ArticleNeurology(R) neuroimmunology & neuroinflammation2017
Time course of glatiramer acetate efficacy in patients with RRMS in the GALA study.
Article in Neurology(R) neuroimmunology & neuroinflammation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01067521 (A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis), which is not on this map. Cited by 5 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind Design
Who cites it
5 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model.Health technology assessment (Winchester, England) · 2026Pooled it
- Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2024Pooled it
- Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Investigation of pregnancy tendency, reproductive characteristics, and disability in women with multiple sclerosis: A secondary data analysis of the national registry in Iran.Current journal of neurology · 2024Article
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Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine the time to efficacy onset of glatiramer acetate (GA) 40 mg/mL 3-times-weekly formulation (GA40).
methodsThis 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.
resultsCompared 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.
conclusionsGA40 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.
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Registered trials
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