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REPORTS on SCIENTIFIC MEETINGS the First Topical REPORTS ON SCIENTIFIC MEETINGS The First Topical Immunomodulator for Atopic Dermatitis reported by Drs. L. S. Ku and W. K. Tang marrow transplantation; and patients with atopic Date: 12 July, 2002 dermatitis develop asthma or allergic rhinitis in later Venue: Sheraton Hotel, Hong Kong life, disorder of the lymphoproliferative system and Organizer: HKSDV, Dept. of Medicine, HKU, The Hong Kong Paediatric Society compartmentalization of immune response have been suggested. Pathogenesis and Epidemiology of Atopic Learning points: Dermatitis Atopic dermatitis is a chronic inflammatory skin Speaker: Dr. H. H. L. Chan disease and there is no cure for it so far. Pro- inflammatory cytokines and IgE play an Atopic dermatitis is a chronic inflammatory skin important role in the pathogenesis of the disease. disease that commonly affects children but without a magic cure so far. The prevalence of this problem varies widely, from 0.3% to 20.5%, in different countries. The exact pathogenesis of atopic dermatitis is Basic Science and Overview of Tacrolimus unknown. But epidemiological, clinical and Speaker: Dr. A. Wollenberg immunological studies give clues to the pathogenesis of the disease. Genetic, immunological, cultural Tacrolimus is a new drug in the class of macrolide. behaviour and environmental factors are considered to It is used as an immunomodulator for the treatment of be important in this disease. Recent studies revealed atopic dermatitis. that there is a biphasic cytokine expression pattern-IL- 4 and IL-13 (TH2's cytokines) for the acute lesions, and Mechanism of action IL-5 and IFN-Alpha (TH1's cytokines) for the chronic Atopic dermatitis is a complex inflammatory lesions in atopic dermatitis. disease. It involves T-cells, Langerhans' cells, mast cells and inflammatory mediators. Tacrolimus acts by first IgE is also found contributory to the pathogenesis binding to calcineurin to form a complex. This complex of atopic dermatitis. It is released from mast cells and eventually inhibits the transcription of pro-inflammatory causes immediate swelling and pruritus of the lesion. cytokines and T-cell proliferation. Tacrolimus was also Infiltration of eosinophils, monocytes, cutaneous found to be able to down-regulate the high affinity IgE antigen presenting cells such as Langerhans' cell and receptor on epidermal dendritic cells, and inhibit the macrophages, which bear IgE receptors on their release of histamine and other inflammatory mediators surfaces, will then follow. This will facilitate allergen from mast cells and basophils. presentation to TH2 cells. Environmental factors, exogenous allergens and bacterial infection may cause and/or aggravate atopic dermatitis. Interestingly, IgE Clinical advantages with tacrolimus antibodies against human cytoplasmic protein from Owing to the large molecular weight (around keratinocytes have also been found. 822KD), tacrolimus can only penetrate into inflamed skin. Studies have shown that there was little or no From the observation that atopic dermatitis absorption into the systemic circulation after repeated develops in Wiskott-Aldrich syndrome and after bone applications to intact skin. The systemic absorption of 138 Hong Kong Dermatology & Venereology Bulletin Scientific Meetings this drug through lesional skin is also minimal and that Clinical Experience of Tacrolimus declines rapidly as the lesions start to heal. Ointment in Japan Speaker: Dr. M. Ohtsuki Another major benefit of this new drug is that it does not affect collagen synthesis and thus does not Tacrolimus is a macrolide derived from cause skin atrophy. The concentration of collagen Streptomyces isolated from a soil sample taken from precursors had been shown to remain unchanged in Mountain Tsukuba in Japan. In 1999, Japan was the tacrolimus treated areas and there was no decrease in first country in the world to launched tacrolimus the skin thickness when compared with topical steroids. ointment as a novel treatment agent for atopic dermatitis. Being a topical immunomodulators, tacrolimus Although tacrolimus by itself is not bactericidal, ointment is the first in a new class of atopic dermatitis the density of colonization of Staphylococcal aureus treatment. After extensive experience from over two was also found to be reduced as the skin condition years of clinical use, its safety was gradually assured improved. and led to the adoption of its long-term use in Japan. High efficacy rates of tacrolimus in the treatment Tacrolimus ointment was developed in Japan, of atopic dermatitis have been shown in multicentre Europe and the US, with more than 12,000 patients trials. Patients usually have significant improvement enrolled into various studies. A two-year open-label non- within the first