title: A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.
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.
authors.affiliation: Neurologische Universitätsklinik, Klinikum Carl Gustav Carus, Fetscherstraße 74, 01307, Dresden, Germany, Tjalf.Ziemssen@uniklinikum-dresden.de.
authors.forename: Tjalf
authors.initials: T
authors.lastname: Ziemssen
authors.forename: Ovidiu A
authors.initials: OA
authors.lastname: Bajenaru
authors.forename: Adriana
authors.initials: A
authors.lastname: Carrá
authors.forename: Nina
authors.initials: N
authors.lastname: de Klippel
authors.forename: João C
authors.initials: JC
authors.lastname: de Sá
authors.forename: Astrid
authors.initials: A
authors.lastname: Edland
authors.forename: Jette L
authors.initials: JL
authors.lastname: Frederiksen
authors.forename: Olivier
authors.initials: O
authors.lastname: Heinzlef
authors.forename: Klimentini E
authors.initials: KE
authors.lastname: Karageorgiou
authors.forename: Rafael H
authors.initials: RH
authors.lastname: Lander Delgado
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Landtblom
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Macías Islas
authors.forename: Niall
authors.initials: N
authors.lastname: Tubridy
authors.forename: Yossi
authors.initials: Y
authors.lastname: Gilgun-Sherki
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D057915:Drug Substitution / Q000639:trends; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D038622:Internationality; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis* / Q000188:drug therapy*; D010455:Peptides / Q000627:therapeutic use*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D010455:Peptides; D000068717:Glatiramer Acetate