4.3 Article

Short-term and long-term safety and tolerability of interferon β-1b in multiple sclerosis

Journal

MULTIPLE SCLEROSIS AND RELATED DISORDERS
Volume 3, Issue 3, Pages 294-302

Publisher

ELSEVIER SCI LTD
DOI: 10.1016/j.msard.2013.11.005

Keywords

Multiple sclerosis; Interferon beta-1b; Tolerability; Safety; Long-term follow-up; Mortality

Funding

  1. Bayer Health Care Pharmaceuticals

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Clinical trials have generated a wealth of data on the safety profile of interferon beta-1b for patients with multiple sclerosis (MS). In general, interferon beta-1b has not been associated with serious or life-threatening side effects during long-term treatment. Flu-like symptoms, injection site reactions, depression, and elevated liver transaminases were the most common adverse events in clinical trials. This review will discuss the rates of these and other common adverse events observed in 3 clinical trials of interferon beta-1b: BENEFIT, BEYOND, and the 16-year Long-Term Follow-up (LTF) of the pivotal interferon beta-1b trial in MS, as well as how these adverse events may influence patient and physician decision making when selecting a disease-modifying therapy. In addition, we will discuss the effects of interferon beta-1b on mortality in the 16-year and 21-year LTF studies. (C) 2013 Elsevier B.V. All rights reserved.

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