Results of Several Studies on AMEVIVE Presented at International Psoriasis
Symposium
Cambridge, Mass., June 20 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) today announced data about the effect of its drug
AMEVIVE(R) (alefacept) that show that one 12-week course of AMEVIVE
administered via intramuscular (IM) injection provided a median duration of
response of 7 months. The response was seen after completion of AMEVIVE
therapy in patients with moderate-to-severe psoriasis who achieved a 75% or
greater reduction in disease area and severity. This is consistent with
response seen with intravenous (IV) AMEVIVE administration. The data were
presented at the International Psoriasis Symposium (IPS) in New York City.
(Logo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
"These analyses confirm that AMEVIVE administered via IM injection
delivers a significant duration of response, as previously seen with IV
administration of the drug. Providing patients with this type of continuing
response after treatment gives them relief from their disease and provides an
extended holiday from AMEVIVE therapy," said Dr. Mark Lebwohl, Chairman of
Dermatology at the Mt. Sinai School of Medicine in New York City. The data
presented this week were based on ongoing analysis of information generated by
Phase III clinical trials.
Psoriasis is an autoimmune skin disease that affects more than 4.5 million
Americans and 80 million people worldwide. AMEVIVE was approved by the U.S.
Food and Drug Administration on January 30, 2003 for the treatment of adults
with moderate-to-severe chronic plaque psoriasis who are candidates for
systemic therapy or phototherapy. It is the only FDA-approved biologic
therapy for the disease.
Patients included in this analysis received 15 mg of AMEVIVE via IM
injection once weekly for 12 doses, followed by 12 weeks of observation in the
double-blind placebo-controlled study and in an extension study. Patients
(n=54) who achieved a 75% or greater reduction in their disease area and
severity experienced a median duration of response of 208 days. Duration of
response was measured as the length of time a patient maintained a 50% or
greater reduction in their disease area and severity after completing one 12-
week course of treatment with AMEVIVE. Among patients (n=40) who achieved a
Physician Global Assessment of "clear" or "almost clear," investigators
observed a median duration of response of 245 days.
AMEVIVE is available in the U.S. as both IM and IV injections.
Other AMEVIVE data presented at IPS, June 18-22, include:
Amevive in Combination with UVB Therapy
-- Data from a pilot study of AMEVIVE given in combination with
ultraviolet light B (UVB) therapy in 60 patients with moderate-to-
severe psoriasis showed that there were no opportunistic infections.
Rash and sore throat were the most frequently reported adverse events
in the study.
-- This was a small study, and the limited data available suggest that
AMEVIVE and UVB therapy together may provide a more rapid onset of
effect compared to AMEVIVE monotherapy.
Patients Report Improved Quality of Life
-- Data pooled from two Phase III studies examined the effect of AMEVIVE
on quality of life among patients who were not candidates for
conventional systemic therapy (cyclosporine, methotrexate, oral
retinoids) or phototherapy because they failed previous treatments,
could not tolerate them or were ineligible to take them due to
contraindications.
-- Investigators reported a statistically significant improvement in
quality of life for these patients after treatment with AMEVIVE, as
measured by the Dermatology Life Quality Index (DLQI).
About AMEVIVE
AMEVIVE is indicated for the treatment of moderate-to-severe chronic
plaque psoriasis in adults who are candidates for systemic therapy or
phototherapy. The treatment is administered via IM or IV injection once per
week for 12 doses under the supervision of a physician.
Important Safety Considerations:
The most serious adverse reactions found in clinical trials were:
lymphopenia, malignancies, serious infections requiring hospitalization and
hypersensitivity.
AMEVIVE reduces lymphocyte counts (also called T-cells). T-cell levels
should be measured weekly during the 12-week dosing period. If T-cell levels
are too low, physicians will either not initiate, withhold or discontinue
treatment.
AMEVIVE is an immunosuppressive agent and may increase the risk of
malignancies. Among 1,357 patients who received AMEVIVE in clinical trials,
there were 23 reported cutaneous malignancies and 3 lymphomas. AMEVIVE also
has the potential to increase the risk of infection and reactivate latent,
chronic infections. Nineteen patients in these clinical trials had serious
infections, examples of which included postoperative and burn wound infection
(4) and pneumonia (3). Hypersensitivity reactions observed in clinical trials
included urticaria (5) and angioedema (2). AMEVIVE should be discontinued if
the patient develops an anaphylactic reaction. AMEVIVE should not be
administered to patients with a history of systemic malignancy, clinically
important infection, known hypersensitivity to AMEVIVE or any of its
components, or to patients receiving other immunosuppressive agents or
phototherapy. Caution should be exercised when considering the use of AMEVIVE
in patients with chronic infection, history of recurrent infection or at high
risk of malignancy.
Commonly observed adverse events in the first course of placebo-controlled
clinical trials with at least a 2% higher incidence in patients treated with
AMEVIVE compared to those treated with placebo were: pharyngitis, dizziness,
increased cough, nausea, pruritus, myalgia, chills, injection site pain,
injection site inflammation and accidental injury.
If a patient becomes pregnant while receiving AMEVIVE or within 8 weeks of
finishing AMEVIVE, she should notify her doctor and consider enrolling in the
Pregnancy Registry by calling 1-866-AMEVIVE.
For more information about AMEVIVE, including prescribing information and
Biogen's comprehensive support services, call 1-866-AMEVIVE or visit
http://www.amevive.com.
About Biogen
Biogen is the world's oldest independent biotechnology company and a
leader in biologics research, development and manufacturing. A pioneer in
leading edge research in immunology, neurobiology and oncology, Biogen brings
novel therapies to improve patients' lives around the world through its global
marketing capabilities. For press releases and additional information about
the company, please visit http://www.biogen.com.
Media Contact: Media Contact:
Amy McKnight Susie Bunson
Associate Director, Public Affairs Spectrum Science Public Relations
Biogen, Inc. Tel: (202) 955-6222
Tel: (617) 914-6524
Investment Community Contact:
Christina Dillon
Manager, Investor Relations
Biogen, Inc.
Tel: (617) 679-2812
SOURCE Biogen, Inc.
 back to top
Related links:
http://www.biogen.com
Company News On-Call:
http://www.prnewswire.com/comp/101550.html
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
CONTACT:
Media, Amy McKnight, Associate Director,
Public Affairs of Biogen, Inc., +1-617-914-6524; or Susie Bunson
of Spectrum Science Public Relations, +1-202-955-6222; or
Investment Community Contact, Christina Dillon, Manager, Investor
Relations of Biogen, Inc., +1-617-679-2812
|
