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A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.

Ziemssen T, Bajenaru OA, Carrá A, de Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, Landtblom AM, Macías Islas MA, Tubridy N, Gilgun-Sherki Y - J. Neurol. (2014)

Bottom Line: Studies suggest that patients with relapsing-remitting multiple sclerosis (RRMS) who do not benefit from other disease-modifying treatments (DMTs) may benefit from converting to glatiramer acetate (GA).Patients improved significantly (p < 0.05) on measures of fatigue, quality of life, depression, and cognition; mobility scores remained stable.The results indicate that changing RRMS patients to GA is associated with positive treatment outcomes.

View Article: PubMed Central - PubMed

Affiliation: Neurologische Universitätsklinik, Klinikum Carl Gustav Carus, Fetscherstraße 74, 01307, Dresden, Germany, Tjalf.Ziemssen@uniklinikum-dresden.de.

ABSTRACT
Studies suggest that patients with relapsing-remitting multiple sclerosis (RRMS) who do not benefit from other disease-modifying treatments (DMTs) may benefit from converting to glatiramer acetate (GA). COPTIMIZE was a 24-month observational study designed to assess the disease course of patients converting to GA 20 mg daily from another DMT. Eligible patients had converted to GA and had received prior DMT for 3-6 months, depending on the reasons for conversion. Patients were assessed at baseline and at 6, 12, 18, and 24 months. In total, 672 patients from 148 centers worldwide were included in the analysis. Change of therapy to GA was prompted primarily by lack of efficacy (53.6 %) or intolerable adverse events (AEs; 44.8 %). Over a 24-month period, 72.7 % of patients were relapse free. Mean annual relapse rate decreased from 0.86 [95 % confidence interval (CI) 0.81-0.91] before the change to 0.32 (95 % CI 0.26-0.40; p < 0.0001) at last observation, while the progression of disability was halted, as the Kurtzke Expanded Disability Status Scale (EDSS) scores remained stable. Patients improved significantly (p < 0.05) on measures of fatigue, quality of life, depression, and cognition; mobility scores remained stable. The results indicate that changing RRMS patients to GA is associated with positive treatment outcomes.

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Related in: MedlinePlus

a Change in Expanded Disability Status Scale (EDSS) score in patients converted to glatiramer acetate, by the reason for the conversion. b Change in fatigue score (Modified Fatigue Impact Scale) in patients converted to glatiramer acetate, by the reason for the conversion. c Change in quality of life score (Functional Assessment of Multiple Sclerosis) in patients converted to glatiramer acetate, by the reason for the conversion. d Change in depression score (Center for Epidemiological Studies Depression Scale) in patients converted to glatiramer acetate, by the reason for the conversion. e Change in cognition score (paced auditory serial addition test) in converting patients by the reason for the conversion
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Fig4: a Change in Expanded Disability Status Scale (EDSS) score in patients converted to glatiramer acetate, by the reason for the conversion. b Change in fatigue score (Modified Fatigue Impact Scale) in patients converted to glatiramer acetate, by the reason for the conversion. c Change in quality of life score (Functional Assessment of Multiple Sclerosis) in patients converted to glatiramer acetate, by the reason for the conversion. d Change in depression score (Center for Epidemiological Studies Depression Scale) in patients converted to glatiramer acetate, by the reason for the conversion. e Change in cognition score (paced auditory serial addition test) in converting patients by the reason for the conversion

Mentions: Data on 399 patients with at least one confirmed EDSS progression after baseline examination were evaluated. The proportion of patients without confirmed progression (343/399 patients, 86.0 %) was significantly higher than with confirmed progression (56/399 patients; 14.0 %; p < 0.0001, binominal-test with H0 proportion = 50 %). When analyzed by reason for conversion only, patients who converted because of intolerable AEs had a significant increase in EDSS from baseline (+0.17; p = 0.0265, Fig. 4a) but there was no significant difference between the values in the two groups.Fig. 4


A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.

