Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study

被引：9

作者：

Chisari, Clara Grazia ^{[1
]}

Solaro, Claudio ^{[2
]}

Annunziata, Pasquale ^{[3
]}

Bergamaschi, Roberto ^{[4
]}

Bianco, Assunta ^{[5
]}

Bonavita, Simona ^{[6
]}

Brescia Morra, Vincenzo ^{[7
]}

Bruno Bossio, Roberto ^{[8
,9
]}

Capello, Elisabetta ^{[10
]}

Castelli, Letizia ^{[11
]}

Cavalla, Paola ^{[12
]}

Costantino, Gianfranco ^{[13
]}

Centonze, Diego ^{[14
,15
]}

Cottone, Salvatore ^{[16
]}

Danni, Maura Chiara ^{[17
]}

Esposito, Federica ^{[18
]}

Gajofatto, Alberto ^{[19
]}

Gasperini, Claudio ^{[20
]}

Guareschi, Angelica ^{[21
]}

Lanzillo, Roberta ^{[7
]}

Lus, Giacomo ^{[22
]}

Maniscalco, Giorgia Teresa ^{[23
]}

Matta, Manuela ^{[24
]}

Paolicelli, Damiano ^{[25
]}

Petrucci, Loredana ^{[26
]}

Pontecorvo, Simona ^{[27
]}

Righini, Isabella ^{[28
]}

Rovaris, Marco ^{[29
]}

Sessa, Edoardo ^{[30
]}

Spinicci, Gabriella ^{[31
]}

Spitaleri, Daniele ^{[32
]}

Valentino, Paola ^{[33
]}

Zaffaroni, Mauro ^{[34
]}

Zappia, Mario ^{[1
]}

Patti, Francesco ^{[1
]}

机构：

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

[2] Mons L Novarese Hosp, Rehabil Unit, Vercelli, Piemonte, Italy

[3] Univ Siena, Dept Med Surg & Neurosci, Fac Med & Chirurg, Siena, Toscana, Italy

[4] Fdn Natl Neurol Inst C Mondino, Inst Hospitalizat & Care Sci, Dept Neurol, Pavia, Lombardia, Italy

[5] Univ Hosp Agostino Gemelli, Multiple Sclerosis Unit, Rome, Lazio, Italy

[6] Univ Campania Luigi Vanvitelli, Dept Med Surg Neurol Metab & Aging Sci, Clin Neurol 2, Naples, Campania, Italy

[7] Federico II Univ Hosp, Dept Neurosci Reprod Sci & Odontostomatol, Multiple Sclerosis Clin Care & Res Ctr, Naples, Campania, Italy

[8] Cosenza Hosp Dist, Neurol Operating Unit, Calabria, Italy

[9] Cosenza Hosp Dist, Multiple Sclerosis Ctr, Calabria, Italy

[10] Univ Genoa, Dept Neurosci Rehabil Ophthalmol Genet Maternal &, Osped Policlin San Martino, Genoa, Liguria, Italy

[11] IRCCS Fdn Don Carlo Gnocchi, Milan, Lombardia, Italy

[12] Azienda Osped Univ Citta Salute & Sci Torino, Dept Neurosci, Osped San Vito, Turin, Piemonte, Italy

[13] Osped Riuniti Foggia, Simple Unit Multiple Sclerosis, Foggia, Puglia, Italy

[14] Univ Roma Tor Vergata, Neurosci Dept, Rome, Lazio, Italy

[15] NEUROMED, Unit Neurol & Neurorehabil, Pozzilli, Molise, Italy

[16] Villa Sofia Cervello United Hosp, Palermo, Sicilia, Italy

[17] Univ Politecn Marche, Dept Expt & Clin Med, Neurol Clin, Ancona, Marche, Italy

[18] Hosp San Raffaele, Dept Neurol, Milan, Lombardia, Italy

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

[20] San Camillo Hosp, Neurol Div, Rome, Lazio, Italy

[21] Fidenza Hosp, Med Dept, Multiple Sclerosis Ctr, Fidenza, Emilia Romagna, Italy

[22] Univ Campania Luigi Vanvitelli, Div Neurol 2, Dept Surg Med Sci Neurol Metab & Aging, Multiple Sclerosis Ctr, Caserta, Campania, Italy

[23] Antonio Cardarelli Hosp, Multiple Sclerosis Ctr, Naples, Campania, Italy

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

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

[26] Pisa Univ Hosp, Multiple Sclerosis Ctr, Pisa, Toscana, Italy

[27] Sapienza Univ Rome, Multiple Sclerosis Ctr, Dept Human Neurosci, Rome, Lazio, Italy

[28] Univ Florence, Neurosci Sect, NEUROFARBA Dept, Florence, Toscana, Italy

[29] Fdn Don C Gnocchi, Multiple Sclerosis Ctr, Milan, Lombardia, Italy

[30] IRCCS Ctr Neurolesi Bonino Pulejo, Multiple Sclerosis Ctr, Messina, Sicilia, Italy

[31] Univ Cagliari, Dept Med Sci, Cagliari, Sardegna, Italy

[32] Azienda Osped Rilievo Nazl & Alta Special San Giu, Multiple Sclerosis Ctr, Avellino, Campania, Italy

[33] Magna Graecia Univ Catanzaro, Inst Neurol, Calabria, Italy

[34] Azienda Socio Sanit Terr Valle Olona, Gallarate Hosp, Multiple Sclerosis Ctr, Gallarate, Lombardia, Italy

来源：

JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY | 2020年 / 91卷 / 09期

关键词：

THC/CBD OROMUCOSAL SPRAY; CANNABIS-BASED MEDICINE; LONG-TERM USE; CLINICAL-PRACTICE; DOUBLE-BLIND; SPASTICITY; SATIVEX(R); SAFETY; SYMPTOMS; MANAGEMENT;

D O I：

10.1136/jnnp-2019-322480

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Introduction: Delta-delta-tetrahydrocannabinol and cannabidiol (THC:CBD) oromucosal spray is used as an add-on therapy option for moderate to severe multiple sclerosis (MS) spasticity resistant to other medications. Aims of this study were to provide real-life data on long-term clinical outcomes in a large population of Italian patients treated with THC:CBD and to evaluate predictors of THC:CBD therapy continuation. Materials and methods: This prospective observational multicentre Italian study screened all patients with MS consecutively included in the Agenzia Italiana del Farmaco e-registry at the start of THC:CBD treatment (baseline), after 4 weeks (T1), 12 +/- 3 weeks (T2), 24 +/- 3 weeks (T3), 48 +/- 3 weeks (T4) and 72 +/- 3 weeks (T5) from baseline. Results: A total of 1845 patients were recruited from 32 MS Italian centres. At T1, 1502 (81.4%) of patients reached a Numerical Rating Scale (NRS) improvement of >= 20%, with an NRS reduction of 26.9% at T1 and of 34.4% at T5. At T5, 725 patients (48.3% of 1502) discontinued treatment with highest discontinuation rate at T2 and T3. Daily number of puffs was generally stable through the observation period. The multivariate analysis showed that higher NRS scores at baseline (OR 2.28, 95% CI 1.15 to 6.36, p<0.01) and higher differences of NRS between T0 and T1 (OR 2.11, 95% CI 1.08 to 8.26, p<0.05) were associated with an increased probability to continue therapy after 18 months. Discussion: THC:CBD effects were sustained for 18 months with a relatively stable number of puffs per day. About 50% of patients abandoned THC:CBD therapy for loss of efficacy or adverse events.

引用

页码：914 / 920

页数：7

共 33 条

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