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

• Published in: Immunologic research Vol. 65; no. 1; pp. 276 - 281
• Main Authors: Shovman, O., Gilburd, B., Chayat, C., Lazar, A. Dortort, Amital, H., Blank, M., Bentow, C., Mahler, M., Shoenfeld, Y.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.02.2017; Springer Nature B.V
• Subjects: Allergology; Autoantibodies - blood; Autoantibodies - immunology; Autoimmune Diseases - blood; Autoimmune Diseases - diagnosis; Autoimmune Diseases - drug therapy; Autoimmune Diseases - immunology; Biomarkers - blood; Biomedical and Life Sciences; Biomedicine; Cell Line, Tumor; Enzyme-Linked Immunosorbent Assay; Humans; Hydroxymethylglutaryl CoA Reductases - immunology; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Immunology; Internal Medicine; Luminescent Measurements; Medicine/Public Health; Muscular Diseases - blood; Muscular Diseases - chemically induced; Muscular Diseases - diagnosis; Muscular Diseases - immunology; Sensitivity and Specificity; Therapeutic Aspects in Autoimmunity; Myositis; Autoantibodies; Anti-HMGCR antibodies; Statins; Immune-mediated necrotizing myopathy (IMNM)
• ISSN: 0257-277X; 1559-0755; 1559-0755
• DOI: 10.1007/s12026-016-8867-x

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.