DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 andSAKURA 2)
DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 andSAKURA 2)
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DOI：
10.1016/j.jaad.2019.06.1313
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发表时间：
2020-04-01
影响因子：
13.8
通讯作者：
Rubio, Roman G.
中科院分区：
文献类型：
--
作者：
Bertucci, Vince;Solish, Nowell;Rubio, Roman G.
背景：注射用A型肉毒杆菌毒素（DAXI）是一种正在临床开发的新型A型肉毒杆菌毒素。第2阶段的数据表明，它提供了一个更长的反应时间比onabotulinumtoxinA.Objective：为了进一步评估的有效性，反应的持续时间，和40 U DAXI的安全性与安慰剂相比，在治疗眉间line.Methods：两个相同的，多中心，随机，双盲，安慰剂对照，第3阶段的研究进行（NCT 03014622和NCT 03014635在www.clinicaltrials.gov）。中度或重度眉间皱纹的参与者被随机分配（2：1）接受40 U DAXI或安慰剂进入皱眉肌/降眉间肌。研究者和参与者评估了长达36周（>= 24周）的Glabellar线严重程度。结果：在609名参与者中（405名DAXI，204名安慰剂），92%完成。DAXI在降低眉间线严重程度方面比安慰剂显著更有效，并且在中位数为24.0周的时间内维持无眉间线或轻度眉间线严重程度。它也是一般耐受性良好的治疗相关的不良反应是最常见的头痛（6.4%对2.0%）和注射部位疼痛（3.7%对3.9%）。局限性：研究人群主要是女性和白色，只接受了一个单一的treatment.Conclusions：DAXI提供了一个眉间线减少反应的持续时间延长，是耐受性良好。
Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A in clinical development. Phase 2 data have shown it offers a more prolonged duration of response than onabotulinumtoxinA.Objective: To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines.Methods: Two identical, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies were performed (NCT03014622 and NCT03014635 on www.clinicaltrials.gov). Participants with moderate or severe glabellar lines were randomly assigned (2:1) to receive 40 U DAXI or placebo into the corrugator/procerus muscles. Glabellar line severity was assessed by investigators and participants for up to 36 weeks (>= 24 weeks).Results: Among 609 participants enrolled (405 DAXI, 204 placebo), 92% completed. DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks. It was also generally well tolerated-treatment-related adverse effects were most commonly headache (6.4% vs 2.0%) and injection site pain (3.7% vs 3.9%).Limitations: The study population was predominantly female and white and received only a single treatment.Conclusions: DAXI offers a prolonged duration of response for glabellar line reduction and is well tolerated.