title: Integrating an evidence-based assessment of benefit and risk in disease-modifying treatment of multiple sclerosis.
abstract: BACKGROUND
  As results from an increasing number of clinical trials with disease-modifying drugs (DMDs) in multiple sclerosis (MS) become available, the challenge for the treating neurologist is how to decide on the appropriate therapy for an individual patient.
  
  
  OBJECTIVE
  An International Working Group for Treatment Optimization in MS met to consider how the principles of evidence-based medicine (EBM) should be used to assess the current best evidence regarding the treatment of MS. This report summarizes the outcome from the workshop at which this topic was addressed.
  
  
  RESULTS
  Class I evidence from head-to-head studies provides the best tool for direct comparisons of DMDs. However, other EBM approaches to data analysis from placebo-controlled trials can be used to help determine the benefits and risks of a particular DMD relative to placebo by calculating the number needed to treat to achieve a positive outcome, such as avoiding a relapse, and the number needed to harm to produce an additional adverse event, such as having a therapy-related dropout. This provides a structured basis for comparisons between DMDs.
  
  
  CONCLUSIONS
  While such comparisons have their limitations, particularly when drugs with substantially different side-effect profiles are to be compared, they can provide useful information to guide treatment decisions.
authors.affiliation: Department of Neurology, University of California, San Francisco, CA 94121, USA. email: dsg@itsa.ucsf.edu
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Goodin
authors.forename: Louis D
authors.initials: LD
authors.lastname: Biermann
authors.forename: Saeed
authors.initials: S
authors.lastname: Bohlega
authors.forename: Alexey
authors.initials: A
authors.lastname: Boiko
authors.forename: Michel
authors.initials: M
authors.lastname: Chofflon
authors.forename: Souheil
authors.initials: S
authors.lastname: Gebeily
authors.forename: Riadh
authors.initials: R
authors.lastname: Gouider
authors.forename: Eva
authors.initials: E
authors.lastname: Havrdova
authors.forename: Gabor
authors.initials: G
authors.lastname: Jakab
authors.forename: Rana
authors.initials: R
authors.lastname: Karabudak
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Karussis
authors.forename: Ariel
authors.initials: A
authors.lastname: Miller
authors.forename: Hossein
authors.initials: H
authors.lastname: Pakdaman
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Selmaj
authors.forename: Mohammad
authors.initials: M
authors.lastname: Sharief
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D019317:Evidence-Based Medicine; D006801:Humans; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000627:therapeutic use*; D008942:Mitoxantrone / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy*; D000069442:Natalizumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab; D016899:Interferon-beta; D008942:Mitoxantrone; D000068556:Interferon beta-1a