18.02.2005 19:01:00
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AMEVIVE -- Alefacept -- Appears to Improve Patients' Psoriatic Arthri
Business Editors/Health/Medical Writers
BIOWIRE2K
NEW ORLEANS--(BUSINESS WIRE)--Feb. 18, 2005--
Psoriasis Foundation Says Results Promising
Preliminary results of an ongoing Phase II study indicate that the psoriasis treatment AMEVIVE(R) (alefacept) provides clinical improvement for patients with active psoriatic arthritis. In the study, 54 percent of patients who received AMEVIVE for 12 weeks achieved an ACR 20 response, or at least a 20 percent improvement in the signs and symptoms of psoriatic arthritis, at 24 weeks. The ACR score is a standard measure developed by the American College of Rheumatology to rate psoriatic arthritis disease improvement. Results of the study were presented by Biogen Idec (NASDAQ: BIIB) at the annual meeting of the American Academy of Dermatology (AAD).
"We've seen AMEVIVE provide long lasting results to some of our psoriasis patients," said Dr. Alan Menter of Baylor University Medical Center, Dallas, Texas. "Now we have evidence that AMEVIVE may offer significant relief to patients with psoriatic arthritis - a condition that's even more debilitating than psoriasis alone. This will certainly give us another option in treating these patients who have both skin and joint involvement."
In this double-blind, placebo-controlled study, 185 patients with active psoriatic arthritis were randomized to receive either methotrexate and AMEVIVE or methotrexate alone. Patients in the AMEVIVE group (n=123) received 15 mg of AMEVIVE by intramuscular injection once a week for 12 weeks, followed by a 12-week observation period.
Patients who received AMEVIVE experienced clinical improvement in their psoriatic arthritis after a single 12-week course of therapy followed by a 12-week observation period. Their response was measured using the ACR scale. ACR 50 and ACR 70 reflect a 50 percent and 70 percent improvement, respectively, in the signs and symptoms of psoriatic arthritis.
Response measured at week 24:
-- | 54% of patients treated with AMEVIVE and methotrexate achieved an ACR 20 response in contrast to 23% in the methotrexate alone group |
-- | 17% of patients treated with AMEVIVE and methotrexate achieved an ACR 50 response and 7% achieved ACR 70, in contrast to 10% and 2% of patients respectively in the methotrexate alone group |
"There are many people who have been disabled by their psoriatic arthritis and are frustrated by a lack of treatment choices," said Gail Zimmerman, President and CEO of the Psoriasis Foundation. "We are excited about AMEVIVE's promising results in psoriatic arthritis and hopeful that this medicine may offer a new option for people coping with this disease."
The most common adverse events were increased liver enzyme levels (6%), back pain (6%) and viral upper-respiratory infections (5%). The incidence of serious adverse events was 2 percent. No serious infections or malignancies were reported in patients treated with AMEVIVE.
According to the Psoriasis Foundation, psoriatic arthritis afflicts 10 to 30 percent of people with psoriasis, causing stiffness, pain, swelling and reduced range of motion in the joints. An immune system disease, psoriatic arthritis can be as severe for some patients as rheumatoid arthritis. In some cases, it leads to joint destruction that is irreversible.
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.
Safety and Efficacy in Elderly, Obese, and Diabetic Patients
Also presented at the AAD annual meeting were integrated long-term safety and efficacy results from Phase II and III studies of AMEVIVE in elderly patients, obese patients and diabetic patients with moderate-to-severe chronic plaque psoriasis. These patient populations can be sensitive to the adverse events of conventional systemic therapies, such as methotrexate and cyclosporine.
This integrated analysis reviewed 99 elderly patients, 652 obese patients and 122 diabetic patients who received up to four 12-week courses of AMEVIVE. The incidence of adverse events for these patient populations, including the frequency of infections and malignancies, was comparable to the overall patient population of Phase II and III studies and did not increase with each subsequent course of AMEVIVE. The rates of serious adverse events ranged from 6 percent to 11 percent in patients receiving one course of AMEVIVE and 5 percent to 8 percent in patients receiving two and three courses of treatment.
The efficacy of AMEVIVE in these patient populations was clinically meaningful and comparable to the overall patient population of Phase II and Phase III studies.
"It's important to offer elderly, diabetic and obese patients a treatment option that works for them. Biogen Idec is also pleased that AMEVIVE is eligible for Medicare coverage with a J code to help accelerate the reimbursement process," said Burt A. Adelman, M.D., Executive Vice President, Development at Biogen Idec.
Important Drug 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.
It has been reported that some patients treated with AMEVIVE have had serious liver injury. Talk to your doctor if you have persistent nausea, loss of appetite, fatigue, vomiting, stomach pain, yellowing of the skin or eyes, easy bruising, dark urine or pale stools.
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.
--30--DC/bo*
CONTACT: MEDIA CONTACTS: Biogen Idec Jose Juves, 617-914-6524 or Spectrum Science Communications Amanda Sellers 202-955-6222, on site: 301-332-5575 or INVESTMENT CONTACT: Biogen Idec Christina Dillon, 617-679-2812
KEYWORD: LOUISIANA INDUSTRY KEYWORD: PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Biogen Idec
Copyright Business Wire 2005
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