Study register · detailKohortenstudie · Multiple Sclerosis · 2019
The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray).
Grimaldi et al.·PloS oneImpact 2.8
Clear benefitGRADEModerate11 citations
Samplen = 290 Pat.
Duration12 weeks
ControlNabiximols without physiotherapy
EndpointNRS
Blindingn.a.
DesignKohortenstudie
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
Nabiximols measurably reduced MS-related spasticity (NRS from 7,6 to 5,5), and physiotherapy improved clinically relevant response rate and treatment persistence.
Summary
Multicenter real-world study n=290 MS patients with moderate to severe spasticity, nabiximols (THC:CBD spray) + physiotherapy (PT) vs. without PT, 12-week follow-up. Mean NRS reduction: 7,6 (T0) → 5,8 (T1, 4 weeks) → 5,5 (T2, 12 weeks). T1: 77% achieved ≥20% improvement (IR), 22% ≥30% (CRR). PT group: higher probability of CRR (OR=2,6; 95% CI 1,3–5,6; p=0,01). Treatment discontinuation: 10,3% at T1, 24,5% at T2; PT reduced late discontinuations (HR=0,41; 95% CI 0,23–0,69; p=0,001).
P
PopulationAdults with moderate to severe MS-related spasticity, n=290 (completed follow-up)
I
InterventionNabiximols (THC:CBD oromucosal spray, Sativex) as add-on therapy, partly combined with physiotherapy
C
ControlNabiximols without physiotherapy
O
OutcomeClinically relevant response rate (≥30% NRS improvement) at T1 higher with physiotherapy (OR=2,6; 95% CI 1,3–5,6; p=0,01); reduced probability of discontinuation with physiotherapy (HR=0,41; 95% CI 0,23–0,69; p=0,001)
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Quality profile
Sample size★★★★★
Blinding—
Effect sizeClear benefit
Citations / year★★★★★
Authors
Grimaldi AE, De Giglio L, Haggiag S, Bianco A, Cortese A, Crisafulli SG, Monteleone F, Marfia G, Prosperini L, Galgani S
Background: Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).
Objectives: To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.
Methods: This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.
Results: A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 +/- 1.1 at T0, 5.8 +/- 1.4 at T1 and 5.5 +/- 1.5 at T2. At T1, 77% of patients reached >/=20% improvement (initial response, IR); 22% reached >/=30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).
Conclusions: Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment.