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Multicenter, prospective, observational study aimed at evaluating SAtivex efFEcts (effectiveness and tolerability) in a large population of Italian multiple sclerosis patients: SA.FE. study
Author(s): ,
F. Patti
Affiliations:
University of Catania, Catania
,
S. Messina
Affiliations:
University of Catania, Catania
,
M.P. Amato
Affiliations:
Department NEUROFARBA, University of Florence, Florence
,
M.D. Benedetti
Affiliations:
University of Verona, Verona
,
R. Bergamaschi
Affiliations:
Fondazione Istituto Neurologico C. Mondino, Pavia
,
A. Bertolotto
Affiliations:
CRESM, Ospedale san Luigi Gonzaga, Orbassano
,
S. Bonavita
Affiliations:
I Clinc of Neurology, II University of Naples, Naples
,
R. Bruno Bossio
Affiliations:
Provincial Health Authority of Cosenza, Operating unit Neurology and Center Multiple Sclerosis, Cosenza
,
V. Brescia Morra
Affiliations:
University Federico II, Naples
,
P. Cavalla
Affiliations:
University of Torino, Torino
,
D. Centonze
Affiliations:
MS Clinical and Research Center, Tor Vergata University, Rome
,
G. Comi
Affiliations:
San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan
,
S. Cottone
Affiliations:
Multiple Sclerosis Center Department of Neurology, A.O.O.R. Villa Sofia-Cervello, Palermo
,
M. Danni
Affiliations:
Azienda Ospedali Riuniti, Ancona
,
A. Francia
Affiliations:
'Sapienza' University of Rome, Multiple Sclerosis Center Department Neurol. Psich., Rome
,
A. Fuiani
Affiliations:
University of Foggia, Foggia
,
C. Gasperini
Affiliations:
Ospedale San Camillo Forlanini, Rome
,
A. Ghezzi
Affiliations:
Ospedale S. Antonio Abate, Gallarate
,
A. Iudice
Affiliations:
Azienda Ospedaliero Universitaria Pisana, Pisa
,
G. Lus
Affiliations:
Department of Clinical and Experimental Medicine and Surgery 'F Magrassi e A Lanzara', Second University of Naples
,
G.T. Maniscalco
Affiliations:
Multiple Sclerosis Centre of AORN 'A. Cardarelli', Naples
,
M.G. Marrosu
Affiliations:
Department of Medical Sciences, University of Cagliari, Cagliari
,
M. Mirabella
Affiliations:
Università Cattolica del Sacro Cuore, Rome
,
E. Montanari
Affiliations:
Ospedale civile di Fidenza, Fidenza
,
C. Pozzilli
Affiliations:
Ospedale S. Andrea, Rome
,
M. Rovaris
Affiliations:
Multiple Sclerosis Center - Neurorehabilitation Unit Scientific Institute Santa Maria Nascente, Fondazione Don Carlo Gnocchi, Milan
,
E. Sessa
Affiliations:
IRCCS - Centro Neurolesi Bonino Pulejo, Messina
,
D. Spitaleri
Affiliations:
UOC Neurologia AORN San G. Moscati, Avellino
,
M. Trojano
Affiliations:
University of Bari, Bari
,
P. Valentino
Affiliations:
University 'Magna Graecia', Catanzaro
,
M. Zappia
Affiliations:
University of Catania, Catania
C. Solaro
Affiliations:
Als3 Genovese, Neurology Unit Department Head and Neck, Genova, Italy
ECTRIMS Online Library. Patti F. Oct 9, 2015; 116223
Francesco Patti
Francesco Patti
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Abstract: P1177

Type: Poster

Abstract Category: Treatment of specific symptoms

Background: Spasticity is a common disabling symptom of multiple sclerosis (MS). The approval of THC:CBD oromucosal spray provides a new option for resistant to other medications moderate to severe MS spasticity. Since introduction in Italy in Q3 2013 a web-based official registry collects data from all prescribed patients.

Aim: To describe effectiveness and tolerability of THC:CBD oromucosal spray use in daily practice in a large Italian population.

Methods: We collected data from the e-registry between Jan '14 and Feb '15. Spasticity evolution in the 0-10 NRS scale is available at baseline 1 (trial period) and 6 months. Other parameters such as treatment discontinuation, tolerability and daily dose have been collected.

