Department of Physical Medicine and Rehabilitation, MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA.
Physical and Rehabilitation Medicine Department, Cliniques universitaires Saint-Luc, Catholic University of Louvain, Brussels, Belgium.
PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.
To examine the safety and efficacy of abobotulinumtoxinA in patients previously treated with botulinum toxin type A (BoNT-A) products other than abobotulinumtoxinA.
Secondary analysis from a phase 3, double-blind, single-cycle, randomized, placebo-controlled study.
Fifty-two centers (11 countries).
Adults with spastic hemiparesis were randomized (1:1:1) to receive abobotulinumtoxinA 1000 U, 1500 U, or placebo in their affected lower limb.
Muscle tone (6-point Modified Ashworth Scale [MAS], 0-5) for the gastrocnemius-soleus complex (GSC); proportion of MAS responders (≥1-point improvement); angle of catch (X ) and spasticity grade (Y) for the GSC and soleus. Assessments were at weeks 1, 4, and 12 post-injection. Only descriptive statistics are presented.
Of 388 patients, 84 received previous BoNT-A treatment (abobotulinumtoxinA 1000 U: N = 30; abobotulinumtoxinA 1500 U: N = 28; placebo: N = 26). At week 4, mean (SD) changes in MAS score in the GSC were - 0.8 (1.1), -0.9 (1.0), and - 0.4 (0.7) for abobotulinumtoxinA 1000 U, 1500 U, and placebo, respectively. Greater MAS responder rates were observed for abobotulinumtoxinA versus placebo at all time points. Mean (SD) changes (week 4) for abobotulinumtoxinA 1000 U, 1500 U, and placebo for X were: GSC, 8° (21), 6° (10) and 1° (7); soleus, 11° (21), 5° (9) and 0° (8), respectively; for Y: GSC, -0.4 (0.7), -0.6 (0.8) and - 0.0 (0.9); soleus, -0.5 (0.7), -0.5 (0.7) and - 0.1 (0.6), respectively. Safety data and adverse events were consistent with the overall known profile of abobotulinumtoxinA.
Patients previously treated with other BoNT-As showed improved muscle tone and spasticity at week 4 following abobotulinumtoxinA injection versus placebo. These findings suggest that abobotulinumtoxinA, at the recommended doses, has a good safety and efficacy profile in adults with lower limb spasticity who were previously treated with other BoNT-A products.
评估先前使用过除 abobotulinumtoxinA 以外的肉毒毒素 A 产品（BoNT-A）的患者使用 abobotulinumtoxinA 的安全性和疗效。
一项 3 期、双盲、单周期、随机、安慰剂对照研究的二次分析。
52 个中心（11 个国家）。
患有痉挛性偏瘫的成年人按 1:1:1 的比例随机（分配）接受受累下肢注射 abobotulinumtoxinA 1000 U、1500 U 或安慰剂。
比目鱼肌-腓肠肌复合体（GSC）的肌肉张力（6 点改良 Ashworth 量表[MAS]，0-5）；MAS 应答者（≥1 点改善）的比例；GSC 和比目鱼肌的捕捉角（X）和痉挛程度（Y）。评估在注射后第 1、4 和 12 周进行。仅呈现描述性统计数据。
在 388 名患者中，84 名患者先前接受过 BoNT-A 治疗（abobotulinumtoxinA 1000 U：N=30；abobotulinumtoxinA 1500 U：N=28；安慰剂：N=26）。在第 4 周时，GSC 中 MAS 评分的平均（SD）变化分别为 abobotulinumtoxinA 1000 U、1500 U 和安慰剂组为-0.8（1.1）、-0.9（1.0）和-0.4（0.7）。与安慰剂相比，abobotulinumtoxinA 在所有时间点均显示出更高的 MAS 应答率。GSC 中 abobotulinumtoxinA 1000 U、1500 U 和安慰剂在第 4 周时 X 的平均（SD）变化分别为：8°（21）、6°（10）和 1°（7）；比目鱼肌，11°（21）、5°（9）和 0°（8）；Y 的平均（SD）变化分别为：GSC，-0.4（0.7）、-0.6（0.8）和-0.0（0.9）；比目鱼肌，-0.5（0.7）、-0.5（0.7）和-0.1（0.6）。安全性数据和不良事件与 abobotulinumtoxinA 的整体已知特征一致。
与安慰剂相比，先前使用过其他 BoNT-A 的患者在接受 abobotulinumtoxinA 注射后的第 4 周时肌肉张力和痉挛程度得到改善。这些发现表明，在先前使用过其他 BoNT-A 产品的下肢痉挛成年人中，abobotulinumtoxinA 在推荐剂量下具有良好的安全性和疗效。
