Treatment Reduced Risk of Acute Rejection Among High Risk Kidney Transplant
Patients
CAMBRIDGE, Mass., Nov. 9 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) announced today that the New England Journal of Medicine
published the results of a randomized multinational study comparing the
outcomes of kidney transplant patients undergoing induction therapy with
Thymoglobulin(R) (Anti-thymocyte globulin [Rabbit]) with those receiving
induction therapy with basiliximab.
Results of the study, Rabbit Antithymocyte Globulin versus Basiliximab
for Induction in Renal Transplantation, showed that treatment with
Thymoglobulin resulted in a significantly reduced risk of acute rejection
and acute rejection requiring antibody therapy, and a similar risk of
delayed graft function, graft loss and death. The study involved 278
patients at high risk for acute rejection or delayed graft function
following a kidney transplant from a deceased donor. The primary endpoint
of the study was a composite measure of the first occurrence of four
factors: acute rejection, delayed graft function, graft loss and death. At
12 months, the incidence of the composite end point was similar in the two
groups (50.4% for the Thymoglobulin group versus 56.2% for the basiliximab
group; P=0.34).
The Thymoglobulin group, as compared with the basiliximab group, had a
38.8% lower incidence of acute rejection (15.6% versus 25.5%, P=0.02) and a
82.5% lower incidence of severe acute rejection that required treatment
with antibody (1.4% versus 8.0%, P=0.005).
"Our study showed the risk of acute rejection was about 1.5 times
higher among patients treated with basiliximab, and the need for antibody
treatment related to acute rejection was six times higher among the
basiliximab group," said Daniel C. Brennan, M.D., director of transplant
nephrology, Washington University School of Medicine. "These results are an
important contribution to our understanding of these treatment approaches,
and we look forward to examining the longer term outcomes of these
patients."
Genzyme Corporation, sponsor of the study, markets Thymoglobulin in
more than 50 countries around the world. In the United States,
Thymoglobulin is indicated for the treatment of acute renal graft rejection
in conjunction with concomitant immunosuppression. In many countries
worldwide, Thymoglobulin is also indicated for the prevention of acute
renal graft rejection (induction), the use examined in this study. In the
United States, Thymoglobulin is not indicated for the prevention of acute
renal graft rejection.
About Thymoglobulin
Thymoglobulin is an immunosuppressive product that contains cytotoxic
antibodies directed against antigens expressed on human T-lymphocytes.
Possible mechanisms by which Thymoglobulin may induce immunosuppression in
vivo include: T-cell clearance from the circulation and modulation of
T-cell activation, homing, and cytotoxic activities.
About the Study
Currently about 70% of kidney transplant patients in the United States
receive antibody induction therapy. This study compared the safety and
efficacy of two of the most commonly used treatment options for induction
therapy, basiliximab and Thymoglobulin. Treatment was administered
intraoperatively and over four days following transplantation among
patients who received a renal allograft from a deceased donor and were at
high risk of acute rejection or delayed graft function. All patients were
randomly assigned to receive either Thymoglobulin or basiliximab in a 1:1
ratio. Patients were followed for 12 months.
In the study, researchers compared short courses of treatment with
either Thymoglobulin or basiliximab. Treatment with Thymoglobulin was
initiated intraoperatively, before graft reperfusion. Subsequent doses were
given daily through post-operative day four for a total dose of 7.5 mg per
kilogram. Treatment with basiliximab at 20 mg was administered
intravenously according to manufacturer's instructions, with a first
infusion before graft reperfusion and a second infusion on post-operative
day four. Both groups received maintenance immunosuppressive therapy
involving cyclosporine modified, mycophenolate mofetil, and prednisone.
In addition to the benefits seen for the Thymoglobulin group in
reducing the incidence of acute rejection and antibody treatment for acute
rejection, the study also showed that the incidences of delayed graft
function and graft loss were statistically similar in both groups. As
anticipated, the Thymoglobulin group experienced a higher initial incidence
of leukopenia and thrombocytopenia immediately after transplantation, but
by day 14 post- transplant there were no significant differences noted
between the treatment groups. While the incidence of adverse events,
serious adverse events and cancer were similar in both groups, patients
treated with Thymoglobulin had a higher incidence of infection (85.5%
versus 75.2%, P=0.03) but a lower incidence of cytomegalovirus disease
(7.8% versus 17.5%, P=0.02).
About Renal Transplant
According to the National Kidney Foundation, there were 16,004 kidney
transplants and 881 combination kidney and pancreas transplants in the
United States in 2004. Of the single kidney transplants that year, 6,647
were from living donors and 9,357 were from cadaveric donors. According to
the American Association of Kidney Patients, using current standard of care
therapy, rejection rates for kidney transplants are estimated at 10-15%.
Important U.S. Safety Information:
WARNING: Thymoglobulin(R) should only be used by physicians experienced
in immunosuppressive therapy for the management of renal transplant
patients.
Thymoglobulin is indicated for the treatment of renal transplant acute
rejection in conjunction with concomitant immunosuppression.
Medical surveillance is required during Thymoglobulin infusion.
Patients with a history of allergy or anaphylaxis to rabbit proteins, or
with an acute viral illness should not use Thymoglobulin. In rare
instances, anaphylaxis has been reported. Thymoglobulin adverse events are
generally manageable or reversible. The most frequent reported adverse
events (more than 25% of patients) include: fever, chills, leukopenia,
pain, headache, abdominal pain, diarrhea, hypertension, nausea,
thrombocytopenia, peripheral edema, dyspnea, asthenia, hyperkalemia,
tachycardia, and infection.
Prolonged use or overdose of Thymoglobulin in association with other
immunosuppressive agents may cause over-immunosuppression. During
Thymoglobulin therapy, monitoring the lymphocyte count may help assess the
degree of T-cell depletion. WBC and platelet counts should also be
monitored. For more information on Thymoglobulin, please see full
prescribing information available at http://www.thymoglobulin.com.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. This year marks the 25th anniversary of Genzyme's
founding. Since 1981, the company has grown from a small start-up to a
diversified enterprise with more than 8,500 employees in locations spanning
the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by
FORTUNE as one of the "100 Best Companies to Work for" in the United
States.
With many established products and services helping patients in more
than 80 countries, Genzyme is a leader in the effort to develop and apply
the most advanced technologies in the life sciences. The company's products
and services are focused on rare inherited disorders, kidney disease,
orthopedics, cancer, transplant and immune diseases, and diagnostic
testing. Genzyme's commitment to innovation continues today with a
substantial development program focused on these fields, as well as heart
disease and other areas of unmet medical need.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line
at 1-800-905-4369 within the United States or 1-703-797-1866 outside the
United States.
Media Contact: Investor Contact:
Dan Quinn Sally Curley
(617) 768-6849 (617) 768-6140
SOURCE Genzyme Corporation
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Related links:
http://www.genzyme.com/
http://www.prnewswire.com/comp/104284.html/
CONTACT:
Media Contact: Dan Quinn, +1-617-768-6849, or
Investor Contact: Sally Curley, +1-617-768-6140, both of Genzyme
Corporation
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