Department of Neurology, Heinrich Heine University Düsseldorf, Düsseldorf, 40225, Germany.
O. Meany Consultancy GmbH, Hamburg, 22339, Germany.
Neurodegener Dis Manag. 2024 Feb;14(1):11-20. doi: 10.2217/nmt-2023-0040. Epub 2024 Feb 6.
This prospective, multicenter, open-label, noninterventional 12-week study investigated the effectiveness and tolerability of add-on nabiximols oromucosal spray (Sativex) in the real-world setting in Germany. The main analysis set comprised 51 adult patients (49 nabiximols responders) with multiple sclerosis (MS) spasticity. The mean overall goal attainment scale score (primary outcome measure) increased by 46% from baseline to week 12 (35.2 vs 51.4; p < 0.001). Mean gait speed was improved by 23% at 4 and 12 weeks. Clinically meaningful improvements in mean 0-10 numerical rating scale scores for spasticity, pain, sleep quality and urinary bladder dysfunction were recorded at 4 and 12 weeks. Nabiximols is a useful therapeutic option for patients with MS spasticity.
这项前瞻性、多中心、开放性、非干预性的 12 周研究，旨在调查纳比昔单抗口腔喷雾剂（Sativex）在德国真实环境中的附加治疗效果和耐受性。主要分析集包含 51 名多发性硬化症（MS）痉挛成年患者（49 名纳比昔单抗应答者）。总体目标达成量表评分（主要观察指标）从基线到第 12 周增加了 46%（35.2 比 51.4；p<0.001）。在 4 周和 12 周时，步态速度分别提高了 23%。痉挛、疼痛、睡眠质量和膀胱功能障碍的 0-10 数字评分量表的平均评分在第 4 周和第 12 周均有显著改善，具有临床意义。纳比昔单抗是治疗多发性硬化症痉挛患者的有效治疗选择。
