The BAP00089 study (BACH) was conducted in Europe and Canada, and included 1032 severe CHE patients who had no response or a transient response (initial improvement and worsening of disease despite continued treatment) to potent topical corticosteroids or were intolerant of potent topical corticosteroids. All phenotypes of CHE were included; approximately 30% of patients had hyperkeratotic only CHE, however the majority of patients had multiple phenotypes. Essentially all patients had signs of skin inflammation, comprising of erythema and/or vesicles. Treatment with alitretinoin led to a significantly higher proportion of patients with clear/almost clear hands, compared to placebo. The response was dose dependent (see Table 1).
The terminal half-life of Warfarin after a single dose is approximately 1 week; however, the effective half-life ranges from 20 to 60 hours, with a mean of about 40 hours. The clearance of R-Warfarin is generally half that of S-Warfarin, thus as the volumes of distribution are similar, the half-life of R-Warfarin is longer than that of S-Warfarin. The half-life of R-Warfarin ranges from 37 to 89 hours, while that of S-Warfarin ranges from 21 to 43 hours. Studies with radiolabeled drug have demonstrated that up to 92% of the orally administered dose is recovered in urine. Very little Warfarin is excreted unchanged in urine. Urinary excretion is in the form of metabolites.