Evidence map›Paper›PMID 34331348›Full record

Trial reportBritish journal of haematology2021

Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis.

Animesh Pardanani, Ayalew Tefferi, Tamás Masszi, Elena Mishchenko, Mark Drummond, Eric Jourdan, Alessandro Vannucchi, Mindaugas Jurgutis, Vincent Ribrag, Alessandro Rambaldi and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 2% 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

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Prognostic and Predictive Models in Myelofibrosis.Current hematologic malignancy reports · 2024
    Review
  17. Article
  18. Observational
  19. Article
  20. Evolving landscape of JAK inhibition in myelofibrosis: monotherapy and combinations.Hematology. American Society of Hematology. Education Program · 2023
    Article
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

14 authors at 12 institutions in 8 countries.

Animesh PardananiMayo Clinic of Rochester, Rochester, MN, USA.ORCID 0000-0002-9084-4148
Ayalew TefferiMayo Clinic of Rochester, Rochester, MN, USA.ORCID 0000-0003-4605-3821
Tamás MassziDepartment of Internal Medicine and Haematology, Semmelweis University, Budapest, Hungary.
Elena MishchenkoLady Davis Medical Center, Haifa, Israel.
Mark DrummondBeatson Cancer Centre, University of Glasgow, Glasgow, UK.
Eric JourdanCHU Caremeau, Nimes, France.
Alessandro VannucchiUniversity of Florence, AOU Careggi, Florence, Italy.
Mindaugas JurgutisKlaipeda Jurininku Hospital, Klaipeda, Lithuania.
Vincent RibragInstitut Gustave Roussy, Villejuif, France.
Alessandro RambaldiDepartment of Oncology and Hematology, University of Milan, Milan, Italy.
Liang Piu KohNational University Hospital Singapore, Singapore, Singapore.
Shelonitda RoseBristol Myers Squibb, Princeton, NJ, USA.
Jun ZhangBristol Myers Squibb, Princeton, NJ, USA.
Claire HarrisonGuy's and St Thomas' Hospital, London, UK.
Bristol-Myers Squibb (United States) · USMayo Clinic · USAzienda Ospedaliero-Universitaria Careggi · ITBeatson West of Scotland Cancer Centre · GBCarmel Medical Center · ILCentre Hospitalier Universitaire de Nîmes · FRInstitut Gustave Roussy · FRNational University Hospital · SGRepublic Klaipeda Hospital · LTSemmelweis University · HUSt Thomas' Hospital · GBUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fedratinib, an oral Janus kinase-2 (JAK2) inhibitor, reduces splenomegaly and improves symptom burden in patients with myelofibrosis. Regulatory approval of fedratinib 400-mg daily was based on results of an updated analysis of the pivotal phase III, placebo-controlled JAKARTA trial in patients with JAK-inhibitor-naïve myelofibrosis. At week 24, spleen volume response rate was 47% and symptom response rate was 40% with fedratinib 400 mg, versus 1% and 9% respectively, with placebo. Common adverse events were diarrhoea, nausea, anaemia, and vomiting. No Wernicke encephalopathy occurred in patients receiving fedratinib 400 mg/day. These updated data support use of first-line fedratinib in patients with myelofibrosis.

Indexed as

Administration, OralAdultAgedAged, 80 and overBenzenesulfonamidesCase-Control StudiesFollow-Up StudiesHumansJanus Kinase 2Janus Kinase InhibitorsMiddle AgedPlacebosPrimary MyelofibrosisPyrrolidinesSafetySpleenBenzenesulfonamidesfedratinibJAK2 protein, humanJanus Kinase 2Janus Kinase InhibitorsPlacebosPyrrolidinesSulfonamidesfedratinibJAK inhibitormyelofibrosis

Identifiers

PMID34331348
PMCPMC9292894
OpenAlexW3184692155

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.