title: QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.
abstract: Treatment of symptoms and signs beyond the expanded disability status scale remains a major target in multiple sclerosis. QualiCOP was an observational, non-interventional, open-label study conducted at 170 sites in Germany. Of the 754 enrolled patients, 96 % had relapsing-remitting multiple sclerosis (MS) and were either disease-modifying therapy naïve (de novo, n = 481) or previously treated (n = 237) with once-daily, subcutaneous 20-mg/mL glatiramer acetate (GA). Assessments of relapse rate, disease progression, overall functioning, quality of life (QoL), cognition, fatigue, and depression were performed over 24 months. GA treatment over 24 months was associated with reduced annual relapse rate for previously treated (from 0.98 to 0.54 relapses) and de novo (from 0.81 to 0.48 relapses) patients. Multiple Sclerosis Functional Composite scores showed slight improvement in both cohorts (all p < 0.01). Paced Auditory Serial Addition Test and Multiple Sclerosis Inventory Cognition scale scores showed robust improvement in cognition among previously treated and de novo cohorts (all p < 0.001). General Depression Scale scores showed significantly reduced depressive symptoms (p < 0.001). Disease severity, fatigue, and QoL were stable over the observational period. These real-world findings suggest that patients with MS show benefit from GA treatment in important QoL parameters beyond standard measures of relapse and disease severity.
authors.affiliation: Center of Clinical Neuroscience, University Clinic Carl Gustav Carus, University of Technology Dresden, Fetscherstrasse 74, 01307, Dresden, Germany. tjalf.ziemssen@uniklinikum-dresden.de.
authors.forename: Tjalf
authors.initials: T
authors.lastname: Ziemssen
authors.affiliation: Division of Molecular and Cognitive Neuroscience, University of Basel, Basel, Switzerland.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Calabrese
authors.affiliation: Department of Cognitive Psychology and Methodology, University of Basel, Basel, Switzerland.
authors.forename: Iris-Katharina
authors.initials: IK
authors.lastname: Penner
authors.affiliation: Teva Deutschland, Berlin, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Apfel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018450:Disease Progression; D005260:Female; D000068717:Glatiramer Acetate / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012008:Recurrence; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000068717:Glatiramer Acetate
keywords: Cognition; Glatiramer acetate; Multiple sclerosis; Quality of life; Relapse rate; Relapsing-remitting