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Abstract

Objective:

To establish criteria for the diagnosis of progressive multifocal leukoencephalopathy (PML).

Methods:

We reviewed available literature to identify various diagnostic criteria employed. Several search strategies employing the terms “progressive multifocal leukoencephalopathy” with or without “JC virus” were performed with PubMed, SCOPUS, and EMBASE search engines. The articles were reviewed by a committee of individuals with expertise in the disorder in order to determine the most useful applicable criteria.

Results:

A consensus statement was developed employing clinical, imaging, pathologic, and virologic evidence in support of the diagnosis of PML. Two separate pathways, histopathologic and clinical, for PML diagnosis are proposed. Diagnostic classification includes certain, probable, possible, and not PML.

Conclusion:

Definitive diagnosis of PML requires neuropathologic demonstration of the typical histopathologic triad (demyelination, bizarre astrocytes, and enlarged oligodendroglial nuclei) coupled with the techniques to show the presence of JC virus. The presence of clinical and imaging manifestations consistent with the diagnosis and not better explained by other disorders coupled with the demonstration of JC virus by PCR in CSF is also considered diagnostic. Algorithms for establishing the diagnosis have been recommended.

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Information & Authors

Information

Published In

Neurology®
Volume 80Number 15April 9, 2013
Pages: 1430-1438
PubMed: 23568998

Publication History

Received: September 26, 2012
Accepted: December 26, 2012
Published online: April 8, 2013
Published in print: April 9, 2013

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Disclosure

J. Berger serves on Data Safety Boards for Millennium and Amgen; has served on scientific advisory boards or as a consultant for Amgen, Bayer, BiogenIdec, Eisai, Genzyme, GlaxoSmithKline, Genentech, Novartis, and Pfizer; has received speaking fees from CMSC, AAN, Bayer, and BiogenIdec; and receives research support from the PML Consortium. A. Aksamit reports no disclosures. D. Clifford is funded by NIH grants U10 NS077384, MH22005, AI25903, and the Alzheimer Association. He serves on Data Safety Boards for Biogen, GSK, Millennium, Genzyme, Genentech, and Pfizer; has been a consultant to Amgen, Brinker, Biddle, Reath (PML Consortium), Genentech, Genzyme, Bristol-Myers Squibb, Millennium, Biogen Idec, and Pfizer; has received research support from Biogen Idec, NeurogesX, Tibotec, and Pfizer; and has received speaking fees from University of Kentucky and CMSC/ACTRIMS and ECTRIMS. L. Davis reports no disclosures. I. Koralnik is funded by NIH grants R56-NS041198, R01-NS047029, R01-NS074995, and K24-NS060950; has received a research grant from Biogen Idec and the National MS Society; served on scientific advisory boards for Hoffmann La-Roche, GlaxoSmithKline, and Merck Serono; received consulting fees from Bristol-Myers Squibb, Ono Pharmaceuticals, Merck Serono, Hoffmann La Roche, GlaxoSmithKline, Perseid Therapeutics, Vertex Pharmaceutical, and Johnson & Johnson; and receives royalties from Up-To-Date for topics on the management of HIV and CNS mass lesions and on PML. J. Sejvar, R. Bartt, E. Major, and A. Nath report no disclosures. Go to Neurology.org for full disclosures.

Study Funding

No targeted funding reported.

