Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria
Abstract Background and purpose Randomized controlled trials and observational studies of nabiximols oromucosal spray in patients with multiple sclerosis (MS) spasticity have shown improvement in a range of associated symptoms (pain, spasms, fatigue, bladder dysfunction, and sleep disturbances). Thi...
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| Format: | Article |
| Language: | English |
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Wiley
2023-04-01
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| Series: | Brain and Behavior |
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| Online Access: | https://doi.org/10.1002/brb3.2947 |
| _version_ | 1797821215779323904 |
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| author | Michael Guger Robert Hatschenberger Fritz Leutmezer |
| author_facet | Michael Guger Robert Hatschenberger Fritz Leutmezer |
| author_sort | Michael Guger |
| collection | DOAJ |
| description | Abstract Background and purpose Randomized controlled trials and observational studies of nabiximols oromucosal spray in patients with multiple sclerosis (MS) spasticity have shown improvement in a range of associated symptoms (pain, spasms, fatigue, bladder dysfunction, and sleep disturbances). This study evaluated the effectiveness and tolerability of add‐on nabiximols in the routine management of patients with MS spasticity in Austria, with a focus on spasticity‐associated symptoms. Methods This was an open, prospective, multicenter, observational, non‐interventional study of patients with MS spasticity receiving add‐on treatment with nabiximols oromucosal spray. Main endpoints were patient‐reported changes from baseline in the frequency (counts) or severity (mean Numerical Rating Scale [NRS] scores) of spasticity‐associated symptoms, and patient‐reported changes from baseline in impairment of daily activities due to spasticity, after 1 and 3 months of nabiximols treatment. No analyses were conducted for statistical significance. Results There were 55 patients in the effectiveness population, and 62 in the safety population. Patients reported clinically relevant reductions from baseline to month 3 in the average number of spasms/day (−68.2%) and number of urinary incontinence episodes (−69.3%) in the week prior to the clinic visit, and reductions in mean 0−10 NRS scores for sleep impairment (−47.2%), fatigue (−26.4%), pain (40.4%), and spasticity severity (39.0%). There was no change from baseline in daily activity impairment due to spasticity. The majority of patients were at least partly satisfied with add‐on nabiximols for spasticity‐associated symptoms. There were 31 adverse events (27 treatment related) reported in 19 patients, with no new safety signals. Conclusions Add‐on nabiximols improved the severity of MS spasticity and a range of spasticity‐associated symptoms during real‐world use in Austria. Nabiximols is an option for patients with MS spasticity who fail first‐line oral antispasticity treatment. |
| first_indexed | 2024-03-13T09:49:30Z |
| format | Article |
| id | doaj.art-56b987ad75cc44da85548cded692f9e7 |
| institution | Directory Open Access Journal |
| issn | 2162-3279 |
| language | English |
| last_indexed | 2024-03-13T09:49:30Z |
| publishDate | 2023-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Brain and Behavior |
| spelling | doaj.art-56b987ad75cc44da85548cded692f9e72023-05-24T14:27:20ZengWileyBrain and Behavior2162-32792023-04-01134n/an/a10.1002/brb3.2947Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in AustriaMichael Guger0Robert Hatschenberger1Fritz Leutmezer2Department of Neurology Pyhrn‐Eisenwurzen Klinikum Steyr Steyr AustriaDepartment of Neurology Klinikum Bad Hall and Bad Schallerbach Bad Schallerbach AustriaDepartment of Neurology Medical University Vienna Vienna AustriaAbstract Background and purpose Randomized controlled trials and observational studies of nabiximols oromucosal spray in patients with multiple sclerosis (MS) spasticity have shown improvement in a range of associated symptoms (pain, spasms, fatigue, bladder dysfunction, and sleep disturbances). This study evaluated the effectiveness and tolerability of add‐on nabiximols in the routine management of patients with MS spasticity in Austria, with a focus on spasticity‐associated symptoms. Methods This was an open, prospective, multicenter, observational, non‐interventional study of patients with MS spasticity receiving add‐on treatment with nabiximols oromucosal spray. Main endpoints were patient‐reported changes from baseline in the frequency (counts) or severity (mean Numerical Rating Scale [NRS] scores) of spasticity‐associated symptoms, and patient‐reported changes from baseline in impairment of daily activities due to spasticity, after 1 and 3 months of nabiximols treatment. No analyses were conducted for statistical significance. Results There were 55 patients in the effectiveness population, and 62 in the safety population. Patients reported clinically relevant reductions from baseline to month 3 in the average number of spasms/day (−68.2%) and number of urinary incontinence episodes (−69.3%) in the week prior to the clinic visit, and reductions in mean 0−10 NRS scores for sleep impairment (−47.2%), fatigue (−26.4%), pain (40.4%), and spasticity severity (39.0%). There was no change from baseline in daily activity impairment due to spasticity. The majority of patients were at least partly satisfied with add‐on nabiximols for spasticity‐associated symptoms. There were 31 adverse events (27 treatment related) reported in 19 patients, with no new safety signals. Conclusions Add‐on nabiximols improved the severity of MS spasticity and a range of spasticity‐associated symptoms during real‐world use in Austria. Nabiximols is an option for patients with MS spasticity who fail first‐line oral antispasticity treatment.https://doi.org/10.1002/brb3.2947multiple sclerosisnabiximolsobservational studyspasticity‐associated symptoms |
| spellingShingle | Michael Guger Robert Hatschenberger Fritz Leutmezer Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria Brain and Behavior multiple sclerosis nabiximols observational study spasticity‐associated symptoms |
| title | Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria |
| title_full | Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria |
| title_fullStr | Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria |
| title_full_unstemmed | Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria |
| title_short | Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria |
| title_sort | non interventional prospective observational study on spasticity associated symptom control with nabiximols as add on therapy in patients with multiple sclerosis spasticity in austria |
| topic | multiple sclerosis nabiximols observational study spasticity‐associated symptoms |
| url | https://doi.org/10.1002/brb3.2947 |
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