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New Analyses from 16-Year Follow-up Trial with Betaseron(R) Demonstrated that Early and Sustained Treatment of Multiple Sclerosis Patients Enrolled in the Trial Affected Their Long-term Outcomes
Date:4/29/2009

term outcomes. Drug exposure was measured as the medication possession ratio (MPR) defined as the actual time the patient received therapy divided by the total time possible before a negative outcome was reached (or at data censor). A statistical method called recursive partitioning was then used to divide treatment groups into "high" or "low" exposure and to determine the relationship between length of drug exposure and long-term outcomes. The use of MPR reduces the bias introduced in long-term trials by the tendency of patients who are doing well on therapy stay on therapy and for patients who are doing poorly to stop a particular therapy. Other statistical approaches including Propensity Scoring were used to control for other known sources of bias.(1) The study, sponsored by Bayer HealthCare Pharmaceuticals, is the longest follow-up of a registrational MS trial cohort. Longitudinal data from 372 patients, collected 16 years after the start of the registrational trial, were used to develop an analytical strategy to investigate the relationship between timing of drug initiation and exposure and long-term outcomes.

INDICATIONS AND USAGE

BETASERON (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

IMPORTANT SAFETY INFORMATION

The most commonly reported adverse reactions are lymphopenia, injection-site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. BETASERON should be used with caution in patients with depression. Injection-site necrosis has been reported in 4% o
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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