Evidence map›Paper›PMID 36105914›Full record

ArticleTherapeutic advances in hematology2022

Efficacy and safety of ruxolitinib in patients with myelofibrosis and low platelet count (50 × 10

Paola Guglielmelli, Jean-Jacques Kiladjian, Alessandro M Vannucchi, Minghui Duan, Haitao Meng, Ling Pan, Guangsheng He, Srdan Verstovsek, Françoise Boyer, Fiorenza Barraco and 10 more

Registry-linked trialAbstract read
In one paragraph

Article in Therapeutic advances in hematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01317875 (A Phase Ib, Open-label, Dose-finding Study of the JAK Inhibitor INC424 Tablets Administered Orally to Patients With Primary Myelofibrosis), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

NCT01317875 phase1completednot on this map

A Phase Ib, Open-label, Dose-finding Study of the JAK Inhibitor INC424 Tablets Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-polycythemia Veramyelofibrosis (PPV-MF) or Post-essentialthrombocythemia-myelofibrosis (PET-MF) and Baseline Platelet Counts ≥50 x109/L and <100 x109/L (EXPAND)

TypeinterventionalSponsorIncyte CorporationRan2011 to 2019Enrolled69ConditionsMyelofibrosisArmsRuxolitinib
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Vitiligo and Mental Health: Natural Compounds' Usefulness.Antioxidants (Basel, Switzerland) · 2023
    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

20 authors.

Paola GuglielmelliCRIMM, Centro di Ricerca e Innovazione per le Malattie Mieloproliferative, AOU Careggi, Dipartimento di Medicina Sperimentale e Clinica, University of Florence, Viale Pieraccini 6, 50134 Firenze, Italy.ORCID https://orcid.org/0000-0003-1809-284X
Jean-Jacques KiladjianAPHP, Hôpital Saint-Louis, Centre d'Investigations Cliniques, INSERM CIC 1427, Université de Paris, Paris, France.
Alessandro M VannucchiCRIMM, Centro di Ricerca e Innovazione per le Malattie Mieloproliferative, AOU Careggi, Dipartimento di Medicina Sperimentale e Clinica, University of Florence, Florence, Italy.
Minghui DuanPeking Union Medical College Hospital, Beijing, China.
Haitao MengDepartment of Hematology, The First Affiliated Hospital, College of Medicine, Institute of Hematology, Zhejiang University, Hangzhou, China.
Ling PanWest China Hospital, Sichuan University, Chengdu, China.
Guangsheng HeDepartment of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.ORCID https://orcid.org/0000-0002-3944-5897
Srdan VerstovsekThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Françoise BoyerCentre Hospitalier Universitaire d'Angers, Angers, France.
Fiorenza BarracoCentre Hospitalier Lyon Sud, Pierre-Bénite, France.
Dietger NiederwieserDepartment of Hematology and Medical Oncology, University of Leipzig, Leipzig, Germany.
Ester PungolinoDivision of Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Anna Marina LiberatiAzienda Ospedaliera Santa Maria di Terni, Università degli Studi di Perugia, Terni, Italy.
Claire HarrisonGuy's and St Thomas' NHS Foundation Trust, London, UK.
Pantelia RoussouNovartis Pharma AG, Basel, Switzerland.
Monika WroclawskaNovartis Pharma AG, Basel, Switzerland.
Divyadeep KarumanchiNovartis Pharmaceuticals, East Hanover, NJ, USA.
Karen SinclairNovartis Pharma AG, Basel, Switzerland.
Peter A W Te BoekhorstErasmus Medical Center, Rotterdam, The Netherlands.
Heinz GisslingerMedical University of Vienna, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Thrombocytopenia is a common feature of myelofibrosis (MF), a myeloproliferative neoplasm driven by dysregulated JAK/STAT signaling; however, pivotal trials assessing the efficacy of ruxolitinib (a JAK1/2 inhibitor) excluded MF patients with low platelet counts (<100 × 10 Objectives: Determination of the maximum safe starting dose (MSSD) of ruxolitinib was the primary endpoint, with long-term safety and efficacy as secondary and exploratory endpoints, respectively. Design: EXPAND (NCT01317875) was a phase 1b, open-label, ruxolitinib dose-finding study in patients with MF and low platelet counts (50 to <100 × 10 Methods: Patients were stratified according to baseline platelet count into stratum 1 (S1, 75 to <100 × 10 Results: Of 69 enrolled patients, 38 received ruxolitinib at the MSSD (S1, Conclusion: The final safety and efficacy results from EXPAND support the use of a 10 mg bid starting dose of ruxolitinib in patients with MF and platelet counts 50 to <100 × 10 Registration: ClinicalTrials.gov NCT01317875.

Indexed as

myelofibrosisruxolitinibthrombocytopenia

Identifiers

PMID36105914
PMCPMC9465569

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Registered trials

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.