Burden of Phlebotomy in Patients with Polycythemia Vera in the United States: Baseline Data from the REVEAL Study

Background: Phlebotomy to maintain hematocrit <45% is considered one of the cornerstones for the management of polycythemia vera (PV). However, phlebotomy procedures may be inconvenient for or poorly tolerated by some patients, and often result in iron deficiency, which may be associated with additional quality-of-life burden, such as fatigue, impaired cognitive function and restless leg syndrome. The REVEAL study (ClinicalTrials.gov, NCT02252159) is being conducted to describe contemporary demographics, burden of disease, clinical management, patient-reported outcomes, and healthcare resource utilization among patients with PV in the US. This early analysis describes the patient self-reported burden of phlebotomy at the time of enrollment.

Methods: REVEAL is a multicenter, noninterventional, nonrandomized, prospective, observational study of adult patients with PV who are currently under the care of a US physician. REVEAL collects physician assessments and patient-reported outcomes during a 36-month observation period. Phlebotomy-related burden is being assessed with a new 21-item phlebotomy burden questionnaire (PBQ-21) at enrollment and every 90 days thereafter; it assesses patient-reported phlebotomy frequency, practice setting, time required for phlebotomy, inconvenience, and phlebotomy-related adverse effects. Phlebotomy-related effects and bother/inconvenience (if experienced within 24 hours after a phlebotomy procedure) are graded on a 4-point scale of 1 (not at all) to 4 (extremely). Analyses of these preliminary data were descriptive.

Results: At the time of data cutoff, 865 patients were enrolled (total planned enrollment, n=2000). Median age was 67 (range, 22-95) years, 55.5% were male, and 89.5% were white. Median time from PV diagnosis to study enrollment was 53 months. Overall, 748 patients completed the PBQ-21 at enrollment and 400 (53.5%) had received a phlebotomy within 3 months prior to enrollment. Mean number of phlebotomies in the past 3 months was 2.2 (SD, 1.7). Phlebotomy was most commonly performed at a doctor's office during a regular medical visit (37.8%), at an infusion center or special cancer care center (26.8%), or at a hospital (18.3%). Patients who had phlebotomy procedures within 90 days before enrollment reported a mean total treatment time of 4.2 (SD, 4.7) hours per phlebotomy procedure; for employed patients, the mean amount of work time missed was 4.6 (SD, 15.6) hours per procedure. Fatigue, bruising, dehydration, and dizziness were among the most commonly reported adverse effects of phlebotomy (Table 1). Twenty percent of patients reported that phlebotomy procedures were moderately or extremely bothersome, inconvenient (18.3%), or painful or physically uncomfortable (16.3%). Furthermore, some patients (8.8%) reported that their family and friends were moderately or severely inconvenienced by phlebotomy procedures.

Conclusion: The PBQ-21 collects important and relevant patient-reported information to systematically assess the impact of phlebotomy on patients and caregivers. From the early view of REVEAL enrollment data, a considerable proportion of patients reported fatigue, bruising, dehydration, and dizziness resulting from phlebotomy procedures. Furthermore, patients reported spending a considerable amount of time (4 hours on average) per phlebotomy procedure, which is a sizeable burden for patients who are employed. In addition, some patients reported that phlebotomy procedures may be inconvenient, painful or uncomfortable, and bothersome. REVEAL provides important information for providers to understand and address when to prescribe phlebotomy for patients with PV.

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