Glatiramer Acetate Offers Long-Term Disease Stability for Patients With Multiple Sclerosis: Presented at WCTRMS

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Title: Glatiramer Acetate Offers Long-Term Disease Stability for Patients With Multiple Sclerosis: Presented at WCTRMS
URL: http://www.pslgroup.com/dg/22CE92.htm
Doctor's Guide
September 22, 2008

By Danny Kucharsky

MONTREAL -- September 22, 2008 -- Almost two-thirds of multiple sclerosis patients on continuous glatiramer acetate therapy for 15 years have experienced no disease progression, and most remain ambulatory without walking aids, according to results of a study presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

The prospective, open-label study was presented here on September 18 by Corey Ford, MD, University of New Mexico School of Medicine, Albuquerque, New Mexico. The study, begun in 1991, included patients who were originally randomised to glatiramer acetate in the pivotal US study, and also included a modified intention-to-treat (mITT) cohort of all 232 study patients who had taken at least 1 dose of glatiramer acetate while in the pivotal study.

The current study furthermore included an ongoing cohort of 100 subjects, which comprises all mITT subjects who continued in the study to February 2008. "These are the ones that are doing well," Dr. Ford said of the latter group. "They obviously feel it's in their best interest to continue injecting themselves every day for over 15 years."

The mean glatiramer acetate exposure was 8.6 years for the mITT cohort, and 13.6 years for the ongoing cohort. Patients in the ongoing cohort were followed every 6 months, and all took daily subcutaneous injections of 20 mg glatiramer acetate.

The study found that 54% of the mITT and 57% of the ongoing cohort had experienced improved or stable Expanded Disability Status Scale scores.

In addition, 75% of the mITT patients with a mean disease duration of 17 years did not reach secondary progressive multiple sclerosis while on glatiramer acetate, while 85% of the ongoing cohort, with a mean disease duration of 22 years, had not reached secondary progressive multiple sclerosis by the 15th year of the glatiramer acetate study.

Dr. Ford said more than 80% of the subjects who continued on glatiramer acetate therapy remained ambulatory without aids.

"The thing that impresses me is that nearly half of the patients who continue on the drug have improved, and their disability has changed very little," Dr. Ford said. "They have not crossed major disability endpoints like needing a cane … or a wheelchair, as you might expect from existing natural history studies."

The finding that many patients respond to the drug and tolerate it for a lengthy period of time "is a reassurance to the prescribers that you can get out that far with at least a reasonable group of your patients," Dr. Ford concluded.

Funding for this study was provided by Teva Neuroscience, Inc.

[Presentation title: Continuous Long-Term Immunomodulatory Therapy in Relapsing Multiple Sclerosis: Results From the 15-year Analysis of the US Prospective Open-Label Study of Glatiramer Acetate. Abstract P44]

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