Download with Tacrolimus Clinical Experience Ointment in Atopic Dermatitis III

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Clinical Efficacy of Topical Tacrolimus
Oedema
Erythema Excoriation Lichenisation Oozing
Scaling
0
Change in score
-0.2
*
-0.4
*
-0.6
-0.8
*
-1.0
*
*
*
*
**
*
*
**
*
Vehicle
0.03% tacrolimus ointment
0.1% tacrolimus ointment
-1.2
*
*
**
Figure 8.3. Vehicle-controlled 12-week studies: reduction in scores for individual signs and symptoms
of atopic dermatitis. *p <0.001 vs. vehicle; **p =0.001 vs. 0.03% tacrolimus ointment
Rate of Healing
The rate of healing in both tacrolimus ointment groups was rapid. Significant improvements in the EASI score were observed as early as week 1. Thereafter, the median EASI score continued to decrease throughout the study and in both groups was
statistically significantly greater than that achieved with vehicle at the end of treatment (p<0.001), (Fig. 8.4). Similarly, pruritus was controlled rapidly and this was
sustained until the end of treatment (Fig. 8.5).
Efficacy in Different Patient Populations
As described above, both vehicle-controlled studies conducted in the U.S. included
an ethnically diverse patient base, comprising approximately 25% African-Americans and 5% Asian-Americans in addition to the Caucasian majority. Tacrolimus
ointment was effective and well tolerated in patients regardless of their ethnicity,
indicating that it can be used with confidence in patients irrespective of their ethnic
background. Tacrolimus ointment was also equally effective in both men and
women, and in young, middle-aged and elderly adults.
139
The rate of healing in both
tacrolimus ointment
groups was rapid
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