ROBOLEO & CO

Author Of 2 Presentations

Clinical Outcome Measures Poster Presentation

P0042 - Clinical evolution of spasticity in adults with multiple sclerosis: systematic review (ID 1615)

Speakers
Presentation Number
P0042
Presentation Topic
Clinical Outcome Measures

Abstract

Background

Spasticity is a common symptom for people with multiple sclerosis (MS), occurring in >80% of MS patients and increasing in prevalence and severity throughout the disease course. Worsening spasticity is associated with pain, sleep disorders, further impaired mobility, bladder dysfunction and other symptoms, impacting negatively on quality of life and increasing health resource utilization and costs. Data showing evolution of spasticity over time appear limited and, when reported, often use non-validated categorical scales.

Objectives

To conduct a systematic review of published evidence on the prevalence and clinical evolution of MS-related spasticity.

Methods

Searches were conducted in bibliographic databases. Two reviewers selected articles according to pre-defined inclusion criteria. Data were extracted to describe the frequency of spasticity, and progression of spasticity severity.

Results

Four studies were eligible for inclusion including a total of 29,196 patients. Study design was either retrospective (n=3), or longitudinal (n=1). Study duration ranged from approximately three to 30 years. Study population, timeframe for evaluation and method of assessment of spasticity within the included studies were heterogeneous which precluded meta-analysis. Two studies reported symptom prevalence and severity (measured using categorical mild/moderate/severe scales) over time. Results demonstrated an increased proportion of patients with severe symptoms, despite treatment. A continuous decrease in the proportion of participants with milder severity was also reported. The remaining two studies reported the clinical evolution of spasticity over time. Both studies used the 0–10 numeric rating scale (NRS) (0 no spasticity to 10 worst possible spasticity) to measure change in spasticity: one compared symptoms pre- vs post-MS diagnosis split by relapse- and progressive-onset disease, and the other in patients with treatment-resistant (≤1 prior therapy) MS-related spasticity, indicated a deterioration in spasticity over time (1 to 3 years [mean 2.1 years], mean NRS 5.7 [1.9] to 5.9 [2.1]).

Conclusions

Few studies consider the evolution of MS spasticity over the longer term. While there was a high degree of variation between the included studies, all indicated a deterioration in MS spasticity symptoms over time despite available treatments. Tracking MS spasticity seems necessary in MS to inform clinical management.

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Clinical Outcome Measures Poster Presentation

P0078 - Evidence for the efficacy of nabiximols oromucosal spray in the management of patients with spasticity: A systematic review (ID 1609)

Speakers
Presentation Number
P0078
Presentation Topic
Clinical Outcome Measures

Abstract

Background

Spasticity is a common symptom for people with multiple sclerosis (MS), and increases in prevalence and severity throughout the disease course. Worsening spasticity is associated with impaired mobility and other symptoms and negatively impacts quality of life, increasing health resource utilization and costs. Nabiximols oromucosal spray, containing mainly tetrahydrocannabinol (THC) and cannabidiol (CBD), and also other CBD and non-CBD components is approved in >25 countries outside of the US as add-on therapy in people with moderate-to-severe MS spasticity who do not respond adequately to other antispasticity medications.

Objectives

To evaluate the efficacy and safety of nabiximols spray as add-on therapy to antispasticity treatment in people with moderate to severe treatment-resistant MS spasticity.

Methods

The review was undertaken following principles published by the Centre for Reviews and Dissemination. A comprehensive search of Medline, Embase, and Cochrane Library databases was conducted. Randomised controlled trials (RCTs) and non-randomised trials investigating the effect of adding nabiximols to standard antispasticity treatment in people with moderate-to-severe MS spasticity were included. Evaluated outcomes included proportion of patients with improvement (30%) in Numeric Rating Scale (NRS) spasticity, mean change in NRS spasticity, quality of life, adverse events. When appropriate data were pooled using meta-analysis.

Results

A total of 7 RCTs with 1,570 participants were eligible for inclusion. Studies scored low risk of bias. Of these studies, data from 4 studies (468 participants) evaluated nabiximols within the approved dose, 1–12 sprays/day: 2 (n=347) were appropriate for pooling (after a 4-week single-blind period, almost half of the enrolled participants met early response criterion [improvement of 20%, label condition] and were randomised). Of these early responders, a greater proportion of patients were clinically relevant responders (30% NRS improvement) with nabiximols than placebo at the end of a 12-week double-blind period (pooled: 75% vs 45%, RR 0.55 [0.33, 0.92]), with a statistically significant reduction in mean NRS spasticity (NRS 0-10) from baseline compared with placebo (pooled: mean difference -1.30 [-2.33, -0.27]). Adverse events were generally mild-to-moderate in severity, transient and rarely required treatment discontinuation. One systematic review of non-randomised studies was identified which reported results in line with those from RCTs.

Conclusions

Add-on nabiximols provides clinically relevant improvement of MS spasticity in patients who do not respond adequately to antispasticity medications both in clinical trial and daily practice settings.
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