Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study)

摘要: Background The approval of Sativex for the management multiple sclerosis (MS) spasticity opened a new opportunity to many patients. In Italy, healthcare payer can be fully reimbursed by involved pharma company with cost treatment patients not responding after 4 week (28 days) trial period (Payment Results, PbR), and 50% 6 weeks (42 other discontinuing (Cost Sharing, CS). The aim our study was describe discontinuation profile from large population treated Italian MS patients. Methods We collected data 30 centres across country starting between January 2014 February 2015. Data were mandatory Medicines Agency (AIFA) web-registry. Predictors assessed using multivariate Cox proportional regression analysis. Results During observation 631 out 1597 (39.5%) discontinued Sativex. Kaplan-Meier estimates curve showed that 333 (20.8%) at while 422 (26.4%) weeks. We found adjusted modeling higher NRS score T1 (adjHR 2.23, 95% 2.07–2.41, p<0.001) lower baseline 0.51 CI 0.46–0.56, predictive discontinuation. Conclusion These show first are useful in identifying those which could effective, thus avoiding longer term evaluation.