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Title: Protopic (Tacrolimus) Appears to Most Effective Treatment for Treating Eczema: Presented at EADV

"Protopic (Tacrolimus) Appears to Most Effective Treatment for Treating Eczema: Presented at EADV"

FLORENCE, ITALY -- November 18, 2004 -- Review of data on topical calcineurin inhibitors (TCIs) confirms their superiority and efficacy in treating atopic dermatitis (AD, atopic eczema). A review of 12 years of data showed that treatment with Protopic® (tacrolimus ointment), the first licensed TCI, avoids the risks associated with long-term steroid use while being significantly more effective in both adults and children than the other commercially available TCI, pimecrolimus (Elidel®, Novartis). These data were presented by Dr Alan B. Fleischer, Jr (Wake Forest University School of Medicine, North Carolina, USA) at the 13th Congress of the European Academy of Dermatology and Venereology (EADV) in Florence, Italy (17-21 November). 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 UK's National Institute for Clinical Excellence also identified these concerns in 2004. "There are a number of myths concerning therapies for atopic dermatitis," explained Dr Fleischer. "TCIs offer distinct advantages over conventional AD therapy and have a unique mode of action, which provides skin-selective treatment that relieves the signs and symptoms of AD. A major advantage is that they can be used for long-term treatment." The presentation also dispelled some myths associated with TCI treatment in AD. Data for both TCIs, Protopic® and pimecrolimus, demonstrate that there is no difference in skin selectivity between the two: both therapies are minimally absorbed following topical application and neither Protopic® nor pimecrolimus accumulate systemically following repeated application.1,2 A theoretical concern that treatment could affect the immune response, including a response to vaccination, has not been substantiated. Clinical studies have demonstrated that Protopic® does not increase the risk of skin infections.3 A study of 26 children who were vaccinated with pneumococcal vaccine after 3 weeks of treatment with Protopic® 0.03% ointment showed that all patients generated a protective antibody response, and this was not affected by Protopic® treatment.4 Recent evidence from three direct comparative studies suggests that the two TCIs have a similar safety profile with a similar low overall incidence of adverse events,5 contrary to some earlier reports from separate studies. The most common application-site adverse events with both Protopic® and pimecrolimus were a burning sensation, erythema, pain and pruritus, the incidences of which were similar for both agents. These randomised investigator-blinded studies also showed that Protopic® 0.1% was significantly more effective than pimecrolimus in all assessments: eczema area and severity index (EASI), itch, investigator's global assessment and percent affected body surface area.5 Protopic® 0.03% was significantly more effective for itch and comparable or better for EASI and percent affected body surface area. In a fourth study in children, more patients were classed as clear or almost clear with Protopic® 0.03% compared with pimecrolimus.6 In conclusion, Dr Fleischer advised, "Extensive clinical experience developed over 12 years shows that Protopic® is significantly more effective in both adults and children than pimecrolimus. This evidence is vital for dermatologists, paediatricians and general physicians across Europe who are committed to help alleviate the misery and hardship of many of their patients - young and old - living with eczema." The prevalence of AD has increased 2-3 fold in the last 30 years. It is estimated to affect between 5 and 20% of children worldwide. Both children and adults suffer from AD. In 70% of cases, disease onset occurs within the first five years of life. AD is now considered to be a major public health problem. 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. Protopic® ointment is available in two strengths containing either 0.03% or 0.1% of tacrolimus. Both ointment formulations are indicated for the treatment of moderate to severe AD in adults who are not adequately responsive to or are intolerant of conventional therapies. The lower strength ointment is indicated for use in children aged 24 months old and above, who have failed to respond adequately to conventional therapies. New European Union-wide label changes approved by the European Commission allow prescribing by any physician experienced in the treatment of AD. Prescription of Protopic® in general practice may lead to fewer referrals to dermatologists. Additionally, the European Commission recommends that in adults, the higher of the two strengths of Protopic® ointment available (Protopic® 0.1%) is used until eczema lesions clear. References: 1. Reitamo S, Wollenberg A, Schopf E, et al. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. Arch Dermatol 2000;136:999-1006. 2. Van Leent EJ, Ebelin ME, Burtin P, Dorobek B, Spuls PI, Bos JD. Low systemic exposure after repeated topical application of pimecrolimus (Elidel), SDZ ASM 981, in patients with atopic dermatitis. Dermatol 2002;204:63-8. 3. Fleischer AB, Jr., Ling M, Eichenfield L, et al. Tacrolimus ointment for the treatment of atopic dermatitis is not associated with an increase in cutaneous infections. J Am Acad Dermatol 2002;47:562-70. 4. Stiehm ER, Roberts RL, Kaplan MS, Corren J, Rico MJ, Parker JC. Tacrolimus ointment does not alter immune responses of eczematous children. American Academy of Allergy, Asthma and Immunology 60th Annual Meeting, Denver, CO, 7-12 March 2003: Abstract 245. 5. Antaya R, Paller A, Duarte A, Kirsner R. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in patients with atopic dermatitis. Society for Pediatric Dermatology, 30th Annual Meeting, Charleston, USA, 17-20 June 2004:Poster presentation. 6. Kempers S, Boguniewicz M, Carter E, et al. A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis. J Am Acad Dermatol 2004;51:515-25. SOURCE: Fujisawa GmbH

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