Observational studyCancer2025
Dosing and clinical outcomes of ruxolitinib in patients with myelofibrosis in a real-world setting: Interim results of the Italian observational study (ROMEI).
Observational study in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- KT-253, a highly potent and selective MDM2 protein degrader, eliminates malignant myelofibrosis stem/progenitor cells.Leukemia · 2026Article
- Primary Myelofibrosis (PMF)-The German ONKOPEDIA Guideline 2025.International journal of cancer · 2026Review
- A dynamic prognostic model for polycythemia vera long-term outcomes in patients treated with ruxolitinib.Blood advances · 2026Article
- High-dose ruxolitinib (25 mg twice daily) in myelofibrosis: feasibility, safety, and long-term treatment exposure in a real-world cohort.Annals of hematology · 2026Article
- Clinical Outcomes of Ruxolitinib Treatment in Patients With IPSS Intermediate-1-Risk Myelofibrosis: Interim Analysis From an Italian, Prospective Study (ROMEI).Hematological oncology · 2026Observational
- Health Care Utilization Databases obtained from health system inform outcome for ruxolitinib treatment in patients with myelofibrosis.HemaSphere · 2026Article
- Real-world patient characteristics and clinical outcomes in patients with myelofibrosis in Japan.PloS one · 2026Article
- Increased Rate of Anemia and Discontinuation in Older Patients with Myelofibrosis Treated with Ruxolitinib.Journal of clinical medicine · 2025Article
- Revised "iRR6" model in intermediate-1 risk myelofibrosis patients treated with ruxolitinib.Cancer · 2025Observational
- Observational
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Authors and funding
56 authors.
Funding
Abstract
backgroundMyelofibrosis (MF) significantly impacts patients' overall survival (OS) and quality of life (QOL). This prospective study analyzed ruxolitinib dosing patterns and associated clinical outcomes in patients with MF over 12 months.
methodsROMEI, a multicenter, observational, ongoing study, enrolled 508 adult patients with MF treated with ruxolitinib. For the current interim analysis, eligible patients with baseline platelet values were categorized into two groups based on ruxolitinib starting dosage: as expected (AsEx, n = 174) and lower than expected (LtEx, n = 132); ruxolitinib dose changes, interruptions and time to permanent discontinuation were analyzed, along with symptoms response, health-related QOL scores, spleen response, OS, and safety.
resultsForty-three percent of patients started at a lower-than-expected dose. Both groups showed reduction in average daily ruxolitinib doses over 12 months. Symptoms response rate was similar in both groups at week 48 (40.8% AsEx vs 40.9% LtEx). The AsEx group demonstrated higher spleen response rates at both 24 weeks (50.0% vs 30.2%) and 48 weeks (57.7% vs 45.8%) with a shorter median time to first response (3.3 vs 11.1 months, p = .019) when compared to the LtEx group. Both groups showed upward trends in health-related QOL values. Estimated median OS was not reached for the AsEx group versus 4.7 years in the LtEx group (p = .014). Adverse events were reported in 87.4% and 84.9% of patients in the AsEx and LtEx groups, respectively.
conclusionsThe ROMEI study demonstrated the importance of optimal ruxolitinib dosage in patients with MF for maximum effectiveness and improved OS, with manageable safety.
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