J Drugs Dermatol. 2021 Sep 1;20(9):980-987. doi: 10.36849/jdd.6263.
To evaluate the efficacy and safety of AbobotulinumtoxinA (ABO) dose escalation in the correction of moderate-to-severe glabellar lines.
Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study.
Adults with moderate-to-severe glabellar lines received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Primary endpoint was week 4 composite ≥2-grade responder rate among those achieving a severity score of 0 (none) or 1 (mild) at maximum frown, evaluated using concurrent investigator and subject assessments. Secondary endpoints included ≥1-grade severity improvement, duration of effect, and reporting of treatment-emergent adverse events (TEAEs).
Overall, 399 subjects were included (88.2% were female). Week 4 composite ≥2-grade ABO responder rate was 80.0% (50 U), 88.8% (75 U), 90.0% (100 U) and 95.1% (125 U), versus 2.6% with placebo (P<0.001). Responder rate (≥1-grade) ranged between 53% (50 U) and 69% (125 U) at week 24 and between 18% (50 U) and 31% (125 U) at week 36. Median time (weeks) to return to baseline severity/worse, among those scoring 0 (none) or 1 (mild), was 32.3 (50 U), 34.3 (75 U), 36.0 (100 U) and 36.6 (125 U), versus 23.7 (placebo). ABO-related TEAEs were reported in 4% of subjects (80% were mild). No seroconversion to ABO neutralizing antibodies was seen.
A single ABO treatment provided rapid and effective improvements in glabellar line severity at all doses. Higher doses tended to demonstrate elevated response rates and longer duration of effect. All ABO doses were well-tolerated with low TEAE incidence. J Drugs Dermatol. 2021;20(9):980-987. doi:10.36849/JDD.6263.
评估阿博特菌素 A（ABO）剂量递增在矫正中度至重度眉间纹中的疗效和安全性。
2 期、36 周、多中心、随机、剂量范围、双盲、安慰剂对照研究。
患有中度至重度眉间纹的成年人接受单次 ABO 治疗，剂量为 50、75、100 或 125U，或安慰剂。主要终点是在最大皱眉时达到 0（无）或 1（轻度）严重程度评分的患者中，治疗后第 4 周复合 ≥2 级应答率，采用同期研究者和患者评估进行评估。次要终点包括 ≥1 级严重程度改善、疗效持续时间和治疗中出现的不良事件（TEAE）报告。
共有 399 名受试者（88.2%为女性）纳入研究。第 4 周复合 ABO ≥2 级应答率分别为 80.0%（50U）、88.8%（75U）、90.0%（100U）和 95.1%（125U），而安慰剂组为 2.6%（P<0.001）。第 24 周和第 36 周时，24 周时应答率（≥1 级）范围在 53%（50U）至 69%（125U）之间，36 周时应答率（≥1 级）范围在 18%（50U）至 31%（125U）之间。对于评分 0（无）或 1（轻度）的患者，中位数（周）恢复到基线严重程度/更差的时间分别为 32.3（50U）、34.3（75U）、36.0（100U）和 36.6（125U），而安慰剂组为 23.7（P<0.001）。在 4%的受试者中报告了 ABO 相关 TEAEs（80%为轻度）。未发现 ABO 中和抗体的血清转化。
单次 ABO 治疗可迅速有效改善眉间纹严重程度，各剂量均有效。较高剂量往往显示出更高的应答率和更长的疗效持续时间。所有 ABO 剂量的不良反应发生率均较低，耐受性良好。J 皮肤病学杂志。2021；20（9）：980-987。doi：10.36849/JDD.6263.
