PHILADELPHIA, Nov. 7 /PRNewswire/ -- Data from an
investigational, open-label, randomized study assessing extended
dosing regimens of PROCRIT(R) (Epoetin alfa) in treating anemia
in subjects with Stages 3 - 4 chronic kidney disease (CKD) were
presented today at the American Society of Nephrology 41st Annual
All three dosing groups, including the FDA-approved
three-times-per-week (TIW) regimen, plus once-a-week (QW) and
once-every-two-weeks (Q2W) investigational regimens, achieved a
mean final hemoglobin (Hb) within the range of 11.0 - 11.9 g/dL.
Based on the increases in Hb, the QW and Q2W investigational
regimens were statistically non-inferior to the TIW regimen
(lower limits of 95 percent confidence intervals [CIs] within the
non-inferiority margin of -1 g/dL).
The percent of subjects with Hb exceeding 11.9 g/dL during the
first 22 weeks of treatment was higher in the TIW group (86.2
percent) than in the QW (78.4 percent) and Q2W (71.2 percent)
groups; the median per-subject frequency of Hb exceeding 11.9
g/dL was 6, 4 and 3 times for the TIW, QW and Q2W groups,
In the first 22 weeks of treatment, the proportion of subjects
experiencing serious adverse events (SAEs) was 15 percent in the
TIW group, compared with 22 percent in both the QW and Q2W
groups. During the entire 44 weeks of treatment, the proportion
of subjects experiencing SAEs was 29, 33 and 33 percent in the
TIW, QW and Q2W groups, respectively. The number of subjects
with investigator-confirmed thromboembolic vascular events (TVEs)
over the first 22 weeks was 2 in the TIW, 2 in the QW and 3 in
the Q2W groups; over 44 weeks, these numbers were 2, 5 and 8 in
the TIW, QW and Q2W groups, respectively. The number of subjects
who died during the first 22 weeks was 0 in the TIW, 6 in the QW
and 3 in the Q2W groups. Over 44 weeks, 4, 6 and 4 subjects
died, respectively. None of the deaths were considered related
to the study drug.
"These data provide important insights into the potential use of
extended-dosing regimens of Epoetin alfa in this patient
population," said Pablo E. Pergola, M.D., Ph.D., Division of
Nephrology, University of Texas Health Science Center and Renal
Associates, P.A., San Antonio, Texas.
In the study, 375 subjects averaging 70 years of age were
randomized equally to one of the three dosing groups (TIW, QW and
Q2W) and treated for 44 weeks. Subjects receiving PROCRIT TIW
were switched to QW dosing after 22 weeks. A dose-adjustment
algorithm was used to achieve a target Hb of 11.0 to 11.9 g/dL.
The primary efficacy endpoint was change in Hb from baseline to
the average of the last eight weeks of treatment through Week 22.
Additional analyses were performed using data through Week 44.
The mean baseline estimated glomerular filtration rate was 30
mL/min/1.73 m2 and the median weekly EPO doses (IU) were 4,382,
4,364 and 6,091 for TIW, QW and Q2W groups, respectively. For
the TIW, QW and Q2W groups, the mean baseline Hb was 9.6, 9.7 and
9.8 g/dL, respectively; the mean Hb increase was 1.8, 1.6 and 1.3
g/dL, respectively, and the mean final Hb was 11.4, 11.3 and 11.1
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most
types of cancer receiving chemotherapy, with chronic renal
failure who are on dialysis and those who are not on dialysis,
who are being treated with zidovudine for HIV infection, and to
reduce the need for transfusion in anemic patients who are
scheduled for elective noncardiac, nonvascular surgery.
Depending on the country in which Epoetin alfa is marketed, these
indications may differ.
Important Safety Information
WARNINGS: Increased Mortality, Serious Cardiovascular and
Thromboembolic Events, and increased risk of tumor progression OR
Renal failure: Patients experienced greater risks for death and
serious cardiovascular events when administered
erythropoiesis-stimulating agents (ESAs) to target higher versus
lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in
two clinical studies. Individualize dosing to achieve and
maintain hemoglobin levels within the range of 10 to 12 g/dL.
-- ESAs shortened overall survival and/or increased the risk of
tumor progression or recurrence in some clinical studies in
patients with breast, non-small cell lung, head and neck,
lymphoid, and cervical cancers (see WARNINGS: Table 1).
-- To decrease these risks, as well as the risk of serious
cardio- and thrombovascular events, use the lowest dose needed to
avoid red blood cell transfusion.
-- Use ESAs only for treatment of anemia due to concomitant
-- ESAs are not indicated for patients receiving
myelosuppressive therapy when the anticipated outcome is cure.
-- Discontinue following the completion of a chemotherapy
Perisurgery: PROCRIT (Epoetin alfa) increased the rate of deep
venous thromboses in patients not receiving prophylactic
anticoagulation. Consider deep venous thrombosis prophylaxis.
