Contributions
Abstract: EP1560
Type: ePoster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Background: This non-interventional study (NIS) aimed to assess the efficacy and tolerability of Glatiramer acetate (GA) with focus on spasticity under everyday conditions. While occurring in approx. 80% of patients with strong impact often, spasticity assessment is difficult, insensitive and time-consuming.
Goals: Objectives were to measure efficacy and tolerability in patients suffering from multiple sclerosis (MS) under routine clinical conditions using established parameters including disease activity and quality of life (QoL) together with MS Spasticity Scale (MSSS88) and Ashworth scale in remitting relapsing MS (RRMS) patients treated with GA.
Methods: An open-label NIS in RRMS outpatients suffering spasticity at least grade 1 on a Modified Ashworth Scale was performed to document demographics, anamnesis, and course of disease with respect to spasticity, QoL, and safety/tolerability.
Results: 305 patients were treated with 20 mg/mL GA daily.
The number of relapse free patients increased from 66.53% in the year before the study to 76.21% (p=0.0114; n=248) during study in all patients, 67.16% to 71.64% (p=0.5127; n=67) after switch to GA and 63.35% to 77.64% (p=0.0043; n=161) in naïve patients.
Mean Ashworth score (n=229, LOCF) improved from 1.2±0.42 (95% CI 1.15-1.26) to 1.12±0.54 (95% CI 1.05-1.19) (p=0.0079) during the course of the study (12 month). Approx. 22% of patients showed an “improvement”.
The mean value using MSSS-88 scale (n=241, LOCF) was 1.73±0.62 (95% CI 1.65-1.81) at baseline and 1.72±0.62 (95% CI 1.64-1.80) after 12 months and remained stable comparable in all subgroups. Subscale improvements were most pronounced for emotional health (46.47%), pain/discomfort (41.91%), and muscle stiffness (41.08%).
Self-reported health status based on EQ-5D improved or remained stable in approx. 80% of patients (n=226).
Pearson correlation showed a linear, highly significant correlation at baseline between the EQ-5D visual analog scale (VAS) and the MSSS88 (r=-0.611; p< 0.0001; n=236).
The tolerability of GA was rated as either “very good” or “good” in >90% of patients. Adverse events were reported by 10.5% of patients, mostly injection side reactions.
Conclusions: Mild spastic symptoms didn"t show progression using GA in RRMS patients using ARR, Ashworth and EQ-5D/VAS score. These results were in accordance with burden of MS measured by the more detail-sensitive MSSS88, qualifying this tool for future evaluations of spasticity of RRMS patients.
Disclosure: Michael Haupts received since 2013 fees for presentations, studies and reimbursements from Allmirall, Bayer Healthcare, BiogenIdec, Merck Serono, Novartis Pharma, TEVA Pharma.
Uwe Faude und Daniel Fendji: nothing to disclose
Abstract: EP1560
Type: ePoster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Background: This non-interventional study (NIS) aimed to assess the efficacy and tolerability of Glatiramer acetate (GA) with focus on spasticity under everyday conditions. While occurring in approx. 80% of patients with strong impact often, spasticity assessment is difficult, insensitive and time-consuming.
Goals: Objectives were to measure efficacy and tolerability in patients suffering from multiple sclerosis (MS) under routine clinical conditions using established parameters including disease activity and quality of life (QoL) together with MS Spasticity Scale (MSSS88) and Ashworth scale in remitting relapsing MS (RRMS) patients treated with GA.
Methods: An open-label NIS in RRMS outpatients suffering spasticity at least grade 1 on a Modified Ashworth Scale was performed to document demographics, anamnesis, and course of disease with respect to spasticity, QoL, and safety/tolerability.
Results: 305 patients were treated with 20 mg/mL GA daily.
The number of relapse free patients increased from 66.53% in the year before the study to 76.21% (p=0.0114; n=248) during study in all patients, 67.16% to 71.64% (p=0.5127; n=67) after switch to GA and 63.35% to 77.64% (p=0.0043; n=161) in naïve patients.
Mean Ashworth score (n=229, LOCF) improved from 1.2±0.42 (95% CI 1.15-1.26) to 1.12±0.54 (95% CI 1.05-1.19) (p=0.0079) during the course of the study (12 month). Approx. 22% of patients showed an “improvement”.
The mean value using MSSS-88 scale (n=241, LOCF) was 1.73±0.62 (95% CI 1.65-1.81) at baseline and 1.72±0.62 (95% CI 1.64-1.80) after 12 months and remained stable comparable in all subgroups. Subscale improvements were most pronounced for emotional health (46.47%), pain/discomfort (41.91%), and muscle stiffness (41.08%).
Self-reported health status based on EQ-5D improved or remained stable in approx. 80% of patients (n=226).
Pearson correlation showed a linear, highly significant correlation at baseline between the EQ-5D visual analog scale (VAS) and the MSSS88 (r=-0.611; p< 0.0001; n=236).
The tolerability of GA was rated as either “very good” or “good” in >90% of patients. Adverse events were reported by 10.5% of patients, mostly injection side reactions.
Conclusions: Mild spastic symptoms didn"t show progression using GA in RRMS patients using ARR, Ashworth and EQ-5D/VAS score. These results were in accordance with burden of MS measured by the more detail-sensitive MSSS88, qualifying this tool for future evaluations of spasticity of RRMS patients.
Disclosure: Michael Haupts received since 2013 fees for presentations, studies and reimbursements from Allmirall, Bayer Healthcare, BiogenIdec, Merck Serono, Novartis Pharma, TEVA Pharma.
Uwe Faude und Daniel Fendji: nothing to disclose