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Current status of clinical outcome measures in inclusion body myositis: a systematised review

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25

 

  1. Yale University School of Medicine, New Haven, CT, USA. bhaskar.roy@yale.edu
  2. Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
  3. Centre for Musculoskeletal Research, the University of Manchester, UK.
  4. University of California, Irvine, CA, USA.
  5. Mayo Clinic, Rochester, MN, USA.
  6. Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  7. Nationwide Children’s Hospital, Columbus, OH, USA.
  8. Purdue University, West Lafayette, IN, USA.
  9. University of South Alabama, Mobile, AL, USA.
  10. The Myositis Association, Columbia, MD, USA.
  11. Leiden University Medical Center, Leiden, The Netherlands.
  12. University College London, UK.
  13. Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  14. Leiden University Medical Center, Leiden, The Netherlands.
  15. University of Washington Medical Center, Seattle, WA, USA.
  16. Harvey Cushing/John Hay Whitney Medical Library, Yale University, New Haven, CT, USA.
  17. University Medical Center Göttingen, Germany.
  18. University of Cincinnati, OH, USA.
  19. Medical College of Georgia at Augusta University, Augusta, GA, USA.
  20. University at Buffalo, NY, USA.
  21. Stanford Neuroscience Health Center, Palo Alto, CA, USA.
  22. University of Siena, Italy.
  23. University of Siena, Italy.
  24. University of California, Irvine, CA, USA.
  25. Johns Hopkins University School of Medicine, Baltimore, MD, USA.

for the International Myositis Assessment and Clinical Studies (IMACS) Inclusion Body Myositis Scientific Interest Group

CER16059
2023 Vol.41, N°2
PI 0370, PF 0378
Reviews

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PMID: 36762744 [PubMed]

Received: 16/07/2022
Accepted : 05/12/2022
In Press: 03/02/2023
Published: 01/03/2023

Abstract

OBJECTIVES:
Sporadic inclusion body myositis (IBM) is a debilitating idiopathic inflammatory myopathy (IIM) which affects hand function, ambulation, and swallowing. There is no approved pharmacological therapy for IBM, and there is a lack of suitable outcome measure to assess the effect of an intervention. The IBM scientific interest group under IMACS reviewed the previously used outcome measures in IBM clinical studies to lay the path for developing a core set of outcome measures in IBM.
METHODS:
In this systematised review, we have extracted all outcome measures reported in IBM clinical studies to determine what measures were being used and to assess the need for optimising outcome measures in IBM.
RESULTS:
We found 13 observational studies, 17 open-label clinical trials, and 15 randomised control trials (RCTs) in IBM. Six-minute walk distance, IBM-functional rating scale (IBM-FRS), quantitative muscle testing, manual muscle testing, maximal voluntary isometric contraction testing, and thigh muscle volume measured by MRI were used as primary outcome measures. Twelve different outcome measures of motor function were used in IBM clinical trials. IBM-FRS was the most used measure of functionality. Swallowing function was reported as a secondary outcome measure in only 3 RCTs.
CONCLUSIONS:
There are inconsistencies in using outcome measures in clinical studies in IBM. The core set measures developed by the IMACS group for other IIMs are not directly applicable to IBM. As a result, there is an unmet need for an IBM-specific core set of measures to facilitate the evaluation of new potential therapeutics for IBM.

DOI: https://doi.org/10.55563/clinexprheumatol/ifacv3

Rheumatology Article

Rheumatology Addendum