Examining the Frequency of Phlebotomy in Patients with Polycythemia Vera (PV) in the United States: An Analysis of Data from the REVEAL Study

Background:Phlebotomy is integral to the clinical management of patients with PV; however, it may be inconvenient and/or poorly tolerated. Frequent and long-term phlebotomies may cause iron deficiency, increased symptom burden, and lost productivity. This analysis from the Prospective Observational Study of Patients With PV in US Clinical Practices (REVEAL) describes the patient-reported burden of phlebotomies at enrollment and ≤6 months post-enrollment.

Design: REVEAL is a prospective, observational study of patients aged ≥18 years with PV under physician supervision. Physician assessments and patient-reported outcomes are being collected every 3 months. Phlebotomy-related burden of patients is evaluated using the 21-item phlebotomy burden questionnaire (PBQ-21) administered every 3 months, assessing frequency, time needed, inconvenience, and phlebotomy-related adverse effects. Of the 2510 enrolled patients, 1173 had ≥1 phlebotomy within 3 months before enrollment and completed the PBQ-21 questionnaire. Phlebotomy-related effects and bother/inconvenience (≤24 hours following the procedure) are graded from 1 (not at all) to 4 (extremely).

Findings: Median (range) age was 65 (22-95) years; patients were mostly male (61.0%) and white (91.2%). Median disease duration (PV diagnosis to enrollment) was 3.2 years (range, 0-39.2). At enrollment, newly diagnosed patients (<6 months) reported receiving a higher mean number of phlebotomies in the previous 3 months (3.2) compared with patients carrying the diagnosis for 6‒12 months (2.31), 1‒<3 years(1.99), 3‒<5 years (1.83), and ≥5 years (1.79). During the follow-up period (≤6 months), patients continued to receive phlebotomies at the rate of approximately 2 phlebotomies per 3-month interval. Patients reported spending approximately half of a work day (4 hours) per procedure. Employed patients (full- or part-time [n=255]) reported missing a mean of 9.31 hours of work within 3 months before enrollment. At enrollment, the majority of patients reported bother/inconvenience (73.1%), and distress (72.5%) due to phlebotomies. During the follow-up period, the proportion of patients bothered/inconvenienced and distressed by phlebotomies increased to 84.1% and 85.8%.

Conclusion: Patients with newly diagnosed PV experience a greater number of phlebotomies than those with a longer history of the disease. Irrespective of duration of disease, patients enrolled in REVEAL continued to receive phlebotomies at rate of approximately 8 phlebotomies per year. Patients reported spending a considerable amount of time undergoing phlebotomies and missing work. Patients continue to report distress, bother, and inconvenience due to phlebotomies.

Implications: These findings provide healthcare professionals with important insight into the patient-reported burden of phlebotomy and may help guide individualized treatment decisions.