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.
Keywords: Sativex®; goal attainment scale; multiple sclerosis; nabiximols; spasticity.
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.