Ziemssen, Tjalf2; Bajenaru, Ovidiu A2; Carrá, Adriana2; de Klippel, Nina2; de Sá, João C2; Edland, Astrid2; Frederiksen, Jette L1; Heinzlef, Olivier2; Karageorgiou, Klimentini E2; Lander Delgado, Rafael H2; Landtblom, Anne-Marie2; Macías Islas, Miguel A2; Tubridy, Niall2; Gilgun-Sherki, Yossi2
1 Neurologisk Klinik, Neurocentret, Rigshospitalet, The Capital Region of Denmark2 unknown
the COPTIMIZE trial
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.
Journal of Neurology, 2014, Vol 261, Issue 11, p. 2101-11
Journal Article; Multicenter Study; Observational Study; Research Support, Non-U.S. Gov't