EADV: Protopic (Tacrolimus Ointment) Appears to Improve Quality of Life for Patients With Atopic Dermatitis

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Title: EADV: Protopic (Tacrolimus Ointment) Appears to Improve Quality of Life for Patients With Atopic Dermatitis
URL: http://www.pslgroup.com/dg/24444A.htm
Doctor's Guide
May 26, 2004

New Data and Label Changes

MUNICH, GERMANY -- May 26, 2004 -- New data presented at the Spring meeting of the

European Academy of Dermatology and Venereology (EADV) in Budapest show that treatment with Protopic^Ž (tacrolimus ointment) significantly improves the quality of life of patients suffering from atopic dermatitis (AD, eczema) compared with topical steroid treatment. An analysis looking at the pharmacoeconomic aspects of AD treatment in different patient groups showed a similar cost-effectiveness between Protopic^Ž and topical corticosteroids.

Topical steroids have been the mainstay of AD treatment for over 50 years. However their long-term use is associated with side effects such as skin thinning, stretch marks (striae), uneven or mottled skin colour (dyspigmentation), rebound effects (flare of symptoms on stopping treatment) and desensitisation to, and reduced effect of, medication (tachyphylaxis).

The irritating, painful and disfiguring nature of AD can profoundly affect the quality of life of patients and their families. The impact of the most distressing physical aspects of eczema on patient's lives can be assessed by the Dermatology Quality of Life Index (DLQI) questionnaire: the intensity of itching, soreness, stinging and pain; the impact of disease on social functioning, such as how eczema affects patients' work, home and leisure activities; and emotional aspects like self-image and self-confidence.

In a 6-month multicentre, double-blind study (n=972) using the DLQI, patients treated with Protopic^Ž not only experienced greater relief from eczema signs and symptoms, but also had greater quality of life improvements than their steroid-treating counterparts. More than 90% of Protopic^Ž-treated patients experienced lesion clearance, excellent, marked or at least moderate improvement in their eczema by Month 6, which correlated with better emotional and social functioning, and a greater sense of well-being in Protopic^Ž-treated patients compared with those using steroids.¹

"If you have not suffered from atopic dermatitis, or have not been kept awake at night by a deeply distressed child, it can sometimes be hard to appreciate just how miserable eczema can make someone's life," said study investigator, Dr Sakari Reitamo, from the University Central Hospital, Helsinki, Finland. "These quality-of-life data are important in helping us to understand the real impact of the condition and the benefits of treatment with Protopic^Ž."

New pharmacoeconomic data from the UK also presented demonstrated that Protopic^Ž treatment is at least as cost-effective as steroids in adults and children with moderate to severe eczema unresponsive to conventional treatments.² Adults with moderate AD treated with Protopic^Ž experienced more days free or virtually free of disease (disease-controlled (DC) days) and at a lower cost than adults using steroids (90 DC days at a cost of GBP 11 per DC day versus 58 days costing GBP 17 per DC day, respectively). Although costs associated with severe AD were higher than those seen with moderate disease, a comparable picture emerged. Similar findings were seen in children with moderate AD who were treated with Protopic^Ž – 175 days disease-free or virtually disease-free at a cost of GBP 10 per DC day compared with 156 days for children using steroids at an average cost of GBP 11 per DC day. As in adults, treating children with severe eczema was more expensive than treating moderate disease; however, Protopic^Ž offered a better clinical outcome at a comparable cost to steroids. Furthermore, if patients with AD were treated with Protopic^Ž in the primary care setting (rather than in an hospital outpatient setting as in this study), then costs would likely be much lower and Protopic^Ž more cost-effective.

"In the current cost-conscious climate, it is reassuring to know that Protopic^Ž is as effective and, despite its high unit cost, is more cost-effective than topical corticosteroids," said Dr Malcolm Rustin, from the Royal Free Hospital, London, UK.

Confirming growing confidence in the use of Protopic^Ž as a well-tolerated, efficacious and steroid-free treatment for AD, new European Union-wide label changes approved by the European Commission will allow prescribing by any physician experienced in the treatment of AD. Prescription of Protopic^Ž in general practice may lead to fewer referrals to dermatologists, which could result in even greater cost savings. Additionally, the European Commission will recommend that in adults, the higher of the two strengths of Protopic^Ž ointment available (Protopic^Ž 0.1%) is used until eczema lesions clear. Until recently, a switch to the lower strength of Protopic^Ž ointment (0.03%) after 3 weeks of treatment was recommended if symptoms persisted. This change is likely to result in even greater long-term control with Protopic^Ž.

Protopic

is a well-tolerated and effective, non-steroidal treatment that provides rapid relief of the signs and symptoms of atopic dermatitis (AD). It can be used to treat AD on all body regions including sensitive areas such as the face and neck. Protopic

works by selectively targeting the underlying immunological imbalance (T-cell overactivity) by local regulation of the immune response. Topical steroids, in contrast, have a more generalised mode of action stimulating or inhibiting gene transcription in a wide range of cells.

Quality of life was measured over 6 months in 972 patients treated with tacrolimus 0.1% compared with hydrocortisone butyrate 0.1% applied to the trunk and extremities and hydrocortisone acetate 1% ointment applied to the neck and head. Using the Dermatology Quality of Life Index (DLQI) and the MOS-36 item short-form health survey (the SF-36 – a generic and well-validated health survey measure), the data show there was a median percentage change on DLQI of –74.3 compared with –69.2 in the tacrolimus- and steroid-treated groups, respectively (i.e., greater improvement in quality of life in the tacrolimus group). The tacrolimus group also showed an improvement in mean scores for both components of the primary outcome measure of the SF-36 (the change between baseline and Month 6 in the physical and mental component summary scores) compared with patients treated with steroids (physical – 3.3 vs 2.3 [p=0.03], and mental – 6.0 vs 3.4 [p=0.0003], respectively).

To evaluate cost-effectiveness, economic modelling was performed on outcomes derived from tacrolimus clinical trials conducted in adults (over 16 years old) with the model covering a 27-week period. In children (aged 2–16 years), efficacy data were obtained from interviews conducted with an expert panel of eight UK dermatologists and covered a 51-week period. This panel also provided data on health resource utilisation.

References

Reitamo S, et al. Quality of life improved in adults with moderate to severe atopic dermatitis treated with 0.1% tacrolimus ointment. Poster presented at the Congress of the European Academy of Dermatology and Venereology, 29 April–1 May 2004, Budapest. Abstract number PS 214

Rustin M, et al. Pharmacoeconomics of 0.1% tacrolimus ointment in adults and children with moderate to severe atopic dermatitis. Poster presented at the Congress of the European Academy of Dermatology and Venereology, 29 April–1 May 2004, Budapest. Abstract number PS 221

Protopic^Ž Summary of Product Characteristics (SPC), May 2004.

SOURCE: Fujisawa GmbH

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