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
N1 - © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.
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 -