Safety and effectiveness of eculizumab for adult patients with atypical hemolytic–uremic syndrome in Japan: interim analysis of post-marketing surveillance View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-06-29

AUTHORS

Hideki Kato, Yoshitaka Miyakawa, Yoshihiko Hidaka, Norimitsu Inoue, Shuichi Ito, Shoji Kagami, Shinya Kaname, Masanori Matsumoto, Masashi Mizuno, Takahisa Matsuda, Akihiko Shimono, Shoichi Maruyama, Yoshihiro Fujimura, Masaomi Nangaku, Hirokazu Okada

ABSTRACT

BackgroundEculizumab has been available for the treatment of atypical hemolytic–uremic syndrome (aHUS) in Japan since 2013. To assess safety and effectiveness of eculizumab in adult aHUS patients in the real-life setting, we performed interim analysis of a post-marketing surveillance mandated by Japanese regulations.MethodsThis study enrolled any patient who was diagnosed with TMA excluding Shiga toxin-producing Escherichia coli-HUS or thrombotic thrombocytopenic purpura based on Japanese clinical guide published in 2013 as inclusion criteria and treated with eculizumab. Although the term aHUS was redefined to denote only complement-mediated HUS in the guide revised in 2016, the patients with TMA caused by other causes (secondary TMA) were included. Patient outcomes and safety were evaluated at 6 months, 12 months, and annually thereafter.ResultsThirty-three patients with aHUS and 27 patients with secondary TMA were enrolled. Median treatment duration of aHUS was 24weeks. Complement genes variants were detected in 11 of 18 patients with aHUS (61.1%). Among the 29 aHUS patients with available baseline data, platelet count (PLT), lactic dehydrogenase and serum creatinine (SCr) improved within 1-month after eculizumab initiation. TMA event-free status, complete TMA response, PLT normalization, and SCr decrease were achieved in 67.9% (19/28), 27.8% (5/18), 56.5% (13/23), and 57.1% (16/28) of patients, respectively. Thirty-three and 11 adverse reactions were observed in patients with aHUS (13/33 patients) and secondary TMA (6/27 patients), respectively.ConclusionsThis interim analysis confirmed the acceptable safety profile and effectiveness of eculizumab for Japanese adult aHUS patients in real-world settings. More... »

PAGES

65-75

Journal

TITLE

Clinical and Experimental Nephrology

ISSUE

1

VOLUME

23

Author Affiliations

  • Division of Nephrology and Endocrinology, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, 113-8655, Tokyo, Japan
  • Department of General Internal Medicine, Thrombosis and Hemostasis Center, Saitama Medical University, 38 Moroyama, Iruma-gun, 350-0495, Saitama, Japan
  • Clinical Division of Pediatrics, Shinshu University Hospital, 3-1-1 Asahi, 390-8621, Matsumoto, Nagano, Japan
  • Department of Tumor Immunology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, 541-8567, Osaka, Japan
  • Department of Pediatrics, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanasawa-ku, 236-0004, Yokohama, Kanagawa, Japan
  • Department of Pediatrics, Institute of Health Biosciences, The University of Tokushima Graduate School, Kuramoto cho 3-chome, 770-8503, Tokushima, Japan
  • Department of Nephrology and Rheumatology, Kyorin University School of Medicine, 6-20-2 Shinkawa, 181-8611, Mitaka, Tokyo, Japan
  • Department of Blood Transfusion Medicine, Nara Medical University, 840 Shijyo-cho, 634-8522, Kashihara, Nara, Japan
  • Renal Replacement Therapy, Division of Nephrology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, 466-8550, Nagoya, Aichi, Japan
  • Alexion Pharma GK, 1-18-14 Ebisu, Shibuya-ku, 150-0013, Tokyo, Japan
  • Department of Nephrology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, 466-8550, Nagoya, Aichi, Japan
  • Japanese Red Cross Kinki Block Blood Center, 7-5-17, Saitoasagi, 567-0085, Ibaraki, Osaka, Japan
  • Department of Nephrology, Saitama Medical University, 38 Moroyama, Iruma-gun, 350-0495, Saitama, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s10157-018-1609-8

    DOI

    http://dx.doi.org/10.1007/s10157-018-1609-8

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1105208689

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29959568


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    344 grid-institutes:grid.412568.c schema:alternateName Clinical Division of Pediatrics, Shinshu University Hospital, 3-1-1 Asahi, 390-8621, Matsumoto, Nagano, Japan
    345 schema:name Clinical Division of Pediatrics, Shinshu University Hospital, 3-1-1 Asahi, 390-8621, Matsumoto, Nagano, Japan
    346 rdf:type schema:Organization
    347 grid-institutes:grid.489169.b schema:alternateName Department of Tumor Immunology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, 541-8567, Osaka, Japan
    348 schema:name Department of Tumor Immunology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, 541-8567, Osaka, Japan
    349 rdf:type schema:Organization
     




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