• 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, and Francesco Patti.
• Department of Medical, Surgical Science and Advanced Technology "GF Ingrassia", section of neurosciences, Università degli Studi di Catania, Catania, Sicilia, Italy.
• J. Neurol. Neurosurg. Psychiatr. 2020 Sep 1; 91 (9): 914-920.

IntroductionDelta-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 MethodsThis 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.ResultsA 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.DiscussionTHC: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.© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

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