Pimecrolimus (
SDZ ASM 981), an
ascomycin derivative, is a nonsteroid, has anti-inflammatory activity, and has demonstrated efficacy in reducing symptoms of
atopic dermatitis in adult and paediatric patients when applied topically. Compared with vehicle, topical
pimecrolimus 1.0% cream was significantly more effective at reducing symptoms of
atopic dermatitis, as measured by the
Eczema Area and Severity Index (EASI), in infants aged 3 to 23 months, children aged 2 to 17 years and adults. The median reductions from baseline in the total EASI score in adults
after treatment with
pimecrolimus 1.0% or corresponding vehicle twice daily for 3 weeks were 47 and 0%, respectively. In infants and children, treatment with
pimecrolimus 1.0% twice daily for 6 weeks resulted in significant decreases in mean EASI scores compared with vehicle. The severity of
pruritus was significantly reduced in patients of all age groups after topical treatment with
pimecrolimus 1.0% cream. Compared with vehicle, the incidence of eczematous flares was also reduced by intermittent long-term use of topical
pimecrolimus 1.0% in adults, children and infants. Sixty percent of children treated with
pimecrolimus for 1 year completed the first 6 months of treatment without experiencing a flare, compared with 35% of patients who received vehicle. Furthermore, the use of topical
corticosteroids for the treatment of uncontrolled flares in adults, children and infants was lower in the
pimecrolimus groups than in the vehicle groups. Topical
pimecrolimus 1.0% cream is well tolerated in
atopic dermatitis patients of all age groups. There were no clinically relevant systemic adverse events reported from any of the studies in patients with
atopic dermatitis. The most frequently reported adverse events pertained to application site reactions, such as burning and a feeling of warmth. In conclusion, topical
pimecrolimus 1.0% cream has shown efficacy in the treatment of mild to moderate
atopic dermatitis in infants, children and adults. Although tolerability data concerning infants and children have not yet been published in full, the
drug appears to be well tolerated in all age groups, and there have been no reports of clinically relevant systemic adverse events. Furthermore,
pimecrolimus 1.0% cream has shown no potential for skin
atrophy, a problem commonly associated with treatment with topical
corticosteroids.
Pimecrolimus 1.0% cream provides a promising and well tolerated treatment option in the management of infants, children and adults with mild to moderate
atopic dermatitis.