Study register · detailKohortenstudie · Multiple Sclerosis · 2020
Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study.
Chisari et al.·Journal of neurology, neurosurgery, and psychiatry
MixedGRADELow8 citations
Samplen = 1.845 Pat.
Duration18 months
EndpointNRS
Blindingn.a.
DesignKohortenstudie
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
NRS improvement of 34,4% after 18 months, but about 50% of patients ended therapy due to loss of effect or side effects.
Summary
Prospective multicenter Italian real-world study on THC:CBD oromucosal spray in MS spasticity (n=1845, 32 centers); 81,4% of patients achieved an NRS improvement ≥20% after 4 weeks (26,9% NRS reduction at T1, 34,4% at T5/18 months); 48,3% discontinued treatment within 18 months; higher baseline NRS scores (OR=2,28, 95% CI 1,15-6,36, p<0.01) and greater NRS differences T0-T1 (OR=2,11, 95% CI 1,08-8,26, p<0.05) predicted therapy continuation.
P
PopulationAdults with multiple sclerosis and moderate to severe spasticity, n=1845, from 32 Italian MS centers
I
InterventionTHC:CBD oromucosal spray (nabiximols), add-on therapy, dosage according to individual titration (number of puffs/day)
O
OutcomeNRS reduction of 26,9% after 4 weeks and 34,4% after 72 weeks; 81,4% of patients achieved ≥20% NRS improvement at T1; 48,3% of responders discontinued therapy by T5; higher baseline NRS value (OR 2,28; 95% CI 1,15–6,36; p<0,01) and stronger NRS reduction T0–T1 (OR 2,11; 95% CI 1,08–8,26; p<0,05) were associated with higher therapy continuation
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Quality profile
Sample size★★★★★
Blinding—
Effect sizeMixed
Citations / year★★★★★
Authors
Chisari CG, Solaro C, Annunziata P, Bergamaschi R, Bianco A, Bonavita S, Brescia Morra V, Bruno Bossio R, Capello E, Castelli L
Introduction: Delta-delta-tetrahydrocannabinol and cannabidiol (THC:CBD) oromucosal spray is used as an add-on therapy option for moderate to severe multiple sclerosis (MS) spasticity resistant to other medications. Aims of this study were to provide real-life data on long-term clinical outcomes in a large population of Italian patients treated with THC:CBD and to evaluate predictors of THC:CBD therapy continuation.
Materials And Methods: This prospective observational multicentre Italian study screened all patients with MS consecutively included in the Agenzia Italiana del Farmaco e-registry at the start of THC:CBD treatment (baseline), after 4 weeks (T1), 12+/-3 weeks (T2), 24+/-3 weeks (T3), 48+/-3 weeks (T4) and 72+/-3 weeks (T5) from baseline.
Results: A total of 1845 patients were recruited from 32 MS Italian centres. At T1, 1502 (81.4%) of patients reached a Numerical Rating Scale (NRS) improvement of >/=20%, with an NRS reduction of 26.9% at T1 and of 34.4% at T5. At T5, 725 patients (48.3% of 1502) discontinued treatment with highest discontinuation rate at T2 and T3. Daily number of puffs was generally stable through the observation period. The multivariate analysis showed that higher NRS scores at baseline (OR 2.28, 95% CI 1.15 to 6.36, p<0.01) and higher differences of NRS between T0 and T1 (OR 2.11, 95% CI 1.08 to 8.26, p<0.05) were associated with an increased probability to continue therapy after 18 months.
Discussion: THC:CBD effects were sustained for 18 months with a relatively stable number of puffs per day. About 50% of patients abandoned THC:CBD therapy for loss of efficacy or adverse events.