Authors

Affiliations & Disclosures

Joseph R. Berger, MD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
Dr. Berger has served on a PML adjudication committees for Millenium, Amgen, and Johnson and Johnson.
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Dr. Berger has received speakers honoraria from Bayer, Teva and BiogenIdec.
Editorial Boards:
1.
Dr. Berger has been an associate editor of the Journal of Neurovirology 2007-present and serves on the following editorial boards: ISRN Education 2011; Neuroscience 2011; World Journal of Rheumatology 2011; MS and Other Related Disorders 2011.
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Dr. Berger has served as a consultant to Bayer, BiogenIdec, GlaxoSmithKline, Genzyme/Sanofi, Eisai, Novartis, Millenium, and Genentech
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
EMD Serono (2008-2011); Biogen-Idec (2010-2011); PML Consortium (2011-2013)
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Allen J. Aksamit, MD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
David B. Clifford, MD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
Amgen - PML Adjudication Board 2012 - Biogen Idec/Quintiles - DSMB for progressive MS trial 2011 -BMS - PML Adjudication Committee 2012 - Genentech PML Advisory Board regarding PML 2007 - 2011 Genzyme DSMB for CARE MS Study 2008-2011 Pfizer DMC for pregabalin neuropsthy study 2010 - 2011Pfizer DMC for MAdCAM study 2011 -Millennium - Chair PML IAC for clinical trials 2009 - 2012 Millennium - ADCETRIS trial adjudication committee member 2012 -
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
PML Consortium support for participation in FDA/EMA meeting on PML - London 2011Biogen travel support for Lecture at Montreal Neurological MS Update 2012
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Millennium Consulting regarding PML 2007-2012 Bristol Meyers Squibb consulting 2008-2011Genzyme consultant 2009-2011Biogen Idec scientific advisor regarding PML 2005-2012IAS-USA speaker honorarium 2010, 2011, 2012CMSC/ACTRIMS speaker honorarium 2012ECTRIMS spearker honorarium 2012Wyeth consultant 2011Genentech - honorarium for participation in Translational Immunology Summit 2011Jannsen - Expert consultant on PML 2011Drinker, Biddle, Reath - Chair Scientific Advisory Committee of PML Consortium
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
(1)Biogen - Study to test mefloquine as treatment for PML (2008-2010)
Research Support, Government Entities:
1.
NIH UO1 NS32228 - Neurologic AIDS Research Consortium (Principal Investigator) 1993 - 2012NIH UO1 AI69495 - Washington University AIDS Clinical Trails Unit (Principal Investigator) 2006 - 2013NIMH 22005 CHARTER Project (Washington U Site PI) 2007 - 2011NIMH MH058076 HIV NeuroCognitive Disorderss: a randomized clinical trial of CNS-targeted HAART (Site PI) 2007-2011NIH R21 3857-53187 (Fogarty Institute) Neurologic manifestations of HIV-2 in West Africa (2008-2011)NIH R01 NR012907 (NINR,Ances - PI), Co-investigator, 2010-2015NIH R01 NR012907 (NINR, Ances - PI), Co-investigator, 2011-2016DIAN TTU 12-243040 (Alzheimer Association, Bateman PI), Co-investigator, 2012-2016.
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Larry Davis, MD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
Royalities for writing Fundamentals of Neurologic Disease by Demos in 2005
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
VA office of Rural Health VA staff funding to explore giving care to remote patients with Parkinson's disease via teleneurology in the VA. One year staff funding.
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
One time consultant to legal firm regarding West Nile encephalitis- 2012
Igor J. Koralnik, MD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
Hoffman La Roche (2007), Glaxo Smith Klyne (2007), Merck Serono (2009)
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Journal Of NeuroVirology, Editorial Board Member (2008-present)
Patents:
1.
NONE
Publishing Royalties:
1.
UpToDate, Topics on the management of HIV and CNS mass lesions and on PML (2002-present)
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Received consulting fees from Bristol Myers Sqibb (2009), Ono pharmaceuticals (2009), Merck Serono (2009),Hoffman La Roche (2007),Glaxo Smith Klyne (2007),Perseid Therapeutics (2010), Vertex Pharamaceutical (2011), Johnson & Johnson (2012)
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Biogen Idec Research grant
Research Support, Government Entities:
1.
NIH R01 NS 047029, PI, 2004-present, NIH NS 074995, PI 2011-present, K24 NS 060950, PI, 2008-present
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
National Multiple Sclerosis society (2011-2012)
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
James J. Sejvar, MD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Russell Bartt, MD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Eugene O. Major, PhD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
National Institute of Neurological Disorders and Stroke,National Institutes of Health, Division of IntramuralResearch as Senior Investigator, NINDS, NIH, HHS
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Avindra Nath, MD
From the Department of Neurology (J.R.B.), University of Kentucky, Lexington; Department of Neurology (A.J.A.), Mayo Clinic, Rochester, MN; Washington University (D.B.C.), St. Louis, MO; Department of Neurology (L.D.), University of New Mexico, Albuquerque; Division of Neurovirology, Department of Neurology, and Center for Virology and Vaccine Research, Department of Medicine (I.J.K.), Beth Israel Deaconess Medical Center, Boston, MA; Centers for Disease Control (J.J.S.), Atlanta, GA; Blue Sky Neurosciences (R.B.), Englewood, CO; the Laboratory of Molecular Medicine and Neuroscience (E.O.M.) and Section of Infections of the Nervous System (A.N.), NINDS, NIH, Bethesda, MD.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Associate Editor, Journal of Neurovirology
Patents:
1.
Tat as an immunogen, filed 4/2002.Diosgenin for Treatment of Neurodegenerative Diseases (JHU Ref.: 4382); 2004Role of Kv Channels in Neuroregeneration and Protection (JHU Ref.: 4986); 2006Role of Lominoid compounds as neuroprotective agents (JHU Ref: 5038); 2006Tat ELISA (JHU Ref: 5087); 2006
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NIH intramural funds
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE

Notes

Correspondence to Dr. Berger: [email protected]
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

Author Contributions

All the authors are members of the PML Guidelines Committee and contributed to the study concept and design. Dr. Berger drafted the first and final versions of the manuscript. Drs. Aksamit, Clifford, Davis, Koralnik, Sejvar, Bartt, Major, and Nath provided critical revisions of the manuscript.

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