Ziemssen T, Bajenaru OA, Carrá A, de Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, Landtblom AM, Macías Islas MA, Tubridy N, Gilgun-Sherki Y - J. Neurol. (2014)

a Change in Expanded Disability Status Scale (EDSS) score in patients converted to glatiramer acetate, by the reason for the conversion. b Change in fatigue score (Modified Fatigue Impact Scale) in patients converted to glatiramer acetate, by the reason for the conversion. c Change in quality of life score (Functional Assessment of Multiple Sclerosis) in patients converted to glatiramer acetate, by the reason for the conversion. d Change in depression score (Center for Epidemiological Studies Depression Scale) in patients converted to glatiramer acetate, by the reason for the conversion. e Change in cognition score (paced auditory serial addition test) in converting patients by the reason for the conversion
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4221652&req=5

Fig4: a Change in Expanded Disability Status Scale (EDSS) score in patients converted to glatiramer acetate, by the reason for the conversion. b Change in fatigue score (Modified Fatigue Impact Scale) in patients converted to glatiramer acetate, by the reason for the conversion. c Change in quality of life score (Functional Assessment of Multiple Sclerosis) in patients converted to glatiramer acetate, by the reason for the conversion. d Change in depression score (Center for Epidemiological Studies Depression Scale) in patients converted to glatiramer acetate, by the reason for the conversion. e Change in cognition score (paced auditory serial addition test) in converting patients by the reason for the conversion
Mentions: Data on 399 patients with at least one confirmed EDSS progression after baseline examination were evaluated. The proportion of patients without confirmed progression (343/399 patients, 86.0 %) was significantly higher than with confirmed progression (56/399 patients; 14.0 %; p < 0.0001, binominal-test with H0 proportion = 50 %). When analyzed by reason for conversion only, patients who converted because of intolerable AEs had a significant increase in EDSS from baseline (+0.17; p = 0.0265, Fig. 4a) but there was no significant difference between the values in the two groups.Fig. 4

Bottom Line: Studies suggest that patients with relapsing-remitting multiple sclerosis (RRMS) who do not benefit from other disease-modifying treatments (DMTs) may benefit from converting to glatiramer acetate (GA).Patients improved significantly (p < 0.05) on measures of fatigue, quality of life, depression, and cognition; mobility scores remained stable.The results indicate that changing RRMS patients to GA is associated with positive treatment outcomes.

View Article: PubMed Central - PubMed

Affiliation: Neurologische Universitätsklinik, Klinikum Carl Gustav Carus, Fetscherstraße 74, 01307, Dresden, Germany, Tjalf.Ziemssen@uniklinikum-dresden.de.

ABSTRACT
Studies suggest that patients with relapsing-remitting multiple sclerosis (RRMS) who do not benefit from other disease-modifying treatments (DMTs) may benefit from converting to glatiramer acetate (GA). COPTIMIZE was a 24-month observational study designed to assess the disease course of patients converting to GA 20 mg daily from another DMT. Eligible patients had converted to GA and had received prior DMT for 3-6 months, depending on the reasons for conversion. Patients were assessed at baseline and at 6, 12, 18, and 24 months. In total, 672 patients from 148 centers worldwide were included in the analysis. Change of therapy to GA was prompted primarily by lack of efficacy (53.6 %) or intolerable adverse events (AEs; 44.8 %). Over a 24-month period, 72.7 % of patients were relapse free. Mean annual relapse rate decreased from 0.86 [95 % confidence interval (CI) 0.81-0.91] before the change to 0.32 (95 % CI 0.26-0.40; p < 0.0001) at last observation, while the progression of disability was halted, as the Kurtzke Expanded Disability Status Scale (EDSS) scores remained stable. Patients improved significantly (p < 0.05) on measures of fatigue, quality of life, depression, and cognition; mobility scores remained stable. The results indicate that changing RRMS patients to GA is associated with positive treatment outcomes.

Show MeSH
Related in: MedlinePlus