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Health Canada Approves Enbrel for the Treatment of Psoriatic Arthritis

TORONTO, ON -- March 31, 2004 -- Canadians living with psoriatic arthritis, a debilitating and destructive form of arthritis, can now receive a medication that is proven to specifically reduce the symptoms of their disease. Health Canada has approved Enbrel® for the treatment of adult patients with psoriatic arthritis (PsA). Enbrel is the first biologic medicine approved for PsA patients.

Psoriatic arthritis is a potentially disabling disease that can that cause the destruction of bones, fusion of vertebrae and shortening of fingers and toes. PsA is linked to psoriasis, a disorder causing areas of the skin to become inflamed and be covered with silvery or grey scales. Psoriasis can also cause the nails on the hands and feet to develop small holes and to lift1.

"This approval is very welcome news for people living with psoriatic arthritis," said Dr. Boulos Haraoui, Clinical Associate Professor of Medicine, Université de Montréal and Director of Clinical Research, Rheumatic Disease Unit, CHUM, Hôpital Notre-Dame. "Until now, we did not have a drug specifically indicated for the treatment of PsA. Enbrel is currently, the only approved medication that is proven to safely and effectively reduce the symptoms of PsA. This medication has the potential to change the lives of those people living with this condition."

In addition to the physical damage PsA causes, people living with the disease must also manage the impact it has on their daily life. A recent survey in the United States conducted by the National Psoriasis Foundation found that 84 per cent of people with PsA said that the disorder had a moderate to large impact on their daily lives. Up to 69 per cent said it impeded their performance at work or school.

Until this point in time, therapy for PsA has been based on medications that have proven successful in treating rheumatoid arthritis. Even commonly prescribed medications have not been extensively studied for their effectiveness in PsA.

Trials have demonstrated that Enbrel effectively reduces the damage caused by PsA. Enbrel has also proven to be well tolerated.

Clinical Studies
Enbrel's effectiveness in treating psoriatic arthritis was studied in randomized, double-blind, placebo-controlled trials. In one phase II trial involving 60 patients :

Enbrel proved effective at treating arthritis, as measured by two different scores:

§ 87 per cent of patients taking Enbrel met the Psoriatic Arthritis Response Criteria (PsARC) at 12 weeks versus 23 per cent in placebo treated patients

§ 73 per cent of patients taking Enbrel achieved a 20 percent improvement in their American College of Rheumatology score (ACR20) at 12 weeks versus 13 per cent of placebo treated patients

PSA in Canada
According to the Arthritis Society, psoriatic arthritis affects up to one percent of Canadians and is commonly associated with the skin condition psoriasis. Most people will develop the disease between the ages of 20 and 50.

If left untreated, PsA will progress throughout the body, causing increasing damage to joints, potentially leading to deformities. PsA patients are also at an increased risk of death compared to the general population.

Unlike RA where the presence of a specific protein in the blood is used for diagnosis, there is no easy way of diagnosing PsA. Some researchers have suggested that, because there is no definitive marker for identifying PsA, it may be an under diagnosed condition.

Enbrel in Canada
Enbrel belongs to a class of anti-arthritis treatments called TNFa inhibitors. Enbrel is the first biologic medicine to receive an indication specifically for adult PsA patients.

Enbrel acts like a sponge to absorb excess TNF in the body. Health Canada has approved Enbrel to reduce the signs and symptoms and inhibit the progression of structural damage of active arthritis in adult patients with psoriatic arthritis.

In Canada, Enbrel has been approved for use in adults with moderate to severe rheumatoid arthritis, as well as for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients aged four to 17 years old.

References:

1. www.arthritis.ca
2. National Psoriasis Foundation. Press kit for psoriatic arthritis survey. January 2002. www.psoriasis.org/files/pdfs/press/papresskit.pdf.
3. Anandarahah, AP, Ritchlin CT. Etanercept in psoriatic arthritis. Expert Opin Biol Ther. February 2003; 3(1): 169-177.
4. Anandarahah, AP et al.
5. Mease, J et al. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomized trial. The Lancet. Vol 356, July 29, 2000, 385-390.
6. Mease, J et al.
7. Mease, J et al.
8. www.arthritis.ca
9. www.arthritis.ca
10. Gladman D, Farewell V. Progression in Psoriatic Arthritis: Role of Time Varying Clinical Indicators. The Journal of Rheumatology. 1999: 26:11, p. 2412.
11. Gladman, D et al. Mortality Studies in Psoriatic Arthritis: Results From a Single Outpatient Center. Prognostic Indicators for Death. Arthritis and Rheumatism. 1998: 41:6, p. 1110.
12. Anandarajah AP, Ritchlin CT. Etanercept in psoriatic arthritis. Expert Opin Biol Ther. Feb 2003; 3(1): 169-177.
13. Anandarajah, AP et al.


SOURCE: Immunex Corporation

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