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June 27, 2014

Evaluation and construction of diagnostic criteria for inclusion body myositis

Thomas E. Lloyd, MD, PhD, Andrew L. Mammen, MD, PhD, Anthony A. Amato, MD, Michael D. Weiss, MD, Merrilee Needham, MBBS, and Steven A. Greenberg, MDAuthors Info & Affiliations
July 29, 2014 issue
83 (5) 426-433
https://doi.org/10.1212/WNL.0000000000000642
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Abstract

Objective:

To use patient data to evaluate and construct diagnostic criteria for inclusion body myositis (IBM), a progressive disease of skeletal muscle.

Methods:

The literature was reviewed to identify all previously proposed IBM diagnostic criteria. These criteria were applied through medical records review to 200 patients diagnosed as having IBM and 171 patients diagnosed as having a muscle disease other than IBM by neuromuscular specialists at 2 institutions, and to a validating set of 66 additional patients with IBM from 2 other institutions. Machine learning techniques were used for unbiased construction of diagnostic criteria.

Results:

Twenty-four previously proposed IBM diagnostic categories were identified. Twelve categories all performed with high (≥97%) specificity but varied substantially in their sensitivities (11%–84%). The best performing category was European Neuromuscular Centre 2013 probable (sensitivity of 84%). Specialized pathologic features and newly introduced strength criteria (comparative knee extension/hip flexion strength) performed poorly. Unbiased data-directed analysis of 20 features in 371 patients resulted in construction of higher-performing data-derived diagnostic criteria (90% sensitivity and 96% specificity).

Conclusions:

Published expert consensus–derived IBM diagnostic categories have uniformly high specificity but wide-ranging sensitivities. High-performing IBM diagnostic category criteria can be developed directly from principled unbiased analysis of patient data.

Classification of evidence:

This study provides Class II evidence that published expert consensus–derived IBM diagnostic categories accurately distinguish IBM from other muscle disease with high specificity but wide-ranging sensitivities.

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Supplementary Material

File (appendices_e-1_and_e-2.pdf)

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Information & Authors

Information

Published In

Neurology®
Volume 83 • Number 5 • July 29, 2014
Pages: 426-433
PubMed: 24975859

Copyright

© 2014 American Academy of Neurology.

Publication History

Received: November 9, 2013
Accepted: April 22, 2014
Published online: June 27, 2014
Published in print: July 29, 2014

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Disclosure

T. Lloyd has consulted for Novartis. A. Mammen is on the medical advisory board for Biogen and aTyr Pharma. A. Amato is on the medical advisory board for Biogen. M. Weiss has consulted for CSL-Behring, Questcor Pharmaceuticals, Baxter, and Grifols and has been on the speakers bureau for Grifols and Walgreens. He has received honoraria for speaking from the AANEM. He has funding support from the ALS Therapy Alliance and Northeast ALS Consortium. M. Needham has consulted for Novartis. S. Greenberg is an inventor on intellectual property owned and managed by Brigham and Women's Hospital, and has had sponsored research by MedImmune, LLC, and consulted for aTyr Pharma. Go to Neurology.org for full disclosures.

Study Funding

No targeted funding reported.

