Multiple Sclerosis - Largest Global Study Launched to Examine Patient Adherence to Drug Therapy

Main Category: Multiple Sclerosis
Article Date: 02 Oct 2005 - 0:00 PDT

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Thursday, September 29, 2005 - Biogen Idec (NASDAQ: BIIB) announced today the initiation of the Global Adherence Project (GAP), the largest multi-national study of its kind to date to evaluate patient adherence to long-term treatments for multiple sclerosis (MS) in a real-world setting. In collaboration with patients and physicians worldwide, GAP is designed to determine adherence to MS drugs and to identify factors that contribute to non-adherence, in order to allow for a better understanding of treatment practices for this chronic, debilitating disease. The announcement was made at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The World Health Organization (WHO) has recognized adherence as a major issue in therapy for chronic diseases and cites non-adherence as one of the most important factors contributing to decreased treatment effectiveness. The WHO defines treatment adherence as both compliance (taking a medication in the dose and according to the schedule prescribed) and persistency (taking a drug regimen over the long term). WHO research has found that adherence is a complex problem affected by: social and economic influences, physician and other healthcare delivery issues, differences among therapies, disease conditions, and individual patient dynamics. The GAP study will evaluate patient experience in these areas in order to identify possible influences on MS treatment adherence.

"For a chronic disease like MS, sustained and consistent treatment is needed to slow disability progression and reduce the frequency of relapses," said Bernd Kieseier, MD, Professor of Neurology, Heinrich-Heine-Universität, Düsseldorf, Germany. "GAP will be the first global study to provide adherence data on disease modifying therapies in MS. Data from the GAP study has the potential to shape our treatment practices and help to improve how effectively we work with patients over the course of their treatment."

GAP is a global multi-center, cross-sectional observational study that will investigate factors that influence non-adherence to MS therapies. The study aims to enroll over 1,800 patients with relapsing remitting MS in 24 countries who are currently taking one of the following therapies: AVONEX® (Interferon beta-1a) im, Betaseron® (Interferon beta-1b) sc, Copaxone® (glatiramer acetate), or Rebif® (Interferon beta-1a) sc. Patients will be evaluated through a validated MS quality of life scale, as well as a self-reported questionnaire that collects data on disease status, treatment, and factors that may have affected adherence to treatment during the course of their therapy.

A similar study investigating adherence in MS is currently underway in the United States, led by the Department of Neurology, University of Texas Southwestern Medical Center. Interim results from more than 700 patients studied indicated that 38 percent were non-compliant at some point during a four-week period. The most common reason for not taking the MS medication as prescribed was simply "forgetting the dose."

"Our analysis of adherence patterns thus far tells us that certain drug-related issues can significantly affect adherence in MS, including frequency of drug administration, medication side effects, as well as how effective the patient perceives their treatment to be," said Elliot Frohman, MD, PhD, Professor of Neurology and Ophthalmology, and Director, Multiple Sclerosis Program and Vertigo and Eye Movement Clinics at University of Texas Southwestern Medical Center, and lead investigator on the U.S. adherence study. "The MS community looks forward to the outcome of these studies which we expect will provide a more sophisticated understanding of how physicians can best identify the most appropriate therapy for individual patients."

About Multiple Sclerosis

MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.

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Biogen Idec
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http://www.biogen.com

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