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Pharmacovigilance during treatment of multiple sclerosis: early recognition of CNS complications
  1. Martijn T Wijburg1,2,
  2. Clemens Warnke3,4,
  3. Christopher McGuigan5,
  4. Igor J Koralnik6,
  5. Frederik Barkhof2,7,
  6. Joep Killestein1,
  7. Mike P Wattjes2,8
  1. 1Department of Neurology, MS Center Amsterdam, Neuroscience Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands
  2. 2Department of Radiology & Nuclear Medicine, MS Center Amsterdam, Neuroscience Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands, Amsterdam, The Netherlands
  3. 3Department of Neurology, University Hospital Köln, University of Cologne, Köln, Germany
  4. 4Department of Neurology, Medical Faculty, Heinrich Heine University, Dusseldorf, Germany
  5. 5Department of Neurology, St Vincent's University Hospital & University College Dublin, Dublin, Ireland
  6. 6Department of Neurological Sciences, Division of Neuroinfectious Diseases, Rush University Medical Center, Chicago, Illinois, USA
  7. 7Institutes of Neurology and Healthcare Engineering, UCL, London, UK
  8. 8Department of Diagnostic and Interventional Neuroradiology, Hannover Medical School, Hannover, Germany
  1. Correspondence to Dr Martijn T Wijburg, Department of Neurology, MS Center Amsterdam, Neuroscience Amsterdam, Amsterdam UMC, Vrije Universiteit, 1081 HV Amsterdam, Noord-Holland, The Netherlands; m.wijburg{at}


An increasing number of highly effective disease-modifying therapies for people with multiple sclerosis (MS) have recently gained marketing approval. While the beneficial effects of these drugs in terms of clinical and imaging outcome measures is welcomed, these therapeutics are associated with substance-specific or group-specific adverse events that include severe and fatal complications. These adverse events comprise both infectious and non-infectious complications that can occur within, or outside of the central nervous system (CNS). Awareness and risk assessment strategies thus require interdisciplinary management, and robust clinical and paraclinical surveillance strategies. In this review, we discuss the current role of MRI in safety monitoring during pharmacovigilance of patients treated with (selective) immune suppressive therapies for MS. MRI, particularly brain MRI, has a pivotal role in the early diagnosis of CNS complications that potentially are severely debilitating and may even be lethal. Early recognition of such CNS complications may improve functional outcome and survival, and thus knowledge on MRI features of treatment-associated complications is of paramount importance to MS clinicians, but also of relevance to general neurologists and radiologists.

  • multiple sclerosis
  • MRI

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  • Contributors MTW and MPW provided the initial idea and outline of content for the manuscript. All authors contributed content and critically reviewed and edited the manuscript. MTW submitted the study and is responsible for the overall content as guarantor.

  • Funding The MS Centre Amsterdam is funded by a programme grant (14-358e) from the Stichting voor MS Research (Voorschoten, The Netherlands). CW received support from the Hertie foundation (P1150063). This work was supported in part by NIH grants R01 NS 047029 and NS 074995 to IJK.

  • Competing interests CW has received institutional fees for consultancy, speaking, or research from Novartis, Biogen, Sanofi-Genzyme and Roche; no personal fees within the last three years. CM has received consultancy or speaking fees from Actelion, Biogen, Merck, Novartis, Roche, Sandoz, Sanofi-Genzyme, Teva. IJK has received consultancy fees from Biogen, Regeneron and Agios Pharmaceuticals. JK has received consultancy fees from Merck-Serono, Teva, Biogen, Genzyme and Novartis. MPW has received consultancy fees from Biogen and Roche.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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