 weeks and long term. *P < 0.001 for ATX-101 vs placebo; †P < 0.05 for ATX-101 vs placebo. CR-SMFRS, Clinician-Reported Submental Fat Rating Scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme); PR-SMFRS, Patient-Reported Submental Fat Rating Scale (0 = no chin fat, 1 = slight amount, 2 = moderate amount, 3 = large amount, 4 = very large amount); SMF, submental fat.
Figure 2.
Figure 2.
Three-year durability of REFINE study ≥2-grade CR-SMFRS response. Responses for the percentage of patients who had achieved a ≥2-grade improvement in SMF from baseline according to the CR-SMFRS (CR-2 response) are shown at 12 weeks and up to 3 years (long-term follow-up) after their last REFINE treatment. *P < 0.001 for ATX-101 vs placebo; †P < 0.05 for ATX-101 vs placebo. CR-SMFRS, Clinician-Reported SMF Rating Scale; SMF, submental fat.
Figure 3.
Figure 3.
Three-year durability of REFINE study patient satisfaction response. Patient-reported satisfaction with appearance of face and chin on the SSRS. SSRS responders reported a score of 4 (slightly satisfied), 5 (satisfied), or 6 (extremely satisfied). Percentage of patients who were SSRS responders at 12 weeks after their last REFINE treatment, and percentage of SSRS responders at 12 weeks who maintained response for up to 3 years during the long-term follow-up are shown. *P < 0.001 for ATX-101 vs placebo; †P < 0.05 for ATX-101 vs placebo. SSRS, Subject Self-Rating Scale (0 = extremely dissatisfied, 1 = dissatisfied, 2 = slightly dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = slightly satisfied, 5 = satisfied, 6 = extremely satisfied).
Figure 4.
Figure 4.
Three-year durability of REFINE study psychological impact of SMF response. Patient assessment of the psychological impact of SMF according to the PR-SMFIS at baseline, at 12 weeks after last treatment, and for up to 3 years of long-term follow-up are shown. *P < 0.001 for change from baseline with ATX-101 vs placebo. PR-SMFIS, Patient-Reported Submental Fat Impact Scale; SMF, submental fat; TSS, total scale score.

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