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Mult Scler. 2017 May;23(6):818-829. doi: 10.1177/1352458516664033. Epub 2016 Aug 8.

Efficacy and safety of a three-times-weekly dosing regimen of glatiramer acetate in relapsing-remitting multiple sclerosis patients: 3-year results of the Glatiramer Acetate Low-Frequency Administration open-label extension study.

Author information

1
The Sastry Foundation Advanced Imaging Laboratory & Multiple Sclerosis Center, Department of Neurology, Wayne State University School of Medicine, Detroit, MI, USA.
2
Department of Neurology, Bamberg Academic Hospital, University of Erlangen, Bamberg, Germany.
3
Department of Neurology, Neurosurgery and Medical Genetic of the Pirogov's Russian National Research Medical University and MS Clinic at the Usupov's Hospital, Moscow, Russia.
4
Department of Neurology, Medical University of Łódź, Łódź, Poland.
5
Teva Pharmaceutical Industries, Netanya, Israel.
6
Teva Pharmaceuticals, Frazer, PA, USA.
7
Teva Pharmaceuticals, Cleveland, OH, USA.
8
Department of Neurology, School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, NY, USA.

Abstract

BACKGROUND:

The 1-year placebo-controlled (PC) phase of the Glatiramer Acetate Low-Frequency Administration (GALA) study showed that glatiramer acetate 40 mg/mL three times weekly (GA40) significantly reduced annualized relapse rate (ARR) and magnetic resonance imaging (MRI) activity in patients with relapsing-remitting multiple sclerosis. Patients completing the PC phase were invited to an open-label (OL) extension.

OBJECTIVE:

To evaluate the effects of early start (ES) and delayed start (DS) of GA40 over 3 years.

METHODS:

A total of 97.2% of patients completing the PC phase received GA40 in the OL extension. ES ( n = 943) patients received GA40 throughout; DS ( n = 461) patients received placebo during the PC phase and GA40 during the OL phase. Relapse, MRI, disease progression, and safety were evaluated.

RESULTS:

A total of 1041 patients completed 3 years of follow-up. During the OL phase, ES and DS patients showed comparable ARRs (0.20-0.22) and similar numbers of gadolinium-enhancing T1 ( p = 0.49) and new or enlarging T2 lesions ( p = 0.51) at Year 3. ES patients showed significantly smaller changes in gray matter volume than DS patients from Months 12 to 36 (mean difference, 0.371%; p = 0.015), with similar trend in whole-brain volume ( p = 0.080). Adverse events were mild, consistent with the well-established glatiramer acetate (GA) safety profile.

CONCLUSION:

GA40 conferred treatment benefit over 3 years: sustained low ARR and lesion activity and favorable safety.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01067521.

KEYWORDS:

Glatiramer acetate; annualized relapse rate; low-frequency regimen; relapsing–remitting multiple sclerosis; safety

PMID:
27503905
DOI:
10.1177/1352458516664033
[Indexed for MEDLINE]

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