TY - JOUR
T1 - Clinical and Disease Characteristics From REVEAL at Time of Enrollment (Baseline)
T2 - Prospective Observational Study of Patients With Polycythemia Vera in the United States
AU - Grunwald, Michael R.
AU - Stein, Brady L.
AU - Boccia, Ralph V.
AU - Oh, Stephen T.
AU - Paranagama, Dilan
AU - Parasuraman, Shreekant
AU - Colucci, Philomena
AU - Mesa, Ruben
N1 - Funding Information:
M.R.G. has served as a consultant and/or advisory board member for Incyte Corporation, Alexion, ARIAD, Amgen, Merck, Pfizer, Cardinal Health, Celgene, and Agios; received research funding from Amgen, Forma Therapeutics, Incyte Corporation, Janssen, and Genentech; and is a stockholder of Medtronic. B.L.S. served as a consultant and member of advisory committees for Incyte Corporation. R.V.B. received honoraria from Incyte Corporation. S.T.O. served as a consultant for Incyte Corporation and received research funding from CTI Biopharma, Gilead, Incyte Corporation, and Janssen. D.P., S.P., and P.C. are employees and stockholders of Incyte Corporation. R.M. served as a consultant for Novartis and received research funding from CTI Biopharma, Genentech, Gilead, Incyte Corporation, NS Pharma, Pfizer, and Promedior.
Publisher Copyright:
© 2018 The Authors
PY - 2018/12
Y1 - 2018/12
N2 - REVEAL is the first large, prospective observational study aimed at examining the contemporary demographics, burden of disease, clinical management, patient-reported outcomes, and health care resource utilization in patients with polycythemia vera in the United States. Background: Polycythemia vera (PV) has a prevalence of 44 to 57 per 100,000 people in the United States. Prospective data concerning the demographics, clinical characteristics, and treatment patterns of patients with PV in the United States are lacking. Patients and Methods: The ongoing, prospective, observational REVEAL study evaluates demographics, disease burden, clinical management, patient-reported outcomes, and health care resource utilization of adult patients with PV in the United States. This report summarizes the demographics and clinical characteristics of patients at enrollment (baseline). Results: Patients (n = 2510) were a median age of 67.0 years, 54.2% were male, and 89.1% were white. The median time from PV diagnosis to study enrollment was 4.0 (range, 0-56.3) years. Most patients (89.7%) were diagnosed after an abnormal blood test. Less than half (49.2%) underwent JAK2 mutation analysis, of whom 95.8% were JAK2 V617F mutation positive; < 1% were positive for JAK2 exon 12 mutations. At enrollment, 47.7% of patients had elevated hematocrit (> 45%), 35.8% had elevated platelets (> 400 × 109/L), and 37.0% had elevated leukocytes (> 10 × 109/L). Most patients (94.5%) were receiving active PV treatment, predominantly therapeutic phlebotomy alone (33.6%), hydroxyurea monotherapy (29.0%), or hydroxyurea plus phlebotomy (23.7%). Thrombotic events occurred in 11.9% of patients before PV diagnosis (venous, 6.7%; arterial, 5.7%), and 8.3% between diagnosis and enrollment. Hypertension (70.6%) was the most common previous medical condition. Conclusion: REVEAL enrollment data inform our understanding of the baseline demographics, diagnostic approach, disease characteristics, and treatment patterns of patients with PV in the United States. Longitudinal real-world data collected in this study will complement information collected during randomized controlled clinical trials.
AB - REVEAL is the first large, prospective observational study aimed at examining the contemporary demographics, burden of disease, clinical management, patient-reported outcomes, and health care resource utilization in patients with polycythemia vera in the United States. Background: Polycythemia vera (PV) has a prevalence of 44 to 57 per 100,000 people in the United States. Prospective data concerning the demographics, clinical characteristics, and treatment patterns of patients with PV in the United States are lacking. Patients and Methods: The ongoing, prospective, observational REVEAL study evaluates demographics, disease burden, clinical management, patient-reported outcomes, and health care resource utilization of adult patients with PV in the United States. This report summarizes the demographics and clinical characteristics of patients at enrollment (baseline). Results: Patients (n = 2510) were a median age of 67.0 years, 54.2% were male, and 89.1% were white. The median time from PV diagnosis to study enrollment was 4.0 (range, 0-56.3) years. Most patients (89.7%) were diagnosed after an abnormal blood test. Less than half (49.2%) underwent JAK2 mutation analysis, of whom 95.8% were JAK2 V617F mutation positive; < 1% were positive for JAK2 exon 12 mutations. At enrollment, 47.7% of patients had elevated hematocrit (> 45%), 35.8% had elevated platelets (> 400 × 109/L), and 37.0% had elevated leukocytes (> 10 × 109/L). Most patients (94.5%) were receiving active PV treatment, predominantly therapeutic phlebotomy alone (33.6%), hydroxyurea monotherapy (29.0%), or hydroxyurea plus phlebotomy (23.7%). Thrombotic events occurred in 11.9% of patients before PV diagnosis (venous, 6.7%; arterial, 5.7%), and 8.3% between diagnosis and enrollment. Hypertension (70.6%) was the most common previous medical condition. Conclusion: REVEAL enrollment data inform our understanding of the baseline demographics, diagnostic approach, disease characteristics, and treatment patterns of patients with PV in the United States. Longitudinal real-world data collected in this study will complement information collected during randomized controlled clinical trials.
KW - Blood tests
KW - Demographics
KW - JAK2 V617F mutation
KW - Myeloproliferative neoplasm
KW - Population characteristics
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U2 - 10.1016/j.clml.2018.08.009
DO - 10.1016/j.clml.2018.08.009
M3 - Article
C2 - 30245100
AN - SCOPUS:85053772314
SN - 2152-2669
VL - 18
SP - 788-795.e2
JO - Clinical Lymphoma
JF - Clinical Lymphoma
IS - 12
ER -
