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  • Review Article
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A critical appraisal of treatment decisions in multiple sclerosis—old versus new

Nature Reviews Neurology volume 7, pages 255–262 (2011)Cite this article

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Abstract

Interferon β and glatiramer acetate have been available for the treatment of multiple sclerosis (MS) for over a decade and their efficacy and safety are well established. These agents have detectable effects on the immune system, but have not been associated with a breakdown of immune surveillance. Novel MS therapies have been approved, or are awaiting approval, that differ from established immunotherapies with regard to their mechanisms of action, modes of administration, adverse-effect profiles and, possibly, the clinical and paraclinical benefits that they may provide for patients. Neurologists will soon be required to make complex treatment decisions with their patients on the basis of very limited clinical data and evidence. Under these circumstances, optimal assessment of risks and benefits will be challenging. In this Review, the anticipated benefits of novel therapies, including reduction in disease activity, possible prevention of disability, and improvement in quality of life, are outlined. In addition, the current acceptance of potential risks—including serious or even life-threatening adverse effects, the likelihood of which may rise with increased cumulative exposure to a particular agent—by patients with MS will be reviewed.

Key Points

  • Emergence of new pharmacotherapies for multiple sclerosis (MS) poses numerous advantages and challenges to the clinical neurologist

  • Decisions on the most appropriate agent for MS patients at any time during the relapsing disease course is becoming more complex

  • The balance between benefit and risk may be perceived differently between individual patients owing to their personal expectations and apprehensions as well as cultural differences

  • Assessments of available therapies should not be static, but should be conducted longitudinally, as both risks and benefits may change over time

  • Head-to-head comparative trials conducted using identical methodology in patients randomized from the same source population are required to compare the efficacy of different MS treatments

  • The identification of MS biomarkers for disease activity will be paramount for any rational treatment choices

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Figure 1: The freedom of disease activity concept.
Figure 2: Annualized relapse rate across pivotal MS studies.

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Authors and Affiliations

  1. Department of Neurology, Heinrich Heine University, Moorenstrasse 5, Düsseldorf, 40255, Germany

    Bernd C. Kieseier

  2. Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center at Dallas, 5423 Harry Hines Boulevard, Dallas, TX 75390-9036, USA

    Olaf Stüve

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Contributions

B. C. Kieseier and O. Stüve contributed equally to researching data, discussion of content, writing and reviewing, and editing of the manuscript.

Corresponding author

Correspondence to Olaf Stüve.

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Competing interests

B. C. Kieseier has acted as a consultant and been a member of a speakers bureau (received honoraria) from Bayer–Schering Pharma, Biogen Idec, Merck Serono, Novartis, Teva Neuroscience. O. Stüve has acted as a consultant for EMO Serono, Novartis, Roche and Teva Neuroscience.

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Kieseier, B., Stüve, O. A critical appraisal of treatment decisions in multiple sclerosis—old versus new. Nat Rev Neurol 7, 255–262 (2011). https://doi.org/10.1038/nrneurol.2011.41

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