Integrating an evidence-based assessment of benefit and risk in disease-modifying treatment of multiple sclerosis.
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.
Goodin
Douglas S
DS
Department of Neurology, University of California, San Francisco, CA 94121, USA. email: dsg@itsa.ucsf.edu
Biermann
Louis D
LD
Bohlega
Saeed
S
Boiko
Alexey
A
Chofflon
Michel
M
Gebeily
Souheil
S
Gouider
Riadh
R
Havrdova
Eva
E
Jakab
Gabor
G
Karabudak
Rana
R
Karussis
Dimitrios
D
Miller
Ariel
A
Pakdaman
Hossein
H
Selmaj
Krzysztof
K
Sharief
Mohammad
M
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
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab; D016899:Interferon-beta; D008942:Mitoxantrone; D000068556:Interferon beta-1a