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Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Final Update 1 Report [Internet]

Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Final Update 1 Report [Internet]

Drug Class Reviews - Oregon Health & Science University

Version: August 2010

Introduction

Multiple sclerosis is a chronic, autoimmune disease of the central nervous system affecting 2.1 million people worldwide and approximately 250 000 to 400 000 people in the United States. Most patients are diagnosed between the ages of 20 and 50 years with women being affected to a greater degree than men by a ratio of 1.6 females to 1 male. The highest prevalence of multiple sclerosis is found in Caucasian women, persons of Northern European descent, and in those who live in northern latitudes. Multiple sclerosis can cause physical, mental, and emotional disability in individuals, independent of age. From a societal perspective, in 2004 multiple sclerosis costs were estimated at $47,215.00 per patient per year, including $16,050.00 (34%) spent on disease-modifying drugs used in the treatment of multiple sclerosis.

Summary

The results of this review are summarized in Table 38, below, and Appendix E summarizes the strength of the evidence for each key question.

Results

Literature searches identified 2655 citations. For Update 1, we received dossiers from 5 pharmaceutical manufacturers: Bayer, Biogen Idec, EMD Serono Inc., Novartis, and Teva Neuroscience Inc. By applying the eligibility and exclusion criteria to titles and abstracts of all identified citations, we obtained full-text copies of 480 citations. After re-applying the criteria for inclusion, we ultimately included 166 publications, comprising 43 for Update 1. See Appendix D for a list of excluded studies and reasons for exclusion at this stage. Figure 1 shows the flow of study selection. Throughout the report we generally refer to the included drugs by their full name, including trade name. This was done in an effort to avoid confusing the drugs, particularly the beta interferons, which have differing doses and routes of administration.

Methods

Adult outpatients (age ≥18 years) with multiple sclerosis,

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