A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials

Asit Parikh (), Kristin Stephens, Eugene Major, Irving Fox, Catherine Milch, Serap Sankoh, Michael H. Lev, James M. Provenzale, Jesse Shick, Mark Patti, Megan McAuliffe, Joseph R. Berger and David B. Clifford
Additional contact information
Asit Parikh: Takeda Pharmaceuticals International Co.
Kristin Stephens: Takeda Pharmaceuticals International Co.
Eugene Major: National Institute of Neurological Disorders and Stroke, National Institutes of Health
Irving Fox: Takeda Pharmaceuticals International Co.
Catherine Milch: Takeda Pharmaceuticals International Co.
Serap Sankoh: Takeda Pharmaceuticals International Co.
Michael H. Lev: Massachusetts General Hospital
James M. Provenzale: Duke University Medical Center
Jesse Shick: Takeda Pharmaceuticals International, Inc
Mark Patti: Takeda Pharmaceuticals International Co.
Megan McAuliffe: Takeda Pharmaceuticals International Co.
Joseph R. Berger: University of Kentucky
David B. Clifford: Washington University School of Medicine

Drug Safety, 2018, vol. 41, issue 8, No 9, 807-816

Abstract: Abstract Introduction Over the past decade, the potential for drug-associated progressive multifocal leukoencephalopathy (PML) has become an increasingly important consideration in certain drug development programmes, particularly those of immunomodulatory biologics. Whether the risk of PML with an investigational agent is proven (e.g. extrapolated from relevant experience, such as a class effect) or merely theoretical, the serious consequences of acquiring PML require careful risk minimisation and assessment. No single standard for such risk minimisation exists. Vedolizumab is a recently developed monoclonal antibody to α4β7 integrin. Its clinical development necessitated a dedicated PML risk minimisation assessment as part of a global preapproval regulatory requirement. Objective The aim of this study was to describe the multiple risk minimisation elements that were incorporated in vedolizumab clinical trials in inflammatory bowel disease patients as part of the risk assessment and minimisation of PML programme for vedolizumab. Methods A case evaluation algorithm was developed for sequential screening and diagnostic evaluation of subjects who met criteria that indicated a clinical suspicion of PML. An Independent Adjudication Committee provided an independent, unbiased opinion regarding the likelihood of PML. Results Although no cases were detected, all suspected PML events were thoroughly reviewed and successfully adjudicated, making it unlikely that cases were missed. Conclusion We suggest that this programme could serve as a model for pragmatic screening for PML during the clinical development of new drugs.

Date: 2018
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DOI: 10.1007/s40264-018-0669-8

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