A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.
A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.
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DOI：
10.1097/dss.0000000000002463
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发表时间：
2021-01-01
期刊：
影响因子：
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通讯作者：
Rubio RG
中科院分区：
文献类型：
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作者：
Green JB;Mariwalla K;Coleman K;Ablon G;Weinkle SH;Gallagher CJ;Vitarella D;Rubio RG
补充数字内容可在正文中找到。Sakura 3是注射用大西肉毒毒素A(Daxi)的3期开放标签重复给药安全性研究；Daxi是最大的眉间美容神经调节剂3期临床开发计划的组成部分。目的：评价达喜(40U)治疗中重度眉毛皱纹的疗效。符合条件的受试者从安慰剂对照试验中滚转(n=477)或重新开始(n=2214)，并在最长84周内接受1至3次治疗。至少每4周评估一次安全性和有效性，直到36周(治疗1和2)和12周(治疗3)。部分受试者可在12周后撤退，如果眉间线条恢复到基线。报道了2691名受试者的安全结果，其中882人接受了第二次治疗，568人接受了第三次治疗。17.8%的受试者发生了与治疗相关的不良事件(AEs)，这些不良事件总体上是轻微的，可以缓解。没有严重的不良反应与治疗有关。眼睑下垂的发生率为0.9%。所有治疗的不良事件都是一致的，没有观察到新的安全信号。达喜在这项大型开放标签安全性研究中的安全性证实了关键3期试验的结果，为其整体安全性提供了保证。
Supplemental Digital Content is Available in the Text. SAKURA 3 was a Phase 3, open-label, repeat-dose safety study of DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 clinical development program of an aesthetic neuromodulator in glabellar lines. To evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines. Eligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 3 treatments over a maximum of 84 weeks. Safety and efficacy were evaluated at least every 4 weeks up to Week 36 (Treatments 1 and 2) and Week 12 (Treatment 3). Select subjects could be retreated after Week 12 if glabellar lines returned to baseline. Safety results are reported for 2,691 subjects, of which 882 received a second treatment and 568 a third. Treatment-related adverse events (AEs) occurred in 17.8% of subjects, which were generally mild and resolved. No serious AEs were treatment-related. Eyelid ptosis occurred in 0.9% of treatments. Adverse events were consistent across treatments and no new safety signals were observed. The safety of DAXI in this large open-label safety study confirms the findings from the pivotal Phase 3 trials, providing reassurance in its overall safety profile.