Largest Prospective Phase IV Study in MS will Evaluate Adherence, Outcomes of Patients in Specialty Pharmacy Medication Therapy Management Programs
Teva Neuroscience today announced baseline patient characteristics from the fully enrolled Therapy Optimization in Multiple Sclerosis (TOP MS) study. TOP MS represents the largest prospective Phase IV study conducted in MS, and these data characterize the MS population receiving treatment and medication therapy management (MTM) via specialty pharmacy programs. The study results, anticipated in late 2012, will provide insight into the benefits of adherence to therapy on MS patients' health outcomes.
"These data provide an overview of the baseline characteristics of the contemporary MS patient populations, which have evolved dramatically over the past twenty years," said MerriKay Oleen-Burkey, PhD, principal investigator of the TOP MS study. "Many specialty pharmacies have reinforced their commitment to MS patients by implementing MTM programs. TOP MS will examine the addition of self-reported patient outcomes to MTM programs, with the goal of providing insight into the benefits of adherence to therapy on MS patients' health outcomes."
Of the 2,901 participants who have completed surveys, initial self-reported patient characteristic data from TOP MS include:
- Participants were 80.4 percent female; 89.9 percent were Caucasian and 5.8 percent were African-American
- Mean age was 49 years old; at baseline, average time since MS diagnosis was 9.4 years
- A total of 36.1 percent reported using a prior disease-modifying therapy (DMT) with a mean number of 1.4 therapies; 74 percent had used one other DMT; 19.4 percent had used two DMTs and 6.6 percent had used three or more therapies
- Most commonly reported first symptoms of MS were numbness and tingling (67.1 percent) or visual symptoms (45.6 percent), fatigue (44.4 percent) and impaired coordination or balance (40.5 percent)
Data from the TOP MS study were presented at the Consortium of Multiple Sclerosis Centers annual meeting in Montreal, Quebec, Canada at the following poster sessions on Friday, June 3, 2011 from 6:30-8:00 PM EDT:
- [S102] THE THERAPY OPTIMIZATION IN MS STUDY: BASELINE DEMOGRAPHIC CHARACTERISTICS
- [S103] THE THERAPY OPTIMIZATION IN MS STUDY: CHARACTERISTICS OF EARLY DISEASE
- [S104] THE THERAPY OPTIMIZATION IN MS STUDY: DISEASE-MODIFYING THERAPY HISTORY
- [S105] THE THERAPY OPTIMIZATION IN MS STUDY: PERSISTENT DISEASE SYMPTOMS
About the TOP MS study
TOP MS is a prospective, open-label parallel group study. Participants were identified at specialty pharmacies with MTM programs. Signed informed consent forms were returned to the pharmacies and study enrollment produced log-on instructions for the study website. Beginning at baseline and at regular intervals over 24 months, enrolled participants receive reminders to respond to survey questions. Self-reported responses are entered directly into the study database.
About MS
MS is a chronic, often disabling disease that attacks the central nervous system. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. In the U.S. today, there are approximately 400,000 people with MS — with 200 more people diagnosed every week. Worldwide, MS is thought to affect more than 2.1 million people.
About Teva
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,450 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on neurological, respiratory and women's health therapeutic areas as well as biologics. Teva's leading innovative product, Copaxone®, is the number one prescribed treatment for relapsing-remitting multiple sclerosis. Teva employs approximately 40,000 people around the world and reached $16.1 billion in net sales in 2010.
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