New Treatment For Chronic Hand Eczema Launched In UK - Toctino(R) (alitretinoin)

Main Category: Eczema / Psoriasis
Article Date: 09 Sep 2008 - 1:00 PDT

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Toctino® (alitretinoin), a new once-daily oral capsule licensed for the treatment of adults with severe chronic hand eczema (CHE) that is unresponsive to potent topical corticosteroids, is now available in the UK. Many patients with severe chronic hand eczema have run out of treatment options and, consequently, have lived for years with persistent itchy blisters, painful cracks and inflamed patches on their hands1,2,3. These symptoms can profoundly impair their quality of life and negatively impact patients' ability to work1,4.

"People who have chronic hand eczema are severely disadvantaged since they are unable to use their hands normally," said Margaret Cox, Chief Executive of the National Eczema Society. "This can lead to them taking time off work or even leaving their job altogether. Also, since the eczema is in a highly visible area - the hands - many patients 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."

Alitretinoin - a naturally-occurring, vitamin A derivative - has been developed for severe chronic hand eczema that does not respond or no longer responds to topical treatments (treatments applied to the skin), including potent topical corticosteroids.

In the largest ever clinical trial in chronic hand eczema, almost half of alitretinoin-treated patients went from having severely affected hands to clear or almost clear hands at 24 weeks5. The trial included patients who were unresponsive to topical corticosteroids and had lived with the condition for an average of approximately nine years.

Dr Stephen Kownacki, a GP in Wellingborough, Northants and chair of the Primary Care Dermatology Society said: "There are a significant number of people whose lives are blighted by chronic hand eczema. Since the hands are essential for everyday life, chronic eczema here can interfere with work and people's social lives. This new treatment would appear to offer patients a long awaited and major chance for improvement."

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 hands1,2,6. Anyone can develop the disease but it 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 burden to the social system2.

It is estimated that 1 in 10 people in the UK have hand eczema and about seven percent of those patients have the more severe, chronic form of the condition many of whom do not respond, or no longer respond to potent topical corticosteroids1,2. Symptoms include redness (erythema), blisters just beneath the surface of the skin (vesicles), scaling, painful cracks (fissures), swelling of the skin (oedema), thickening of the outer layer of skin (hyperkeratosis), itching and pain1.

Clinical trial data5

Toctino has been licensed in the UK based on the results of a clinical development programme, including the Benefit of Alitretinoin in Chronic Hand eczema (BACH) study, a double blind, placebo-controlled Phase III study, sponsored by Basilea Pharmaceutica International Ltd. 1032 patients whose severe chronic disease was unresponsive to potent topical corticosteroids were randomised to a once-daily oral dose of 30 mg alitretinoin, 10 mg alitretinoin or placebo for 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.

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

35 percent of the total alitretinoin responders (30 mg responders plus 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 percent achieved clear or almost clear hands during a second round of alitretinoin treatment in a follow up study7.

Alitretinoin is a naturally occurring, physiological retinoid (derivative of Vitamin A) and its safety profile in the Phase III clinical trials is consistent with retinoid class effects. Approximately 10 percent of alitretinoin-treated patients experience some mucocutaneous effect, namely adverse events relating to the skin or mucous membranes such as dry skin, dry eyes, dry mouth and dry lips. No direct comparison to other retinoids were made, however, the incidence of mucocutaneous effects appears lower than those reported for other retinoids.

Overall, 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 reversible.

Since retinoids are known potent teratogens (substances that can cause birth defects), Toctino is contraindicated in females of child bearing potential unless strict pregnancy testing and pregnancy prevention is followed one month before, during and one month after cessation of treatment with alitretinoin.

http://www.eczema.org

The National Eczema Society is registered as a charity with the Charity Commission of England and Wales under No 1009671. Established in 1975 the NES runs a helpline for people affected by eczema: Freephone 0800 0891122, open Monday to Friday between 8am and 8pm or email helpline@eczema.org

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX:BSLN). Basilea's integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance and on the development of dermatology drugs. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting. The company owns a diversified portfolio including compounds under regulatory review and in phase-III investigational studies. Alitretinoin (Toctino®) is approved in the United Kingdom and has been recommended for approval in ten additional EU Member States and is under regulatory review in Canada and Switzerland. The company is currently building its sales and marketing organization to commercialise and to co-promote its portfolio in North America and in other European countries, subject to approval. The first commercial group established was the UK in 2007, based in Guildford, Surrey. Basilea employs more than 250 people worldwide. http://www.basilea.com

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

References

1. Diepgen TL, et al. Management of chronic hand eczema. Contact Dermatitis 2007; 57: 203-210
2. Menne T and Maibach H. Hand Eczema, 2nd edition. Dermatology: Clinical and Basic Science Series
3. Meding B, Wrangsjö K, Järvolm B. Br J Dermatology 2005; 152: 795-980
4. Cvetovski RS, et al. Contact Dermatitis 2006; 54(2):106-111
5. Ruzicka T, et al. Br J Dermatology 2008; 158: 808-817
6. Burns T, et al. Rook's Textbook of Dermatology. 7th edition. 2004. Blackwell Science
7. Re-treatment study of Alitretinoin, Protocol BAP00091, EADV 2007 Poster 280

Basilea Pharmaceutica Ltd.

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