Immunologic Research

, Volume 65, Issue 1, pp 276–281 | Cite as

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

  • O. Shovman
  • B. Gilburd
  • C. Chayat
  • A. Dortort Lazar
  • H. Amital
  • M. Blank
  • C. Bentow
  • M. Mahler
  • Y. Shoenfeld
Therapeutic Aspects in Autoimmunity


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.


Autoantibodies Immune-mediated necrotizing myopathy (IMNM) Myositis Anti-HMGCR antibodies Statins 


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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • O. Shovman
    • 1
    • 2
  • B. Gilburd
    • 1
  • C. Chayat
    • 1
  • A. Dortort Lazar
    • 3
  • H. Amital
    • 1
    • 2
    • 4
  • M. Blank
    • 1
    • 4
  • C. Bentow
    • 5
  • M. Mahler
    • 5
  • Y. Shoenfeld
    • 1
    • 4
    • 6
  1. 1.Zabludowitz Center for Autoimmune Diseases Sheba Medical CenterTel HashomerIsrael
  2. 2.Department of Medicine ‘B’Sheba Medical CenterTel HashomerIsrael
  3. 3.Rheumatology UnitRabin Medical CenterBeilinsonIsrael
  4. 4.Sackler Faculty of MedicineTel-Aviv UniversityTel AvivIsrael
  5. 5.Research and DevelopmentInova DiagnosticsSan DiegoUSA
  6. 6.Incumbent of the Laura Schwarz-Kipp Chair for Research of Autoimmune Diseases, Sackler Faculty of MedicineTel-Aviv UniversityTel AvivIsrael

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