University of British Columbia, Vancouver, British Columbia, Canada; Carruthers & Humphrey, Vancouver, British Columbia, Canada.
University of California, Davis, Sacramento, California.
J Am Acad Dermatol. 2016 Oct;75(4):788-797.e7. doi: 10.1016/j.jaad.2016.04.028. Epub 2016 Jul 16.
ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat.
We sought to evaluate the efficacy and safety of ATX-101.
In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging-based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes.
Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site.
Follow-up was limited to 44 weeks.
ATX-101 is an alternative treatment for SMF reduction.
ATX-101 是一种可注射的脱氧胆酸形式，当皮下注射到脂肪中时会导致脂肪细胞溶解。
我们旨在评估 ATX-101 的疗效和安全性。
在这项 III 期试验（REFINE-2）中，对中度或重度颏下脂肪（SMF）不满意的成年人被随机分配到 ATX-101 或安慰剂组。主要终点为末次治疗后 12 周时，Clinician- 和 Patient-Reported SMF 评分量表均观察到 1 个或多个等级以及 2 个或更多等级的 SMF 复合改善。其他终点包括基于磁共振成像的颏下体积评估、SMF 对心理影响的评估以及其他患者报告的结果。
在接受 ATX-101 或安慰剂治疗的患者中（n=258/治疗组），分别有 66.5%和 22.2%达到 SMF 的 1 个或多个等级的复合改善（Mantel-Haenszel 风险比 2.98；95%置信区间 2.31-3.85），18.6%和 3.0%达到 2 个或更多等级的复合改善（Mantel-Haenszel 风险比 6.27；95%置信区间 2.91-13.52；均<.001）。接受 ATX-101 治疗的患者更有可能通过磁共振成像确认颏下体积减少，更显著降低 SMF 的心理影响，以及对治疗的满意度（均<.001）。总体而言，ATX-101 组的不良事件中有 85.7%和安慰剂组的 76.9%发生在注射部位。
随访时间限于 44 周。
ATX-101 是减少 SMF 的一种替代治疗方法。
