@article{153c980a05e3486c83330b39d95e3f80,
title = "Symptom Burden and Blood Counts in Patients With Polycythemia Vera in the United States: An Analysis From the REVEAL Study",
abstract = "Background: Approximately 50% of patients with polycythemia vera (PV) have PV-related symptoms at diagnosis; these symptoms might develop or worsen with time. Symptoms have been shown to negatively affect quality of life and interfere with daily activities. To our knowledge, an analysis to evaluate the relationship between blood count control and symptoms has not been published. Patients and Methods: The Prospective Observational Study of Patients with Polycythemia Vera in US Clinical Practices (REVEAL; NCT02252159) is a multicenter, noninterventional, nonrandomized prospective observational study of patients with PV in the United States. Patients included were required to have a complete blood count result within 30 days before completing the at-enrollment Myeloproliferative Neoplasm Self-Assessment Form Total Symptom Score (MPN-SAF TSS). Symptom severity was compared between those who had blood count control versus those who did not. Results: At the time of enrollment, 1714 patients (94.5%) were being managed with cytoreductive therapy; 468 patients (25.8%) had complete hematologic remission (CHR), 1614 patients (89.0%) had ≥1 controlled blood count, and 1122 patients (61.9%) had ≥2 controlled blood counts. Mean MPN-SAF TSSs were similar across patients in different blood count control groups. Fatigue was the most frequently reported symptom. The severity of individual symptoms, except those of pruritus and night sweats, was not affected by CHR or the number of blood counts that were controlled. Conclusion: Symptom burden in patients with PV can persist despite control of blood counts, which suggests some discordance between laboratory values and symptom burden. Consequently, regular monitoring of symptom burden should be factored into the assessment of disease control.",
keywords = "Blood count control, MPN-SAF TSS, Polycythemia vera, REVEAL, Symptom burden",
author = "Grunwald, {Michael R.} and Burke, {John M.} and Kuter, {David J.} and Gerds, {Aaron T.} and Brady Stein and Walshauser, {Mark A.} and Shreekant Parasuraman and Philomena Colucci and Dilan Paranagama and Savona, {Michael R.} and Ruben Mesa",
note = "Funding Information: Michael R. Grunwald has provided consultancy to Incyte, Abbvie, Amgen, Cardinal Health, Celgene, Pfizer, Agios, Merck, and Daiichi Sankyo, and has received research funding from Incyte , Janssen , Forma Therapeutics , and Genentech / Roche . John M. Burke has provided consultancy to Incyte, Celgene, Bayor, Genentech, and Gilead. David J. Kuter has provided consultancy to Syntimmune, Rigel, Protalex, BMS, Incyte, 3SBIO, Pfizer, Zafgen, Fujifilm, ONO, Merck, Genzyme, Argenx, Shire, Alexion, Amgen, Novartis, and Dova, and has received research funding from Syntimmune , Rigel , Protalex , BMS , Incyte , Shire , and Alexion , and royalties from Up-To-Date. Dr Kuter has also served on an advisory committee for Dova. Aaron T. Gerds has provided consultancy to Incyte, CTI Biopharma, Apexx Oncology, and Celgene. Brady Stein has provided consultancy to Incyte and Apexx Oncology. Mark A. Walshauser has no conflicts of interest to disclose. Shreekant Parasuraman, Philomena Colucci, and Dilan Paranagama are employees and shareholders of Incyte Corporation. Michael R. Savona receives licensing fees from Boehringer-Ingelheim, has served as advisory for Astex, Celgene, Incyte, Karyopharm, and TG Therapeutics, had received research funding from Astex , Incyte Corporation , Sunesis , Takeda , and TG Therapeutics , and is a shareholder of Karyopharm. Ruben Mesa has provided consultancy to Novartis and received research funding from Incyte , CTI , Genentech , and Celgene . Funding Information: The authors thank the patients and their families, the investigators, and the site personnel who participated in this study. This study was sponsored by Incyte Corporation (Wilmington, DE). Medical writing assistance was provided by Michael R. Convente, PhD, of Scientific Pathways, Inc (Hamilton, NJ), and funded by Incyte Corporation . Funding Information: Michael R. Grunwald has provided consultancy to Incyte, Abbvie, Amgen, Cardinal Health, Celgene, Pfizer, Agios, Merck, and Daiichi Sankyo, and has received research funding from Incyte, Janssen, Forma Therapeutics, and Genentech/Roche. John M. Burke has provided consultancy to Incyte, Celgene, Bayor, Genentech, and Gilead. David J. Kuter has provided consultancy to Syntimmune, Rigel, Protalex, BMS, Incyte, 3SBIO, Pfizer, Zafgen, Fujifilm, ONO, Merck, Genzyme, Argenx, Shire, Alexion, Amgen, Novartis, and Dova, and has received research funding from Syntimmune, Rigel, Protalex, BMS, Incyte, Shire, and Alexion, and royalties from Up-To-Date. Dr Kuter has also served on an advisory committee for Dova. Aaron T. Gerds has provided consultancy to Incyte, CTI Biopharma, Apexx Oncology, and Celgene. Brady Stein has provided consultancy to Incyte and Apexx Oncology. Mark A. Walshauser has no conflicts of interest to disclose. Shreekant Parasuraman, Philomena Colucci, and Dilan Paranagama are employees and shareholders of Incyte Corporation. Michael R. Savona receives licensing fees from Boehringer-Ingelheim, has served as advisory for Astex, Celgene, Incyte, Karyopharm, and TG Therapeutics, had received research funding from Astex, Incyte Corporation, Sunesis, Takeda, and TG Therapeutics, and is a shareholder of Karyopharm. Ruben Mesa has provided consultancy to Novartis and received research funding from Incyte, CTI, Genentech, and Celgene.The authors thank the patients and their families, the investigators, and the site personnel who participated in this study. This study was sponsored by Incyte Corporation (Wilmington, DE). Medical writing assistance was provided by Michael R. Convente, PhD, of Scientific Pathways, Inc (Hamilton, NJ), and funded by Incyte Corporation. Publisher Copyright: {\textcopyright} 2019 The Authors",
year = "2019",
month = sep,
doi = "10.1016/j.clml.2019.06.001",
language = "English (US)",
volume = "19",
pages = "579--584.e1",
journal = "Clinical Lymphoma",
issn = "2152-2669",
publisher = "Cancer Media Group",
number = "9",
}