Nabiximols therapy reduced baseline spasticity symptoms in patients with multiple sclerosis (MS), a new study published in the European Journal of Neurology found. One-third of the studied patients maintained the treatment at 18 months.
“This study aimed to assess the relationship between changes in spasticity severity (measured on the 0-10 [numerical rating scale] and the presence of associated symptoms in patients treated with nabiximols; and to investigate the presence of the newly-described ‘Spasticity-Plus syndrome’,” the authors wrote.
“Overall, the analysis indicated that nabiximols responders can achieve a relevant and durable improvement in MS spasticity as well as resolution or improvement of many MS spasticity-associated symptoms at stable doses of around 6 sprays/day.”
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The research team conducted a retrospective, multicenter observational study to analyze data on 1138 adults in the Italian Medicines Agency (Agenzia Italiana del Farmaco) e-Registry with moderate to severe MS spasticity. At baseline, all had severe spasticity and moderately severe disability. They were treated with nabiximols for spasticity symptoms for up to 18 months, between January 2015 and June 2018.
During the 18-month study period, 633 patients discontinued the treatment due to ineffectiveness or adverse events. Approximately 35% of patients maintained treatment with nabiximols at 18 months. The average dose was 6.6 sprays per day, which decreased to 5.9 sprays at 18 months. After 4 weeks of treatment, the symptoms that resolved the most were spasms/cramps, clonic movements, and sleep disturbances. At 18 months, in those continuing with treatment, there was symptom resolution in spasms/cramps and mood disorders.
The authors note that the frequent clustering of spasticity, pain and spasms/cramps observed in their cohort and reported in the literature supports the notion of a “Spasticity-Plus syndrome,” which could be effectively treated with nabiximols therapy.
Patti F, Chisari CG, Fernández Ó, et al. A real-world evidence study of nabiximols in multiple sclerosis patients with resistant spasticity: analysis in relation to the newly-described ‘Spasticity-Plus syndrome’. Eur J Neurol. Published online May 19, 2022. doi:10.1111/ene.15412