Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

F. Patti, S Messina, C. Solaro, M P Amato, R Bergamaschi, M. S. Bonavita, R. Bruno Bossio, Vincenzo Brescia Morra, G F Costantino, P. Cavalla, D Centonze, G Comi, S. Cottone, M. Danni, A Francia, Alberto Gajofatto, C. Gasperini, A. Ghezzi, A. Iudice, G. LusGiorgia Teresa Maniscalco, M. G. Marrosu, M. Matta, Massimiliano Mirabella, E Montanari, C. Pozzilli, M Rovaris, E Sessa, Daniele Spitaleri, Maria Trojano, P. Valentino, M. Zappia, SA.FE. study group

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)944-51
Number of pages8
JournalJournal of Neurology, Neurosurgery and Psychiatry
Volume87
Issue number9
DOIs
Publication statusPublished - Sep 2016

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Cannabinoids
Multiple Sclerosis
Safety
Chronic Progressive Multiple Sclerosis
Cannabidiol
Therapeutics
Italy
Registries
Multivariate Analysis
Observation
tetrahydrocannabinol-cannabidiol combination

Keywords

  • Journal Article

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

In: Journal of Neurology, Neurosurgery and Psychiatry, Vol. 87, No. 9, 09.2016, p. 944-51.

Research output: Contribution to journalArticle

Patti, F, Messina, S, Solaro, C, Amato, MP, Bergamaschi, R, Bonavita, MS, Bruno Bossio, R, Brescia Morra, V, 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 & SA.FE. study group 2016, 'Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity', Journal of Neurology, Neurosurgery and Psychiatry, vol. 87, no. 9, pp. 944-51. https://doi.org/10.1136/jnnp-2015-312591
Patti, F. ; Messina, S ; Solaro, C. ; Amato, M P ; Bergamaschi, R ; Bonavita, M. S. ; Bruno Bossio, R. ; Brescia Morra, Vincenzo ; Costantino, G F ; Cavalla, P. ; Centonze, D ; Comi, G ; Cottone, S. ; Danni, M. ; Francia, A ; Gajofatto, Alberto ; Gasperini, C. ; Ghezzi, A. ; Iudice, A. ; Lus, G. ; Maniscalco, Giorgia Teresa ; Marrosu, M. G. ; Matta, M. ; Mirabella, Massimiliano ; Montanari, E ; Pozzilli, C. ; Rovaris, M ; Sessa, E ; Spitaleri, Daniele ; Trojano, Maria ; Valentino, P. ; Zappia, M. ; SA.FE. study group. / Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity. In: Journal of Neurology, Neurosurgery and Psychiatry. 2016 ; Vol. 87, No. 9. pp. 944-51.
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abstract = "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.",
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author = "F. Patti and S Messina and C. Solaro and Amato, {M P} and R Bergamaschi and Bonavita, {M. S.} and {Bruno Bossio}, R. and {Brescia Morra}, Vincenzo and Costantino, {G F} and P. Cavalla and D Centonze and G Comi and S. Cottone and M. Danni and A Francia and Alberto Gajofatto and C. Gasperini and A. Ghezzi and A. Iudice and G. Lus and Maniscalco, {Giorgia Teresa} and Marrosu, {M. G.} and M. Matta and Massimiliano Mirabella and E Montanari and C. Pozzilli and M Rovaris and E Sessa and Daniele Spitaleri and Maria Trojano and P. Valentino and M. Zappia and {SA.FE. study group}",
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TY - JOUR

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, M. S.

AU - Bruno Bossio, R.

AU - Brescia Morra, Vincenzo

AU - Costantino, G F

AU - Cavalla, P.

AU - Centonze, D

AU - Comi, G

AU - Cottone, S.

AU - Danni, M.

AU - Francia, A

AU - Gajofatto, Alberto

AU - Gasperini, C.

AU - Ghezzi, A.

AU - Iudice, A.

AU - Lus, G.

AU - Maniscalco, Giorgia Teresa

AU - Marrosu, M. G.

AU - Matta, M.

AU - Mirabella, Massimiliano

AU - Montanari, E

AU - Pozzilli, C.

AU - Rovaris, M

AU - Sessa, E

AU - Spitaleri, Daniele

AU - Trojano, Maria

AU - Valentino, P.

AU - Zappia, M.

AU - SA.FE. study group

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/9

Y1 - 2016/9

N2 - 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.

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.

KW - Journal Article

U2 - 10.1136/jnnp-2015-312591

DO - 10.1136/jnnp-2015-312591

M3 - Article

C2 - 27160523

VL - 87

SP - 944

EP - 951

JO - Journal of Neurology, Neurosurgery and Psychiatry

JF - Journal of Neurology, Neurosurgery and Psychiatry

SN - 0022-3050

IS - 9

ER -