Evidence map›Paper›PMID 41877599›Full record

Observational studyHematological oncology2026

Clinical Outcomes of Ruxolitinib Treatment in Patients With IPSS Intermediate-1-Risk Myelofibrosis: Interim Analysis From an Italian, Prospective Study (ROMEI).

Paola Guglielmelli, Massimo Breccia, Francesco Mendicino, Maurizio Martelli, Nicola Di Renzo, Giuseppe A Palumbo, Monica Crugnola, Maurizio Musso, Silvia Sibilla, Paolo Sportoletti and 46 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Hematological oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

56 authors.

Paola GuglielmelliDepartment of Experimental and Clinical Medicine, CRIMM, Center for Research and Innovation of Myeloproliferative Neoplasms, AOU Careggi, University of Florence, Florence, Italy.ORCID https://orcid.org/0000-0003-1809-284X
Massimo BrecciaHematology, Department of Translational and Precision Medicine, Azienda Policlinico Umberto I, Sapienza University, Rome, Italy.ORCID https://orcid.org/0000-0003-1163-6162
Francesco MendicinoA. O. di Cosenza, Presidio Ospedaliero Annunziata, Cosenza, Italy.
Maurizio MartelliA. O. Policlinico Umberto I, Università La Sapienza, Roma, Italy.
Nicola Di RenzoHematology and Hematopoietic Stem Cell Transplantation Unit. PO "Vito Fazzi". ASL Lecce, Lecce, Italy.
Giuseppe A PalumboDepartment of Scienze Mediche, Chirurgiche e Tecnologie Avanzate "G.F. Ingrassia", University of Catania, Catania, Italy.
Monica CrugnolaHematology Unit, University Hospital of Parma, Parma, Italy.
Maurizio MussoOspedale La Maddalena, Palermo, Italy.
Silvia SibillaUnit of Hematology and Hemopoietic Stem Cell Transplantation, Ospedale Cardinale G Panico, Tricase, Italy.
Paolo SportolettiInstitute of Hematology-Centro di Ricerche Emato-Oncologiche (CREO), University of Perugia, Perugia, Italy.ORCID https://orcid.org/0000-0002-5630-9862
Elisabetta AbruzzeseHematology, S. Eugenio Hopsital, ASL Roma 2, Tor Vergata University, Rome, Italy.ORCID https://orcid.org/0000-0001-5228-6491
Stefana ImperaU.O.C. Ematologia, A. O.ad Alta Specializzazione Ospedale Garibaldi Nesima, Catania, Italy.
Alessandra MalatoA.O. Ospedali Riuniti Villa Sofia-Cervello - P.O. Cervello, Palermo, Italy.
Sergio SiragusaAz. Osp. Univ. Policlinico P Giaccone Università degli Studi Palermo, Palermo, Italy.
Carmine SelleriHematology and Bone Marrow Unit, AOU S.Giovanni di Dio e Ruggi d'Aragona, Department of Medicine and Surgery, University of Salerno, Fisciano, Italy.
Fabrizio PaneA. O. U. Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy.
Bruno MartinoA.O. Bianchi Melacrino Morelli - Presidio Ospedali Riuniti, Reggio di Calabria, Italy.
Alessandra RiccoAz. Osp. Univ. Consorziale Policlinico di Bari Università degli Studi, Bari, Italy.
Angelo GardelliniDivision of Hematology, Valduce Hospital, Como, Italy.
Anna Marina LiberatiS.C. Oncoematologia Azienda Ospedaliera S Maria di Terni, Terni, Italy.
Agostino TafuriHematology, Department of Clinical and Molecular Medicine, University Hospital Sant'Andrea-Sapienza, Rome, Italy.
Maria LangellaPresidio Ospedaliero Andrea Tortora - ASL Salerno, Pagani, Italy.
Marco BrocinerASST Sette Laghi Osp. di Circolo e Fond Macchi, Varese, Italy.
Paolo DitonnoIRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Domenico PastoreUOC Ematologia e Trapianto di Midollo, Presidio Osp. A. Perrino ASL BR, Brindisi, Italy.
Olga MulasA. O. Brotzu Osp. Onc. Armando Businco Centro Rif Onc. Reg, Cagliari, Italy.
Barbara PocaliDip. Pneumo-Oncoematologico, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Napoli, Italy.
Marco De GobbiDepartment Clinical and Biological Sciences University of Torino, A.O.U. S. Luigi Gonzaga Orbassano, Turin, Italy.
Erika MorsiaDepartment of Hematology, A.O.U. Ospedali Riuniti di Ancona Presidio Umberto I, Ancona, Italy.
Giulia BenevoloHematology U., A.O.U. Città della Salute e della Scienza, Turin, Italy.
Elena Maria ElliHematology Division and Bone Marrow Unit, Fondazione IRCCS, San Gerardo dei Tintori, Monza, Italy.
Valerio De StefanoSection of Hematology, Catholic University, Fondazione Policlinico A. Gemelli IRCCS, Roma, Italy.
Antonietta Pia FalconeDivision of Hematology IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Daniele VallisaHematology and Bone Marrow Transplant Unit, Presidio Ospedaliero di Piacenza AUSL, Piacenza, Italy.
Simona TomassettiHematology Unit, Infermi Hospital Rimini, Rimini, Italy.
Francesca LunghiUnit of Hematology and Bone Marrow Transplantation, IRCCS San Raffaele Hospital, Milan, Italy.
Nicola OrofinoDivision of Hematology, Legnano's Hospital, Milan, Italy.
Giuseppe CarliPresidio Ospedaliero S. Bortolo ULSS 6 Vicenza, Vicenza, Italy.
Tiziana UrbanoHematology Ospedale San Giuseppe Moscati, Taranto, Italy.
Alessandro LucchesiIRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy.ORCID https://orcid.org/0000-0002-0624-5311
Marta BrunoventreU.O. Oncologia Medica, ASST Fatebenefratelli Sacco Ospedale Fatebenefratelli Oftalmico, Milano, Italy.
Massimiliano BonifacioDepartment of Engineering for Innovation Medicine, Section of Innovation Biomedicine, University of Verona, Verona, Italy.ORCID https://orcid.org/0000-0003-0716-1686
Gianni BinottoDepartment of Medicine, Hematology Unit, Padova University Hospital, Padova, Italy.ORCID https://orcid.org/0000-0003-4571-6611
Francesco CavazziniAz. Osp. Univ. Ferrara Arcispedale S Anna Univ. degli Studi, Ferrara, Italy.
Paola RanalliDepartment of Medicine and Aging Sciences, "G. D'Annunzio" University, Chieti, Italy.
Alessandro AllegraAz. Ospe.Universitaria Policlinico G. Martino Univ. di, Messina, Italy.
Barbara AnaclericoAzienda Ospedaliera S Giovanni Addolorata, Rome, Italy.
Serena MazzottaDivision of Hematology, Ospedale "C. e G. Mazzoni", ASUR Marche-AV5, Ascoli Piceno, Italy.
Filippo GherlinzoniPres.Ospedaliero S. Maria di Ca' Foncello, Treviso, Italy.
Mario TiribelliDivision of Hematology and BMT, ASUFC and Department of Medicine, University of Udine, Udine, Italy.ORCID https://orcid.org/0000-0001-9449-2621
Chiara CastiglioniNovartis Farma S.P.A., Milano, Italy.
Marina LandoniNovartis Farma S.P.A., Milano, Italy.
Diletta ValsecchiNovartis Farma S.P.A., Milano, Italy.
Michela MagnoliOPIS s.r.l., Desio, Italy.
Francesco PassamontiUniversità degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID https://orcid.org/0000-0001-8068-5289
Francesca PalandriIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.ORCID https://orcid.org/0000-0001-8367-5668

