Evidence map›Paper›PMID 26466831›Full record

Trial reportInternational journal of hematology2015

Efficacy and safety of rituximab in Japanese patients with relapsed chronic immune thrombocytopenia refractory to conventional therapy.

Yoshitaka Miyakawa, Shinya Katsutani, Takahiro Yano, Shosaku Nomura, Kaichi Nishiwaki, Yoshiaki Tomiyama, Masaaki Higashihara, Yukari Shirasugi, Masakatsu Nishikawa, Katsutoshi Ozaki and 6 more

Abstract readClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

9 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Advances in Diagnosis and Treatments for Immune Thrombocytopenia.Clinical medicine insights. Blood disorders · 2016
    Review
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

16 authors at 14 institutions in 1 country.

Yoshitaka Miyakawa
Shinya Katsutani
Takahiro Yano
Shosaku Nomura
Kaichi Nishiwaki
Yoshiaki Tomiyama
Masaaki Higashihara
Yukari Shirasugi
Masakatsu Nishikawa
Katsutoshi Ozaki
Takayuki Abe
Kayoko Kikuchi
Yuzuru Kanakura
Kingo Fujimura
Yasuo Ikeda
Shinichiro Okamoto
Keio University · JPHiroshima University · JPJichi Medical University · JPJikei University Kashiwa hospital · JPKansai Medical University · JPKitasato University Hospital · JPMie University Hospital · JPOsaka University · JPOsaka University Hospital · JPSaitama Medical University · JPTokai University Hospital · JPTokyo Medical Center · JPWaseda University · JPYasuda Women's University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Primary immune thrombocytopenia (ITP) is an autoimmune disease mediated by the production of autoantibody against platelets. Rituximab, an anti-CD20 antibody, is reported to be useful for treatment of ITP. In Japan, however, robust evidence on this treatment has not been accumulated. Hence, we conducted this open-label phase III clinical trial to confirm the efficacy and safety of rituximab, administered at 375 mg/m² once per week at weekly intervals for 4 consecutive weeks in Japanese patients with chronic ITP, who had relapsed and were refractory to conventional therapy. The primary endpoint was defined as the percentage of patients with a platelet count above 50 × 10⁹/L at week 24 after the first dose of rituximab, which was 30.8% of 26 patients (95% confidence interval 14.3-51.8%). Although the lower confidence limit of primary endpoint failed to meet the pre-specified threshold of 20%, the clinical efficacy of rituximab is substantial in consideration of the 2% response rate in the placebo arm in other clinical studies in patients with chronic ITP. We conclude that rituximab is clinically useful and safe in the treatment of Japanese patients with chronic ITP, achieving the goal of maintaining platelet count and reducing risk of bleeding while minimizing treatment-related toxicity.

Indexed as

AdultAsian PeopleChronic DiseaseFemaleHumansImmunologic FactorsMaleMiddle AgedPlatelet CountPurpura, Thrombocytopenic, IdiopathicRecurrenceRituximabTreatment OutcomeImmunologic FactorsRituximab

Identifiers

PMID26466831
OpenAlexW2194569845

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.