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Efficacy and Safety Profile of Basilea's Alitretinoin for Severe,Refractory Chronic Hand Eczema Confirmed by Data Shown at European,Dermatology Congress

clinical studies with an adverse event profile typical of the retinoid drug class.

Patients with CHE often relapse, however, approximately 70% of patients treated with alitretinoin in the BACH trial remained relapse free, as defined in the protocol, during a six month post-treatment observation period without any form of maintenance treatment.

Basilea's re-treatment study (280) demonstrated that those patients with disease recurrence remained responsive to another course of alitretinoin treatment with a response rate of 80% in the 30mg group. The primary and secondary efficacy endpoints were consistent with previously reported primary treatment studies and repeated treatment courses of alitretinoin were generally well tolerated.

An open-label study (281) provided further safety data confirming that in patients with severe refractory CHE, exposure to alitretinoin 30mg beyond six months is well tolerated.

Summary of Poster Presentations

P275 / Efficacy and safety of alitretinoin in severe refractory chronic hand eczema. Ruzicka T, Gupta A, Jemec G, Gerlach B, Maares J, Wevelsiep L.

P280 / Re-treatment study of alitretinoin (9-cis retinoic acid) in severe chronic hand eczema refractory to topical treatment. Ruzicka T, Lahfa M, Lynde Ch, Coenraads PJ, Harsch M, Maares J.

P281 / An open label study of the safety and efficacy of alitretinoin in severe refractory chronic hand eczema. Diepgen T, Maleszka R, Bissonnette R, Augustin M, Harsch M, Brown T.

P286 / Alitretinoin (BAL4079; 9-cis retinoic acid): Pharmacokinetic interactions between aitretinoin, ketoconazole, simvastatin and cyclosporine A. Schmitt-Hoffmann A, Roos B, Baumgaertner E, Maares J.

P287 / Alitretinoin (BAL4079; 9-cis retinoic acid): Pharmacokinetics after single and repeated oral dosing of 20 and 40mg in healthy volunteers. Schmitt-Hoffman A, Roos B, Brown T, Meyer I.

P288 / Alitretinoin (BAL4079; 9-cis retinoic acid): Pharmacokinetics
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