Evidence map›Paper›PMID 32875487›Full record

ArticleInternational journal of hematology2020

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

Yachiyo Kuwatsuka, Yoshiko Atsuta, Akihiro Hirakawa, Naoyuki Uchida, Yoshihiro Inamoto, Yuho Najima, Kazuhiro Ikegame, Tetsuya Eto, Yukiyasu Ozawa, Tatsuo Ichinohe and 5 more

Abstract read
PubMed Publisher
In one paragraph

Article in International journal of hematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

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  4. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 1 country.

Yachiyo KuwatsukaDepartment of Advanced Medicine, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan. ykuwatsuka@med.nagoya-u.ac.jp.ORCID http://orcid.org/0000-0001-6092-3948
Yoshiko AtsutaJapanese Data Center for Hematopoietic Cell Transplantation, Nagoya, Japan.
Akihiro HirakawaDivision of Biostatistics and Data Science, Clinical Research Center, Tokyo Medical and Dental University, Tokyo, Japan.
Naoyuki UchidaDepartment of Hematology, Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospsital, Tokyo, Japan.
Yoshihiro InamotoDepartment of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
Yuho NajimaHematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Kazuhiro IkegameDepartment of Hematology, Hyogo College of Medicine Hospital, Nishinomiya, Japan.
Tetsuya EtoDepartment of Hematology, Hamanomachi Hospital, Fukuoka, Japan.
Yukiyasu OzawaDepartment of Hematology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.
Tatsuo IchinoheDepartment of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.
Masami InoueDepartment of Hematology/Oncology, Osaka Women's and Children's Hospital, Izumi, Japan.
Takafumi KimuraPreparation Department, Japanese Red Cross Kinki Block Blood Center, Ibaraki, Japan.
Shinichiro OkamotoDivision of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.
Koichi MiyamuraDepartment of Hematology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.
Takahiro FukudaDepartment of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
Hamanomachi Hospital · JPHiroshima University · JPHyogo Medical University · JPJapanese Red Cross Society, Japan · JPKeio University · JPNagoya University Hospital · JPOsaka Women's and Children's Hospital · JPThe Japanese Data Center for Hematopoietic Cell Transplantation · JPTokyo Medical and Dental University · JPTokyo Metropolitan Komagome Hospital · JPToranomon Hospital · JP

Funding

Japan Society for the Promotion of Science 17K08911Japan Society for the Promotion of Science 26860346
6 · The paper itself

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.

Indexed as

RegistriesAcute DiseaseAdultBeclomethasoneChronic DiseaseCidofovirCytomegalovirus InfectionsEtanerceptFemaleFoscarnetGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansInfliximabJapanMaleBeclomethasoneCidofovirEtanerceptFoscarnetInfliximabMycophenolic AcidDrug lagGraft-versus-host diseasePost-transplant viral infectionRegistryStem cell transplantation

Identifiers

PMID32875487
OpenAlexW3082430665

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.