RT Journal Article
SR Electronic
T1 Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP 914
OP 920
DO 10.1136/jnnp-2019-322480
VO 91
IS 9
A1 Chisari, Clara Grazia
A1 Solaro, Claudio
A1 Annunziata, Pasquale
A1 Bergamaschi, Roberto
A1 Bianco, Assunta
A1 Bonavita, Simona
A1 Brescia Morra, Vincenzo
A1 Bruno Bossio, Roberto
A1 Capello, Elisabetta
A1 Castelli, Letizia
A1 Cavalla, Paola
A1 Costantino, Gianfranco
A1 Centonze, Diego
A1 Cottone, Salvatore
A1 Danni, Maura Chiara
A1 Esposito, Federica
A1 Gajofatto, Alberto
A1 Gasperini, Claudio
A1 Guareschi, Angelica
A1 Lanzillo, Roberta
A1 Lus, Giacomo
A1 Maniscalco, Giorgia Teresa
A1 Matta, Manuela
A1 Paolicelli, Damiano
A1 Petrucci, Loredana
A1 Pontecorvo, Simona
A1 Righini, Isabella
A1 Rovaris, Marco
A1 Sessa, Edoardo
A1 Spinicci, Gabriella
A1 Spitaleri, Daniele
A1 Valentino, Paola
A1 Zaffaroni, Mauro
A1 Zappia, Mario
A1 Patti, Francesco
YR 2020
UL http://jnnp.bmj.com/content/91/9/914.abstract
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.