Publications

Authors:

Messina, Silvia; Solaro, Claudio; Righini, Isabella; Bergamaschi, Roberto; Bonavita, Simona; Bossio, Roberto Bruno; Brescia Morra, Vincenzo; Costantino, Gianfranco; Cavalla, Paola; Centonze, Diego; Comi, Giancarlo; Cottone, Salvatore; Danni, Maura Chiara; Francia, Ada; Gajofatto, Alberto; Gasperini, Claudio; Zaffaroni, Mauro; Petrucci, Loredana; Signoriello, Elisabetta; Maniscalco, Giorgia Teresa; Spinicci, Gabriella; Matta, Manuela; Mirabella, Massimiliano; Pedà, Graziella; Castelli, Letizia; Rovaris, Marco; Sessa, Edoardo; Spitaleri, Daniele; Paolicelli, Damiano; Granata, Alfredo; Zappia, Mario; Patti, Francesco

Title:

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

Year:

2017

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Format:

Elettronico

Referee:

Sì

Name of journal:

PLoS ONE

ISSN of journal:

1932-6203

N° Volume:

12

Number or Folder:

8

Page numbers:

1-10

Keyword:

Sativex; multiple sclerosis spasticity; discontinuation; effectiveness; evaluation

Short description of contents:

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 NRS score at T1 (adjHR 2.23, 95% 2.07-2.41, p<0.001) and a lower baseline NRS 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.ts 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.

Web page:

https://doi.org/10.1371/journal.pone.0180651

Product ID:

98623

Handle IRIS:

11562/967394

Last Modified:

November 15, 2022

Bibliographic citation:

Messina, Silvia; Solaro, Claudio; Righini, Isabella; Bergamaschi, Roberto; Bonavita, Simona; Bossio, Roberto Bruno; Brescia Morra, Vincenzo; Costantino, Gianfranco; Cavalla, Paola; Centonze, Diego; Comi, Giancarlo; Cottone, Salvatore; Danni, Maura Chiara; Francia, Ada; Gajofatto, Alberto; Gasperini, Claudio; Zaffaroni, Mauro; Petrucci, Loredana; Signoriello, Elisabetta; Maniscalco, Giorgia Teresa; Spinicci, Gabriella; Matta, Manuela; Mirabella, Massimiliano; Pedà, Graziella; Castelli, Letizia; Rovaris, Marco; Sessa, Edoardo; Spitaleri, Daniele; Paolicelli, Damiano; Granata, Alfredo; Zappia, Mario; Patti, Francesco, Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study) «PLoS ONE» , vol. 12 , n. 8 , 2017 , pp. 1-10

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