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

被引：28

作者：

Messina, Silvia ^{[1
]}

Solaro, Claudio ^{[2
]}

Righini, Isabella ^{[3
]}

Bergamaschi, Roberto ^{[4
]}

Bonavita, Simona ^{[5
]}

Bossio, Roberto Bruno ^{[6
,7
]}

Morra, Vincenzo Brescia ^{[8
]}

Costantino, Gianfranco ^{[9
]}

Cavalla, Paola ^{[10
]}

Centonze, Diego ^{[11
,12
,13
]}

Comi, Giancarlo

Cottone, Salvatore ^{[14
]}

Danni, Maura Chiara ^{[15
]}

Francia, Ada ^{[16
]}

Gajofatto, Alberto ^{[17
]}

Gasperini, Claudio ^{[18
]}

Zaffaroni, Mauro ^{[19
]}

Petrucci, Loredana ^{[20
]}

Signoriello, Elisabetta ^{[21
]}

Maniscalco, Giorgia Teresa ^{[22
]}

Spinicci, Gabriella ^{[23
]}

Matta, Manuela ^{[24
]}

Mirabella, Massimiliano ^{[25
]}

Peda, Graziella ^{[26
]}

Castelli, Letizia ^{[27
]}

Rovaris, Marco ^{[28
]}

Sessa, Edoardo ^{[29
]}

Spitaleri, Daniele ^{[30
]}

Paolicelli, Damiano ^{[31
]}

Granata, Alfredo ^{[32
]}

Zappia, Mario ^{[1
]}

Patti, Francesco ^{[1
]}

机构：

[1] Univ Catania, Dept Med Surg Sci & Adv Technol GF Ingrassia, Catania, Italy

[2] Dept Head & Neck, Neurol Unit, ASL3, Genoa, Italy

[3] Univ Florence, Dept NEUROFARBA, Florence, Italy

[4] Neurol Inst C Mondino, Dept Neurol, Pavia, Italy

[5] II Univ Naples, Clin Neurol 1, Naples, Italy

[6] Neurol Operating Unit, Cosenza, Italy

[7] Multiple Sclerosis Ctr, Prov Hlth Author Cosenza, Cosenza, Italy

[8] Univ Federico II, Multiple Sclerosis Ctr, Naples, Italy

[9] Foggia Hosp, Demyelinating Dis Ctr, Foggia, Italy

[10] Cittadella Salute & Sci Torino, AOU, Turin, Italy

[11] Univ Tor Vegata, Neurosci Dept, Rome, Italy

[12] IRCCS, Neuromed, Unit Neurol & Neurorehabil, Pozzilli, IS, Italy

[13] Osped San Raffaele, Dept Neurol, Milan, Italy

[14] Villa Sofia Cervello Hosp, Neuroimmunol Unit, Palermo, Italy

[15] Ancona Hosp, Neurol Clin, Ancona, Italy

[16] Psich Sapienza Univ, Dept Neurol, Multiple Sclerosis Ctr, Rome, Italy

[17] Univ Verona, Dept Neurosci, Biomed & Movement Multiple Sclerosis Ctr, Verona, Italy

[18] San Camillo Hosp, Neurol Div, Rome, Italy

[19] Sant Antonio Abate Hosp, Multiple Sclerosis Ctr, Gallarate, Italy

[20] Univ Hosp Pisa, Multiple Sclerosis Ctr, Pisa, Italy

[21] Univ Naples 2, Multiple Sclerosis Ctr, Naples, Italy

[22] Cardarelli Hosp, Multiple Sclerosis Ctr, Naples, Italy

[23] Univ Cagliari, Dept Med Sci, Cagliari, Italy

[24] San Luigi Gonzaga Hosp, Multiple Sclerosis Ctr CRESM, Orbassano, Italy

[25] Cattol Univ, Multiple Sclerosis Ctr, Rome, Italy

[26] Vaio Hosp, Multiple Sclerosis Ctr, Fidenza, Italy

[27] S Andrea Hosp, Multiple Sclerosis Ctr, Rome, Italy

[28] IRCCS, Don Gnocchi Fdn, Multiple Sclerosis Ctr, Milan, Italy

[29] IRCCS, Bonino Pulejo Ctr, Multiple Sclerosis Ctr, Messina, Italy

[30] San G Moscati Hosp, Multiple Sclerosis Ctr, Avellino, Italy

[31] Univ Bari Aldo Moro, Dept Basic Med Sci Neurosci & Sense Organs, Bari, Italy

[32] Magna Graecia Univ Catanzaro, Inst Neurol, Dept Med Sci, Catanzaro, Italy

来源：

PLOS ONE | 2017年 / 12卷 / 08期

关键词：

CANNABIS-BASED MEDICINE; DOUBLE-BLIND; SYMPTOMS; MANAGEMENT; IMPACT;

D O I：

10.1371/journal.pone.0180651

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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.

引用

页数：10

共 31 条

[31] CD206-Targeted Liposomal Myelin Basic Protein Peptides in Patients with Multiple Sclerosis Resistant to First-Line Disease-Modifying Therapies: A First-in-Human, Proof-of-Concept Dose-Escalation Study
Belogurov, Alexey, Jr.
Zakharov, Konstantin
Lomakin, Yakov
Surkov, Kirill
Avtushenko, Sergey
Kruglyakov, Peter
Smirnov, Ivan
Makshakov, Gleb
Lockshin, Curtis
Gregoriadis, Gregory
Genkin, Dmitry
Gabibov, Alexander
Evdoshenko, Evgeniy
NEUROTHERAPEUTICS, 2016, 13 (04) : 895 - 904

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