Nabiximols reduced spasticity NRS in a clinically meaningful way and improved quality of life in the majority of treated MS patients.
Summary
n=238 MS spasticity patients (out of 276; Belgian multicentre study), Sativex® after failure of previous anti-spasticity drugs. Spasticity NRS decreased from 8,1 (baseline) to 5,2 (week 4), 4,6 (week 8) and 4,1 (week 12). EQ-VAS increased from 39 to 59 (week 12). 74 % of patients with ≥30 % NRS improvement at week 12 (clinically meaningful response). Treatment discontinuation rate by week 12: 33,7 % (mainly lack of efficacy).
P
PopulationAdults with treatment-resistant MS spasticity who responded insufficiently to previous anti-spasticity medications, n=276 (effectiveness data n=238), 8 Belgian centres
I
InterventionNabiximols (Sativex®) oromucosal cannabinoid spray, average 6 sprays/day, add-on therapy
O
OutcomeNRS spasticity score from 8,1 (baseline) to 4,1 (week 12); EQ VAS from 39 to 59 (week 12); 74% of evaluable patients achieved ≥30% NRS improvement (clinically relevant response) by week 12
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 sizeClear benefit
Citations / year★★★★★
Authors
D'hooghe M, Willekens B, Delvaux V, D'haeseleer M, Guillaume D, Laureys G, Nagels G, Vanderdonckt P, Van Pesch V, Popescu V.
<h4>Background</h4>This retrospective study evaluates patient-reported outcomes in patients with multiple sclerosis (MS) spasticity who were treated with a cannabinoid oromucosal spray (Sativex®, USAN name: nabiximols) after not sufficiently responding to previous anti-spasticity medications.<h4>Methods</h4>Of 276 patients from eight centers in Belgium who began treatment prior to 31 December 2017, effectiveness assessment data were available for 238 patients during the test period of 4 to 8/12 weeks, and for smaller patient cohorts with continued treatment for 6/12 months.<h4>Results</h4>Mean 0-10 spasticity Numerical Rating Scale (NRS) scores improved from 8.1 at baseline to 5.2 (week 4), 4.6 (week 8) and 4.1 (week 12). Mean EuroQoL Visual Analogue Scale (EQ VAS) scores increased from 39 at baseline to 52 (week 4), 57 (week 8) and 59 (week 12). Mean NRS and EQ VAS scores remained in the same 12 weeks' range in patients with longer-term data. The average dose of cannabinoid oromucosal spray was 6 sprays/day. Most of the 93 out of 276 patients, with initial prescription (33.7%), who discontinued treatment by week 12 did so within the first 8 weeks, mainly due to lack of effectiveness. By week 12, 171 (74%) of the 230 effectiveness evaluable patients reported a clinically meaningful response, corresponding to ≥30% NRS improvement. The tolerability of cannabinoid oromucosal spray was consistent with its known safety profile.<h4>Conclusions</h4>More than 60% of the patients with MS who started add-on treatment with cannabinoid oromucosal spray reported a clinically relevant symptomatic effect and continued treatment after 12 weeks.