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

Clara Grazia Chisari; Claudio Solaro; Pasquale Annunziata; Roberto Bergamaschi; Assunta Bianco; Simona Bonavita; Vincenzo Brescia Morra; Roberto Bruno Bossio; Elisabetta Capello; Letizia Castelli; Paola Cavalla; Gianfranco Costantino; Diego Centonze; Salvatore Cottone; Maura Chiara Danni; Federica Esposito; Alberto Gajofatto; Claudio Gasperini; Angelica Guareschi; Roberta Lanzillo; Giacomo Lus; Giorgia Teresa Maniscalco; Manuela Matta; Damiano Paolicelli; Loredana Petrucci; Simona Pontecorvo; Isabella Righini; Marco Rovaris; Edoardo Sessa; Gabriella Spinicci; Daniele Spitaleri; Paola Valentino; Mauro Zaffaroni; Mario Zappia; Francesco Patti

doi:10.1136/jnnp-2019-322480

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

Clara Grazia Chisari, Claudio Solaro, Pasquale Annunziata, Roberto Bergamaschi, Assunta Bianco, Simona Bonavita, Vincenzo Brescia Morra, Roberto Bruno Bossio, Elisabetta Capello, Letizia Castelli, Paola Cavalla, Gianfranco Costantino, Diego Centonze, Salvatore Cottone, Maura Chiara Danni, Federica Esposito, Alberto Gajofatto, Claudio Gasperini, Angelica Guareschi, Roberta LanzilloGiacomo Lus, Giorgia Teresa Maniscalco, Manuela Matta, Damiano Paolicelli, Loredana Petrucci, Simona Pontecorvo, Isabella Righini, Marco Rovaris, Edoardo Sessa, Gabriella Spinicci, Daniele Spitaleri, Paola Valentino, Mauro Zaffaroni, Mario Zappia, Francesco Patti

Research output: Contribution to journal › Article

Abstract

INTRODUCTION: Delta-δ-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

Original language	English
Journal	J. Neurol. Neurosurg. Psychiatry
DOIs	https://doi.org/10.1136/jnnp-2019-322480
Publication status	Published - Jul 13 2020

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Chisari, C. G., Solaro, C., Annunziata, P., Bergamaschi, R., Bianco, A., Bonavita, S., Brescia Morra, V., Bruno Bossio, R., Capello, E., Castelli, L., Cavalla, P., Costantino, G., Centonze, D., Cottone, S., Danni, M. C., Esposito, F., Gajofatto, A., Gasperini, C., Guareschi, A., ... Patti, F. (2020). Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study. J. Neurol. Neurosurg. Psychiatry. https://doi.org/10.1136/jnnp-2019-322480

Nabiximols discontinuation rate in a large population of patients with multiple sclerosis : a 18-month multicentre study. / Chisari, Clara Grazia; Solaro, Claudio; Annunziata, Pasquale; Bergamaschi, Roberto; Bianco, Assunta; Bonavita, Simona; Brescia Morra, Vincenzo; Bruno Bossio, Roberto; Capello, Elisabetta; Castelli, Letizia; Cavalla, Paola; Costantino, Gianfranco; Centonze, Diego; Cottone, Salvatore; Danni, Maura Chiara; Esposito, Federica; Gajofatto, Alberto; Gasperini, Claudio; Guareschi, Angelica; Lanzillo, Roberta; Lus, Giacomo; Maniscalco, Giorgia Teresa; Matta, Manuela; Paolicelli, Damiano; Petrucci, Loredana; Pontecorvo, Simona; Righini, Isabella; Rovaris, Marco ; Sessa, Edoardo; Spinicci, Gabriella; Spitaleri, Daniele; Valentino, Paola; Zaffaroni, Mauro; Zappia, Mario; Patti, Francesco.

In: J. Neurol. Neurosurg. Psychiatry, 13.07.2020.

Research output: Contribution to journal › Article

Chisari, CG, Solaro, C, Annunziata, P, Bergamaschi, R, Bianco, A, Bonavita, S, Brescia Morra, V, Bruno Bossio, R, Capello, E, Castelli, L, Cavalla, P, Costantino, G, Centonze, D, Cottone, S, Danni, MC, Esposito, F, Gajofatto, A, Gasperini, C, Guareschi, A, Lanzillo, R, Lus, G, Maniscalco, GT, Matta, M, Paolicelli, D, Petrucci, L, Pontecorvo, S, Righini, I, Rovaris, M , Sessa, E, Spinicci, G, Spitaleri, D, Valentino, P, Zaffaroni, M, Zappia, M & Patti, F 2020, 'Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study', J. Neurol. Neurosurg. Psychiatry. https://doi.org/10.1136/jnnp-2019-322480

