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Use of the combination of teriflunomide and glatiramer acetate for treating multiple sclerosis

A technology of glatiramer acetate and multiple sclerosis, which is applied in the direction of drug combinations, medical preparations containing active ingredients, organic active ingredients, etc., and can solve the undisclosed problems of effectiveness and safety in the treatment of multiple sclerosis

Inactive Publication Date: 2012-09-05
SANOFI AVENTIS US LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the above patent discloses that teriflunomide may be combined with other compounds known to be effective in the treatment of multiple sclerosis for the treatment of the disease, however, no specific combination exhibiting said efficacy and safety for the treatment of multiple sclerosis has been disclosed

Method used

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  • Use of the combination of teriflunomide and glatiramer acetate for treating multiple sclerosis
  • Use of the combination of teriflunomide and glatiramer acetate for treating multiple sclerosis
  • Use of the combination of teriflunomide and glatiramer acetate for treating multiple sclerosis

Examples

Experimental program
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Effect test

Embodiment 1

[0077] A placebo-controlled, randomized, double-blind study in relapsing-remitting multiple sclerosis patients coadministered with stable doses of glatiramer acetate. The subcutaneous dose of glatiramer acetate is 20 mg per day.

[0078] Approximately 40 patients were treated in each treatment group (placebo group: 41, 7 mg group: 42, and 14 mg group: 40). Demographic and baseline disease characteristics were essentially comparable among the 3 treatment groups. The mean age of the study population was 41.4 years. The majority of patients were women (78.9%) with relapsing-remitting MS (94.3%) who had been diagnosed with MS since about 8 years ago and about 41% of patients had no relapse in the previous year. Baseline Expanded Disability Status Scale (EDSS) scores were similar between treatment groups (approximately 2.5). 28.6% of patients in the 7 mg group had magnetic resonance imaging (MRI) disease activity (at least one T1-Gd lesion) at baseline, slightly more than the pl...

Embodiment 2

[0114] Design / Methods: Of the 123 patients randomized to study treatment during the first 6 months of Example 1 (placebo: 40; 7 mg: 42; 14 mg: 41), 96 completed The 6-month treatment period and agreed to continue dosing for another 6 months (placebo group: 37, 7 mg group: 30, 14 mg group: 29). Of the 96 treated patients, 5 patients withdrew from the study treatment prematurely (placebo group: 3, 7 mg group: 0, 14 mg group: 2). By TEAE, physical examination (every 6 weeks), laboratory data (every 6 weeks), vital signs (every 6 weeks), ECG (at study close-out visit), pancreatic ultrasound (at Safety was assessed by end-of-study follow-up) and brain MRI (at end-of-study follow-up). Relapses were recorded and EDSS was performed every 6 weeks. Annualized relapse rate (ARR) was analyzed by a Poisson model with the total number of confirmed relapses initiated between the date of randomization and the date of last dose as the response variable, treatment and region as covariates, lo...

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PUM

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Abstract

This invention is related to the use of the combination of teriflunomide or a pharmaceutically acceptable salt thereof and glatiramer acetate for treating multiple sclerosis.

Description

field of invention [0001] The present invention relates to the use of the combination of teriflunomide and glatiramer acetate for the treatment of multiple sclerosis. Background technique [0002] Multiple sclerosis (MS) is a debilitating inflammatory neurological disease characterized by demyelination of the central nervous system. The disease mainly affects young adults and occurs more frequently in women. Symptoms of the disease include fatigue, numbness, tremors, tingling, dysesthesia, visual disturbances, vertigo, cognitive impairment, urinary disturbances, decreased mobility, and depression. Clinically, the disease is divided into four categories: relapsing-remitting, secondary progressive, primary-progressive and progressive-relapsing (progressive-relapsing) ( S.L. Hauser and D.E. Goodkin, Multiple Sclerosis and Other Demyelinating Diseases in Harrison's Principles of Internal Medicine 14 th Edition, vol.2, Mc Graw-Hill, 1998, pp.2409-2419). [0003] The exact ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P25/00A61K31/277A61K31/785
CPCA61K31/277A61K31/785A61P25/00A61K2300/00
Inventor W.伯恩斯P.多伊利特G.弗兰金
Owner SANOFI AVENTIS US LLC
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