Skip to main content
Canna~Fangled Abstracts

Sativex® (nabiximols) cannabinoid oromucosal spray in patients with resistant multiple sclerosis spasticity: the Belgian experience

By June 22, 2021June 23rd, 2021No Comments
. 2021 Jun 22;21(1):227.

doi: 10.1186/s12883-021-02246-0.

Marie D’hooghe 1 2, Barbara Willekens 3 4, Valerie Delvaux 5, Miguel D’haeseleer 6, Daniel Guillaume 7, Guy Laureys 8, Guy Nagels 6, Patrick Vanderdonckt 9, Vincent Van Pesch 10, Veronica Popescu 11 12
Affiliations 

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

 

Keywords: Cannabinoid oromucosal spray, Multiple sclerosis spasticity, Observational study, Treatment effect, Treatment satisfaction

References

    1. Barnes M, Kocer S, Murie Fernandez M, Balcaitiene J, Fheodoroff K. An international survey of patients living with spasticity. Disabil Rehabil. 2017;39(14):1428–34. https://doi.org/10.1080/09638288.2016.1198432 . – DOI – PubMed
    1. Kister I, Bacon TE, Chamot E, Salter AR, Cutter GR, Kalina JT, et al. Natural history of multiple sclerosis symptoms. Int J MS Care. 2013;15(3):146–58. https://doi.org/10.7224/1537-2073.2012-053 . – DOI – PubMed – PMC
    1. Flachenecker P, Henze T, Zettl UK. Spasticity in patients with multiple sclerosis-clinical characteristics, treatment and quality of life. Acta Neurol Scand. 2014;129(3):154–62. https://doi.org/10.1111/ane.12202 . – DOI – PubMed
    1. Bensmail D, Vermersch P. Epidemiology and clinical assessment of spasticity in multiple sclerosis. [Article in French]. Rev Neurol (Paris). 2012;168(Suppl3):S45–50. – DOI
    1. Arroyo R, Massana M, Vila C. Correlation between spasticity and quality of life in patients with multiple sclerosis: the CANDLE study. Int J Neurosci. 2013;123(12):850–8. https://doi.org/10.3109/00207454.2013.812084 . – DOI – PubMed

Leave a Reply