Evidence map›Paper›PMID 39163611›Full record

Trial reportBlood advances2024

Combination therapy with ruxolitinib and pegylated interferon alfa-2a in newly diagnosed patients with polycythemia vera.

Anders Lindholm Sørensen, Vibe Skov, Lasse Kjær, Mads Emil Bjørn, Christina Schjellerup Eickhardt-Dalbøge, Morten Kranker Larsen, Claus H Nielsen, Carsten Thomsen, Lise Mette Rahbek Gjerdrum, Trine Alma Knudsen and 4 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood advances, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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.

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

21 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. [Progress in the study of polycythemia vera in children].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2026
    Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Polycythaemia vera.Nature reviews. Disease primers · 2025
    Review
  20. 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.

Anders Lindholm SørensenDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.
Vibe SkovDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0003-0097-7826
Lasse KjærDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.
Mads Emil BjørnDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0002-0264-6388
Christina Schjellerup Eickhardt-DalbøgeDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0002-0740-0555
Morten Kranker LarsenDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0002-2873-5928
Claus H NielsenInstitute for Inflammation Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-7543-9016
Carsten ThomsenDepartment of Diagnostic Imaging, Zealand University Hospital, Roskilde, Denmark.
Lise Mette Rahbek GjerdrumDepartment of Pathology, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0003-4377-3209
Trine Alma KnudsenDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0001-9829-3099
Christina EllervikDepartment of Research, Production, and Innovation, Soroe, Denmark.
Ulrik Malthe OvergaardDepartment of Hematology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Christen Lykkegaard AndersenDepartment of Hematology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Hans HasselbalchDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0003-3936-8032

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractWe report the 2-year end-of-study results from the phase 2 COMBI II clinical trial investigating the combination treatment of ruxolitinib and low-dose pegylated interferon alfa-2a in patients with newly diagnosed polycythemia vera (PV). The primary outcome was safety and key secondary endpoints were efficacy, based on hematologic parameters, quality-of-life measurements, and JAK2V617F variant allele frequency (VAF). We used the 2013 European LeukemiaNet and International Working Group-Myeloproliferative Neoplasms Research remission criteria. The remission criteria included remissions in symptoms, splenomegaly, peripheral blood counts, and bone marrow. We included 25 patients with PV with a median age of 70 years; 5 of those had prior thromboembolic events and 3 had computed tomography-verified splenomegaly. Two patients stopped both study drugs; 1 of these due to progression to post-PV myelofibrosis, the only one with a grade 3 infection. No events of herpes zoster infections were observed. None of the patients discontinued treatment due to psychiatric symptoms. The peripheral blood cell count remission rate was 92% at 24 months. Using the 2013 European LeukemiaNet and International Working Group-Myeloproliferative Neoplasms Research remission criteria, 14 (56%) achieved remission at 24 months; 3 (12%) achieved complete remission and 11 (44%) achieved partial remission. The following items from the Myeloproliferative Neoplasm Symptom Total Symptom Score were significantly reduced: abdominal discomfort, night sweats, itching, and bone pain. The median JAK2V617F VAF decreased from 47% (95% confidence interval [CI], 35-59) to 7% (95% CI, 3-15), and 60% of patients achieved molecular remission. In conclusion, combination treatment improved cell counts; bone marrow cellularity, and fibrosis; and decreased JAK2V617F VAF; with acceptable toxicity in patients with PV. The trial was registered at www.clinicaltrialsregister.eu as #EudraCT2018-004150-13.

Indexed as

Interferon-alphaJanus Kinase 2NitrilesPolycythemia VeraPolyethylene GlycolsPyrazolesPyrimidinesRecombinant ProteinsAgedAged, 80 and overFemaleHumansMaleMiddle AgedTreatment OutcomeInterferon-alphaJAK2 protein, humanJanus Kinase 2Nitrilespeginterferon alfa-2aPolyethylene GlycolsPyrazolesPyrimidinesRecombinant Proteinsruxolitinib

Identifiers

PMID39163611
PMCPMC11526083

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.