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

Tjalf Ziemssen,Klimentini E Karageorgiou,Adriana Carrá,João C De Sá,Jette L Frederiksen,Ovidiu A Bajenaru,Nina De Klippel,Olivier Heinzlef,Niall Tubridy,Yossi Gilgun-Sherki,Astrid Edland,Miguel A Macías Islas,Anne-Marie Landtblom,Rafael H Lander Delgado

doi:10.1007/s00415-014-7446-0

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.

Highlights

Multiple sclerosis (MS) is a chronic, progressive, autoimmune diffuse inflammatory disease of the central nervous system [1]
The results indicate that changing relapsing-remitting multiple sclerosis (RRMS) patients to glatiramer acetate (GA) is associated with positive treatment outcomes
A change of therapy to GA was prompted primarily by lack of efficacy (343/640; 53.6 %) or intolerable adverse events (AEs) (287/640; 44.8 %), caused by the corresponding premedication. [Note: The number of patients who changed to GA due to a lack of efficacy (343) and the number that changed due to AEs (287) sums to 630, not 640, as there are multiple reasons aside from these two that were cited by patients for changing therapy]

Summary

Introduction

Multiple sclerosis (MS) is a chronic, progressive, autoimmune diffuse inflammatory disease of the central nervous system [1]. The disease and the efficacy of MS treatments were measured by the extent to which clinical progression was slowed or halted, using relapse rates or the progression of disability [2, 3]. At least 30 % of patients show a suboptimal response to first-line disease-modifying treatments (DMTs) for relapsing-remitting multiple sclerosis (RRMS) during the first year of treatment [5]. One study analyzed whether the first relapse and time from the first to second relapse would be able to predict treatment failure [14]. None of these criteria has proved useful in determining whether a patient would benefit from a treatment change

Methods

Results

Conclusion