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New Targeted Biological Treatment Available for Canadian Psoriasis Patients

Raptiva(R) is the first continuous use biological treatment to provide effective and safe control of psoriasis signs and symptoms offering new hope for patients with moderate-to-severe chronic plaque psoriasis

TORONTO, CANADA -- October 31, 2005 -- Health Canada has approved Raptiva(R) (efalizumab), a biological therapy for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy. Raptiva is the first continuous use biological therapy approved in Canada that can provide effective and safe continuous control of psoriasis signs and symptoms.

Approximately one million Canadians suffer from psoriasis(1,2) - a life-long, immune mediated skin disease that can significantly affect a patient's well-being.(3,4) Plaque psoriasis, the most common form of the disease, is characterized by inflamed patches of skin (lesions) topped with silvery white scales.

Next to congestive heart failure, the physical symptoms of psoriasis have a greater negative impact on its sufferers than diabetes, chronic lung disease and arthritis.(5) Psoriasis ranks close to depression as having a profound mental impact on the lives of sufferers.(6) Up to 10 per cent of psoriasis patients, especially younger patients, harbour suicidal thoughts.(7,8)

"People with psoriasis have to manage the disease over their lifetime," says Dr. Neil Shear, Phelan Professor and Chief of Dermatology at Sunnybrook and Women's College Health Sciences Centre in Toronto. "When uncontrolled, the pain from psoriasis can reduce and often prevent simple daily activities such as walking or even opening a jar. The symptoms can also lead patients to miss work and in extreme cases lose their jobs."

In the longest trial to date of moderate-to-severe chronic plaque psoriasis patients receiving continuous treatment with biological therapy, up to 86 per cent of patients on Raptiva achieved a clinical benefit (a 50 per cent or greater improvement of their Psoriasis Area and Severity Index (PASI) or a Static Physician Global Assessment (sPGA) grading of mild, minimal or clear) at week 12 and maintained the initial response with continuous therapy over 24 months.(9) Raptiva patients also reported a significant improvement in their quality of life.(10)

"Finding a treatment that offers long-term, sustainable relief with a favourable safety track record has been a challenge until now," comments Dr. Yves Poulin, Dermatologist at Centre dermatologique du Québec métropolitain and assistant clinical professor at Hôpital Hôtel Dieu in Québec City. "Raptiva meets patients' needs and gives them an opportunity to live a more normal life, especially in more severe cases."

Traditional psoriasis treatments including phototherapy and older systemic therapies can be effective for moderate-to-severe psoriasis sufferers in the short-term, but their extended use is limited by the risk of potentially serious toxicities.(11) Patients frequently have to switch or discontinue these therapies for periods of time, with the possibility of symptoms returning. With Raptiva, patients have control of their disease without having to undergo intermittent or cyclic/rotational therapy regimens.

About Raptiva

Raptiva is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells (a type of white blood cell) that lead to the development of psoriasis symptoms. Raptiva can be self-administered by patients at home through a single, once weekly subcutaneous (under the skin) injection.

It is the only biological therapy that has this unique triple mode of action, addressing three key steps in the cause of psoriasis. Unlike other biological treatments, Raptiva's effect is reversible and does not deplete or eliminate T-cells.

"We are delighted to receive Canadian approval for Raptiva," said Deborah Brown, General Manager and Regional Vice President of Serono Canada Inc. "We look forward to bringing Raptiva to patients who deserve a new treatment for this serious condition."

More than 3,500 patients worldwide have been included in Raptiva trials to date, creating one of the largest existing databases studied with biologic therapy for psoriasis.(12) Raptiva demonstrated rapid onset of action in the reduction of symptoms associated with psoriasis - in some patients as early as two weeks after initiating treatment.(13) Additional research has shown that Raptiva is also effective in controlling the disease in "high need" moderate-to-severe patients who are not controlled by, intolerant to or contraindicated to at least two currently available systemic therapies.(14)

Raptiva is well tolerated.(15) Adverse events including headache, chills, fever, myalgia, and pain, tended to be mild-to-moderate flulike symptoms that occurred following the first one-to-two injections of Raptiva. Serious adverse events were infrequent and occurred at only a slightly greater frequency in the Raptiva group (two per cent) than in the placebo group (one per cent). No cumulative end-organ toxicity or increased malignancy or infection was apparent in patients taking Raptiva in short-term or long-term studies.(16)

Raptiva is marketed in Canada by Serono Canada Inc. and has been available in the U.S. since November 2003. In Canada, Raptiva is indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy. Serono has the rights to develop and market Raptiva worldwide outside of the United States and Japan. To date, Raptiva has been launched in over 35 countries, amongst them many countries in Europe, Latin America, Asia as well as Switzerland and Australia. Development and marketing rights in the United States remain with Genentech Inc.

REFERENCES:
1. Christophers E (2001). Psoriasis - epidemiology and clinical spectrum. Clin Exp Dermatol 26:314-320.
2. Nail L, Gulliver W, Charmley P, et al. (1999. Search for the psoriasis susceptibility gene: The Newfoundland Study. Cutis 64:323-329.
3. Krueger G, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol 2001; 137: 280-284.
4. Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41:401-407.
5. Ibid.
6. Krueger G, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol 2001;137:280-284.
7. Ibid.
8. Gupta MA, et al. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998;139:846-850.
9. Raptiva product monograph.
10. Gordon K, Pariser D, Langley R, et al. Efficacy and safety of efalizumab in a large cohort of patients with moderate to severe plaque psoriasis: Pooled results from randomized phase III trials. Presented at 62nd Annual Meeting of the American Academy of Dermatology. February 6-11, 2004; Washington, DC. Poster No. 4.
11. Naldi L, Griffiths C.E.M. Traditional therapies in the management of moderate to severe chronic plaque psoriasis: an assessment of the benefits and risks. British Journal of Dermatology 2005:152:597-615.
12. Tiffani K, Hamilton, MD. Clinical considerations of efalizumab therapy in patients with psoriasis. Seminars in Cutaneous Medicine and Surgery. Vol. 24 No. 1 March 2005.
13. Menter A, Gordon K, Carey W, Hamilton T, Glazer S, Caro I, Li N, Gulliver W. Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol. 2005 Jan;141(1):31-8.
14. Gordon K, Pariser D, Langley R, et al. Efficacy and safety of efalizumab in a large cohort of patients with moderate to severe plaque psoriasis: Pooled results from randomized phase III trials. Presented at 62nd Annual Meeting of the American Academy of Dermatology. February 6-11, 2004; Washington, DC. Poster No. 4.
15. Raptiva product monograph.
16. Gordon K, Pariser D, Langley R, et al. Efficacy and safety of efalizumab in a large cohort of patients with moderate to severe plaque psoriasis: Pooled results from randomized phase III trials. Presented at 62nd Annual Meeting of the American Academy of Dermatology. February 6-11, 2004; Washington, DC. Poster No. 4.


SOURCE: Serono

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