A retrospective study of serum KL-6 levels during treatment with biological disease-modifying antirheumatic drugs in rheumatoid arthritis patients: a report from the Ad?Hoc Committee for Safety of Biological DMARDs of the Japan College of Rheumatology

详细信息    查看全文

• 作者：Akito Takamura (1)
  Shintaro Hirata (2)
  Hayato Nagasawa (3)
  Hideto Kameda (4)
  Yohei Seto (5)
  Tatsuya Atsumi (6)
  Makoto Dohi (7)
  Takao Koike (8)
  Nobuyuki Miyasaka (1) (10)
  Masayoshi Harigai (1) (9)
  
• 关键词：Rheumatoid arthritis ; Biological disease ; modifying antirheumatic drug ; KL ; 6
• 刊名：Modern Rheumatology
• 出版年：2013
• 出版时间：March 2013
• 年：2013
• 卷：23
• 期：2
• 页码：297-303
• 全文大小：244 KB
• 参考文献：1. Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67:189-4. CrossRef
  2. Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009;36:898-06. CrossRef
  3. Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients. Mod Rheumatol Japan Rheum Assoc. 2011.
  4. Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients. Ann Rheum Dis. 2011;70:2148-1. CrossRef
  5. Koike R, Takeuchi T, Eguchi K, Miyasaka N. Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis. Mod Rheumatol. 2007;17:451-. CrossRef
  6. Koike R, Harigai M, Atsumi T, Amano K, Kawai S, Saito K, et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol. 2009;19:351-. CrossRef
  7. Japan College of Rheumatology. Guideline for the use of TNF inhibitors in rheumatoid arthritis, Japan College of Rheumatology. Tokyo 2010 (in Japanese). http://www.ryumachi-jp.com/info/guideline_TNF_100930.html (updated 30-09-2010; cited 01-11-2011).
  8. Japan College of Rheumatology. Guideline for the use tocilizumab in rheumatoid arthritis, Japan College of Rheumatology (in Japanese). 2010. http://www.ryumachi-jp.com/info/guideline_TCZ_100716.html (updated 16-07-2010).
  9. Stahel RA, Gilks WR, Lehmann HP, Schenker T. Third International Workshop on Lung Tumor and Differentiation Antigens: overview of the results of the central data analysis. Int J Cancer Suppl. 1994;8:6-6. CrossRef
  10. Kohno N, Awaya Y, Oyama T, Yamakido M, Akiyama M, Inoue Y, et al. KL-6, a mucin-like glycoprotein, in bronchoalveolar lavage fluid from patients with interstitial lung disease. Am Rev Respir Dis. 1993;148:637-2. CrossRef
  11. Miyata M, Sakuma F, Fukaya E, Kobayashi H, Rai T, Saito H, et al. Detection and monitoring of methotrexate-associated lung injury using serum markers KL-6 and SP-D in rheumatoid arthritis. Intern Med. 2002;41:467-3. CrossRef
  12. Nakajima H, Harigai M, Hara M, Hakoda M, Tokuda H, Sakai F, et al. KL-6 as a novel serum marker for interstitial pneumonia associated with collagen diseases. J Rheumatol. 2000;27:1164-0.
  13. Nakamura H, Tateyama M, Tasato D, Haranaga S, Yara S, Higa F, et al. Clinical utility of serum beta-d -glucan and KL-6 levels in / Pneumocystis jirovecii pneumonia. Intern Med. 2009;48:195-02. CrossRef
  14. Ohnishi H, Yokoyama A, Yasuhara Y, Watanabe A, Naka T, Hamada H, et al. Circulating KL-6 levels in patients with drug induced pneumonitis. Thorax. 2003;58:872-. CrossRef
  15. Tasaka S, Hasegawa N, Kobayashi S, Yamada W, Nishimura T, Takeuchi T, et al. Serum indicators for the diagnosis of pneumocystis pneumonia. Chest. 2007;131:1173-0. CrossRef
  16. Takeuchi T, Miyasaka N, Inoue K, Abe T, Koike T. Impact of trough serum level on radiographic and clinical response to infliximab plus methotrexate in patients with rheumatoid arthritis: results from the RISING study. Mod Rheumatol Japan Rheum Assoc. 2009;19:478-7. CrossRef
  17. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31:315-4. CrossRef
  18. Harigai M, Takamura A, Atsumi T, Dohi M, Hirata S, Kameda H, et al. Elevation of KL-6 serum levels in clinical trials of tumor necrosis factor inhibitors in patients with rheumatoid arthritis—a report from the ad-hoc committee for safety of biological DAMRDs of the Japan College of Rheumatology. 2012 (submitted).
  19. van den Blink B, Wijsenbeek MS, Hoogsteden HC. Serum biomarkers in idiopathic pulmonary fibrosis. Pulm Pharmacol Ther. 2010;23:515-0. CrossRef
  20. Oyama T, Kohno N, Yokoyama A, Hirasawa Y, Hiwada K, Oyama H, et al. Detection of interstitial pneumonitis in patients with rheumatoid arthritis by measuring circulating levels of KL-6, a human MUC1 mucin. Lung. 1997;175:379-5. CrossRef
  
• 作者单位：Akito Takamura (1)
  Shintaro Hirata (2)
  Hayato Nagasawa (3)
  Hideto Kameda (4)
  Yohei Seto (5)
  Tatsuya Atsumi (6)
  Makoto Dohi (7)
  Takao Koike (8)
  Nobuyuki Miyasaka (1) (10)
  Masayoshi Harigai (1) (9)
  
  1. Department of Medicine and Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
  2. The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
  3. Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan
  4. Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Faculty of Medicine, Keio University, Tokyo, Japan
  5. Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan
  6. Department of Internal Medicine II, Graduate School of Medicine, Hokkaido University, Sapporo, Japan
  7. Department of Allergy and Rheumatology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan
  8. Sapporo Medical Center NTT EC, Sapporo, Hokkaido, Japan
  10. Global Center of Excellence Program, International Research Center for Molecular Science in Tooth and Bone Diseases, Tokyo Medical and Dental University, Tokyo, Japan
  9. Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
  
• ISSN：1439-7609

文摘

Objective We investigated associations between treatment with methotrexate (MTX) or biological disease-modifying antirheumatic drugs (DMARDs) and elevation of serum Krebs von den Lungen-6 (KL-6) levels in Japanese patients with rheumatoid arthritis (RA). Methods Using a standardized form, data were collected retrospectively from medical records and analyzed descriptively. Results Of a total of 198 RA patients with KL-6 serum levels measured at initiation of treatment (month?0) and two or more times by month?12, 27 (17.9?%) of 151 RA patients treated with biological DMARDs, including infliximab, etanercept, adalimumab, and tocilizumab (the biological DMARDs group), and 5 (10.6?%) of 47 patients treated without biological DMARDs but with MTX (MTX group), met criterion?B (max. KL-6 ?00?U/ml and >1.5-fold from baseline) by 12?months. The majority of patients (n?=?28) meeting criterion?B had no apparent interstitial lung disease or malignancy. Of these 28 patients, 21 had serum KL-6 levels available after reaching their maximum level, and 13 (61.9?%) of the 21 then met criterion?R [decrease to less than 500?U/ml or to less than (baseline?+?0.5?×?(maximum???baseline))] by month?12. Conclusion Serum KL-6 levels may increase during treatment with MTX or these biological DMARDs without significant clinical events.