全球首发︱保妥适治疗咬肌肥大/突出III期重复治疗研究数据
2023年12月7日，第十八届中国医师协会皮肤科医师年会暨全国美容皮肤科学大会（CDA），上海，中国
 
大会要点
 
两篇摘要：《保妥适重复给药治疗咬肌突出的有效性和安全性：一项Ⅲ期多地区研究的结果》《保妥适重复给药治疗咬肌突出的患者自评结局：一项Ⅲ期多地区研究的结果》均被CDA大会录用为电子壁报。
 
 
 
摘要重点
 
  • 咬肌的功能是延展和提升用于咀嚼的下颌骨。咬肌肥大/突出可能表现为下面部变宽，这是偏好较窄下面部形态个体的美容顾虑。向咬肌注射onabotulinumtoxinA（onabotA）可以帮助减小咬肌的大小和实现理想的形状。
  • OnabotA 72 U可有效改善咬肌突出（MMP）问题，与初次治疗相比，OnabotA 72 U重复治疗咬肌突出的疗效更好。且受试者自评报告的MMP体征，社会心理影响和MMP相关治疗满意度进一步改善。
  • 在接受最多3次OnabotA72 U治疗的受试者中，在超过18个月的整个研究期间， OnabotA72 U治疗咬肌突出安全耐受性良好，重复治疗的事件发生率呈下降趋势。
 
 
和两篇摘要的中国作者吴艳教授进行了交流，吴艳教授表示：保妥适治疗MMP的III期研究中引入了重复治疗的研究设计更符合实际临床需求，解决了患者因为担心重复治疗的疗效和安全性的问题，从而有利于医生更好地和患者进行术前沟通。在患者评估结局（PRO）重复治疗结果中我们可以看出，因为医美治疗的特殊性，临床上在与患者沟通中，我们不仅会关注治疗的疗效结局，同时更在意患者对疗效结果的满意感。  
临床试验达到的严苛的主要终点往往和实际求美者追求的美学效果是有差距的，而保妥适治疗MMP的PRO结果显示，患者既达到了治疗的目标，同时患者在下面部外观，社会心理和治疗满意度上都得到了提升，这和研究的疗效结果是一致的。从而全方位的证明了保妥适治疗MMP的效果。
     
 
Original Data Disclosure︱Phase III study of Botox in the repeat administration for treatment of Masseter Muscle Prominence (MMP)
7th December 2023，Chinese Dermatologist Association meeting（CDA），Shanghai，China
 
News
 
Two Abstracts :”Efficacy and Safety of Repeat Administration(s) of OnabotulinumtoxinA for the Treatment of Masseter Muscle Prominence: Results From a Phase 3 Multiregional Study”，”Patient-Reported Outcomes With Repeat Administration(s) of OnabotulinumtoxinA for the Treatment of Masseter Muscle Prominence: Results From a Phase 3 Multiregional Study》are accepted by CDA as e-poster.
 
 
 
Highlights
 
  • The masseter muscle functions to protract and elevate the mandible for mastication. Prominence of the masseter muscle can appear as a widened lower face, which is an aesthetic concern for individuals who prefer a narrower lower face shape. Compared with conservative approaches, BOTOX may produce a relatively rapid, predictable, and desired effect of reducing the size and shape of the masseter muscles
  • OnabotA 72 U can effectively improve the masseter muscle prominence (MMP) , OnabotA 72 U retreatment is more effective than the first treatment. Improvements in PRO measures were incrementally greater upon the first onabotA retreatment, and similar results were observed among subjects who received retreatment.
  • OnabotA demonstrated an acceptable safety profile with a trend toward lower incidence of events with repeat treatment throughout the study period of over 18 month.
 
 
After communicating with Professor Wu Yan, the Chinese author of the two abstracts. Professor Wu Yan said that the study design of repeated treatment introduced in the Phase III study of Botox treatment for MMP was more in line with the clinical practic needs, and solved the problem that patients were worried about the efficacy and safety of repeated treatment, helping doctors to better communicate with patients before iinjection.  
In the patient reported outcome (PRO) repeated treatment results, we coould see that because of the particularity of cosmetic area, in clinical communication with patients, we will not only pay attention to the outcome of treatment, but also pay more attention to patients' satisfactio. The rigorous primary endpoints achieved by clinical trials are sometimes different with the patient needs. However, the PRO results of Botox treatment of MMP show that patients not only achieve the treatment goal, but also improve the appearance of the lower face, social psychology and treatment satisfaction, which is consistent with the efficacy results of the study. The effect of botox on MMP was proved comprehensively.