1. Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study)
- Author
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Silvia Messina, Claudio Solaro, Isabella Righini, Roberto Bergamaschi, Simona Bonavita, Roberto Bruno Bossio, Vincenzo Brescia Morra, Gianfranco Costantino, Paola Cavalla, Diego Centonze, Giancarlo Comi, Salvatore Cottone, Maura Chiara Danni, Ada Francia, Alberto Gajofatto, Claudio Gasperini, Mauro Zaffaroni, Loredana Petrucci, Elisabetta Signoriello, Giorgia Teresa Maniscalco, Gabriella Spinicci, Manuela Matta, Massimiliano Mirabella, Graziella Pedà, Letizia Castelli, Marco Rovaris, Edoardo Sessa, Daniele Spitaleri, Damiano Paolicelli, Alfredo Granata, Mario Zappia, Francesco Patti, SA.FE. study group, 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., 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, Morra, Vincenzo Brescia, and Pedã , Graziella
- Subjects
Registrie ,Genetics and Molecular Biology (all) ,Male ,Economics ,Social Sciences ,Drug research and development ,Biochemistry ,Severity of Illness Index ,0302 clinical medicine ,Multiple Sclerosi ,80 and over ,Ethnicities ,Medicine ,Dronabinol ,lcsh:Science ,Drug Approval ,Aged, 80 and over ,evaluation ,Sativex ,multiple sclerosis spasticity ,discontinuation ,effectiveness ,Drug Combinations ,Neurology ,Italy ,Regression Analysis ,Human ,medicine.medical_specialty ,Multiple Sclerosis ,Drug Industry ,Immunology ,Plant Extract ,03 medical and health sciences ,Health Economics ,Pharmacotherapy ,Drug Therapy ,Severity of illness ,Humans ,Spasticity ,Adult ,Aged ,Cannabidiol ,Cost Sharing ,Drug Costs ,Female ,Kaplan-Meier Estimate ,Middle Aged ,Multivariate Analysis ,Muscle Spasticity ,Parasympatholytics ,Plant Extracts ,Proportional Hazards Models ,Registries ,Young Adult ,Biochemistry, Genetics and Molecular Biology (all) ,Agricultural and Biological Sciences (all) ,Adverse effect ,Demography ,Pharmacology ,Proportional hazards model ,Parasympatholytic ,lcsh:R ,Biology and Life Sciences ,Management of multiple sclerosis ,medicine.disease ,Discontinuation ,Health Care ,Proportional Hazards Model ,Population Groupings ,lcsh:Q ,Clinical Medicine ,030217 neurology & neurosurgery ,Multivariate analysis ,lcsh:Medicine ,Medicine (all) ,Geographical Locations ,Clinical trials ,Drug Combination ,Medicine and Health Sciences ,030212 general & internal medicine ,Multivariate Analysi ,Drug Cost ,Multidisciplinary ,Pharmaceutics ,Neurodegenerative Diseases ,Italian People ,Phase III clinical investigation ,Europe ,Settore MED/26 - NEUROLOGIA ,Research Design ,medicine.symptom ,Research Article ,Clinical Research Design ,Research and Analysis Methods ,Settore MED/26 ,Regression Analysi ,Autoimmune Diseases ,Internal medicine ,business.industry ,Demyelinating Disorders ,People and Places ,Physical therapy ,Clinical Immunology ,Adverse Events ,business - Abstract
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
- Published
- 2017