Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

F. Patti, S. Messina, C. Solaro, M. P. Amato, R. Bergamaschi, S. Bonavita, R. Bruno Bossio, V. Brescia Morra, G. F. Costantino, P. Cavalla, D. Centonze, G. Comi, S. Cottone, M. Danni, A. Francia, A. Gajofatto, C. Gasperini, A. Ghezzi, A. Iudice, G. LusG. T. Maniscalco, M. G. Marrosu, M. Matta, M. Mirabella, E. Montanari, C. Pozzilli, M. Rovaris, E. Sessa, D. Spitaleri, M. Trojano, P. Valentino, M. Zappia, on behalf of the SA.FE. study group

Research output: Contribution to journalArticle

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Abstract

Background The approval of 9-d-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

Original languageEnglish
JournalJournal of Neurology, Neurosurgery and Psychiatry
DOIs
Publication statusAccepted/In press - May 9 2016

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Cannabinoids
Multiple Sclerosis
Safety
Chronic Progressive Multiple Sclerosis
Cannabidiol
Efficacy
Spray
Italy
Registries
Therapeutics
Multivariate Analysis
Population
tetrahydrocannabinol-cannabidiol combination
Rating Scales

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health
  • Surgery
  • Arts and Humanities (miscellaneous)

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Patti, F., Messina, S., Solaro, C., Amato, M. P., Bergamaschi, R., Bonavita, S., ... on behalf of the SA.FE. study group (Accepted/In press). Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity. Journal of Neurology, Neurosurgery and Psychiatry. https://doi.org/10.1136/jnnp-2015-312591

Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity. / Patti, F.; Messina, S.; Solaro, C.; Amato, M. P.; Bergamaschi, R.; Bonavita, S.; Bossio, R. Bruno; Morra, V. Brescia; Costantino, G. F.; Cavalla, P.; Centonze, D.; Comi, G.; Cottone, S.; Danni, M.; Francia, A.; Gajofatto, A.; Gasperini, C.; Ghezzi, A.; Iudice, A.; Lus, G.; Maniscalco, G. T.; Marrosu, M. G.; Matta, M.; Mirabella, M.; Montanari, E.; Pozzilli, C.; Rovaris, M.; Sessa, E.; Spitaleri, D.; Trojano, M.; Valentino, P.; Zappia, M.; on behalf of the SA.FE. study group.

In: Journal of Neurology, Neurosurgery and Psychiatry, 09.05.2016.

Research output: Contribution to journalArticle

Patti, F, Messina, S, Solaro, C, Amato, MP, Bergamaschi, R, Bonavita, S, Bossio, RB, Morra, VB, Costantino, GF, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, GT, Marrosu, MG, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M & on behalf of the SA.FE. study group 2016, 'Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity', Journal of Neurology, Neurosurgery and Psychiatry. https://doi.org/10.1136/jnnp-2015-312591
Patti, F. ; Messina, S. ; Solaro, C. ; Amato, M. P. ; Bergamaschi, R. ; Bonavita, S. ; Bossio, R. Bruno ; Morra, V. Brescia ; Costantino, G. F. ; Cavalla, P. ; Centonze, D. ; Comi, G. ; Cottone, S. ; Danni, M. ; Francia, A. ; Gajofatto, A. ; Gasperini, C. ; Ghezzi, A. ; Iudice, A. ; Lus, G. ; Maniscalco, G. T. ; Marrosu, M. G. ; Matta, M. ; Mirabella, M. ; Montanari, E. ; Pozzilli, C. ; Rovaris, M. ; Sessa, E. ; Spitaleri, D. ; Trojano, M. ; Valentino, P. ; Zappia, M. ; on behalf of the SA.FE. study group. / Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity. In: Journal of Neurology, Neurosurgery and Psychiatry. 2016.
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abstract = "Background The approval of 9-d-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",
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T1 - Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

AU - Patti, F.

AU - Messina, S.

AU - Solaro, C.

AU - Amato, M. P.

AU - Bergamaschi, R.

AU - Bonavita, S.

AU - Bossio, R. Bruno

AU - Morra, V. Brescia

AU - Costantino, G. F.

AU - Cavalla, P.

AU - Centonze, D.

AU - Comi, G.

AU - Cottone, S.

AU - Danni, M.

AU - Francia, A.

AU - Gajofatto, A.

AU - Gasperini, C.

AU - Ghezzi, A.

AU - Iudice, A.

AU - Lus, G.

AU - Maniscalco, G. T.

AU - Marrosu, M. G.

AU - Matta, M.

AU - Mirabella, M.

AU - Montanari, E.

AU - Pozzilli, C.

AU - Rovaris, M.

AU - Sessa, E.

AU - Spitaleri, D.

AU - Trojano, M.

AU - Valentino, P.

AU - Zappia, M.

AU - on behalf of the SA.FE. study group

PY - 2016/5/9

Y1 - 2016/5/9

N2 - Background The approval of 9-d-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

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