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Observational Study
. 2016 Sep;87(9):944-51.
doi: 10.1136/jnnp-2015-312591. Epub 2016 May 9.

Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

F Patti  1 , S Messina  1 , C Solaro  2 , M P Amato  3 , R Bergamaschi  4 , S Bonavita  5 , R Bruno Bossio  6 , V Brescia Morra  7 , G F Costantino  8 , P Cavalla  9 , D Centonze  10 , G Comi  11 , S Cottone  12 , M Danni  13 , A Francia  14 , A Gajofatto  15 , C Gasperini  16 , A Ghezzi  17 , A Iudice  18 , G Lus  19 , G T Maniscalco  20 , M G Marrosu  21 , M Matta  22 , M Mirabella  23 , E Montanari  24 , C Pozzilli  25 , M Rovaris  26 , E Sessa  27 , D Spitaleri  28 , M Trojano  29 , P Valentino  30 , M Zappia  1 ; SA.FE. study group
Collaborators, Affiliations
Observational Study

Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

F Patti et al. J Neurol Neurosurg Psychiatry. 2016 Sep.

Abstract

Background: The approval of 9-δ-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex) for the management of treatment-resistant multiple sclerosis (MS) spasticity opened a new opportunity for many patients. The aim of our study was to describe Sativex effectiveness and adverse events profile in a large population of Italian patients with MS in the daily practice setting.

Methods: We collected data of all patients starting Sativex between January 2014 and February 2015 from the mandatory Italian medicines agency (AIFA) e-registry. Spasticity assessment by the 0-10 numerical rating scale (NRS) scale is available at baseline, after 1 month of treatment (trial period), and at 3 and 6 months.

Results: A total of 1615 patients were recruited from 30 MS centres across Italy. After one treatment month (trial period), we found 70.5% of patients reaching a ≥20% improvement (initial response, IR) and 28.2% who had already reached a ≥30% improvement (clinically relevant response, CRR), with a mean NRS score reduction of 22.6% (from 7.5 to 5.8). After a multivariate analysis, we found an increased probability to reach IR at the first month among patients with primary and secondary progressive MS, (n=1169, OR 1.4 95% CI 1.04 to 1.9, p=0.025) and among patients with >8 NRS score at baseline (OR 1.8 95% CI 1.3-2.4 p<0.001). During the 6 months observation period, 631(39.5%) patients discontinued treatment. The main reasons for discontinuation were lack of effectiveness (n=375, 26.2%) and/or adverse events (n=268, 18.7%).

Conclusions: Sativex can be a useful and safe option for patients with MS with moderate to severe spasticity resistant to common antispastic drugs.

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Figures

Figure 1
Figure 1
Patient flow chart. *Data not available at the specific time point.
Figure 2
Figure 2
Multiple sclerosis spasticity NRS evolution between T0 and T1. NRS, numerical rating scale.
Figure 3
Figure 3
Multiple sclerosis spasticity NRS evolution between T0 and T3. NRS, numerical rating scale.
See this image and copyright information in PMC

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