Study register · detailKohortenstudie · Multiple Sclerosis · 2016
Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity.
Patti et al.·Journal of neurology, neurosurgery, and psychiatry
Clear benefitGRADELow116 citations
Samplen = 1.615 Pat.
Duration6 months observation
EndpointNRS
Blindingn.a.
DesignKohortenstudie
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
After one month, 70,5% of patients achieved a ≥20% improvement in spasticity; 28,2% achieved a clinically relevant ≥30% improvement with a mean NRS reduction of 22,6%.
Summary
Italian AIFA registry n=1615 MS patients with treatment-resistant spasticity, THC:CBD spray (Sativex). After 1 month: 70,5% achieved ≥20% NRS improvement (Initial Response), 28,2% ≥30% (Clinically Relevant Response); mean NRS reduction 22,6% (7,5→5,8). Multivariate analysis: increased probability of IR with progressive MS (OR=1,4; 95% CI 1,04–1,9; p=0,025) and baseline NRS >8 (OR=1,8; 95% CI 1,3–2,4; p<0,001). 39,5% treatment discontinuations in 6 months (26,2% loss of effect, 18,7% adverse effects).
P
PopulationAdults with treatment-resistant MS spasticity from 30 Italian MS centres, n=1615
Outcome70,5% of patients achieved an NRS reduction ≥20% after 1 month (IR); 28,2% a reduction ≥30% (CRR); mean NRS reduction 22,6% (from 7,5 to 5,8); discontinuation rate after 6 months 39,5%
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Background: The approval of 9-delta-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.