-- PROCRIT is contraindicated in patients with uncontrolled
hypertension or with known hypersensitivity to albumin (human) or
mammalian cell-derived products.
Additional Important Safety Information
-- Patients with chronic renal failure experienced greater risks
for death and serious cardiovascular events (including myocardial
infarction, stroke, congestive heart failure, and hemodialysis
vascular access thrombosis) when administered ESAs to target
higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs.
10 g/dL) in two clinical studies; these risks also increased in
controlled clinical trials of patients with cancer. A rate of
hemoglobin rise of 1 g/dL over 2 weeks may contribute to these
-- Dose of PROCRIT
-- Chronic renal failure patients: The dose of PROCRIT should be
titrated for each patient to achieve and maintain hemoglobin
levels between 10 to 12 g/dL. If a patient does not attain
hemoglobin levels of 10 to 12 g/dL despite 12 weeks of
appropriate PROCRIT therapy, see DOSAGE and ADMINISTRATION in the
PROCRIT Prescribing Information.
-- Cancer patients: PROCRIT therapy should not be initiated at
hemoglobin levels greater than or equal to 10 g/dL. The dose of
PROCRIT should be titrated for each patient to achieve and
maintain the lowest hemoglobin level sufficient to avoid the need
for blood transfusion. Discontinue if after 8 weeks of therapy
there is no response as measured by hemoglobin levels or if
transfusions are still required (see recommended Dose
Modification section in DOSAGE and ADMINISTRATION of the PROCRIT
-- HIV patients: The dose of PROCRIT should be titrated for each
patient to achieve and maintain the lowest hemoglobin level
sufficient to avoid transfusion and not to exceed the upper
safety limit of 12 g/dL.
-- Monitor hemoglobin regularly during therapy, weekly until
hemoglobin becomes stable.
-- Cases of pure red cell aplasia (PRCA) and of severe anemia,
with or without other cytopenias, associated with neutralizing
antibodies to erythropoietin have been reported in patients
treated with PROCRIT; predominantly in patients with chronic
renal failure receiving PROCRIT by subcutaneous administration.
If any patient develops a sudden loss of response to PROCRIT,
accompanied by severe anemia and low
reticulocyte count, and anti-erythropoietin antibody-associated
anemia is suspected, withhold PROCRIT and other erythropoietic
proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or
1-888-227-5624) to perform assays for binding and neutralizing
antibodies. If erythropoietin antibody-mediated anemia is
confirmed, PROCRIT should be permanently discontinued and
patients should not be switched to other erythropoietic proteins.
-- The safety and efficacy of PROCRIT therapy have not been
established in patients with a known history of a seizure
disorder or underlying hematologic disease (e.g., sickle cell
anemia, myelodysplastic syndromes, or hypercoagulable disorders).
-- In some female patients, menses have resumed following
PROCRIT therapy; the possibility of pregnancy should be discussed
and the need for contraception evaluated.
-- Prior to and regularly during PROCRIT therapy monitor iron
status; transferrin saturation should be greater than or equal to
20% and ferritin should be greater than or equal to 100 ng/mL.
During therapy absolute or functional iron deficiency may develop
and all patients
will eventually require supplemental iron to adequately support
erythropoiesis stimulated by PROCRIT.
-- Treatment of patients with grossly elevated serum
erythropoietin levels (e.g., >200 mUnits/mL) is not recommended.
-- During PROCRIT therapy, blood pressure should be monitored
carefully and aggressively managed, particularly in patients with
an underlying history of hypertension or cardiovascular disease.
-- In studies, the most common side effects included fever
(pyrexia), diarrhea, nausea, vomiting, swelling of hands or feet
(edema), lack or loss of strength or weakness (asthenia,
fatigue), shortness of breath, high blood pressure, headache,
joint pain (arthralgias), abnormal skin sensations (as tingling
or tickling or itching or burning; paresthesia), rash,
constipation and upper respiratory infection.
Please visit www.procrit.com for the full Prescribing
Information, including the Boxed WARNINGS, and for the Medication
Guide and Patient Instructions for Use.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical
company devoted to helping improve the lives of patients with
cancer and with anemia due to multiple causes, including chronic
kidney disease. Since it was founded in 1990, Ortho Biotech and
its worldwide affiliates have earned a global reputation for
researching, manufacturing and marketing innovative products that
enhance patients' health. Located in Bridgewater, N.J., Ortho
Biotech is an established market leader in Epoetin alfa therapy
for anemia management. The company also markets treatments for
recurrent ovarian cancer, rejection of transplanted organs and
other serious illnesses. For more information, visit
Source: Ortho Biotech Products, L.P.
CONTACT: Bill Foster, +1-908-541-4057, +1-908-392-6057 (cell),
WFoster@its.jnj.com, for Ortho Biotech Products, L.P.
Web Site: http://www.orthobiotech.com/