title: Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity.
abstract: 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.
  
  
  
  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.
  
  
  
  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%).
  
  
  
  Sativex can be a useful and safe option for patients with MS with moderate to severe spasticity resistant to common antispastic drugs.
authors.affiliation: Department of Medical, Surgical Science and Advanced Technology "GF Ingrassia", University of Catania, Catania, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Patti
authors.affiliation: Department of Medical, Surgical Science and Advanced Technology "GF Ingrassia", University of Catania, Catania, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Messina
authors.affiliation: Neurology Unit, Department Head and Neck, ASL3 Genova, Genova, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Solaro
authors.affiliation: Department NEUROFARBA, University of Florence, Florence, Italy.
authors.forename: M P
authors.initials: MP
authors.lastname: Amato
authors.affiliation: Department of Neurology, Neurology Institute C Mondino, Pavia, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Bergamaschi
authors.affiliation: I Clinic Neurology, II University of Naples, Naples, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Bonavita
authors.affiliation: Neurology Operating Unit, Multiple Sclerosis Center, Provincial Health Authority of Cosenza, Cosenza, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Bruno Bossio
authors.affiliation: Multiple Sclerosis Centre, University Federico II, Naples, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Brescia Morra
authors.affiliation: Demyelinating Diseases Centre, Foggia Hospital, Foggia, Italy.
authors.forename: G F
authors.initials: GF
authors.lastname: Costantino
authors.affiliation: Multiple Sclerosis Centre, S. Giovanni Battista, Molinette Hospital, Turin, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Cavalla
authors.affiliation: Department of Systems Medicine, Multiple Sclerosis Clinical and Research Center, Tor Vergata University, Rome, Italy Unit of Neurology and of Neurorehabilitation, IRCCS Neuromed, Pozzilli (IS), Italy.
authors.forename: D
authors.initials: D
authors.lastname: Centonze
authors.affiliation: Department of Neurology, San Raffaele Hospital, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Comi
authors.affiliation: Neuroimmunology Unit, Villa Sofia-Cervello Hospital, Palermo, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Cottone
authors.affiliation: Neurology Clinic, Ancona Hospital, Ancona, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Danni
authors.affiliation: Department Neurol Psich, Multiple Sclerosis Center, Sapienza University, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Francia
authors.affiliation: Multiple Sclerosis Centre, University of Verona, Verona, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Gajofatto
authors.affiliation: Neurology Division, San Camillo Hospital, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Gasperini
authors.affiliation: Multiple Sclerosis Centre, Sant'Antonio Abate Hospital, Gallarate, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Ghezzi
authors.affiliation: Multiple Sclerosis Centre, University Hospital Pisa, Pisa, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Iudice
authors.affiliation: Multiple Sclerosis Center, Second University of Naples, Naples, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Lus
authors.affiliation: Multiple Sclerosis Centre, Cardarelli Hospital, Naples, Italy.
authors.forename: G T
authors.initials: GT
authors.lastname: Maniscalco
authors.affiliation: Department of Medical Sciences, University of Cagliari, Cagliari, Italy.
authors.forename: M G
authors.initials: MG
authors.lastname: Marrosu
authors.affiliation: Multiple Sclerosis Centre (CRESM), San Luigi Gonzaga Hospital, Orbassano, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Matta
authors.affiliation: Multiple Sclerosis Centre, Cattolica University, Rome, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Mirabella
authors.affiliation: Multiple Sclerosis Centre, Vaio Hospital, Fidenza, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Montanari
authors.affiliation: Multiple Sclerosis Centre, S. Andrea Hospital, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Pozzilli
authors.affiliation: Multiple Sclerosis Centre, IRCCS Don Gnocchi Foundation, Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Rovaris
authors.affiliation: Multiple Sclerosis Centre, IRCCS-Bonino Pulejo Centre, Messina, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Sessa
authors.affiliation: Multiple Sclerosis Centre, San G. Moscati Hospital, Avellino, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Spitaleri
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro", Bari, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Trojano
authors.affiliation: Department of Medical Sciences, Institute of Neurology, University "Magna Graecia", Catanzaro, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Valentino
authors.affiliation: Department of Medical, Surgical Science and Advanced Technology "GF Ingrassia", University of Catania, Catania, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Zappia
mesh_terms: D000284:Administration, Oral; D002185:Cannabidiol; D013759:Dronabinol; D004338:Drug Combinations; D006801:Humans; D007558:Italy; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy*; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety
chemical_list: D004338:Drug Combinations; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols