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):