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The Pharmaceutical Journal Vol 267 No 7172 p633-638
3 November 2001

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Tacrolimus ointment shows promising results in improving atopic eczema

Tacrolimus ointment shows similar efficacy to the topical steroid hydrocortisone-17-butyrate ointment 0.1 per cent in adult atopic eczema, a study shows.

The study was presented on behalf of Fujisawa, manufacturer of tacrolimus, at the 10th annual congress of the European Academy of Dermatology and Venereology in Munich recently. A second study demonstrated that tacrolimus ointment is more effective than the standard treatment of hydrocortisone acetate ointment 1 per cent in paediatric eczema.

The phase III, randomised parallel-group study of 570 adults with moderate to severe atopic eczema showed that tacrolimus ointment 0.1 per cent achieved improvement rated as "excellent or clearance" (>90 per cent improvement) in 50 per cent of patients after three weeks. This matched the improvement achieved in patients randomised to hydrocortisone-17-butyrate ointment 0.1 per cent. The most common adverse event with tacrolimus — local irritation — generally resolved after a few days.

In the paediatric study, 560 children aged two to 15 years with moderate to severe atopic eczema were randomised to receive tacrolimus ointment (0.03 per cent or 0.1 per cent) or hydrocortisone acetate ointment 1 per cent. Results showed excellent improvement or clearance (>90 per cent improvement) in 38.5 per cent of patients treated with tacrolimus ointment 0.03 per cent, compared with 48.4 per cent of those using tacrolimus 0.1 per cent. Of the children randomised to receive hydrocortisone acetate, 15.7 per cent showed this level of improvement.

Dr Malcolm Rustin, consultant dermatologist, Royal Free Hospital, London, said: "Tacrolimus ointment represents ... an alternative to potent corticosteroids. Because it does not cause skin thinning, it is suitable for the treatment of atopic eczema on sensitive areas such as the face and neck." He added: "In the adult study, a clinical response was apparent with tacrolimus as early as three days after the start of treatment, with improvement continuing until the end of the treatment period of three weeks."

Tacrolimus works by inhibiting the production of cytokines produced in response to allergens. Studies have shown that it is particularly effective in reducing the inflammation mediated by T helper 1 cells occurring in superimposed infections in chronic atopic eczema skin lesions.

Tacrolimus ointment is expected to become available in the United Kingdon next year. — Contributed.

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