Chisari, Clara Grazia ; Solaro, Claudio ; Annunziata, Pasquale ; Bergamaschi, Roberto ; Bianco, Assunta ; Bonavita, Simona ; Brescia Morra, Vincenzo ; Bruno Bossio, Roberto ; Capello, Elisabetta ; Castelli, Letizia ; Cavalla, Paola ; Costantino, Gianfranco ; Centonze, Diego ; Cottone, Salvatore ; Danni, Maura Chiara ; Esposito, Federica ; Gajofatto, Alberto ; Gasperini, Claudio ; Guareschi, Angelica ; Lanzillo, Roberta ; Lus, Giacomo ; Maniscalco, Giorgia Teresa ; Matta, Manuela ; Paolicelli, Damiano ; Petrucci, Loredana ; Pontecorvo, Simona ; Righini, Isabella ; Rovaris, Marco ; Sessa, Edoardo ; Spinicci, Gabriella ; Spitaleri, Daniele ; Valentino, Paola ; Zaffaroni, Mauro ; Zappia, Mario ; Patti, Francesco. / Nabiximols discontinuation rate in a large population of patients with multiple sclerosis : a 18-month multicentre study. In: J. Neurol. Neurosurg. Psychiatry. 2020.

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

abstract = "INTRODUCTION: Delta-δ-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",

author = "Chisari, {Clara Grazia} and Claudio Solaro and Pasquale Annunziata and Roberto Bergamaschi and Assunta Bianco and Simona Bonavita and {Brescia Morra}, Vincenzo and {Bruno Bossio}, Roberto and Elisabetta Capello and Letizia Castelli and Paola Cavalla and Gianfranco Costantino and Diego Centonze and Salvatore Cottone and Danni, {Maura Chiara} and Federica Esposito and Alberto Gajofatto and Claudio Gasperini and Angelica Guareschi and Roberta Lanzillo and Giacomo Lus and Maniscalco, {Giorgia Teresa} and Manuela Matta and Damiano Paolicelli and Loredana Petrucci and Simona Pontecorvo and Isabella Righini and Marco Rovaris and Edoardo Sessa and Gabriella Spinicci and Daniele Spitaleri and Paola Valentino and Mauro Zaffaroni and Mario Zappia and Francesco Patti",

note = "{\textcopyright} Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2020",

month = jul,

day = "13",

doi = "10.1136/jnnp-2019-322480",

language = "English",

journal = "J. Neurol. Neurosurg. Psychiatry",

issn = "0022-3050",

publisher = "BMJ Publishing Group",

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TY - JOUR

T1 - Nabiximols discontinuation rate in a large population of patients with multiple sclerosis

T2 - a 18-month multicentre study

AU - Chisari, Clara Grazia

AU - Solaro, Claudio

AU - Annunziata, Pasquale

AU - Bergamaschi, Roberto

AU - Bianco, Assunta

AU - Bonavita, Simona

AU - Brescia Morra, Vincenzo

AU - Bruno Bossio, Roberto

AU - Capello, Elisabetta

AU - Castelli, Letizia

AU - Cavalla, Paola

AU - Costantino, Gianfranco

AU - Centonze, Diego

AU - Cottone, Salvatore

AU - Danni, Maura Chiara

AU - Esposito, Federica

AU - Gajofatto, Alberto

AU - Gasperini, Claudio

AU - Guareschi, Angelica

AU - Lanzillo, Roberta

AU - Lus, Giacomo

AU - Maniscalco, Giorgia Teresa

AU - Matta, Manuela

AU - Paolicelli, Damiano

AU - Petrucci, Loredana

AU - Pontecorvo, Simona

AU - Righini, Isabella

AU - Rovaris, Marco

AU - Sessa, Edoardo

AU - Spinicci, Gabriella

AU - Spitaleri, Daniele

AU - Valentino, Paola

AU - Zaffaroni, Mauro

AU - Zappia, Mario

AU - Patti, Francesco

PY - 2020/7/13

Y1 - 2020/7/13

N2 - INTRODUCTION: Delta-δ-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

AB - INTRODUCTION: Delta-δ-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

U2 - 10.1136/jnnp-2019-322480

DO - 10.1136/jnnp-2019-322480

M3 - Article

JO - J. Neurol. Neurosurg. Psychiatry

JF - J. Neurol. Neurosurg. Psychiatry

SN - 0022-3050

ER -