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, S.
AU - Bruno Bossio, R.
AU - Brescia Morra, V.
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, Massimiliano
AU - Montanari, E.
AU - Pozzilli, C.
AU - Rovaris, M.
AU - Sessa, E.
AU - Spitaleri, D.
AU - Trojano, M.
AU - Valentino, P.
AU - Zappia, M.
PY - 2016
Y1 - 2016
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 - multiple sclerosis, cannabinoid
KW - multiple sclerosis, cannabinoid
UR - http://hdl.handle.net/10807/77790
U2 - 10.1136/jnnp-2015-312591
DO - 10.1136/jnnp-2015-312591
M3 - Article
SN - 0022-3050
VL - 2016
SP - jnnp-2015-312591-N/A
JO - Journal of Neurology, Neurosurgery and Psychiatry
JF - Journal of Neurology, Neurosurgery and Psychiatry
ER -