Use of unapproved or off-label drugs in Japan for the treatment of graft-versus-host disease and post-transplant viral infection View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2020-09-01

AUTHORS

Yachiyo Kuwatsuka, Yoshiko Atsuta, Akihiro Hirakawa, Naoyuki Uchida, Yoshihiro Inamoto, Yuho Najima, Kazuhiro Ikegame, Tetsuya Eto, Yukiyasu Ozawa, Tatsuo Ichinohe, Masami Inoue, Takafumi Kimura, Shinichiro Okamoto, Koichi Miyamura, Takahiro Fukuda

ABSTRACT

Many drugs are used for unapproved indications in Japan for post hematopoietic stem cell transplant (HCT) complications. To investigate unapproved or off-label drug usage for graft-versus-host disease (GVHD) and virus infections after allogeneic HCT, we analyzed the data of Japanese HCT registry. Between 2006 and 2017, 39,941 adults and children received HCT for a variety of disease and their transplant data were captured in the registry. Among them, 14,687 and 8914 patients receiving treatment for acute and/or chronic GVHD, 24,828 patients with cytomegalovirus (CMV) infection or receiving therapies for CMV, and 4943 who received treatment for other viral infections were included in the analyses of off-label or unapproved drugs. For GVHD, mycophenolate mofetil was the most frequently used off-label drug, followed by beclomethasone, infliximab, and etanercept. For viral infections other than CMV, foscarnet was the most frequently used off-label drug. Cidofovir, which is not approved for use in Japan, was mainly used for adenovirus infection. This study demonstrated that numerous off-label and unapproved drugs have been used as key drugs for GVHD and post-transplant viral infection, and the real world date in the transplant registry may serve as an important asset to regulatory purposes. More... »

PAGES

841-850

References to SciGraph publications

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  • Journal

    TITLE

    International Journal of Hematology

    ISSUE

    6

    VOLUME

    112

    Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s12185-020-02972-0

    DOI

    http://dx.doi.org/10.1007/s12185-020-02972-0

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1130507632

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/32875487


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