Effect of Nabiximols On Goal Attainment Scale Scores in Patients With treatment-resistant Multiple Sclerosis Spasticity

Abstract

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.

Keywords:

• goal attainment scale
• multiple sclerosis
• nabiximols
• Sativex^®
• spasticity

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at:www.tandfonline.com/doi/full/10.2217/nmt-2020-0060

Acknowledgments

The authors acknowledge and thank the involvement of all participating patients, the Charité Berlin MS clinic team and other recruiting investigators and centers: B Elias-Hamp (Hamburg), M Krause (Wolfrathshausen), G Reifscheider (Erbach) and H Schreiber and M Lang (Ulm).

Study implementation and statistical analysis were performed by the Clinical Research Organization, Winicker Norimed GmbH, Nuremberg, Germany.

Financial & competing interests disclosure

The study was sponsored by Almirall S.A. (Barcelona, Spain). F Paul has received honoraria for lecturing, and travel expenses for attending meetings from Guthy Jackson Foundation, Bayer, Biogen, Merck Serono, Sanofi Genzyme, Novartis, Alexion, Viela Bio, Roche, UCB, Mitsubishi Tanabe and Celgene. His research is funded by the German Ministry for Education and Research (BMBF), Deutsche Forschungsgemeinschaft (DFG), Einstein Foundation, Guthy Jackson Charitable Foundation, EU FP7 Framework Program, Biogen, Genzyme, Merck Serono, Novartis, Bayer, Alexion, Roche, Parexel and Almirall. C Vila is a fulltime employee of Almirall S.A. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance for this article was provided by Rob Furlong and Kerry Dechant on behalf of Content Ed Net (Madrid, Spain) with funding from Almirall S.A. (Barcelona, Spain).

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.