Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Pediatric Upper and Lower Limb Spasticity: Results From 2 Open-Label, Long-term Extension Trials.

IF 2 4区医学 Q3 CLINICAL NEUROLOGY

Journal of Child Neurology Pub Date : 2024-12-23 DOI:10.1177/08830738241288431

Mark Gormley, Darcy Fehlings, Heakyung Kim, Marcin Bonikowski, Marta Banach, Fatma Gul, Jill Meilahn, Brad Racette, Nuoyu Huang, Xiaomeng Niu, Lynn M James, Rozalina Dimitrova

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引用次数: 0

Abstract

Aim: To evaluate the efficacy and safety of onabotulinumtoxinA for treating upper and lower limb spasticity among pediatric patients in 2 open-label extension trials.

Methods: Patients aged <18 years received ≤5 doses of onabotulinumtoxinA (maximum: 8 U/kg [300 U], cycle 1; 10 U/kg [340 U], cycles 2-5) over 60 weeks. Week 6 efficacy endpoints included mean change from baseline in Modified Ashworth Scale-Bohannon and Modified Tardieu Scale scores, and mean Clinical Global Impression of Overall Change score. Adverse events and laboratory assessments of bone health were monitored.

Results: A total of 580 patients received onabotulinumtoxinA. Modified Ashworth Scale-Bohannon change from baseline ranged from -1.01 to -1.9. Modified Tardieu Scale change from baseline was 13.6 to 18.1 (ankle), 25.8 to 44.1 (elbow), and -5.0 to -26.3 (wrist). Clinical Global Impression of Overall Change scores were 1.5 to 2.2. The most common treatment-emergent adverse events were upper respiratory tract infection (16.9%) and nasopharyngitis (15.7%).

Interpretation: Repeat administration of onabotulinumtoxinA was safe and efficacious for treating upper and lower limb spasticity in children.

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onabotulintoxina治疗小儿上肢和下肢痉挛的疗效和安全性：来自2个开放标签、长期扩展试验的结果

目的：通过2项开放标签扩展试验，评价单肉毒杆菌毒素a治疗小儿上肢和下肢痉挛的疗效和安全性。结果：580例患者接受肉毒杆菌毒素治疗。修正Ashworth量表- bohannon从基线变化范围从-1.01到-1.9。改良Tardieu量表从基线变化为13.6至18.1（踝关节），25.8至44.1（肘关节），-5.0至-26.3（手腕）。临床总体印象评分在1.5到2.2之间。最常见的治疗不良事件是上呼吸道感染（16.9%）和鼻咽炎（15.7%）。解释：反复应用肉毒杆菌毒素a治疗儿童上肢和下肢痉挛是安全有效的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Child Neurology 医学-临床神经学

CiteScore

4.20

自引率

5.30%

发文量

111

审稿时长

3-6 weeks

期刊介绍： The Journal of Child Neurology (JCN) embraces peer-reviewed clinical and investigative studies from a wide-variety of neuroscience disciplines. Focusing on the needs of neurologic patients from birth to age 18 years, JCN covers topics ranging from assessment of new and changing therapies and procedures; diagnosis, evaluation, and management of neurologic, neuropsychiatric, and neurodevelopmental disorders; and pathophysiology of central nervous system diseases.