clinical assistant professor, Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.
plastic surgeon in private practice in Greenwood Village, CO, USA.
Aesthet Surg J. 2021 Oct 15;41(11):NP1532-NP1539. doi: 10.1093/asj/sjab100.
ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week Phase 3 studies (REFINE-1 and REFINE-2).
The aim of this study was to evaluate the durability of effect and long-term safety of ATX-101.
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.
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.
Improvements in submental contour achieved with ATX-101 are maintained for 3 years in most patients. No new safety signals emerged.
在两项为期 24 周的 3 期研究（REFINE-1 和 REFINE-2）中，ATX-101（脱氧胆酸）显著降低了颏下脂肪（SMF）的严重程度。
本研究旨在评估 ATX-101 的疗效持久性和长期安全性。
在 REFINE 研究中，在最后一次 REFINE 治疗后 12 周，Clinician-Reported SMF Rating Scale（CR-1）评分至少改善 1 级的患者（CR-1 应答者）有资格参加这项多中心、双盲、非治疗、长期随访研究（NCT02163902）。主要终点为第 1、2 和 3 年的 CR-1 应答。监测患者报告的满意度、心理影响和不良事件。
共有 224 名患者（ATX-101 组，n=113；安慰剂组，n=111）入组。ATX-101 组的 CR-1 应答在第 1 年（86.4%比 56.8%；P<0.001）、第 2 年（90.6%比 73.8%；P=0.014）和第 3 年（82.4%比 65.0%；P=0.03）的维持率明显优于安慰剂组。在第 12 周时，74%的 ATX-101 治疗患者感到满意，其中大多数（74%）在第 3 年仍感到满意。心理影响评分从基线的显著降低在第 3 年持续存在（P<0.001）。未报告新的与治疗相关的不良事件。
大多数患者在使用 ATX-101 后颏下轮廓的改善可维持 3 年。未出现新的安全性信号。
