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Innovative Treatment Approach Offers New Hope For Eczema Sufferers With Moderate To Severe Disease

Main Category: Eczema / Psoriasis
Also Included In: Dermatology
Article Date: 09 Jul 2009

The British Association of Dermatology annual meeting sees the launch of the first topical calcineurin inhibitor to be approved for the maintenance treatment of moderate to severe atopic eczema to prevent flares and prolong flare-free intervals. PROTOPIC ointment (tacrolimus monohydrate) is already licensed to treat moderate and severe eczema (atopic dermatitis), often involving the treatment of flares as and when they occur.* It is now also approved for twice-weekly application to previously affected skin to prevent these exacerbations and prolong flare-free periods in PROTOPIC-responsive patients.⁪ Clinical studies have shown that this new approach brings significant benefits with over 40% of patients with moderate to severe eczema remaining flare-free for at least a year.1 Flares are known to place an enormous burden on patients. The International Study of Life with Atopic Eczema (ISOLATE) found that about 55% of these patients worried about the onset of their next exacerbation and that they spent on average over a third of the year (136 days) with their eczema in flare.2

"Patients should aim to treat the acute flares and try to prevent further ones" said Dr Anthony Abdullah from the Birmingham Skin Centre. He added: "the concept of prevention of exacerbation and maintenance therapy is well understood and utilised in other common and related atopic disorders such as bronchial asthma."

The standard approach to managing eczema has been to treat flares as and when they occur with topical anti-inflammatory agents. However, a deeper understanding of the pathology of this disease has revealed that sub-clinical inflammation persists, even after the clinical signs of flare have resolved.3,4 This new twice-weekly treatment regimen with PROTOPIC ointment will allow physicians to actively manage appropriate patients with moderate to severe atopic dermatitis in between flares, in order to prevent flare recurrence and prolong the time that patients are free from flares.

* in adults and children (≥ 2 years) who are unresponsive or intolerant to conventional therapies such as topical corticosteroids

⁪ in patients who experienced at least four flares per year, who respond to a maximum of six weeks of twice-daily treatment with PROTOPIC

Approval of the twice-weekly regimen of PROTOPIC was based on sub-analysis of the results from two phase III studies (CONTROL) conducted in 524 adults and children in 13 European countries, which found that once patients had responded to twice-daily treatment of their flares with PROTOPIC ointment, continuing treatment to previously affected areas with a twice-weekly regimen significantly reduced the number of flares compared to a flare treatment-only regimen.5,6 Patients in the twice-weekly PROTOPIC ointment group also noticed a significant delay in time to first flare (123 vs. 14 days in adults, and 146 vs. 17 days in children), compared to those treated with the standard PROTOPIC treatment regimen.1

Atopic dermatitis is highly prevalent, with approximately one in nine people in England affected by the disease in 2005.7 Research has also shown that around one in five children in England (<10 years) have eczema. 7 Incidences have trebled over the past 30 years in industrialised societies,8 with cases per 1,000 population in England increasing by over 40% between 2001 and 2005.7 It is a chronic problem, with patients typically experiencing recurrent flares which can have a significant impact on quality of life. The ISOLATE study, involving over 2,000 eczema patients, showed that on average, patients with moderate to severe disease experienced nine flares per year, each lasting for over two weeks.2 75% of patients reported that greater control of their disease would be the single most important improvement to their quality of life.2

About PROTOPIC

PROTOPIC ointment (tacrolimus monohydrate) has been marketed in Europe for the treatment of moderate to severe atopic dermatitis in adults and children aged two and over since its launch in 2001. This new indication is for maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice-daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). Discovered and developed by Astellas Pharma Inc., PROTOPIC has been marketed in 45 countries worldwide, including Japan, the US, and countries in Europe, Asia and Latin America.

References

1. PROTOPIC Summary of Product Characteristics. 2009

2. Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol 2006;11:226-232

3. Leung DY, Boguniewicz M, Howell MD, et al. New insights into atopic dermatitis. J Clin Invest 2004;113:651-7

4. Wollenberg A and Bieber T. Proactive therapy of atopic dermatitis - an emerging concept. Allergy 2009;64:276-278

5. Wollenberg A, Reitamo S, Atzori F, et al. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy 2008;63:742-750

6. Thaçi D, Reitamo S, Gonzalez Ensenat MA, et al. Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study. Brit J Dermatol 2008;159:1348-56

7. Simpson CR, Newton J, Hippisley-Cox J, et al. Trends in the epidemiology and prescribing of medication for eczema in England. J R Soc Med 2009;102;108-117

8. Bieber T. Mechanisms of disease: atopic dermatitis. N Engl J Med 2008;358:1483-1494

Source
Astellas UK

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