Abstract Details

Title Does Change in Acetylcholine Receptor Antibody (AChR-Ab) Level Predict or Correlate with Clinical Change in Myasthenia Gravis (MG)?

Topic Muscle Disease/Neuromuscular Junction

Presentation(s) S45 - (-)

Poster/Presentation
Number 006

Objective

Background AChR-Ab levels are frequently used as a biomarker in clinical trials of MG, and to monitor the response to treatment in the clinic.

Design/Methods We reviewed outcome data from all 85 patients in the Duke MG Registry who had at least two AChR-Ab determinations performed at the same laboratory and data from the Muscle Study Group prospective trial of mycophenolate mofetil(MMF). Antibody levels were measured at the same commercial laboratory.

Results Change in AChR-Ab levels at 12 weeks in the MMF trial correlated only weakly with change in outcome measures such as Quantitative MG and MG-Composite scores. In the Duke MG patients, antibody levels fell in 88% of those who improved by clinical assessment and in 56% of those who were clinically unchanged or worse. Combining results from the two cohorts, a fall in AChR-Ab level had a sensitivity of 92% but specificity of only 37% for clinical improvement, a positive predictive value for clinical improvement of 83% and a negative predictive value of 59%.

Conclusions Although AChR-Ab levels fell in most MG patients who improved after treatment, they also fell in the majority of those who did not improve. Based on these results, we do not recommend the use of commercially-available AChR-Ab levels as a biomarker for following the clinical status of patients with MG in the clinic, nor in clinical trials. However, lack of antibody fall may indicate inadequate immunotherapy.

Authors/Disclosures
Donald B. Sanders, MD, FAAN (Duke University Medical Center) PRESENTER	Dr. Sanders has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Accordant Health Services. Dr. Sanders has received personal compensation in the range of $0-$499 for serving as a Consultant for Cabaletta BIO. Dr. Sanders has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kashiv Biosciences. Dr. Sanders has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Momenta Pharmaceuticals. Dr. Sanders has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen RnD. Dr. Sanders has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-aventis. Dr. Sanders has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for VielaBio. Dr. Sanders has received publishing royalties from a publication relating to health care.
Ted M. Burns, MD	Dr. Burns has nothing to disclose.
Gary R. Cutter, PhD (University of Alabama At Birmingham)	Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biodelivery Sciences International, Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein-Buendel Incorporated, Medimmune/Viela Bio, Medday, Merck/Serono, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion/Cerexis Pharmaceuticals, Regeneron, Reckover Pharmaceuticals, Roche, TG Therapeutics.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Applied Therapeutics, AI therapeutics, AMO Pharma, Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Green Valley Pharma, Horizon Pharmaceuticals, Immunic, Karuna Therapeutics, Mapi Pharmaceuticals LTD, Merck, Mitsubishi Tanabe Pharma Holdings, Opko Biologics,Prothena Biosciences, Novartis, Regeneron, Sanofi-Aventis, Reata Pharmaceuticals, NHLBI (Protocol Review Committee), University of Texas Southwestern, University of Pennsylvania, Visioneering Technologies, Inc.. Dr. Cutter has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Allison Brashear, MD, MBA, FAAN (Univeristy of Buffalo)	Dr. Brashear has received personal compensation for serving as an employee of McKnight Brain Res Found. Dr. Brashear has received personal compensation for serving as an employee of American Board of Psychiatry and Neurology. Dr. Brashear has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for ABPN. Dr. Brashear has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for McKnight Brain Research Foundation i. Dr. Brashear has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Care Directions- start up . Dr. Brashear has stock in Caredirections . The institution of Dr. Brashear has received research support from NINDS. Dr. Brashear has received publishing royalties from a publication relating to health care. Dr. Brashear has received personal compensation in the range of $500-$4,999 for serving as a Special government employee and study section reviewer with NIH. Dr. Brashear has received personal compensation in the range of $0-$499 for serving as a Adminstrative board -travel reimbursement with AAMC.
Janice M. Massey, MD, FAAN (Duke University Medical Center)	Dr. Massey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenix. Dr. Massey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance Therapeutics. Dr. Massey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Momenta. The institution of Dr. Massey has received research support from Revance .
Vern C. Juel, MD, FAAN (Duke University Medical Center)	Dr. Juel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunovant. Dr. Juel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Juel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Accordant Health Services. Dr. Juel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. The institution of Dr. Juel has received research support from argenx. The institution of Dr. Juel has received research support from Alexion. The institution of Dr. Juel has received research support from Janssen. The institution of Dr. Juel has received research support from NIH Rare Diseases Network.
Lisa Hobson-Webb, MD, FAAN (Duke University Medical Center)	An immediate family member of Dr. Hobson-Webb has received personal compensation for serving as an employee of G1 Therapeutics. Dr. Hobson-Webb has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley Publishing. The institution of Dr. Hobson-Webb has received research support from Sanofi Genzyme.
	No disclosure on file

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