Highly anticipated biologic for psoriasis now approved in Canada

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By Sarah Carter

AMEVIVE (alefacept), the first new medication for psoriasis in over a decade, has been approved in Canada for the treatment of patients with moderate to severe chronic plaque psoriasis who are candidates for systemic or phototherapy. ÊAMEVIVE is a biologic medication and it is the first and only biologic to be classified as a selective immunomodulating antipsoriatic agent. ÊAMEVIVE is a systemic therapy that works by helping to rebalance overactive T-cells in the immune system. These T-cells are thought to play a major role in the underlying cause of psoriasis. AMEVIVE, which was developed by Biogen Idec, has a dual mechanism of action that includes selectively reducing the number of these disease-causing T-cells.

AMEVIVE is administered via an intramuscular injection, once a week for 12 weeks. While some patients respond very well after one 12-week course of therapy, 7 out of 10 patients achieved a clinically meaningful response after two 12-week courses of therapy. The administration of AMEVIVE can be done either in a physician’s office, or it can be conveniently self-administered by the patient or caregiver in their home. Biogen Idec’s extensive Amevive Care Programä will offer training and support to patients to ensure proper use and administration of the drug.

AMEVIVE has been shown in clinical studies to continue to provide relief after treatment stops. Two well-controlled clinical studies have shown that patients with moderate-to-severe chronic plaque psoriasis who respond to AMEVIVE can maintain their response for a median of seven months after completing therapy. Additionally, AMEVIVE is the first and only remittive systemic therapy allowing patients a meaningful treatment-free period and the ability to lead normal disease-free lives for considerable lengths of time.

“This is clearly a significant development for moderate to severe psoriasis patients who previously had no meaningful treatment option for their painful disease,” says Dr. Charles Lynde of Toronto, a practicing dermatologist and Assistant Professor of Dermatology at the University of Toronto, and past President of the Canadian Dermatology Association. “We, as Dermatologists, are looking for safe and effective treatment options for psoriasis sufferers, which also provides them with long-term remission periods. In this regard, AMEVIVE is a breakthrough medication.”

AMEVIVE has been shown in clinical trials to have a safety profile similar to placebo. The safety experience with multiple course treatment was similar to a single course. AMEVIVE also had a similar safety profile to that of the phase III clinical trials when combined with other psoriasis treatments including systemic treatments and phototherapy. Because AMEVIVE reduces the overactive T-cells, which are thought to play a major role in the cause of psoriasis, patients should have periodic blood tests during the dosing period to check their T-cell levels.

Psoriasis is an autoimmune skin disease in which skin cells multiply 10 times faster than the normal rate. It is characterized by sharply defined, raised, reddened, scaly plaques. Patients with moderate to severe psoriasis can have from 10-90% of their body surface area covered with plaques. These plaques can be painful, unsightly and persist for long periods of time.

Psoriasis has a major impact on patients’ health related quality of life. Patients with psoriasis have reported reductions in their physical and mental functioning that is comparable to other major medical diseases including cancer, arthritis, hypertension, heart disease, diabetes and depression. In clinical trials, AMEVIVE was demonstrated to significantly improve a patient’s quality of life. October is Psoriasis Awareness Month in Canada – especially notable since Canada has over one million patients suffering from this stubborn skin disease.

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. Biogen Idec Canada is based in Mississauga, Ontario. www.biogenidec.com.