Incyte Corporation (Nasdaq: INCY) today announced that it is sponsoring
the first major observational study of patients living with polycythemia
vera (PV) in the U.S. PV is a rare and progressive blood cancer that can
lead to debilitating symptoms, serious cardiovascular complications, and
death.1,2 The REVEAL (PROSPECTIVE OBSERVATIONAL
STUDY OF PATIENTS WITH POLYCYTHEMIA VERA IN US CLINICAL
PRACTICES) study will seek to describe the real-world clinical burden of
PV and how healthcare services are utilized in the management of this
disease.
“Despite increased clinical knowledge of PV in recent years, we have
more to learn about the impact of PV on patients’ quality of life, work
productivity, and activity impairment. We also have more to learn about
treatment patterns in real-world clinical practice settings,” said Brady
Lee Stein, MD, MHS, Assistant Professor, Medicine, Hematology Oncology
Division; Feinberg School of Medicine, and co-chair of the Scientific
Advisory Committee for the REVEAL study. “Results from REVEAL should
provide relevant information on contemporary disease management
strategies and clinical outcomes to the scientific community and
practicing oncologists and hematologists in the interest of improving
the lives of patients with PV in the future.”
Incyte is partnering with approximately 200 community and academic
medical centers to conduct the study in the U.S. REVEAL, which recently
began enrolling patients, is expected to include 2,000 patients under
the supervision of a physician for the active management of PV for a
period of three years.
PV is a form of blood cancer leading to the overproduction of red blood
cells, white blood cells and platelets.3,4,5,6 Patients with
PV often suffer from an enlarged spleen and a significant symptom burden
caused by thickening of the blood and lack of oxygen to parts of the
body.7 These symptoms commonly include fatigue, itching,
night sweats, bone pain, fever, and weight loss.7
“Insights gathered from REVEAL may help us better understand PV and lead
to better ways to treat and manage the disease in the future,” said
Nicholas Sarlis, M.D., Ph.D., Vice President, Medical Affairs, Incyte.
“We encourage patients and physicians to consider participating in this
study.”
About the REVEAL Study
The REVEAL study is a multicenter, non-interventional, non-randomized,
prospective, observational study designed to provide an understanding of
the natural history of PV and information on the management of this
disease in the U.S., including response to PV therapies. All patients in
the study will be 18 years or older, have been diagnosed with clinically
overt PV and followed in either community or academic medical centers in
the U.S. Patients are being enrolled over a 12-month period and observed
for 36 months. Secondary objectives are to:
-
Characterize the evolution of the clinical manifestations of and
complications from PV
-
Describe practice patterns and therapy strategies in patients treated
for PV
-
Describe patterns of sequencing in the introduction of various
therapies and how they relate to clinical outcomes
-
Assess the impact of PV on Patient Reported Outcomes (PROs), including
Health Related Quality of Life (HRQoL), symptoms, work productivity
and activity impairment
Characteristics such as age, medical history, health-system resource
utilization (ER and doctor visits, hospitalizations, phlebotomy,
paid/unpaid caregiver services, etc.), and therapeutic regimens will be
observed. Researchers will also explore possible association of various
clinical parameters with survival and other objectives such as
determining the risk profile for disease progression.
REVEAL is the first study of its kind in the U.S. Visit www.revealpvstudy.com
for more information.
About Polycythemia Vera
Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN)
characterized by an overproduction of red blood cells, white blood cells
and platelets that leads to an increased risk of thrombosis.3-6
Erythrocytosis (elevated red blood cell mass) is the most prominent
clinical manifestation of PV, distinguishing it from other MPNs.8
PV may occur at any age but often presents later in life, with a median
age at diagnosis of 60 years.9,10 Approximately 25,000
patients in the United States living with PV11 are considered
uncontrolled because they develop resistance to or intolerance of
hydroxyurea12,13.
Although patients may be asymptomatic for many years, PV is associated
with significant symptom burden, and the most common signs and symptoms
of PV are fatigue, pruritus, night sweats, bone pain, fever and weight
loss.7 Splenomegaly is present in 30 percent to 40 percent of
patients with PV.7 In patients who experience severe and
burdensome symptoms, data show that the disease causes a significant and
clinically meaningful erosion of quality of life.14,15
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics, primarily for oncology. For additional
information on Incyte, please visit the Company’s website at www.incyte.com.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release, including statements regarding the
Company’s plans and expectations regarding the REVEAL study, contain
predictions, estimates and other forward-looking statements. These
forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including the results of and risks
associated with research and development, the ability to enroll
sufficient numbers of patients in research studies, and other risks
detailed from time to time in the Company’s reports filed with the
Securities and Exchange Commission, including its Form 10-K for the year
ended December 31, 2014. Incyte disclaims any intent or obligation to
update these forward-looking statements.
References
1 Marchioli R, Finazzi G, Specchia G, et al. Thrombosis.
2011:1-9.
2 Leukemia & Lymphoma Society. “Polycythemia
Vera.” 2007.
3 Vannucchi AM, Guglielmelli P, Tefferi A. CA
Cancer J Clin. 2009;59:171-91.
4 Marchioli R,
Finazzi G, Specchia G, et al. N Engl J Med. 2013;368:22-33.
5
Tefferi A. Am J Hematol. 2013;88:507-16.
6 Spivak
JL. Blood. 2002;100:4272-90.
7 Passamonti F. Blood.
2012;120(2):275-84.
8 Spivak JL. Ann Intern Med. 2010;152:300-6.
9
Tefferi A, Rumi E, Finazzi G, et al. Leukemia. 2013;27:1874-81.
10
Gruppo Italiano Studio Policitemia. Ann Intern Med. 1995;123:656-64.
11
Data on file. Incyte Corporation
12 Barosi G, Birgegard
G, Finazzi G, et al. Br J Haematol. 2010;149:961-3.
13
Alvarez-Larrán A, Pereira A, Cervantes F, et al. Blood.
2012;119:1363-9
14 Mesa RA, Niblack J, Wadleigh M, et
al. Cancer. 2007;109(1):68-76.
15 Johansson P,
Mesa R, Scherber R, et al. Leuk Lymphoma. 2012;53(3):441-4.
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