Download with Tacrolimus Clinical Experience Ointment in Atopic Dermatitis III

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Efficacy of Tacrolimus Ointment in Children
(Fig. 9.3). Both strengths of tacrolimus ointment proved significantly more effective
than hydrocortisone acetate 1%, with a mean improvement from baseline of approximately 50% with 0.03% tacrolimus ointment, 60% with 0.1% tacrolimus ointment,
and 36% with the corticosteroid (p<0.001). The higher-strength 0.1% tacrolimus
ointment was significantly more effective than the lower-strength 0.03% formulation
(p=0.006). A similar degree of superiority was observed when the face and neck
region was considered independently.
The findings for mEASI AUC were matched by results for the physician’s global
evaluation of clinical response, which also indicated a stronger therapeutic response
with tacrolimus ointment treatment than with standard corticosteroid-based therapy (Fig. 9.4). In total, 62.6% of patients treated with 0.03% tacrolimus ointment and
73.9% of patients treated with 0.1% tacrolimus achieved a global improvement of at
least 75% in the 3-week trial, compared with 32.4% of corticosteroid-treated patients.
Similarly, the percentage of BSA affected by atopic dermatitis was reduced to a
greater degree in the tacrolimus ointment groups than in the group treated with the
corticosteroid. The mean percentage decrease in the percent affected BSA was 30.5%
for the hydrocortisone acetate group, 56.9% for the 0.03% tacrolimus group, and 67%
for the 0.1% tacrolimus group (Fig. 9.5). At baseline, the median percentage affected
BSA ranged from 23.3% to 26.0%. After 3 weeks, a median reduction of 6.7% in to-
Cleared (100% improvement)
Excellent (90%–99% improvement)
Marked (75%–89% improvement)
Moderate (50%–74% improvement)
Patients (%)
1% hydrocortisone
0.03% tacrolimus
0.1% tacrolimus
Figure 9.4. Comparison with corticosteroids: physician’s global assessment of improvement