Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: A 18-month multicentre study: Journal of Neurology, Neurosurgery and Psychiatry

C.G. Chisari, C. Solaro, P. Annunziata, R. Bergamaschi, A. Bianco, S. Bonavita, V. Brescia Morra, R. Bruno Bossio, E. Capello, L. Castelli, P. Cavalla, G. Costantino, D. Centonze, S. Cottone, M.C. Danni, F. Esposito, A. Gajofatto, C. Gasperini, A. Guareschi, R. LanzilloG. Lus, G.T. Maniscalco, M. Matta, D. Paolicelli, L. Petrucci, S. Pontecorvo, I. Righini, M. Rovaris, E. Sessa, G. Spinicci, D. Spitaleri, P. Valentino, M. Zaffaroni, M. Zappia, F. Patti

Research output: Contribution to journalArticlepeer-review

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 languageEnglish
Pages (from-to)914-920
Number of pages7
JournalJ. Neurol. Neurosurg. Psychiatry
Volume91
Issue number9
DOIs
Publication statusPublished - 2020

Keywords

  • nabiximols
  • cannabidiol
  • dronabinol
  • adult
  • adverse event
  • Article
  • clinical outcome
  • disease registry
  • drug efficacy
  • drug withdrawal
  • female
  • human
  • major clinical study
  • male
  • multicenter study
  • multiple sclerosis
  • numeric rating scale
  • observational study
  • prediction
  • priority journal
  • prospective study
  • treatment duration
  • clinical trial
  • drug combination
  • middle aged
  • patient compliance
  • time factor
  • treatment outcome
  • treatment withdrawal
  • Adult
  • Cannabidiol
  • Dronabinol
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multiple Sclerosis
  • Patient Compliance
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • Withholding Treatment

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