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Sativex and spasticity


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Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study).
Messina S, Solaro C, Righini I, Bergamaschi R, Bonavita S, Bossio RB, Brescia Morra V, Costantino G, Cavalla P, Centonze D, Comi G, Cottone S, Danni MC, Francia A, Gajofatto A, Gasperini C, Zaffaroni M, Petrucci L, Signoriello E, Maniscalco GT, Spinicci G, Matta M, Mirabella M, Pedà G, Castelli L, Rovaris M, Sessa E, Spitaleri D, Paolicelli D, Granata A, Zappia M, Patti F; SA.FE. study group. PLoS One. 2017:12(8):e0180651. doi: 10.1371/journal.pone.0180651. eCollection 2017.

BACKGROUND: The approval of Sativex for the management of multiple sclerosis (MS) spasticity opened a new opportunity to many patients. In Italy, the healthcare payer can be fully reimbursed by the involved pharma company with the cost of treatment for patients not responding after a 4 week (28 days) trial period (Payment by Results, PbR), and 50% reimbursed with the cost of 6 weeks (42 days) treatment for other patients discontinuing (Cost Sharing, CS). The aim of our study was to describe the Sativex discontinuation profile from a large population of spasticity treated Italian MS patients.

METHODS:We collected data of patients from 30 MS centres across the country starting Sativex between January 2014 and February 2015. Data were collected from the mandatory Italian Medicines Agency (AIFA) web-registry. Predictors of treatment discontinuation were assessed using a multivariate Cox proportional regression analysis.
RESULTS: During the observation period 631 out of 1597 (39.5%) patients discontinued Sativex. The Kaplan-Meier estimates curve showed that 333 patients (20.8%) discontinued treatment at 4 weeks while 422 patients (26.4%) discontinued at 6 weeks. We found after adjusted modeling that a higher Numerical Rating Score at T1 (adjHR 2.23, 95% 2.07-2.41, p<0.001) and a lower baseline Numerical Rating Score (adjHR 0.51 95% CI 0.46-0.56, p<0.001) were predictive of treatment discontinuation.
CONCLUSION: These data show that the first 6 weeks are useful in identifying those patients in which Sativex could be effective, thus avoiding the cost of longer term evaluation.

This study shows that sativex does not work for every body and that about 30% had discontinued within 6 weeks presumably because of lack of activity or unwanted side effects and those less affected at baseline were more likely to discontinue. At least in Itally people are getting access to the drug which is not occurring in most parts of the UK.

Unwanted side effects is a problem with many agents controlling spasticity and this is why it remains untreated early after spasticity onset. I am conflicted because we hope we have generated an anti-spastic that lacks the sedative potential. We will find out if it works as the trial is now fully recruited and will all be done and dusted by the summer. 

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