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- Title
Ruxolitinib in patients with polycythemia vera resistant and/or intolerant to hydroxyurea: European observational study.
- Authors
Theocharides, Alexandre; Gisslinger, Heinz; De Stefano, Valerio; Accurso, Vincenzo; Iurlo, Alessandra; Devos, Timothy; Egyed, Miklos; Lippert, Eric; Delgado, Regina Garcia; Cantoni, Nathan; Dahm, Anders E. A.; Sotiropoulos, Damianos; Houtsma, Erik; Smyth, Aoife; Iqbal, Amir; Di Matteo, Paola; Zuurman, Mike; te Boekhorst, Peter A. W.
- Abstract
Background: Hydroxyurea (HU) is a commonly used first‐line treatment in patients with polycythemia vera (PV). However, approximately 15%–24% of PV patients report intolerance and resistance to HU. Methods: This phase IV, European, real‐world, observational study assessed the efficacy and safety of ruxolitinib in PV patients who were resistant and/or intolerant to HU, with a 24‐month follow‐up. The primary objective was to describe the profile and disease burden of PV patients. Results: In the 350 enrolled patients, 70% were >60 years old. Most patients (59.4%) had received ≥1 phlebotomy in the 12 months prior to the first dose of ruxolitinib. Overall, 68.2% of patients achieved hematocrit control with 92.3% patients having hematocrit <45% and 35.4% achieved hematologic remission at month 24. 85.1% of patients had no phlebotomies during the study. Treatment‐related adverse events were reported in 54.3% of patients and the most common event was anemia (22.6%). Of the 10 reported deaths, two were suspected to be study drug‐related. Conclusion: This study demonstrates that ruxolitinib treatment in PV maintains durable hematocrit control with a decrease in the number of phlebotomies in the majority of patients and was generally well tolerated.
- Subjects
POLYCYTHEMIA vera; RUXOLITINIB; HYDROXYUREA; ADVERSE health care events; SCIENTIFIC observation
- Publication
European Journal of Haematology, 2024, Vol 112, Issue 3, p379
- ISSN
0902-4441
- Publication type
Article
- DOI
10.1111/ejh.14124