Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics (2008)

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Schmitt-Hoffmann, A.H. et al.

A.H. Schmitt-Hoffmann, B. Roos, J. Sauer, J. Spickermann, K. Stoeckel, D. Edwards, J. van de Wetering, P.J. Coenraads, J. Maares,

Pharmacokinetics, efficacy and safety of alitretinoin in moderate or severe chronic hand eczema.

BACKGROUND: Recent studies have found that alitretinoin can induce clinically significant responses in subjects with severe chronic hand eczema (CHE) unresponsive to topical corticosteroids. AIMS: To assess the pharmacokinetics (PK), efficacy and safety of alitretinoin 10 or 30 mg once daily. METHODS: This was a randomized, double-blind study, which enrolled 32 subjects aged 18-75 years with CHE unresponsive to potent topical corticosteroids. Subjects received alitretinoin 10 mg (n = 16) or 30 mg (n = 16) once daily for 12 or 24 weeks. Standard PK variables [area under the curve (AUC) of plasma concentration vs. time, maximum plasma concentration (C(max)), time to maximum plasma concentration (t(max)), elimination half-life (t(1/2)), total systemic clearance (CL/F) and volume of distribution (Vd/F)] were determined for alitretinoin and metabolites. Efficacy was assessed using the Physician's Global Assessment (PGA) scale. RESULTS: Chronic administration of alitretinoin for up to 24 weeks did not result in accumulation or time-dependent changes in the disposition of alitretinoin. Exposure was found to be proportional to dose. Systemic exposure (AUC) to alitretinoin was proportional to dose for 10 and 30 mg alitretinoin; 62.8% of subjects achieved clear/almost clear hands in the 30 mg group and 12.5% in the 10 mg group. Alitretinoin was well tolerated. CONCLUSIONS: Chronic administration of alitretinoin for 12-24 weeks did not lead to accumulation or time-dependent changes in drug exposure. Alitretinoin was effective and well tolerated in the treatment of subjects with moderate or severe CHE unresponsive to potent topical corticosteroids.[1]

References

Pharmacokinetics, efficacy and safety of alitretinoin in moderate or severe chronic hand eczema. Schmitt-Hoffmann, A.H., Roos, B., Sauer, J., Spickermann, J., Stoeckel, K., Edwards, D., van de Wetering, J., Coenraads, P.J., Maares, J. Clin. Exp. Dermatol. (2011) [Pubmed]

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