few days of treatment. And in paediatric comparative Japanese phase III trials for 0.1% patients, 0.03% tacrolimus had been shown to be as tacrolimus ointment in adult atopic dermatitis was effective as that at 0.1%. discussed. Its strength was equal or superior to betamethasone valerate as an anti-inflammatory agent. It had rapid onset of action on eczema over the face and Clinical disadvantages with tacrolimus neck as well as acute and sub-acute lesions over the Local irritation, such as burning sensation, is the trunk. Eczema with severe lichenification or prurigo most common adverse effect with tacrolimus. But it took longer time to resolve. Although all these usually subsides within a few days when the skin heals. symptoms could be improved by long-term tacrolimus Folliculitis might occasionally occur with the ointment application (monotherapy), quicker response was preparation. expected by the preceding use of topical steroid (sequential therapy). It was also recommended that for Tacrolimus cannot be considered as a "cure" for very severe eczema, initial use of potent steroid could atopic dermatitis. It is most efficacious in treating mild alleviate the condition quickly and then followed by to moderate but not severe disease. Continuous tacrolimus therapy. Skin atrophy due to topical steroid treatment is needed to maintain clinical improvement. was improved with long term use of tacrolimus, probably due to its steroid sparing effect. The reduction in irritation and burning was obvious with time. The Learning points: blood concentration of tacrolimus in long term follow Tacrolimus is an immunomodulator belonging up was transient and trivial. The incidence of folliculitis to the macrolide group. It has shown promising was 6.3%, impetigo was 0.3%, superficial fungal results in the treatment of atopic dermatitis at infection was 0.5% and herpes simplex was 1.5%. It no expense of skin atrophy and systemic side was found that the incidence of skin infections markedly effects. decreased in the second year of treatment. Vol.10 No.3, September 2002 139 Scientific Meetings In another controlled double-blinded Japanese 0.03% tacrolimus with 1% hydrocortisone acetate phase III paediatric trial, vehicles, 0.03% and 0.1% ointment. The results showed that both 0.1% and 0.03% tacrolimus ointment were compared. Tacrolimus tacrolimus were significantly more effective than 1% ointment 0.1% and 0.03% were found to be more hydrocortisone acetate ointment. Thirty-nine percent of effective than vehicles and the difference in efficacy children treated with tacrolimus ointment 0.03% showed between 0.1% and 0.03% tacrolimus ointment in excellent improvement (=90%) in disease status or paediatric patients was less marked than in adult studies. clearance compared with 16% of patients in the Tacrolimus ointment provides a beneficial treatment hydrocortisone group (p=0.001). Improvement was seen option to physicians and patients and is one of the most as early as three days after commencement of treatment. important products for long-term atopic dermatitis By week one, tacrolimus 0.03% therapy led to 46% control. As tacrolimus is still a new agent, there is a reduction in pruritus scores, compared with a 33% need for further investigation in its therapeutic role. reduction with hydrocortisone acetate. The differences were more pronounced at the end of treatment, namely 58% and 31% respectively. It was also found out that greater improvement was achieved with tacrolimus Learning points: 0.1% than with 0.03% concentration. Tacrolimus ointment provides a beneficial treatment option to physicians and patients and The speaker remarked that the potency of is one of the important products for long-term tacrolimus was comparable to class III topical steroid atopic dermatitis control. and there was no dose restriction for tacrolimus ointment. Adult patients can be treated with 0.1% tacrolimus twice a day during the acute phase and switch to 0.03% tacrolimus twice a day for maintenance. Paediatric patients should only be treated with 0.03% Clinical Experience of Tacrolimus tacrolimus throughout. The followings are some good Ointment in Europe indications for tacrolimus: the presence of steroid Speaker: Dr. J. Berth-Jones dependence, steroid phobia, steroid allergy, steroid side effects and tachyphylaxis. Sensitive skin regions like Tacrolimus ointment has been approved for the the face are good indications as well. treatment of severe atopic dermatitis in the US, Japan, the European Union, Canada and Switzerland. Clinical In conclusion, tacrolimus ointment is safe and studies involving more than 10,000 patients performed effective for long-term treatment of moderate to during its global development have shown that severe atopic dermatitis. Long-term studies have tacrolimus
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