PT  - JOURNAL ARTICLE
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
TI  - Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study
AID  - 10.1136/jnnp-2019-322480
DP  - 2020 Sep 01
TA  - Journal of Neurology, Neurosurgery & Psychiatry
PG  - 914--920
VI  - 91
IP  - 9
4099  - http://jnnp.bmj.com/content/91/9/914.short
4100  - http://jnnp.bmj.com/content/91/9/914.full
SO  - J Neurol Neurosurg Psychiatry2020 Sep 01; 91
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<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.