PHILADELPHIA — Real-life outcomes support the long-term effectiveness of tetrahydrocannabinol and cannabidiol (THC:CBD) to improve spasticity in patients with multiple sclerosis (MS) resistant to other medications. This research was presented at the 2019 American Academy of Neurology Annual Meeting, held May 4-10, in Philadelphia.
The investigators of this observational, prospective, multicenter study sought to evaluate real-life, long-term efficacy outcomes of THC:CBD oromucosal spray to treat a large population of Italian patients with treatment-resistant MS spasticity. Spasticity was assessed using a numerical rating scale (0-10) at baseline, 1 month, 6 months, 12 months, and 18 months after treatment initiation.
After one month, 1502 (81.4%) of 1845 patients achieved ≥20% improvement in numerical rating scale for spasticity and 814 (40.2%) achieved ≥30% improvement. The mean reduction in spasticity scores was 28.9% at month 1 and 36.8% at month 18. A total of 727 (39.4%) participants discontinued treatment: 388 reported a lack of effectiveness whereas 339 experienced adverse events. The most frequently reported adverse events were vertigo (37.5%), sleepiness (34.8%), worsening of fatigue (28.3%), and cognitive symptoms (15.9%). In multivariate analysis, patients with a higher baseline spasticity score (odds ratio 2.21; 95% CI, 1.12-6.28; P <.01) or a greater change in scores between baseline and month 1 (odds ratio 2.03; 95% CI, 1.04-8.14; P <.05) were twice as likely to maintain therapy beyond 18 months.
The investigators suggest these results confirm the effectiveness of THC:CBD therapy to reduce treatment-resistant MS spasticity and sustain improvement for 18 months.
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Patti F, Chisari C, D’Amico E, et al. Long-term effectiveness of 9-δ-tetrahydrocannabinol:cannabidiol oromucosal spray in clinical practice: results from a 18-months multicenter Italian study. Poster presented at: 2019 American Academy of Neurology Annual Meeting; May 9, 2019; Philadelphia, PA.
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