Evidence map›Paper›PMID 35318505›Full record

ArticleAnnals of hematology2022

Safety and effectiveness of ruxolitinib in the real-world management of polycythemia vera patients: a collaborative retrospective study by pH-negative MPN latial group.

Sara Pepe, Elena Rossi, Malgorzata Trawinska, Caterina Tatarelli, Ambra Di Veroli, Luca Maurillo, Atelda Romano, Sabrina Leonetti Crescenzi, Tommaso Caravita di Toritto, Agostino Tafuri and 5 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Annals of hematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 32% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

15 authors at 9 institutions in 1 country.

Sara PepeHematology, Department of Translational and Precision Medicine, Az. Policlinico Umberto I-Sapienza University, Via Benevento 6, 00161, Rome, Italy.
Elena RossiSection of Hematology, Department of Radiological and Hematological Sciences, Catholic University, Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy.
Malgorzata TrawinskaOspedale S. Eugenio, Rome, Italy.
Caterina TatarelliHematology, Department of Clinical and Molecular Medicine, University Hospital Sant'Andrea, Sapienza University of Rome, Rome, Italy.
Ambra Di VeroliBelcolle Hospital, Viterbo, Italy.
Luca MaurilloTor Vergata University, Rome, Italy.
Atelda RomanoHematology, IFO, Rome, Italy.
Sabrina Leonetti CrescenziS. Giovanni Addolorata Hospital, Rome, Italy.
Tommaso Caravita di TorittoUOSD Ematologia ASL, Roma 1, Rome, Italy.
Agostino TafuriHematology, Department of Clinical and Molecular Medicine, University Hospital Sant'Andrea, Sapienza University of Rome, Rome, Italy.
Roberto LatagliataBelcolle Hospital, Viterbo, Italy.
Emilia ScalzulliHematology, Department of Translational and Precision Medicine, Az. Policlinico Umberto I-Sapienza University, Via Benevento 6, 00161, Rome, Italy.
Alessandro AndrianiSpaziani Hospital, Frosinone, Italy.
Valerio De StefanoSection of Hematology, Department of Radiological and Hematological Sciences, Catholic University, Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy.
Massimo BrecciaHematology, Department of Translational and Precision Medicine, Az. Policlinico Umberto I-Sapienza University, Via Benevento 6, 00161, Rome, Italy. breccia@bce.uniroma1.it.ORCID http://orcid.org/0000-0003-1163-6162
Policlinico Umberto I · ITAgostino Gemelli University Polyclinic · ITOspedale di Belcolle · ITSapienza University of Rome · ITASL Roma · ITAzienda Ospedaliera San Giovanni Addolorata · ITIstituti Fisioterapici Ospitalieri · ITSt. Eugenio Hospital · ITUniversity of Rome Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ruxolitinib is approved for polycythemia vera (PV) patients after failure to previous cytoreductive therapy, based on durable results observed in phase 3 trials. We report a multicenter retrospective study demonstrating the efficacy and safety of ruxolitinib in real-life setting. Eighty-three patients were evaluated. Median follow-up was 24.5 months (IQR 14.0-29.3). At a 3-month response assessment, ruxolitinib provided significant benefit in reducing hematocrit (HCT) level (p < 0.001), phlebotomy requirement (p < 0.001), leucocytes (p = 0.044), and disease-related symptoms (p < 0.001). The exposure-adjusted rates (per 100 patient-years) of infectious complications, thromboembolic events, and secondary malignancies were 6.9, 3, and 3.7, respectively. Non-melanoma skin cancers (NMSC) were the most frequent (40%) SM type. Lymphoproliferative disorders were not detected. Five (6%) patients permanently discontinued ruxolitinib treatment and four (5%) evolved in myelofibrosis (MF), but none in acute leukemia. The rate of MF evolution per 100 patient-years of exposure was 2.8. In our experience, ruxolitinib confirmed its efficacy and safety outside of clinical trials.

Indexed as

Polycythemia VeraPrimary MyelofibrosisHumansHydrogen-Ion ConcentrationNitrilesPyrazolesPyrimidinesRetrospective StudiesNitrilesPyrazolesPyrimidinesruxolitinibPolycythemia veraReal-lifeRuxolitinib

Identifiers

PMID35318505
OpenAlexW4221036323

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.