title: Efficacy and safety of nabiximols (Sativex(®)) on multiple sclerosis spasticity in a real-life Italian monocentric study.
abstract: Multiple sclerosis (MS) patients frequently suffer from limb spasticity and pain despite antispastic treatments. To investigate nabiximols efficacy and safety in a real-world monocentric Italian cohort, the following data were collected at baseline, week 4, 14 and 48: Ambulation Index (AI), 10-min walking test (10MWT), combined Modified Ashworth scale (cMAS), scores at numerical rating scale for spasticity (sNRS) and pain (pNRS). Responder status was defined as a ≥20 % reduction in sNRS after 4 weeks of treatment. 144 MS patients (123 progressive and 21 relapsing-remitting) complaining of moderate-to-severe spasticity (mean sNRS: 7.5) were included: 138 (95.8 %) completed the first month of therapy and were classified as follows-23.2 % were non-responders, 5.1 % were responders but discontinued treatment due to side effects, 71.7 % were responders with a mean 32 % reduction in sNRS (p < 0.001). In responders sNRS further decreased between 4 and 14 weeks (p = 0.03). Similarly, pNRS improvement was seen during the first month and between 4 and 14 weeks (p < 0.001 and p = 0.004, respectively). Moreover, at 4 weeks responders showed a significant (p < 0.05) improvement in cMAS, AI and 10MWT, which was maintained at 14 weeks. At 1-year follow-up, a benefit was still evident on spasticity and painful symptoms with a low drop-out rate. Confusion/ideomotor slowing, fatigue and dizziness were the most frequent side effects; no major adverse events were reported. Shorter disease duration at treatment start was associated with better response. This real-world study confirms nabiximols efficacy and safety in the treatment of MS-related spasticity and pain, which is maintained up to 48 weeks.
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.|Laboratory of Genetics of Complex Neurological Disorders, Institute of Experimental Neurology (INSPE), Division of Neuroscience, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Ferrè
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.|Experimental Neurophysiology Unit, Institute of Experimental Neurology (INSPE), San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Arturo
authors.initials: A
authors.lastname: Nuara
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Pavan
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Radaelli
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Moiola
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.
authors.forename: Mariaemma
authors.initials: M
authors.lastname: Rodegher
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Colombo
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.|Laboratory of Genetics of Complex Neurological Disorders, Institute of Experimental Neurology (INSPE), Division of Neuroscience, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Ignacio Juan
authors.initials: IJ
authors.lastname: Keller Sarmiento
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Martinelli
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.|Experimental Neurophysiology Unit, Institute of Experimental Neurology (INSPE), San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Letizia
authors.initials: L
authors.lastname: Leocani
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy. martinelli.filippo@hsr.it.|Laboratory of Genetics of Complex Neurological Disorders, Institute of Experimental Neurology (INSPE), Division of Neuroscience, San Raffaele Scientific Institute, Milan, Italy. martinelli.filippo@hsr.it.
authors.forename: Filippo
authors.initials: F
authors.lastname: Martinelli Boneschi
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy. esposito.federica@hsr.it.|Laboratory of Genetics of Complex Neurological Disorders, Institute of Experimental Neurology (INSPE), Division of Neuroscience, San Raffaele Scientific Institute, Milan, Italy. esposito.federica@hsr.it.
authors.forename: Federica
authors.initials: F
authors.lastname: Esposito
mesh_terms: D000328:Adult; D002185:Cannabidiol / Q000009:adverse effects* / Q000627:therapeutic use*; D015331:Cohort Studies; D013759:Dronabinol / Q000009:adverse effects* / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications*; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols
keywords: Multiple sclerosis; Nabiximols; Pain; Spasticity