Predictors of Nabiximols (Sativex®) discontinuation over long-term follow-up: a real-life study

• Published in: Journal of neurology 2020-06, Vol.267 (6), p.1737-1743
• Main Authors: Carotenuto, Antonio, Costabile, Teresa, De Lucia, Mario, Moccia, Marcello, Falco, Fabrizia, Petruzzo, Martina, De Angelis, Marcello, Russo, Cinzia Valeria, Saccà, Francesco, Lanzillo, Roberta, Brescia Morra, Vincenzo
• Format: Article
• Language: English
• Subjects: Adult; Analgesics, Non-Narcotic - administration & dosage; Cannabidiol - administration & dosage; Cognitive ability; Cognitive Dysfunction - etiology; Dronabinol - administration & dosage; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Multiple sclerosis; Multiple Sclerosis - complications; Multiple Sclerosis - drug therapy; Multiple Sclerosis - physiopathology; Muscle Spasticity - drug therapy; Muscle Spasticity - etiology; Neurology; Neuroradiology; Neurosciences; Original Communication; Patient Compliance; Patient Dropouts; Retrospective Studies; Severity of Illness Index; Spasticity; Titration
• ISSN: 0340-5354; 1432-1459
• DOI: 10.1007/s00415-020-09739-x

Nabiximols is an effective treatment for spasticity in MS. However, treatment discontinuation over-time might occur and predictors of sustained treatment persistence over long-term follow-up in real-world settings are highly needed. We aim at evaluating baseline predictors of treatment persistence on Nabiximols. This is a retrospective real-world study including MS patients treated with Nabiximols. At baseline (Nabiximols prescription), we evaluated disability using the EDSS, and cognitive function using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS). Nabiximols discontinuation was evaluated after 4 weeks of treatment (“titration phase’’), and over the follow-up (“treatment phase”). We included 396 MS patients (228 females and 168 males). After 4 weeks (titration phase), 266 MS patients (67.2%) were considered persistent on treatment, while 130 patients dropped out. After 19 ± 21 months (treatment phase), 136 out of 266 MS patients (51.1%) were still on treatment, whereas 130 patients dropped at follow-up. Higher EDSS and cognitive impairment predicted treatment discontinuation at follow-up ( p  = 0.04 and p  = 0.005, respectively). In conclusion, higher physical and cognitive disability predicted Nabiximols treatment discontinuation over 2 years in MS patients suffering from spasticity. Nabiximols should be started earlier to decrease the likelihood of treatment discontinuation over time.