Funding

Novartis Farma S.p.A, Milano, Italy
6 · The paper itself

Abstract

Ruxolitinib (RUX), a JAK1/2 inhibitor, demonstrated treatment benefits for myelofibrosis (MF) in intermediate-1 (Int-1)-risk patients with a significant disease burden; however, the evidence is scarce. This interim analysis investigated the efficacy and safety of ruxolitinib in patients with Int-1-risk MF. ROMEI, a multicenter, observational, prospective study, enrolled 508 adult patients with MF receiving ruxolitinib according to approved indications. The present interim analysis was focused on 107 eligible patients in the Int-1-risk group. Primary endpoints included changes in symptoms response and health-related quality of life scores. Secondary endpoints included spleen response evaluation, overall survival, and safety including dosing pattern and dose interruptions. Among the 107 Int-1-risk patients with a median age of 63 years, 65.5% were highly symptomatic (total symptoms score: ≥ 20), while the spleen was palpable at ≥ 5 cm and ≥ 10 cm in 74% and 27% of patients, respectively, with baseline EuroQol visual analogue scale (EQ-VAS) score of 65.1 ± 19.4. After RUX treatment, 42.1% and 43.9% of patients demonstrated a symptom response at 24 and 48 weeks, while 38.9% and 46.8% showed a spleen response at 24 and 48 weeks, respectively. EQ-VAS increased to 71.8 ± 16.3 at 24 weeks and 69.3 ± 19.2 at 48 weeks. Furthermore, 11.2% and 25.2% of patients reported temporary and permanent discontinuation, respectively with no new adverse events reported. The interim analysis showed that ruxolitinib provided clinical benefits, a manageable safety profile, and improved quality of life for Int-1-risk subgroup patients with frequent and sustained responses with acceptable toxicity.

Indexed as

Primary MyelofibrosisPyrazolesAdultAgedAged, 80 and overFemaleHumansItalyMaleMiddle AgedNitrilesProspective StudiesPyrimidinesQuality of LifeTreatment OutcomeNitrilesPyrazolesPyrimidinesruxolitinibefficacyintermediate‐1 IPSSmyelofibrosisROMEI studyruxolitinibsafety

Identifiers

PMID41877599
PMCPMC13014119

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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.