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

Publication ,  Journal Article
Parikh, A; Stephens, K; Major, E; Fox, I; Milch, C; Sankoh, S; Lev, MH; Provenzale, JM; Shick, J; Patti, M; McAuliffe, M; Berger, JR; Clifford, DB
Published in: Drug Saf
August 2018

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.

Duke Scholars

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Published In

Drug Saf

DOI

EISSN

1179-1942

Publication Date

August 2018

Volume

41

Issue

8

Start / End Page

807 / 816

Location

New Zealand

Related Subject Headings

  • Risk Assessment
  • Randomized Controlled Trials as Topic
  • Pharmacology & Pharmacy
  • Multicenter Studies as Topic
  • Leukoencephalopathy, Progressive Multifocal
  • Inflammatory Bowel Diseases
  • Humans
  • Gastrointestinal Agents
  • Clinical Trials, Phase III as Topic
  • Clinical Trials, Phase II as Topic
 

Citation

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Parikh, A., Stephens, K., Major, E., Fox, I., Milch, C., Sankoh, S., … Clifford, D. B. (2018). A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials. Drug Saf, 41(8), 807–816. https://doi.org/10.1007/s40264-018-0669-8
Parikh, Asit, Kristin Stephens, Eugene Major, Irving Fox, Catherine Milch, Serap Sankoh, Michael H. Lev, et al. “A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials.Drug Saf 41, no. 8 (August 2018): 807–16. https://doi.org/10.1007/s40264-018-0669-8.
Parikh A, Stephens K, Major E, Fox I, Milch C, Sankoh S, et al. A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials. Drug Saf. 2018 Aug;41(8):807–16.
Parikh, Asit, et al. “A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials.Drug Saf, vol. 41, no. 8, Aug. 2018, pp. 807–16. Pubmed, doi:10.1007/s40264-018-0669-8.
Parikh A, Stephens K, Major E, Fox I, Milch C, Sankoh S, Lev MH, Provenzale JM, Shick J, Patti M, McAuliffe M, Berger JR, Clifford DB. A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials. Drug Saf. 2018 Aug;41(8):807–816.
Journal cover image

Published In

Drug Saf

DOI

EISSN

1179-1942

Publication Date

August 2018

Volume

41

Issue

8

Start / End Page

807 / 816

Location

New Zealand

Related Subject Headings

  • Risk Assessment
  • Randomized Controlled Trials as Topic
  • Pharmacology & Pharmacy
  • Multicenter Studies as Topic
  • Leukoencephalopathy, Progressive Multifocal
  • Inflammatory Bowel Diseases
  • Humans
  • Gastrointestinal Agents
  • Clinical Trials, Phase III as Topic
  • Clinical Trials, Phase II as Topic