Multiple Course Efficacy and Safety Results of AMEVIVE-R- -Alefacept- in Psoriasis Patients
Friday February 18, 1:00 pm ET
NEW ORLEANS--(BUSINESS WIRE)--Feb. 18, 2005--Results from two multiple course efficacy and safety analyses of AMEVIVE® (alefacept) were presented by Biogen Idec (NASDAQ: BIIB - News) at the American Academy of Dermatology annual meeting.
"Psoriasis is a chronic, relapsing disease for which long-term therapy is needed," said Dr. Alan Menter of Baylor University Medical Center, Dallas, Texas. "I have seen AMEVIVE give some of my patients a new lease on life and this data gives me even more confidence that AMEVIVE is one of the treatment options that will continue to deliver strong results over the long haul."
Efficacy Analysis
This analysis evaluated the efficacy of AMEVIVE over five courses of treatment and, in addition, measured patients' clinical response to a second course of treatment after they failed to achieve a high response in their initial course. Data for this analysis were collected through two double-blind, placebo-controlled Phase III studies and open-label extension studies.
In these studies, AMEVIVE was administered once a week for 12 weeks as a 15 mg intramuscular (IM) dose or as a 7.5 mg intravenous (IV) dose. Patients then participated in a 12-week observation phase in which their psoriasis was evaluated using the Psoriasis Area and Severity Index (PASI), a standard measure used to gauge psoriasis improvement in clinical trials. Scores of PASI 75, PASI 50 and PASI 25 represent a 75 percent, 50 percent and 25 percent improvement, respectively, in disease area and severity.
Multiple course data show that additional treatment with AMEVIVE may provide incremental benefit regardless of response to the initial treatment.
Patients who received multiple courses of IV AMEVIVE experienced improved clinical response rates after each subsequent course:
The proportion of patients achieving both PASI 50 and PASI 75 increased with each course (the number of patients in courses 1 through 5 was 521, 327, 217, 158, and 39, respectively)
Even among patients who did not achieve PASI 50 or PASI 25 during the first course of therapy, a second course of AMEVIVE improved clinical response
Approximately half of the patients who failed to achieve PASI 50 or PASI 25 in the first course achieved PASI 50 with a second course of AMEVIVE.
"Dermatologists often rotate psoriasis patients through therapies because the medicines have stopped working or posed health risks," said Burt A. Adelman, M.D., Executive Vice President, Development at Biogen Idec. "This analysis shows that AMEVIVE appears to keep working and may provide additional benefit with multiple courses of treatment. We believe AMEVIVE provides an option to help physicians manage their patients' psoriasis."
Multiple Course Safety Analysis
The safety analysis examined integrated data from 1,869 patients who received up to nine courses of AMEVIVE over a five-year period. These data were analyzed from double-blind, placebo-controlled Phase I, II and III clinical trials and their open-label extensions.
Over a five-year period:
-- 1,869 patients received (> or =) 1 course
-- 1,152 received (> or =) 2 courses
-- 554 received (> or =) 3 courses
-- 362 received (> or =) 4 courses
-- 171 received (> or =) 5 course
-- 56 received (> or =) 6 courses
-- 39 received (> or =) 7 courses
-- 21 received (> or =) 8 courses
-- 8 received (> or =) 9 courses
The most commonly reported side effects in the first course were headache (14%), upper respiratory infections (10%), influenza (8%), upper respiratory tract infection (8%) and pruritus (8%). In subsequent courses, these reports of adverse events were consistent and had no notable increases in their incidence.
The incidence of serious adverse events, including serious infections or malignancies, was low (less than 1 percent) and there was no increase in their incidence over multiple courses of treatment. There were no cases of tuberculosis or opportunistic infections in the 2,132 patients who received AMEVIVE in the clinical program.
About psoriasis
Approximately 4.5 million Americans suffer from psoriasis, an autoimmune skin disease in which skin cells multiply ten times faster than the normal rate. The excess cells pile up on the skin's surface, forming red, raised, scaly plaques that can be painful and disfiguring.
About AMEVIVE
AMEVIVE is a biologic therapy approved to treat adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. It is unique among treatments for psoriasis because it may continue to provide relief after patients stop taking the medicine. In two large controlled clinical studies, some patients with moderate-to-severe psoriasis maintained their response for up to seven months after completing one 12-week course of therapy.
AMEVIVE is eligible for Medicare coverage and has a J code, (J0215), which helps accelerate the Medicare reimbursement process.
Important Safety Information
AMEVIVE reduces the number of T cells, which are one of the body's ways to fight off cancer and infections. This could increase the possibility of getting cancer and serious infections. Before taking AMEVIVE, be sure to tell your doctor if you have had cancer or a serious infection.
Among 1,357 patients treated in clinical studies, 25 patients were diagnosed with 35 cancers.23 were skin cancers and 3 were cancers of the lymph system. There were 19 patients (1.5%) who experienced serious infections. The most frequent infections were wound infections (4) and pneumonia (3).
During and after taking AMEVIVE, if you notice anything unusual about your health, or any signs of infection such as swollen glands, fever or chills, notify your doctor right away.
Because AMEVIVE reduces the number of T cells, you should have a blood test every week during the dosing period to check your T cell levels. If your T cell levels are too low, your physician will not begin treatment with AMEVIVE, or will postpone or stop treatment with AMEVIVE.
AMEVIVE should not be taken if you are known to be allergic to AMEVIVE or any of its components, since serious allergic reactions, such as hives, with or without swelling of the mouth and tongue, have been seen.
Since AMEVIVE has been on the market, cases of liver disease have been reported, including one case of hepatitis (liver inflammation with jaundice).
Commonly observed side effects that occurred in clinical studies more frequently with AMEVIVE included: sore throat, dizziness, increased cough, nausea, itching, muscle aches, chills, injection site pain, injection site inflammation and accidental injury.
If you become pregnant while taking AMEVIVE, or within eight weeks of finishing AMEVIVE, tell your doctor and consider enrolling in the Pregnancy Registry by calling 1-866-AMEVIVE.
About Biogen Idec
Biogen Idec creates new standards of care in oncology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For press releases and additional information about the company, please visit www.biogenidec.com.
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