Experimental & Clinical Research Center & NeuroCure Clinical Research Center, Max Delbrueck Center for Molecular Medicine & Charité-Universitätsmedizin Berlin, Berlin, Germany.
Global Medical Affairs, Almirall S.A., Barcelona, Spain.
Neurodegener Dis Manag. 2021 Apr;11(2):143-153. doi: 10.2217/nmt-2020-0060. Epub 2021 Mar 1.
Nabiximols oromucosal spray (Sativex) is an approved add-on treatment option for moderate-to-severe treatment-resistant multiple sclerosis (MS) spasticity. This prospective, observational, noninterventional, 3-month follow-up pilot study assessed the evolution of patient-selected goal attainment scale (GAS) item scores and of MS spasticity and associated symptoms during nabiximols treatment. In the full analysis set (n = 21), the mean (SD) overall unweighted GAS score increased from 32.1 (3.4) at baseline to 43.6 (14.6) at month 3 (p = 0.0060), constituting a clinically meaningful change. Slight improvements were observed in MS spasticity and most associated symptoms. Nabiximols improved walking ability and was well tolerated. The study provides proof-of-concept that GAS methodology can be applied to MS management in daily practice.
那比非司特口腔喷雾剂(Sativex)是一种已获批的附加治疗选择,适用于中度至重度治疗抵抗性多发性硬化症(MS)痉挛。这项前瞻性、观察性、非干预性、为期 3 个月的随访性先导研究评估了患者选择的目标实现量表(GAS)项目评分的演变,以及那比非司特治疗期间 MS 痉挛和相关症状的演变。在全分析集(n=21)中,整体未加权 GAS 评分从基线时的 32.1(3.4)平均值增加到第 3 个月时的 43.6(14.6)(p=0.0060),构成了有临床意义的变化。MS 痉挛和大多数相关症状也观察到了轻微改善。那比非司特改善了行走能力,且耐受性良好。该研究提供了概念验证,证明 GAS 方法可应用于日常实践中的 MS 管理。