【 文献重点摘要 】

Background

Unwanted submental fat (SMF) may result in an unattractive chin profile and dissatisfaction with appearance. An approved and rigorously tested non-surgical method for SMF reduction is lacking.

Objective

To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized, double-blind, placebo-controlled study.

Methods

Patients (n = 360) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm2 or placebo injected into their SMF for up to four treatments ~28 days apart, with a 12-week follow-up. Coprimary efficacy endpoints were the proportions of treatment responders, defined as a ≥1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS), and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale (SSRS score ≥4). Secondary efficacy endpoints included a ≥1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and changes in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded. Adverse events (AEs) and laboratory test results were monitored.

Results

Compared with placebo, a greater proportion of patients treated with ATX-101 1 and 2 mg/cm2 showed a ≥1-point improvement in CR-SMFRS (58.3% and 62.3%, respectively, vs. 34.5% with placebo; P < 0.001) and patient satisfaction (SSRS score ≥4) with the appearance of their face and chin (68.3% and 64.8%, respectively, vs. 29.3%; P < 0.001). Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity (PR-SMFRS; P = 0.009 for ATX-101 1 mg/cm2, P < 0.001 for ATX-101 2 mg/cm2 vs. placebo) and emotions and perceived self-image (PR-SMFIS; P < 0.001). No overall worsening of skin laxity was observed. AEs were mostly transient, mild to moderate in intensity and localized to the treatment area.

Conclusion

ATX-101 was effective and well tolerated, and may be an alternative to surgery for patients desiring improvement of their submental profile.

背景

多余的颏下脂肪(SMF)可能会导致不美观的下巴轮廓和对外观的不满意。缺少一种经批准和严格测试的非手术SMF复位方法。

目的

在一项三期随机、双盲、安慰剂对照研究中，评价ATX-101对药物减少不需要的SMF的疗效和安全性。

方法

将360例中、重度SMF病患者随机分为两组，分别接受ATX-101 1或2 mg/cm2或安慰剂注射至SMF，间隔28天，共4次治疗，随访12周。主要疗效终点是治疗应答者的比例，在临床医生报告的颏下脂肪评分量表(CR-SMFRS)中定义为SMF减少≥1分，在受试者自我评分量表(SSRS评分≥4)中定义为治疗后对其面部和颏部外观满意的比例。次要疗效终点包括在SMF患者报告的颏下脂肪分级量表(PR-SMFRS)中≥1分的改善和患者报告的颏下脂肪影响量表(PR-SMFIS)的变化。记录了额外的患者报告结果和皮肤松弛评分量表的变化。监测不良事件和实验室检测结果。

结果

与安慰剂相比，接受ATX-101 1和2 mg/cm2治疗的患者中，有更大比例的患者的认知-心理-行为反应评分改善≥1分(分别为58.3%和62.3%，而安慰剂组为34.5%；P < 0.001)和患者对其面部和下巴外观的满意度(SSRS评分≥4分)(分别为68.3%和64.8%，对29.3%；P < 0.001)。患者报告的次要疗效终点显示SMF严重程度有显著改善。ATX-101 1毫克/平方厘米时P = 0.009，ATX-101 2毫克/平方厘米时P < 0.001，与安慰剂相比)，以及情绪和感知自我形象(PR-SMFIS；P < 0.001)。没有观察到皮肤松弛的整体恶化。不良事件大多是暂时性的，轻度至中度，局限于治疗区域。

结论

ATX-101有效且耐受性好，对于希望改善颏下外形的患者，可作为手术的替代方案。