Acitretin (Page 3 of 10)

CLINICAL STUDIES

In 2 double-blind, placebo-controlled trials, acitretin was administered once daily to subjects with severe psoriasis (e.g., covering at least 10% to 20% of the body surface area). At 8 weeks (see Table 1) subjects treated in Trial A with 50 mg of acitretin per day showed significant improvements (P ≤ 0.05) relative to baseline and to placebo in the physician’s global evaluation and in the mean ratings of severity of psoriasis (scaling, thickness, and erythema). In Trial B, differences from baseline and from placebo were statistically significant (P ≤ 0.05) for all variables at both the 25-mg and 50-mg doses; it should be noted for Trial B that no statistical adjustment for multiplicity was carried out.

Table 1. Summary of the Efficacy Results of the 8-Week Double-Blind Phase of Trials A and B of Acitretin

Efficacy Variables

Trial A

Trial B

Total Daily Dose

Total Daily Dose

Placebo

(N = 29)

50 mg

(N = 29)

Placebo

(N = 72)

25 mg

(N = 74)

50 mg

(N = 71)

Physician’s

Global Evaluation

Baseline

4.62

4.55

4.43

4.37

4.49

Mean Change After 8 Weeks

−0.29

−2.00a

−0.06

−1.06a

−1.57a

Scaling

Baseline

4.10

3.76

3.97

4.11

4.10

Mean Change After 8 Weeks

−0.22

−1.62a

−0.21

−1.50a

−1.78a

Thickness

Baseline

4.10

4.10

4.03

4.11

4.20

Mean Change After 8 Weeks

−0.39

−2.10a

−0.18

−1.43a

−2.11a

Erythema

Baseline

4.21

4.59

4.42

4.24

4.45

Mean Change After 8 Weeks

−0.33

−2.10a

−0.37

−1.12a

−1.65a

a Values were statistically significantly different from placebo and from baseline (P ≤ 0.05). No adjustment for multiplicity was done for Trial B.

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 7-point scale (0 = none, 1 = trace, 2 = mild, 3 = mild-moderate, 4 = moderate, 5 = moderate-severe, 6 = severe).

A subset of 141 subjects from both pivotal Trials A and B continued to receive acitretin 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 Therapy with Acitretin (24 Weeks)

Variables

Trial A

Trial B

Mean Total Daily Dose of Acitretin (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

−2.26a

−2.60a

Scaling

N = 59

N = 132

Baseline

3.97

4.07

Mean Change from Baseline

−2.15a

−2.42a

Thickness

N = 59

N = 132

Baseline

4.00

4.12

Mean Change from Baseline

−2.44a

−2.66a

Erythema

N = 59

N = 132

Baseline

4.35

4.33

Mean Change from Baseline

−2.31a

−2.29a

a 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 7-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 subjects from Trial A treated for a second, 6-month maintenance course of therapy (for a total of 12 months of treatment); a small subset of subjects (n = 4) from Trial A continued to improve after a third 6-month course of therapy (for a total of 18 months of treatment).

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