PT  - JOURNAL ARTICLE
AU  - F Patti
AU  - S Messina
AU  - C Solaro
AU  - M P Amato
AU  - R Bergamaschi
AU  - S Bonavita
AU  - R Bruno Bossio
AU  - V Brescia Morra
AU  - G F Costantino
AU  - P Cavalla
AU  - D Centonze
AU  - G Comi
AU  - S Cottone
AU  - M Danni
AU  - A Francia
AU  - A Gajofatto
AU  - C Gasperini
AU  - A Ghezzi
AU  - A Iudice
AU  - G Lus
AU  - G T Maniscalco
AU  - M G Marrosu
AU  - M Matta
AU  - M Mirabella
AU  - E Montanari
AU  - C Pozzilli
AU  - M Rovaris
AU  - E Sessa
AU  - D Spitaleri
AU  - M Trojano
AU  - P Valentino
AU  - M Zappia
TI  - Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity
AID  - 10.1136/jnnp-2015-312591
DP  - 2016 Sep 01
TA  - Journal of Neurology, Neurosurgery & Psychiatry
PG  - 944--951
VI  - 87
IP  - 9
4099  - http://jnnp.bmj.com/content/87/9/944.short
4100  - http://jnnp.bmj.com/content/87/9/944.full
SO  - J Neurol Neurosurg Psychiatry2016 Sep 01; 87
AB  - 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.