Spasticity in patients with multiple sclerosis - clinical characteristics, treatment and quality of life

Flachenecker, Peter; Henze, Thomas; Zettl, Uwe K.

doi:10.1111/ane.12202

Cited by 106 publications

(86 citation statements)

References 21 publications

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“…However, many patients fail to respond adequately to these classical medications at tolerable doses or they become resistant to treatment. Burden of disease studies have identified considerable scope to improve further the management and well-being of patients with MS spasticity across Europe [12,13]. …”

Section: Introductionmentioning

confidence: 99%

Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study

Trojano¹,

Vila²

2015

Eur Neurol

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Background: The prospective, non-interventional Mobility Improvement (MOVE) 2 study was designed to provide real life data on clinical outcomes of patients with treatment-resistant multiple sclerosis (MS) spasticity receiving routine treatment with tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®), subsequent to its approval in European countries. Methods: This interim analysis reports on MOVE 2 patients from Italy. Results: Interim data from 322 patients (58.3% female; mean age 51.1 ± 10.2 years) were analyzed. From baseline to month 3 of treatment (Visit 3), the mean 0-10 Numerical Rating Scale (NRS) score decreased by -19.1% (-1.6 points, p < 0.0001) and the mean modified Ashworth score decreased from 2.6 to 2.3 points (p < 0.0001). At Visit 3, 24.6% of 203 patients with available data were clinically relevant responders (≥30% improvement from baseline NRS score; p < 0.001 vs. baseline). The mean reported dose of THC:CBD oromucosal spray was 6.1 ± 2.5 sprays/day at Visit 1 (1 month) and 5.1 ± 2.6 sprays/day at Visit 3 (range 1-12 sprays/day at both timepoints). Forty-one (13.1%) patients reported at least one adverse event (AE), which included 3 serious AEs (1 unrelated). AEs with an incidence ≥1% were dizziness (5.6%), confusion (2.5%), nausea (1.25%) and somnolence (1.25%). Conclusion: In everyday clinical practice in Italy, THC:CBD oromucosal spray provided symptomatic relief of MS spasticity with good tolerability in a relevant number of previously resistant patients.

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Section: Introductionmentioning

confidence: 99%

Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study

Trojano¹,

Vila²

2015

Eur Neurol

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“…The epidemiological burden of disease MOVE (MObility ImproVEment) 1 study from Germany reported that MS-related spasticity impaired patients' personal well-being and QoL, and that patients and physicians were largely dissatisfied with pharmacological options for spasticity [1]. Using a protocol similar to that of the German study, MOVE 1 was extended to other European countries; 300 patients were recruited from 32 centers in seven countries: Belgium, Finland, France, Ireland, Norway, Poland and Portugal [2].…”

Section: Ms Spasticity ‘Burden Of Disease' In Europementioning

confidence: 99%

“…Associated symptoms such as spasms, pain and sleep disturbances combine to impact negatively on QoL. Cross-sectional studies from Europe have indicated that advancing severity of MS spasticity correlates directly with worsening QoL [1,3,4]. …”

Section: Impact Of Thc:cbd Oromucosal Spray On Daily Activities and Qmentioning

confidence: 99%

Clinical Case Reviews and Poster Sessions in Multiple Sclerosis Spasticity: Main Outcomes and Highlights

Trojano

Celius²,

Donzé³

et al. 2014

Eur Neurol

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Background: Individuals with multiple sclerosis (MS) spasticity present with a range of symptoms and disability levels that are frequently challenging to manage. Summary: Clinical case reviews in treatment-resistant MS spasticity were presented in five country-specific sessions conducted in parallel at the MS Experts Summit. Attendees at the Norwegian session discussed early response to new treatments for severe spasticity and highlighted the importance of titrating THC:CBD oromucosal spray (Sativex®) when adding it to baclofen. The French group focussed on MS symptoms and patient characteristics that interact with spasticity and agreed on a list of minimum ratings for diagnosis of MS spasticity symptoms. Attendees at the Spanish session concurred that THC:CBD oromucosal spray is effective and well tolerated as add-on therapy in treatment-resistant MS spasticity, particularly for pain, spasms and gait disturbances. The Italian group discussed the use of add-on THC:CBD oromucosal spray and other possible combination therapies for treatment-resistant MS spasticity. Attendees at the German session highlighted the need to address trigger factors for MS spasticity to reduce the potential for impact on activities of daily living (ADL) and quality of life (QoL). Three innovative studies of MS spasticity from the poster session were selected for closer review. The MOVE 1 EU epidemiological study indicated that, across western Europe, patients with MS spasticity continue to have unmet management needs. A literature review demonstrated that symptomatic relief of MS spasticity in patients who respond to THC:CBD oromucosal spray translates into sustainable improvements in ADL and QoL. Enriched-design studies of medications targeting the endocannabinoid system require careful interpretation due to possible pharmacodynamic ‘priming', i.e. carry-over effects of successful active treatment during the enrichment phase. Key Messages: Sharing experiences of clinical practice, including experience with the use of THC:CBD oromucosal spray, may be useful to overcome some of the challenges in the overall management of patients with moderate to severe treatment-resistant MS spasticity.

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“…Although there is considerable heterogeneity in its clinical expression [5], spasticity is frequently associated with bladder dysfunction, pain and sleep disturbances [3]. In a relevant proportion of patients, spasticity contributes to mobility restrictions and interferes with a wide range of daily activities, increasing the burden of disease for MS patients and their carers [6][7][8]. Worsening spasticity is associated with an increasingly negative impact on health-related quality of life [6,9,10] and higher utilization of healthcare resources [3,10,11].…”

mentioning

confidence: 99%

“…However, good quality evidence regarding their relative efficacy and safety is lacking [13] and many patients with MS spasticity do not respond, do not tolerate or become resistant to their antispasticity medications. Recent burden of disease studies from around Europe reported an overall low level of satisfaction among physicians and patients with available oral pharmacotherapy options for MS spasticity [6,7]. Thus, a need remains for effective options to treat spasticity in MS patients with inadequate symptomatic relief [6,7].…”

mentioning

confidence: 99%

Effect of Sativex on spasticity-associated symptoms in patients with multiple sclerosis

Meuth

Vila

Dechant³

2015

Expert Review of Neurotherapeutics

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Individuals with multiple sclerosis (MS) spasticity may experience a range of symptoms, such as bladder dysfunction, pain, impaired sleep quality and mobility restrictions that worsen as spasticity severity increases. In this review, the effects of Sativex(®) oromucosal spray on symptoms and functional impairment associated with MS-related spasticity were examined. Across Sativex studies, there was a clear trend for improvement in spasticity-associated symptoms that was more pronounced and sustained over time in Sativex responders. Meaningful symptomatic improvement was achieved within the recommended dosage limit of ≤12 sprays per day. In appropriate patients, Sativex has the potential to minimize the consequences of spasticity-related symptoms on quality of life and reduce the economic burden on healthcare systems.

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Spasticity in patients with multiple sclerosis - clinical characteristics, treatment and quality of life

Abstract: Spasticity and its symptoms impair personal well-being and quality-of-life. Treatment of spasticity with drugs and physiotherapy is common, but satisfaction with the currently available anti-spastic pharmacotherapy is low.

Cited by 106 publications

References 21 publications

Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study

Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study

Clinical Case Reviews and Poster Sessions in Multiple Sclerosis Spasticity: Main Outcomes and Highlights

Effect of Sativex on spasticity-associated symptoms in patients with multiple sclerosis

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