Results: 30 large MS centers provided data from 1534 patients. Mean age: 51.0 y (SD 9.6), gender: 52.8% female, mean MS duration 17.6 y (SD 8.6), EDSS mean score 6.4 (SD 1.2), MS type: 63.7% SP, 19.9% RR, 16.1% PP. A total of 1350 patient reached 1st month visit. Out of the 1534 patients, 61.9% of patients continued treatment after proving enough effect (>20% spasticity improvement from baseline) and acceptable tolerability. About 25%of patients showed NRS improvement over 30%. From the discontinuing, 51% reported lack of effectiveness, 31.5% tolerability and 8% reported both. Main adverse events leading to discontinuation after 1 month were cognitive/psychiatric (43/242), fatigue (42/242), drowsiness (41/242), dizziness (31/242), gastrointestinal related symptoms (22/242) and oral discomfort (10/242). A total of 559 patients reached the 6 months visit at analyses date (41.4% from possible). Two hundred twenty-five patients (40.2%) reached NRS improvements over 30% at 6 months. The mean number of puffs were 6.8±2.6 (1st month) and 6.2±2.8 (6th month, p< 0.0001). Five serious adverse events were reported (1 renal failure, 1 death for acute myocardial infarction, 1 hypertensive crisis, 1 laryngeal carcinoma and 1 breast cancer). Multivariate analysis showed patients in progressive MS (80% of sample) have higher chances to improve vs. RR MS patients (OR 1.5, p=0.002, 95% CI 1.2-2.0).

Conclusion: THC:CBD oromucosal spray is effective and well tolerated in the management of resistant MS spasticity. Strict use of the trial period helps the responders' selection. Patients' improvement is slightly better in practice than in clinical trials, with lower mean doses. No herbal cannabis-related risks (abuse, diversion) found.

Disclosure:

Dr Patti has received honoraria for scientific lectures and travel payment from Biogen Idec, Novartis, Teva, Genzyme, Bayer Schering, Merck Serono, Almirall.

Dr Messina has received honoraria for scientific lectures form Biogen Idec, Almirall and travel payment from Novartis, Biogen Idec, Genzyme, Almirall Bayer Schering, Merck Serono.

Prof. Maria Pia Amato serves on scientific advisory boards for Biogen Idec, Merck Serono and receives speaker honoraria and research support from Biogen Idec, Merck Serono, Novartis, Almirall and Genzyme.

Dr Benedetti has nothing to disclose

Dr Bergamaschi has received honoraria for scientific lectures and travel payment from Biogen Idec, Novartis, Teva, Genzyme, Bayer Schering, Merck Serono, Almirall.

Dr Bertolotto has received honoraria for scientific lectures and travel payment from Biogen Idec, Novartis, Teva, Genzyme, Bayer Schering, Merck Serono, Almirall.

Dr Bonavita received speaker and advisory board honoraria from Biogen, Novartis and Merck-Serono

Dr Bruno Bossio received gran for advisory board activities from Almirall

Dr Brescia Morra has received honoraria for scientific lectures and travel payment from Biogen Idec, Novartis, Teva, Genzyme, Bayer Schering, Merck Serono, Almirall.

Dr Cavalla has nothing to disclose

Dr. Diego Centonze is an Advisory Board member of Almirall, Bayer Schering, Biogen, Genzyme, GW Pharmaceuticals, Merck-Serono, Novartis, Teva and received honoraria for speaking or consultation fees from Almirall, Bayer Schering, Biogen Idec, Genzyme, GW Pharmaceuticals, Merck Serono, Novartis, Sanofi-Aventis, Teva. He is also an external expert consultant of the European Medicine Agency (EMA), and the principal investigator in clinical trials for Bayer Schering, Biogen Idec, Merck Serono, Mitsubishi, Novartis, Roche, Sanofi-aventis, Teva. His preclinical and clinical research was supported by grants from Bayer, Biogen, Merck Serono, Novartis e Teva.

Dr Comi has received honoraria for scientific lectures from Biogen Idec, Novartis, Teva, Genzyme, Bayer Schering, Merck Serono, Almirall.

Dr Cottone has nothing to disclose

Dr Danni has nothing to disclose

Dr Francia received grant for advisory board activities from Almirall

Dr Fuiani has nothing to disclose

Dr Gasperini received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Teva

Dr Ghezzi received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Teva

Dr Iudice has nothing to disclose

Dr Lus received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Teva

Dr Maniscalco received speaking and advisory honoraria from Biogen, Novartis and Teva

Dr Marrosu has received speaker honoraria and honoraria for serving on advisory board activities from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi Aventis and Teva, and research grants from Merck Serono and Novartis.

Dr Mirabella received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Teva

Dr Montanari received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Teva

Dr Pozzilli received honoraria for scientific lectures from Biogen Idec, Novartis, Teva, Genzyme, Bayer Schering, Merck Serono, Almirall.

Dr Rovaris received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Teva

Dr Sessa received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Teva

Dr Spitaleri has nothing to disclose

Dr Trojano received honoraria for scientific lectures from Biogen Idec, Novartis, Teva, Genzyme, Bayer Schering, Merck Serono, Almirall.

Dr Valentino has nothing to disclose

Dr Zappia has received compensation for consulting services from Boehringer-Ingelheim, Lundbeck, Union Chimique Belge and scientific grants from AIFA- Agenzia Italiana del Farmaco, Novartis, Lundbeck

Dr Solaro received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Teva

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