RT Journal Article
T1 A real-world evidence study of nabiximols in multiple sclerosis patients with resistant spasticity: Analysis in relation to the newly described 'spasticity-plus syndrome'.
A1 Patti, Francesco
A1 Grazia-Chisari, Clara
A1 Fernandez, Oscar
A1 Sarroca, Jorge
A1 Ferrer-Picon, Elena
A1 Hernandez-Vicente, Francisco
A1 Vila-Silvan, Carlos
K1 e-Registry analysis
K1 Multiple sclerosis
K1 Nabiximols
K1 Spasticity-plus syndrome
K1 Spasticity-related symptoms
AB Nabiximols is a therapeutic option for patients with multiple sclerosis (MS) spasticity whose symptoms are poorly controlled by conventional oral first-line medications. This study aimed to assess the relationship between changes in spasticity severity (measured on the 0-10 numeric rating scale [NRS]) and the presence of associated symptoms in patients treated with nabiximols, and to investigate the presence of the newly described 'spasticity-plus syndrome'. We analyzed real-world data from the Italian Medicines Agency e-Registry on 1138 patients with MS spasticity who began treatment with nabiximols. Evaluation time points were baseline, 4 weeks, and 3, 6, 12 and 18 months after treatment start. Common symptoms associated with MS spasticity in this cohort were pain (38.4% at baseline), sleep disturbances (32.7%), and spasms/cramps (28.5%). Pain was frequently clustered with sleep disturbances (57.2% of pain cases) and spasms/cramps (43.9%). Approximately one-third of patients with data at all evaluation time points maintained treatment at 18 months. Nabiximols reduced the baseline mean spasticity 0-10 NRS score by 24.6% at Week 4, and by 33.9% at 18 months in treatment continuers. Nabiximols resolved a range of MS spasticity-associated symptoms at Week 4, and after 18 months in treatment continuers. This real-world analysis supports the concept of a spasticity-plus syndrome and suggests that nabiximols can favorably impact a range of spasticity-associated symptoms.
PB John Wiley & Sons
YR 2022
FD 2022-04-29
LK http://hdl.handle.net/10668/19955
UL http://hdl.handle.net/10668/19955
LA en
NO Patti F, Chisari CG, Fernández Ó, Sarroca J, Ferrer-Picón E, Hernández Vicente F, et al. A real-world evidence study of nabiximols in multiple sclerosis patients with resistant spasticity: Analysis in relation to the newly described 'spasticity-plus syndrome'. Eur J Neurol. 2022 Sep;29(9):2744-2753
NO http://creativecommons.org/licenses/by-nc/4.0/
DS RISalud
RD Apr 5, 2025