Evidence map›Paper›PMID 27188338›Full record

Trial reportInternational journal of hematology2016

Efficacy and safety of rituximab in Japanese patients with acquired thrombotic thrombocytopenic purpura refractory to conventional therapy.

Yoshitaka Miyakawa, Kazunori Imada, Tatsuo Ichinohe, Kenji Nishio, Takayuki Abe, Mitsuru Murata, Yasunori Ueda, Yoshihiro Fujimura, Masanori Matsumoto, Shinichiro Okamoto

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Guideline
  2. Review
  3. Review
  4. ADAMTS13 in the New Era of TTP.International journal of molecular sciences · 2024
    Review
  5. How We Interpret Thrombosis with Thrombocytopenia Syndrome?International journal of molecular sciences · 2024
    Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Observational
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

10 authors at 6 institutions in 1 country.

Yoshitaka MiyakawaDepartment of General Internal Medicine, Saitama Medical University, 38 Morohongo, Moroyamamachi, Irumagun, Saitama, 350-0495, Japan. miyakawa@saitama-med.ac.jp.
Kazunori ImadaDepartment of Hematology, Kokura Memorial Hospital, Fukuoka, Japan.
Tatsuo IchinoheDepartment of Hematology and Oncology, Hiroshima University, Hiroshima, Japan.
Kenji NishioDepartment of General Medicine, Nara Medical University, Nara, Japan.
Takayuki AbeDepartment of Preventive Medicine and Public Health, Biostatistics Unit at the Clinical and Translational Research Center, Keio University School of Medicine, Tokyo, Japan.
Mitsuru MurataDepartment of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan.
Yasunori UedaDepartment of Hematology/Oncology, Kurashiki Central Hospital, Okayama, Japan.
Yoshihiro FujimuraDepartment of Blood Transfusion Medicine, Nara Medical University, Nara, Japan.
Masanori MatsumotoDepartment of Blood Transfusion Medicine, Nara Medical University, Nara, Japan.
Shinichiro OkamotoDivision of Hematology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Keio University · JPNara Medical University · JPHiroshima University · JPKurashiki Central Hospital · JPOsaka Red Cross Hospital · JPSaitama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Thrombotic thrombocytopenic purpura (TTP), while rare, is a potentially life-threatening disorder. Plasma exchange (PE) is considered the primary treatment for TTP. In Western countries, rituximab, an anti-CD20 antibody, is recommended with PE for the treatment of refractory/relapsed TTP, and as up-front therapy in newly diagnosed TTP with neurological/cardiac pathology. The present open-label, single-arm, multicenter study evaluated the efficacy and safety of rituximab in Japanese patients with refractory/relapsed TTP. Patients received rituximab 375 mg/m(2) intravenously, once weekly for a total of four treatments, with PE and steroids. Of six evaluable patients in the full analysis set, two met the primary efficacy endpoint (platelet count >150 × 10(9)/L at week 4), yielding a 33.3 % response rate (95 % confidence interval: 4.3-77.7). While the lower confidence limit of the primary efficacy endpoint failed to reach the pre-specified threshold of 30 %, clinically significant recovery of platelet count with discontinuation of PE, increase of ADAMTS13 activity, disappearance of ADAMTS13 inhibitor, and improvement of TTP-associated clinical manifestations were observed after rituximab therapy in all patients. No safety concerns were identified in this study; therefore, rituximab is considered a useful treatment option in Japanese TTP patients who are refractory to conventional therapy. Trial registration JMA-IIA00160.

Indexed as

ADAMTS13 ProteinAsian PeopleHumansPlasma ExchangePlatelet CountPurpura, Thrombotic ThrombocytopenicRecurrenceRituximabSecondary PreventionTreatment OutcomeADAMTS13 ProteinADAMTS13 protein, humanRituximabADAMTS13RituximabThrombotic thrombocytopenic purpura

Identifiers

PMID27188338
OpenAlexW2395615978

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.