Anti-HMGCR antibodies demonstrate high diagnostic value in the diagnosis of immune-mediated necrotizing myopathy following statin exposure.
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.
Zabludowitz Center for Autoimmune Diseases Sheba Medical Center, 52621, Tel Hashomer, Israel.|Department of Medicine 'B', Sheba Medical Center, Tel Hashomer, Israel.
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O
Shovman
Zabludowitz Center for Autoimmune Diseases Sheba Medical Center, 52621, Tel Hashomer, Israel.
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B
Gilburd
Zabludowitz Center for Autoimmune Diseases Sheba Medical Center, 52621, Tel Hashomer, Israel.
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C
Chayat
Rheumatology Unit, Rabin Medical Center, Beilinson, Israel.
A Dortort
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Lazar
Zabludowitz Center for Autoimmune Diseases Sheba Medical Center, 52621, Tel Hashomer, Israel.|Department of Medicine 'B', Sheba Medical Center, Tel Hashomer, Israel.|Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
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Amital
Zabludowitz Center for Autoimmune Diseases Sheba Medical Center, 52621, Tel Hashomer, Israel.|Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
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Blank
Research and Development, Inova Diagnostics, San Diego, CA, USA.
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Bentow
Research and Development, Inova Diagnostics, San Diego, CA, USA.
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Mahler
Zabludowitz Center for Autoimmune Diseases Sheba Medical Center, 52621, Tel Hashomer, Israel. shoenfel@post.tau.ac.il.|Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel. shoenfel@post.tau.ac.il.|Incumbent of the Laura Schwarz-Kipp Chair for Research of Autoimmune Diseases, Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel. shoenfel@post.tau.ac.il.
Y
Y
Shoenfeld
D001323:Autoantibodies / Q000097:blood* / Q000276:immunology; D001327:Autoimmune Diseases / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D045744:Cell Line, Tumor; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D006903:Hydroxymethylglutaryl CoA Reductases / Q000276:immunology*; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D008163:Luminescent Measurements; D009135:Muscular Diseases / Q000097:blood / Q000139:chemically induced / Q000175:diagnosis* / Q000276:immunology; D012680:Sensitivity and Specificity
D001323:Autoantibodies; D015415:Biomarkers; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C553220:HMGCR protein, human; D006903:Hydroxymethylglutaryl CoA Reductases
Anti-HMGCR antibodies; Autoantibodies; Immune-mediated necrotizing myopathy (IMNM); Myositis; Statins