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Soriatane

Clinical Pharmacology
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Clinical Pharmacology

The efficacy variables consisted of: the mean severity rating of scale, lesion thickness, erythema, and the physician's global evaluation of the current status of the disease. Ratings of scaling, erythema, and lesion thickness, and the ratings of the global assessments were made using a seven-point scale (0=none, 1=trace, 2=mild, 3=mild-moderate, 4=moderate, 5=moderate-severe, 6=severe).

A subset of 141 patients from both pivotal studies A and B continued to receive Soriatane in an open fashion for up to 24 weeks. At the end of the treatment period, all efficacy variables, as indicated in Table 2, were significantly improved (p ≤ 0.01) from baseline, including extent of psoriasis, mean ratings of psoriasis severity and physician's global evaluation.

Table 2. Summary of the First Course of Soriatane Therapy (24 Weeks)

Variables Study A Study B
Mean Total Daily Soriatane Dose (mg) 42.8 43.1
Mean Duration of Therapy (Weeks) 21.1 22.6
Physician's Global Evaluation N=39 N=98
Baseline 4.51 4.43
Mean Change From Baseline - 2.26* - 2.60*
Scaling N=59 N=132
Baseline 3.97 4.07
Mean Change From Baseline - 2.15* - 2.42*
Thickness N=59 N=132
Baseline 4.00 4.12
Mean Change From Baseline - 2.44* - 2.66*
Erythema N=59 N=132
Baseline 4.35 4.33
Mean Change From Baseline - 2.31* - 2.29*
* Indicates that the difference from baseline was statistically significant (p ≤ 0.01).

The efficacy variables consisted of: the mean severity rating of scale, lesion thickness, erythema, and the physician's global evaluation of the current status of the disease. Ratings of scaling, erythema, and lesion thickness, and the ratings of the global assessments were made using a seven-point scale (0=none, 1=trace, 2=mild, 3=mild-moderate, 4=moderate, 5=moderate-severe, 6=severe).

All efficacy variables improved significantly in a subset of 55 patients from Study A treated for a second, 6-month maintenance course of therapy (for a total of 12 months of treatment); a small subset of patients (n=4) from Study A continued to improve after a third 6-month course of therapy (for a total of 18 months of treatment).

Brand Name: Soriatane
Generic Name: Acitretin

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