Relief for Canadians managing chronic and painful skin condition

Toctino made widely available in Canada

  • Nearly 50 per cent of Toctino-treated patients had clear or almost clear hands after 12-24 weeks of treatment in largest-ever clinical trial in patients with severe Chronic Hand Eczema.

  • It is estimated that up to 10 per cent of people in Canada have hand eczema.

  • In a survey of occupational hand eczema, almost 20 per cent of sufferers experienced prolonged sick leave, and 23 per cent had lost their jobs due to hand eczema during the past 12 months. [8]

LAVAL, QC, April 28 /CNW/ - Actelion Pharmaceuticals Canada Inc. announced today that Toctino® (alitretinoin), a once-daily oral capsule approved for the treatment of adults with severe chronic hand eczema (CHE) that is unresponsive to potent topical (treatment applied directly to the skin) corticosteroids, is now available for use in Canada and approved by Health Canada. This is important news for Canadian patients with severe chronic hand eczema that have run out of treatment options and, consequently, have lived for years with persistent itchy blisters, painful cracks and sores on their hands. [2,3,4]

"Unfortunately, few studies exist showing how devastating chronic hand eczema is for working adults, but I see the challenges everyday in my office. It affects people from all walks of life, health care professionals, people working with chemicals, metal or plastic and even those that stay at home. Some are forced to take a leave or change professions because they cannot continue with the raw and broken skin, associated infections and terrible itch. It's socially devastating to them, not to mention the awful symptoms associated with the condition," explains Dr. Charles Lynde, Dermatologist, University Health Network (Toronto Western), Toronto, Ontario. "Treating eczema is a constant battle, but Toctino demonstrates long-lasting relief for these patients, and gets them back to work."

Toctino - a naturally-occurring, physiologic vitamin A derivative - has been developed for severe chronic hand eczema that does not respond or no longer responds to topical treatments, including potent topical corticosteroids.

In the largest-ever clinical trial in chronic hand eczema, almost half of Toctino-treated patients went from having severely affected hands to clear or almost clear hands after 12-24 weeks of treatment. [1] The pivotal clinical trial included patients who were unresponsive to topical corticosteroids and had lived with the condition for an average of approximately nine years.

"People who have severe chronic hand eczema are severely disadvantaged since they are unable to use their hands normally," said Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada. "This can lead to them taking time off work or even leaving their job altogether. Also, since the disease is localized in a highly visible area - the hands - sufferers often experience embarrassment and low self-esteem. Anything that can help treat the symptoms of this painful and distressing condition will be welcomed by chronic hand eczema sufferers."

What is chronic hand eczema?
Also known as chronic hand dermatitis, chronic hand eczema (CHE) is a persistent, relapsing inflammatory condition of the skin that is confined largely or wholly to the hands. [2,3,6] Anyone can develop the disease but is more likely to occur in adults in their peak working ages - between 20 and 49. CHE is a leading occupational disease, contributing to sickness leave, compensation and early retirement, causing a significant economic and social burden to the system. [3]

It is estimated that up to 10 per cent of the general population have hand eczema and five to seven per cent of those patients have the more severe, chronic form of the condition where many of the patients do not respond, or no longer respond to potent topical corticosteroids. [2,3] Symptoms include redness (erythema), blisters just beneath the surface of the skin (vesicles), scaling, painful cracks (fissures), swelling of the skin (edema), thickening of the outer layer of skin (hyperkeratosis) and itching and pain. [2]

Clinical trial data [1]
Toctino has been approved in Canada based on the results of a clinical development program, including the Benefit of Alitretinoin in Chronic Hand eczema (BACH) study, a double-blind, placebo-controlled Phase III study, in which 1032 patients whose severe chronic disease was unresponsive to potent topical corticosteroids were randomized to a once-daily oral dose of 30 mg Toctino, 10 mg Toctino or placebo for a treatment duration of up to 24 weeks. The primary endpoint of the study was the proportion of patients whose hands were rated as clear or almost clear by the Physicians Global Assessment.

Toctino's efficacy was superior to placebo at both of the doses tested. The difference between the active groups and placebo was highly statistically significant, with 48 per cent of patients in the 30 mg group (p<0.001) and 28 per cent of patients in the 10 mg group (p=0.004) achieving clear or almost clear hands, versus 17 per cent in the placebo group.

Only 35 per cent of the total Toctino responders (30 mg responders and 10 mg responders) relapsed to a severity that required re-treatment during the six-month post- treatment observation period, and of those who relapsed, up to 80 per cent achieved clear or almost clear hands during a second round of Toctino treatment (12-24 weeks) in a follow up study. [7]

Toctino has a safety profile in the Phase III clinical trials that is consistent with retinoid class effects. The most frequently reported adverse events in the Phase III clinical trials were headache, flushing and increased levels of blood lipids. These were dose-dependent and usually transient.

Approximately 10 per cent of Toctino-treated patients experience some mucocutaneous effect, referring to adverse events relating to the skin or mucus membranes such as dry skin, dry eyes, dry mouth and dry lips.

Since retinoids are known potent teratogens (substances that can cause birth defects), Toctino is contraindicated in females of child bearing potential unless contraception is followed for one month before, during and one month after cessation of treatment. In addition, they must undergo pregnancy testing before, during and five weeks after the end of treatment.

References

  1. Ruzicka T. et al., Br J Dermatology 2008; 158: 808-817
  2. Diepgen TL et al. Management of chronic hand eczema. Contact Dermatitis 2007; 57: 203-210
  3. Menne T and Maibach H. Hand Eczema, 2nd edition. Dermatology: Clinical and Basic Science Series
  4. Meding B, Wrangsjö K, Järvolm B. Br J Dermatology 2005; 152: 795-980
  5. Cvetovski RS, et al. Contact Dermatitis 2006; 54(2):106-111
  6. Burns T et al. Rook's Textbook of Dermatology. 7th edition. 2004. Blackwell Science
  7. Bissonette R et al., Br J Dermatol. 2009 Nov 10.
  8. Cvetkovski RS et al., Relation between diagnosis on severity , sick leave and loss of job among patients with occupational hand eczema, Br J Dermtol 2005:152:93-98

Actelion Ltd.

Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion's over 2,400 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®).

Actelion was appointed exclusive distributor for Toctino in Canada by Basilea Pharmaceutica International Ltd.

SOURCE Actelion

For further information:

Actelion Roland Haefeli
                                Vice President, Head of Investor Relations & Public Affairs
                                Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
                                +41 61 565 62 62
                                +1 650 624 69 36
                                www.actelion.com
   
Actelion                Marie-Claude Lefebvre
  Canada  Medical Director
                                Actelion Canada, 2550 Daniel-Johnson, Laval, Quebec, Canada
                                450-681-1664

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Actelion

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