NEWS: AMEVIVE -- Alefacept -- Appears to Improve Patients' Psoriatic Arthritis in Phase II Study

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February 18, 2005 01:00 PM US Eastern Timezone

AMEVIVE -- Alefacept -- Appears to Improve Patients' Psoriatic Arthritis in

Phase II Study

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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® (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.

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