NICE Issues Preliminary Recommendations For First Licensed Treatment For Chronic Hand Eczema

NICE’s Appraisal Consultation Document  recommends Toctino® (alitretinoin) within its licensed indication when the patient has severe disease and significant impairment of their quality of life

Once-daily alitretinoin is the first drug licensed for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids

Chronic hand eczema is a persistent, inflammatory skin disease of the hands that reduces patients’ ability to perform everyday activities, including work

30 April 2009. The National Institute for Health and Clinical Excellence (NICE) today published a positive preliminary recommendation for Toctino (alitretinoin) for adults with chronic hand eczema that is unresponsive to potent topical steroids when the patient has severe disease and their quality of life is significantly impaired.

The preliminary NICE recommendation (Appraisal Consultation Document) also noted patients should be treated with alitretinoin when their condition has not responded to prior treatment with oral immunosuppressants (i.e. ciclosporin and azathioprine) or phototherapy (i.e. PUVA: psoralen and ultraviolet A radiation), or when these are contraindicated or the patient is intolerant to them. This is not the final NICE guidance, which is expected in August 2009.

“This preliminary recommendation from NICE is a significant advance in the management of chronic hand eczema since alitretinoin offers patients the potential to clear their hands of eczema,” said John English, Consultant Dermatologist at Queen’s Medical Centre, Nottingham. “However, given that older treatments such as ciclosporin, azathioprine and PUVA are unlicensed and may have serious adverse effects, it should be the responsibility of clinicians to decide, after careful discussion with the patient, when their use is warranted in preference to a licensed therapy.”

“Whilst NICE’s decision is good news for those chronic hand eczema sufferers who fit the somewhat limited criteria for inclusion, alitretinoin should be more widely available to all patients who fall within the approved indication,” said Margaret Cox, Chief Executive of the National Eczema Society. “People who have chronic hand eczema are severely disadvantaged since they are unable to use their hands normally. 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. ”

Basilea will continue to work with NICE on this preliminary recommendation through the standard consultation process in an effort to secure better access to alitretinoin for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids.

Once-daily alitretinoin is the first licensed treatment for people with this condition and the only treatment proven in trials to be effective and well tolerated.

1, In the largest ever Phase III clinical trial programme in chronic hand eczema, alitretinoin was the first treatment able to show effective clearing of severe chronic hand eczema unresponsive to potent topical corticosteroids, with clear or almost clear hands achieved in nearly 50 percent of patients treated with 30 mg alitretinoin.4

The Appraisal Consultation Document is available online at www.nice.org.uk and the general public and other interested parties can submit their responses directly to NICE at www.nice.org.uk/guidance/index.jsp?action=article&o=43984&subaction=loginform.

About chronic hand eczema

Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. It is one of the most common occupational skin diseases and a frequent reason for patients to consult a dermatologist. Hand eczema is reported to affect up to ten percent of the general population.2 The more severe, chronic form of the condition is thought to affect five to seven percent of these patients, impairing hand use and having a considerable impact on their quality of life. 2

About Toctino® (alitretinoin)

Toctino® (alitretinoin) was developed by Basilea Pharmaceutica International Ltd. In the largest ever Phase III clinical trial programme in chronic hand eczema, alitretinoin was the first treatment able to show effective clearing of severe chronic hand eczema, with clear or almost clear hands achieved in nearly 50% of patients treated with the 30 mg dose.4 The mean time to response to the once-daily oral therapy was 12.9 weeks. In the six month post-treatment observation period, nearly 63% of those who responded to
30 mg alitretinoin had not relapsed.1

Alitretinoin is a convenient once-daily capsule to be taken with food. The recommended starting dose is 30 mg in most patients and a treatment course lasts up to 24 weeks depending on response.1

Alitretinoin is a naturally occurring, physiological retinoid that is thought to work in chronic hand eczema through anti-inflammatory and immunomodulatory effects.

Alitretinoin is a known potent teratogen (a substance that can cause birth defects when women are exposed during pregnancy). Strict pregnancy prevention one month before, during, and one month after cessation of treatment as well as monthly pregnancy testing are required for women of childbearing age.1 A comprehensive pregnancy prevention programme has been developed and implemented.1 In clinical trials alitretinoin was well tolerated and has a safety profile overall consistent with the retinoid class. Side effects were generally dose-dependent and reversible.

About Basilea –

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology 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 two commercialized drugs (alitretinoin, ceftobiprole) and one investigational drug in phase III (isavuconazole). Toctino® (alitretinoin) is marketed in the United Kingdom, Denmark and Germany and is approved in Austria, Belgium, Finland, France, Luxemburg and Netherlands. Alitretinoin has been recommended for approval in two additional EU Member States and is under regulatory review in Canada, Switzerland and 15 additional European countries. Furthermore a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Ceftobiprole is marketed in Canada and Ukraine under the brand name ZEFTERA(TM) and in Switzerland under Zevtera(TM). Marketing applications for ceftobiprole were submitted in the U.S., the EU and several other countries. The company has set up commercial organizations in UK, Denmark, Germany and Canada, while it is building sales and marketing organizations in other countries to commercialize alitretinoin and to co-promote ceftobiprole, subject to approval.

 

Press Release Supplied With the Kind Permission of Tracy-Jane Bailey-Burnley, Basilea Pharmaceuticals Ltd

 

Page created: 1 May 2009