Time course of glatiramer acetate efficacy in patients with RRMS in the GALA study
| Autor: | Mat D. Davis, Volker Knappertz, Joshua R. Steinerman, Natalia Ashtamker |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
business.industry Treatment difference Gastroenterology Article Clinical trial 03 medical and health sciences 0302 clinical medicine Neurology Internal medicine Post-hoc analysis Time course T2 lesions Medicine Treatment effect In patient 030212 general & internal medicine Neurology (clinical) Glatiramer acetate business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Neurology® Neuroimmunology & Neuroinflammation |
| ISSN: | 2332-7812 |
| DOI: | 10.1212/nxi.0000000000000327 |
| Popis: | Objective:To determine the time to efficacy onset of glatiramer acetate (GA) 40 mg/mL 3-times-weekly formulation (GA40).Methods:This post hoc analysis of data from the 1-year, double-blind, placebo-controlled phase of the Glatiramer Acetate Low-Frequency Administration study (NCT01067521) of GA40 in patients with relapsing-remitting MS (RRMS) sought to determine the timing of efficacy onset using a novel data-censoring approach.Results:Compared with placebo-treated patients, those receiving GA40 exhibited a >30% reduction in the accumulated annualized relapse rate (ARR) within 2 months of initiating treatment and generally sustained this treatment difference during the 1-year study. Similarly, the proportion of GA40-treated patients who remained relapse-free was distinctly greater by month 2 and continued to increase up to a 10.8% difference at the end of the study. In addition, GA40 treatment was associated with a significant reduction in the number of gadolinium-enhancing T1 lesions and new/enlarging T2 lesions by month 6, with full treatment effect observed after 1 year.Conclusions:GA40 contributes to efficacy within 2 months of the start of treatment in patients with RRMS. These results are consistent with the observed time to efficacy onset for patients treated with GA 20 mg/mL daily in previous randomized, placebo-controlled clinical trials.Classification of evidence:This study provides Class II evidence that for patients with RRMS, a 3-times-weekly formulation of GA 40 mg/mL leads to a >30% reduction in the ARR within 2 months. |
| Databáze: | OpenAIRE |
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