title: Long-term effectiveness of glatiramer acetate in clinical practice conditions.
abstract: Glatiramer acetate currently represents one of the main treatments for relapsing-remitting multiple sclerosis (RRMS). However, the information available about its long-term effect in clinical practice is still limited. Thus, this multicenter retrospective cohort study aimed to assess the long-term effectiveness of glatiramer acetate in this setting. The study population included RRMS patients treated with glatiramer acetate for at least 5 years after its marketing authorization and the primary endpoint was long-term clinical effectiveness, defined as absence of disability progression for at least five consecutive years. A total of 149 patients were included into the study, who had received glatiramer acetate for a mean of 6.9 ± 1.4 years (5 years, n=149; 6 years, n=112; 7 years, n=63; 8 years, n=32; 9 years, n=21). More than 85% of patients remained free from disability progression through years 1 to 9 of glatiramer acetate treatment, and 75.2% showed absence of disability progression for at least five consecutive years. Expanded Disability Status Scale (EDSS) scores were maintained, with most patients showing stable/improved EDSS and 92.6% sustaining EDSS <6. Decreased annual relapse rates and increased proportion of relapse-free patients were maintained during the whole glatiramer acetate treatment compared to the year prior to its authorization (p<0.001). The number of gadolinium-enhanced T1-weighted lesions also decreased from pre-glatiramer-acetate assessment to last follow-up whilst on glatiramer acetate (p<0.05). In conclusion, administration of glatiramer acetate shows long-term clinical effectiveness for RRMS treatment; its effect under clinical practice conditions slowed disability progression and reduced relapse occurrence for up to 9 years.
authors.affiliation: Neurology Service, Hospital Universitario Virgen de las Nieves, Avenida Juan Pablo II, S/N, 18013 Granada, Spain. Electronic address: tmearmen@hotmail.com.
authors.forename: Carmen
authors.initials: C
authors.lastname: Arnal-García
authors.affiliation: Neurology Department, Complexo Hospitalario de Pontevedra, Pontevedra, Spain.
authors.forename: Maria Del Campo
authors.initials: Mdel C
authors.lastname: Amigo-Jorrin
authors.affiliation: Neurology Department, Complexo Hospitalario Universitario de A Coruña, As Xubias, A Coruña, Spain.
authors.forename: Ana Maria
authors.initials: AM
authors.lastname: López-Real
authors.affiliation: Neurology Department, Complexo Hospitalario Universitario de A Coruña, As Xubias, A Coruña, Spain.
authors.forename: Carme
authors.initials: C
authors.lastname: Lema-Devesa
authors.affiliation: Medical Department, TEVA Pharmaceutical Ltd., Alcobendas, Spain.
authors.forename: Noemi
authors.initials: N
authors.lastname: Llopis
authors.affiliation: Medical Department, TEVA Pharmaceutical Ltd., Alcobendas, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Sanchez-de la Rosa
mesh_terms: D000328:Adult; D004185:Disability Evaluation; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D010455:Peptides / Q000627:therapeutic use*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate
keywords: Clinical practice; Disability; Glatiramer acetate; Long-term effectiveness; Multiple sclerosis; Relapse