Study register · detailKohortenstudie · Multiple Sclerosis · 2016
Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years.
Patti et al.·European neurologyImpact 1.1
Clear benefitGRADELow6 citations
Samplen = 1.534 Pat.
Duration1,5 years
EndpointNRS
Blindingn.a.
DesignKohortenstudie
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
61,9% of patients achieved sufficient improvement in spasticity (≥20% NRS) after 1 month, 40,2% showed a clinically meaningful ≥30% NRS improvement after 6 months.
Summary
AIFA registry Italy (January 2014–February 2015), n=1.534 MS spasticity patients from 30 centres, mean disease duration 17,6±8,6 years, EDSS 6,4±1,2. After 1 month titration: 61,9% achieved ≥20% NRS improvement; after 6 months: 40,2% with ≥30% NRS reduction. Mean dose 6,2–6,7 sprays/day. Adverse effects in 15% (mostly mild-moderate).
P
PopulationAdults with MS spasticity (treatment-resistant), n=1.534, from 30 Italian MS centres, mean disease duration 17,6 years, mean EDSS 6,4
I
InterventionTHC:CBD oromucosal spray (Sativex), mean dose 6,2–6,7 sprays/day
O
OutcomeAfter 1 month 61,9% achieved a ≥20% NRS improvement; after 6 months 40,2% of patients continuing treatment showed a ≥30% NRS improvement; adverse drug reactions in 15% (predominantly mild to moderate)
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Background: In Italy, all prescriptions for THC:CBD oromucosal spray for treatment of multiple sclerosis (MS) spasticity are linked to the official Agenzia Italiana del Farmaco (AIFA) web-based registry, which tracks the effectiveness and tolerability of medications in a prospective and observational manner.
Methods: AIFA e-registry data for THC:CBD oromucosal spray collected between January 2014 and February 2015 for 1,534 patients from 30 large Italian specialized MS centres were compiled. Patients had a long disease history (17.6 +/- 8.6 years) and significant impairment (mean Expanded Disability Status Scale score 6.4 +/- 1.2). MS spasticity was evaluated using the 0-10 numerical rating scale (NRS).
Results: After the first month titration and trial period, 61.9% of patients achieved sufficient improvement in spasticity (>/=20% NRS) to qualify for continued treatment. After 6 months, clinically meaningful >/=30% NRS improvement was recorded in 40.2% of patients continuing with treatment. Spasticity-associated symptoms such as cramps and nocturnal spasms improved in most responding patients. Mean reported doses of THC:CBD oromucosal spray (6.2-6.7 sprays/day) were lower than those reported in clinical trials. Adverse events (mainly mild to moderate) were reported by 15% of patients; no new safety concerns beyond the approved label were identified.
Conclusion: The results of the AIFA e-registry analysis align with those of other THC:CBD observational projects and reaffirm the characteristics of this therapeutic option in the management of treatment-resistant MS spasticity, a frequently overlooked symptom.