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Anti-HMGCR antibodies demonstrate high diagnostic value in the diagnosis of immune-mediated necrotizing myopathy following statin exposure

  • Therapeutic Aspects in Autoimmunity
  • Published:
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Abstract

Anti-HMGCR antibodies represent a characteristic serological feature of statin-exposed and statin-unexposed patients with immune-mediated necrotizing myopathy (IMNM). We assessed anti-HMGCR antibodies in patients with suspected IMNM following statin exposure and patients with other autoimmune rheumatic diseases. We evaluated the presence of anti-HMGCR autoantibodies in sera samples from 13 statin-exposed patients who were suspected of having IMNM, 38 patients with different inflammatory and autoimmune rheumatic diseases and 29 healthy subjects. The autoantibodies were evaluated by two assays: a new chemiluminescence QUANTA Flash HMGCR kit utilizing BIO-FLASH system and QUANTA Lite® HMGCR ELISA kit. Twelve samples from patients with suspicion for IMNM were found positive for anti-HMGCR antibodies by both assays. Only one of the 13 samples that were found positive by ELISA was negative by CIA. A very good qualitative correlation (κ = 0.95; 95 % CI 0.85–1.0) and quantitative agreement (Spearman’s rho 0.87; P value < 0.0001; 95 % CI 0.62–0.96) were found between these two assays. All samples from healthy subjects and from the disease-controlled patient cohort were negative for anti-HMGCR antibodies. In comparison with ELISA results, the CIA exhibited high sensitivity and specificity values of 92.3 and 100 %, respectively. Receiver operating characteristic analysis for CIA and ELISA yielded area under the curve values of 0.99. The presence of anti-HMGCR antibodies may be a useful biomarker of IMNM in statin-exposed patients. There is a good correlation between the two anti-HMGCR antibody assays evaluated in the present study.

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Authors and Affiliations

  1. Zabludowitz Center for Autoimmune Diseases Sheba Medical Center, 52621, Tel Hashomer, Israel

    O. Shovman, B. Gilburd, C. Chayat, H. Amital, M. Blank & Y. Shoenfeld

  2. Department of Medicine ‘B’, Sheba Medical Center, Tel Hashomer, Israel

    O. Shovman & H. Amital

  3. Rheumatology Unit, Rabin Medical Center, Beilinson, Israel

    A. Dortort Lazar

  4. Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel

    H. Amital, M. Blank & Y. Shoenfeld

  5. Research and Development, Inova Diagnostics, San Diego, CA, USA

    C. Bentow & M. Mahler

  6. Incumbent of the Laura Schwarz-Kipp Chair for Research of Autoimmune Diseases, Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel

    Y. Shoenfeld

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  1. O. Shovman
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  2. B. Gilburd
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  3. C. Chayat
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  4. A. Dortort Lazar
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  5. H. Amital
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  6. M. Blank
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  7. C. Bentow
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  8. M. Mahler
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  9. Y. Shoenfeld
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Correspondence to Y. Shoenfeld.

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Shovman, O., Gilburd, B., Chayat, C. et al. Anti-HMGCR antibodies demonstrate high diagnostic value in the diagnosis of immune-mediated necrotizing myopathy following statin exposure. Immunol Res 65, 276–281 (2017). https://doi.org/10.1007/s12026-016-8867-x

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  • DOI: https://doi.org/10.1007/s12026-016-8867-x

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