Risks of erythrocytosis in polycythemia vera (PV)

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PV is a rare, chronic MPN that can be 
life-threatening if uncontrolled1,2

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PV is estimated to affect over 90,000 people

This is seen in the United States across various ages and ethnicities3,4

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PV is characterized by erythrocytosis

Erythrocytosis in PV is associated with elevated HCT levels, increased blood viscosity, and increased risk of TEs that can be life-threatening5-8

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HCT control is a fundamental goal of disease management

Historical PV management (treatments that seek to maintain HCT levels <45%) includes acute therapeutic phlebotomies, or rescue phlebotomies, chemotherapy (hydroxyurea), and other CRTs (JAK inhibitors and interferons)2,8

Uncontrolled HCT can lead to life-threatening risk2

Rescue phlebotomies may quickly bring HCT levels down, but they are an acute and reactive intervention which can exacerbate iron deficiency and related symptoms4
Up to 78% of patients fail to consistently maintain HCT <45% in real-world practice despite treatment
*Based on a retrospective, observational real-world study of 28,306 patients with PV who initiated treatment in the US between 2011 and 2019. Real-world analyses are subject to inherent limitations, including incomplete or missing data and potential misclassification of diagnoses derived from database records. Results should be interpreted with caution.10
HCT 45%–50% associated with ~4x higher risk of major TEs or CV death vs HCT <45%
†Of the 365 PV patients treated with phlebotomy, hydroxyurea, or both in an Italian randomized controlled study (CYTO-PV), 2.7% (n=5/182) of patients with HCT <45% had major TEs or died from CV causes vs 9.8% (n=18/183) of patients with HCT 45%-50%, after a median follow-up of 31 months (HR, 3.91; 95% CI, 1.45-10.53; P=0.007). TEs may be underdiagnosed or inaccurately reported, and should be interpreted with caution.2
19% of patients with PV have a 5-year mortality risk; 1 in 3 PV deaths are from thromboembolic complications; 39%-41% of patients with PV experience thromboembolic events following diagnosis

Patients with PV often experience persistent symptoms that interfere with daily function, even with treatment6,13

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PV symptoms may be linked to higher HCT levels and may persist despite available treatment options14,15

  • Fatigue, which can be debilitating, remains a prevalent and unresolved symptom for many patients6
  • In an observational study, the majority of patients with worsening symptoms were already receiving active treatment for PV16‡

‡This multicenter, retrospective observational study included patients from 13 academic and community centers. Eligible participants were adults (>18 years) diagnosed with PV, ET, or MF (primary or post-PV/ET) according to World Health Organization and/or International Consensus criteria who had completed at least one MPN-SAF TSS questionnaire between April 2013 and August 2022. In total, 285 patients were included. Of these, 227 patients (79%) were receiving CRT, and 217 (76%) were on antiplatelet therapy. Additionally, 133 patients (47%) experienced worsening symptoms.16

CI=confidence interval; CRT=cytoreductive therapy; CV=cardiovascular; CYTO-PV=Cytoreductive Therapy in Polycythemia Vera; ET=essential thrombocythemia; HCT=hematocrit; HR=hazard ratio; JAK=Janus kinase; MF=myelofibrosis; MPN=myeloproliferative neoplasm; MPN-SAF TSS=Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score; PV=polycythemia vera; TE=thrombotic event.

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IMPORTANT SAFETY INFORMATION AND INDICATION

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