PRAGUE, May 21 /PRNewswire/ --

- Ointment (Tacrolimus Monohydrate) in a New Twice-Weekly Regimen can Help Prevent Eczema Flares

Today sees the European launch of the first topical calcineurin inhibitor to be approved for the maintenance treatment of 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)

Helping patients to reduce the number of flares they experience will lift many of the burdens patients face on a day to day basis, said Dr Sakari Reitamo, Hospital for Skin and Allergic Diseases, Helsinki University Central Hospital, Finland. He added: We are giving patients the opportunity to get on with their lives without the worry of a flare hanging over them.

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 the sub-clinical inflammation between flares in appropriate patients with moderate to severe disease, in order to prevent flare recurrence and prolong the time that patients are free from flares.

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 the time they experienced their first flare (from 14 to 123 days in adults and 17 to 146 days in children), compared to those treated with the standard PROTOPIC treatment regimen. (1)

Eczema is on the increase - affecting up to 30% of children and 10% of adults in developed countries.(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)

Dr Reitamo concluded: Until now, more severe eczema often controlled the lives of patients. Now, maybe for the first time, this has reversed - patients control their eczema.

Notes for Editors


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.

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organisation is committed to becoming a global company by combining outstanding RD and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 20 affiliate offices located across Europe, the Middle East and Africa, an RD site and three manufacturing plants with approximately 3,400 staff.


(*) in adults and children (more than or equal to 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


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

PROTOPIC is a trade mark of Astellas Pharma Inc. and its related entities.

Contacts for enquiry or additional information: Astellas Pharma Europe, Mindy Dooa, Tel: +44(0)1784-419-408, Email:; Ketchum, Caroline Magee, Direct line: +44(0)20-7611-3562, Mobile: +44(0)7974-643-763, Email:; Helen Crow, Tel: +44(0)20-7611-3654, Mobile : +44(0)7787-533-023, Email: