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Rheumatology Advance Access originally published online on October 5, 2009
Rheumatology 2009 48(12):1570-1574; doi:10.1093/rheumatology/kep290
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Clinical usefulness of anti-RNA polymerase III antibody measurement by enzyme-linked immunosorbent assay

Takashi Satoh1, Osamu Ishikawa2, Hironobu Ihn3, Hirahito Endo4, Yasushi Kawaguchi5, Tetsuo Sasaki6, Daisuke Goto7, Kazuo Takahashi8, Hiroki Takahashi9, Yoshikata Misaki10, Tsuneyo Mimori11, Yoshinao Muro12, Norihito Yazawa13, Shinichi Sato14, Kazuhiko Takehara15 and Masataka Kuwana1

1Department of Internal Medicine, Division of Rheumatology, Keio University School of Medicine, Tokyo, 2Department of Dermatology, Gunma University Graduate School of Medicine, Maebashi, 3Department of Dermatology, Kumamoto University Graduate School of Medical Sciences, Kumamoto, 4Department of Internal Medicine, Kitasato University School of Medicine, Sagamihara, 5Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, 6Department of Dermatology, Atami Hospital, International University of Health and Welfare, Atami, 7Department of Internal Medicine, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, 8Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine, Yokohama, 9First Department of Internal Medicine, Sapporo Medical University School of Medicine, Sapporo, 10Department of Allergy and Rheumatology, University of Tokyo Graduate School of Medicine, Tokyo, 11Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, 12Department of Dermatology, Nagoya University Graduate School of Medicine, Nagoya, 13Department of Dermatology, University of Tokyo Graduate School of Medicine, Tokyo, 14Department of Dermatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki and 15Department of Dermatology, Kanazawa University Graduate School of Medical Science, Ishikawa, Japan.

Correspondence to: Masataka Kuwana, Department of Internal Medicine, Division of Rheumatology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan. E-mail: kuwanam{at}sc.itc.keio.ac.jp


  Abstract

Objective. To evaluate the clinical usefulness of measuring anti-RNA polymerase (RNAP) III antibody with a commercially available ELISA in Japanese patients with SSc.

Methods. This multicentre study involved 354 patients with SSc, 245 with non-SSc CTDs and 102 healthy controls. ELISAs were used to detect anti-RNAP III antibody, anti-topo I antibody and ACA. The presence of anti-RNAP III antibody in selected serum samples was confirmed by immunoprecipitation (IP) assay.

Results. By ELISA, anti-RNAP III antibody was detected in 38 (10.7%) patients with SSc, 3 (1.2%) with non-SSc CTD and no healthy controls. The clinical specificity for SSc was excellent (98.8%), although a small number of false positives occurred. The sensitivity of the anti-topo I and ACA ELISAs for SSc was 59.9%, which increased to 68.2% without a reduction in specificity when the anti-RNAP III measurement was added. Clinical features associated with positivity for the anti-RNAP III antibody include dcSSc, a high total skin score and a trend towards high prevalence of renal crisis, consistent with previous studies that used an IP assay. Furthermore, on clinical severity scales, SSc patients with anti-RNAP III antibody scored highest for skin and renal involvement among patients subgrouped by the presence of individual SSc-related antibodies.

Conclusions. The measurement of anti-RNAP III antibody by ELISA is useful in routine clinical practice, because it helps diagnose SSc and identify a disease subset with severe skin and renal involvement.

KEY WORDS: Autoantibody, RNA polymerase, Systemic sclerosis, ELISA, Renal crisis, SSc severity scale

Submitted 24 April 2009; revised version accepted 6 August 2009.
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