Authors

Affiliations & Disclosures

Thomas E. Lloyd, MD, PhD
From the Departments of Neurology (T.E.L., A.L.M.), Neuroscience (T.E.L.), and Medicine (A.L.M.), Johns Hopkins University School of Medicine and Johns Hopkins Bayview Myositis Center, Baltimore, MD; Department of Neurology (A.A.A., S.A.G.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Department of Neurology (M.D.W.), University of Washington, Seattle; Department of Neurology (M.N.), Australian Neuromuscular Research Institute, University of Western Australia; and Children’s Hospital Informatics Program (S.A.G.), Boston Children’s Hospital and Harvard-MIT Division of Health Sciences and Technology, Boston, MA.
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.
Consultant for Novartis
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
08/01/2013 -11/30/2016 Sponsor: Novartis Study of efficacy and safety of BYM338 in sporadic inclusion body myositis Role: Site PI, 10% effort
Research Support, Government Entities:
1.
04/15/2013-03/31/2018 NIH/NINDS RO1 NS082563 role: PI, 50% effort 07/01/2008-6/30/2013 NIH/NINDS K08-NS062890 Role: PI, 75% effort
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
08/01/2013 � 07/31/2016 MDA Award 277551 Muscular Dystrophy Association PI: Charlotte Sumner, M.D., Role: Co-PI, 0% effort
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
View all articles by this author
Andrew L. Mammen, MD, PhD
From the Departments of Neurology (T.E.L., A.L.M.), Neuroscience (T.E.L.), and Medicine (A.L.M.), Johns Hopkins University School of Medicine and Johns Hopkins Bayview Myositis Center, Baltimore, MD; Department of Neurology (A.A.A., S.A.G.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Department of Neurology (M.D.W.), University of Washington, Seattle; Department of Neurology (M.N.), Australian Neuromuscular Research Institute, University of Western Australia; and Children’s Hospital Informatics Program (S.A.G.), Boston Children’s Hospital and Harvard-MIT Division of Health Sciences and Technology, Boston, MA.
Disclosure
Scientific Advisory Boards:
1.
aTYR pharmaceuticals advisory board Biogen advisory board
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Experimental Neurology, Editorial Board, 2013-
Patents:
1.
Patented test for anti-HMGCR antibodies that is licensed to INOVA diagnostics
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.
NIH, K08
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.
Licensed test for anti-HMGCR antibodies to INOVA Diagnostics
Royalty Payments, Technology or Inventions:
1.
Licensed test for anti-HMGCR antibodies to INOVA Diagnostics
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Anthony A. Amato, MD
From the Departments of Neurology (T.E.L., A.L.M.), Neuroscience (T.E.L.), and Medicine (A.L.M.), Johns Hopkins University School of Medicine and Johns Hopkins Bayview Myositis Center, Baltimore, MD; Department of Neurology (A.A.A., S.A.G.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Department of Neurology (M.D.W.), University of Washington, Seattle; Department of Neurology (M.N.), Australian Neuromuscular Research Institute, University of Western Australia; and Children’s Hospital Informatics Program (S.A.G.), Boston Children’s Hospital and Harvard-MIT Division of Health Sciences and Technology, Boston, MA.
Disclosure
Scientific Advisory Boards:
1.
Medical Advisory Board for MedImmune, Amgen, Novartis, Baxter, Biogen DSMB for NIH
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Associate Editor for Neurology and Muscle & Nerve
Patents:
1.
NONE
Publishing Royalties:
1.
Amato AA, Russell J. Neuromuscular Disease. New York: McGraw-Hill, 2008
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Medical Consultant for MedImmune, Amgen, Biogen, Baxter, Novartis, and Best Doctors
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Co-I on clinical trial in Inclusion Body Myositis sponsored by Novartis Co-I on clinical trial in Polymyositis and Dermatomyositis sponsored by Novartis Co-1 on a GWAS study in patients with painful neuropathy sponsored by Amgen
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
View all articles by this author
Michael D. Weiss, MD
From the Departments of Neurology (T.E.L., A.L.M.), Neuroscience (T.E.L.), and Medicine (A.L.M.), Johns Hopkins University School of Medicine and Johns Hopkins Bayview Myositis Center, Baltimore, MD; Department of Neurology (A.A.A., S.A.G.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Department of Neurology (M.D.W.), University of Washington, Seattle; Department of Neurology (M.N.), Australian Neuromuscular Research Institute, University of Western Australia; and Children’s Hospital Informatics Program (S.A.G.), Boston Children’s Hospital and Harvard-MIT Division of Health Sciences and Technology, Boston, MA.
Disclosure
Scientific Advisory Boards:
1.
Immunosuppression Study for ALS
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
1. Walgreens, speaker honoraria 2. Grifols USA, speaker honoraria
Editorial Boards:
1.
1. Muscle and Nerve, editorial board member, 2008-present 2. Journal Clinical Neuromuscular Disease, editorial board member, 2009-2011
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
1. Consulted for CSL Behring 2. Consulted for Washington State Department of Labor and Industries 3. Consulted for Questcor
Speakers' Bureaus:
1.
1. Walgreens 2. Grifols USA
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
1. Northeast ALS Consortium 2. ALS Therapy Alliance
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
View all articles by this author
Merrilee Needham, MBBS
From the Departments of Neurology (T.E.L., A.L.M.), Neuroscience (T.E.L.), and Medicine (A.L.M.), Johns Hopkins University School of Medicine and Johns Hopkins Bayview Myositis Center, Baltimore, MD; Department of Neurology (A.A.A., S.A.G.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Department of Neurology (M.D.W.), University of Washington, Seattle; Department of Neurology (M.N.), Australian Neuromuscular Research Institute, University of Western Australia; and Children’s Hospital Informatics Program (S.A.G.), Boston Children’s Hospital and Harvard-MIT Division of Health Sciences and Technology, Boston, MA.
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.
I consulted for Novartis Pharmaceuticals in an unrelated area.
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.
The Inclusion Body Myositis foundation Myositis Foundation
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
View all articles by this author
Steven A. Greenberg, MD
From the Departments of Neurology (T.E.L., A.L.M.), Neuroscience (T.E.L.), and Medicine (A.L.M.), Johns Hopkins University School of Medicine and Johns Hopkins Bayview Myositis Center, Baltimore, MD; Department of Neurology (A.A.A., S.A.G.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Department of Neurology (M.D.W.), University of Washington, Seattle; Department of Neurology (M.N.), Australian Neuromuscular Research Institute, University of Western Australia; and Children’s Hospital Informatics Program (S.A.G.), Boston Children’s Hospital and Harvard-MIT Division of Health Sciences and Technology, Boston, MA.
Disclosure
Scientific Advisory Boards:
1.
MedImmune
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
(1) Genzyme, (2) Biogen
Editorial Boards:
1.
NONE
Patents:
1.
(1) Composition and Methods for Diagnosing and Assessing Inflammatory Myopathies
Publishing Royalties:
1.
(1) EMG Pearls, Hanley & Belfus, 2004
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
(1) MedImmune (2) aTyr Pharma
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
(1) Novartis, (2) MedImmune
Research Support, Government Entities:
1.
(1) NIH 5U19AI067854-07 subcontract PI, (2) NIH R21AR056626 PI, (3) NIH R21NS057225-02 PI
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
(1) Muscular Dystrophy Association
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
(1) Composition and Methods for Diagnosing and Assessing Inflammatory Myopathies, MedImmune
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
View all articles by this author

Notes

Correspondence to Dr. Lloyd: [email protected] or Dr. Greenberg: [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

T.E.L. and S.A.G. designed the study, analyzed and interpreted data, and drafted and revised the manuscript. A.L.M., A.A.A., M.D.W., and M.N. analyzed patient data and revised the manuscript.

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