RESUMO
Background: Nabiximols oromucosal spray (Sativex®) is an approved add-on treatment option for moderate-to-severe treatment-resistant multiple sclerosis (MS) spasticity. Materials & methods: 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. Results: 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. Conclusion: The study provides proof-of-concept that GAS methodology can be applied to MS management in daily practice.
Lay abstract Many people with multiple sclerosis (MS) have muscle stiffness in their arms and legs that hinders their ability to perform usual daily activities such as walking or using a smartphone. This study followed 21 people with MS to see whether adding nabiximols (Sativex®) spray to usual medications for muscle stiffness might help them to achieve goals (e.g., 'less fatigue', 'better walking') which had been selected individually as most important before starting treatment. After 3 months of treatment, the higher average score on the Goal Attainment Scale suggested that, overall, nabiximols can improve MS spasticity-related patient goals although outcomes varied considerably among patients. Patients also perceived improvements in muscle stiffness, other symptoms of MS and walking ability.