Pimecrolimus cream safe, effective for atopic dermatitis in young children

Using pimecrolimus cream as a first-line treatment for atopic dermatitis in infants spares the need for topical corticosteroids as frequently and appears safe over the long term, according to a study published online March 23 in Pediatrics.

“The efficacy results suggest that pimecrolimus has similar efficacy to topical corticosteroids in a real-world setting, which is noteworthy because pimecrolimus is not currently widely used as first-line therapy for atopic dermatitis, given the perception of lower efficacy than topical corticosteroids,” Dr. Bardur Sigurgeirsson of the University of Iceland, Reykjavik, and his associates said.

The researchers randomized 2,418 infants, between ages 3 and 12 months, to receive either pimecrolimus 1% cream, a noncorticosteroid topical calcineurin inhibitor that selectively suppresses activation of T cells and mast cells, or topical corticosteroids to treat mild to moderate atopic dermatitis affecting at least 5% of body surface area. The 1,205 infants receiving the pimecrolimus cream also received topical corticosteroids to treat short-term disease flares. Corticosteroids used were typically either 1% hydrocortisone or 0.1% hydrocortisone butyrate cream.

Success was defined as a 0 (clear) or 1 (mostly clear) on the Investigator’s Global Assessment scale, which ranges from 0 to 5.

More than half of the patients in both groups experienced cleared symptoms within the first three weeks (52.6% with pimecrolimus and 50.5% with corticosteroids). Five years later, among 1,710 patients still enrolled, 88.7% receiving pimecrolimus and 92.3% receiving corticosteroids had overall success. Facial treatment success was seen in 96.6% of infants in the pimecrolimus group and 97.2% of of those in the corticosteroids group, Dr. Sigurgeirsson and associates reported (Pediatrics 2015 March 23 [doi: 10.1542/peds.2014-1990]).

Those receiving pimecrolimus only required topical corticosteroids for a median 7 days, compared to 178 days in the corticosteroids group over the 5-year period. Just over a third (36%) of pimecrolimus patients never used topical corticosteroids.

Both groups experienced similar rates of adverse events, and neither showed negative effects on children’s humoral or cellular immunity, with similar antibody responses in both groups to routine vaccinations. Both groups also had similar growth rates, the investigators reported.

Using pimecrolimus cream as a first-line treatment for atopic dermatitis in infants spares the need for topical corticosteroids as frequently and appears safe over the long term, according to a study published online March 23 in Pediatrics.

“The efficacy results suggest that pimecrolimus has similar efficacy to topical corticosteroids in a real-world setting, which is noteworthy because pimecrolimus is not currently widely used as first-line therapy for atopic dermatitis, given the perception of lower efficacy than topical corticosteroids,” Dr. Bardur Sigurgeirsson of the University of Iceland, Reykjavik, and his associates said.

The researchers randomized 2,418 infants, between ages 3 and 12 months, to receive either pimecrolimus 1% cream, a noncorticosteroid topical calcineurin inhibitor that selectively suppresses activation of T cells and mast cells, or topical corticosteroids to treat mild to moderate atopic dermatitis affecting at least 5% of body surface area. The 1,205 infants receiving the pimecrolimus cream also received topical corticosteroids to treat short-term disease flares. Corticosteroids used were typically either 1% hydrocortisone or 0.1% hydrocortisone butyrate cream.

Success was defined as a 0 (clear) or 1 (mostly clear) on the Investigator’s Global Assessment scale, which ranges from 0 to 5.

More than half of the patients in both groups experienced cleared symptoms within the first three weeks (52.6% with pimecrolimus and 50.5% with corticosteroids). Five years later, among 1,710 patients still enrolled, 88.7% receiving pimecrolimus and 92.3% receiving corticosteroids had overall success. Facial treatment success was seen in 96.6% of infants in the pimecrolimus group and 97.2% of of those in the corticosteroids group, Dr. Sigurgeirsson and associates reported (Pediatrics 2015 March 23 [doi: 10.1542/peds.2014-1990]).

Those receiving pimecrolimus only required topical corticosteroids for a median 7 days, compared to 178 days in the corticosteroids group over the 5-year period. Just over a third (36%) of pimecrolimus patients never used topical corticosteroids.

Both groups experienced similar rates of adverse events, and neither showed negative effects on children’s humoral or cellular immunity, with similar antibody responses in both groups to routine vaccinations. Both groups also had similar growth rates, the investigators reported.

Using pimecrolimus cream as a first-line treatment for atopic dermatitis in infants spares the need for topical corticosteroids as frequently and appears safe over the long term, according to a study published online March 23 in Pediatrics.

“The efficacy results suggest that pimecrolimus has similar efficacy to topical corticosteroids in a real-world setting, which is noteworthy because pimecrolimus is not currently widely used as first-line therapy for atopic dermatitis, given the perception of lower efficacy than topical corticosteroids,” Dr. Bardur Sigurgeirsson of the University of Iceland, Reykjavik, and his associates said.

The researchers randomized 2,418 infants, between ages 3 and 12 months, to receive either pimecrolimus 1% cream, a noncorticosteroid topical calcineurin inhibitor that selectively suppresses activation of T cells and mast cells, or topical corticosteroids to treat mild to moderate atopic dermatitis affecting at least 5% of body surface area. The 1,205 infants receiving the pimecrolimus cream also received topical corticosteroids to treat short-term disease flares. Corticosteroids used were typically either 1% hydrocortisone or 0.1% hydrocortisone butyrate cream.

Success was defined as a 0 (clear) or 1 (mostly clear) on the Investigator’s Global Assessment scale, which ranges from 0 to 5.

More than half of the patients in both groups experienced cleared symptoms within the first three weeks (52.6% with pimecrolimus and 50.5% with corticosteroids). Five years later, among 1,710 patients still enrolled, 88.7% receiving pimecrolimus and 92.3% receiving corticosteroids had overall success. Facial treatment success was seen in 96.6% of infants in the pimecrolimus group and 97.2% of of those in the corticosteroids group, Dr. Sigurgeirsson and associates reported (Pediatrics 2015 March 23 [doi: 10.1542/peds.2014-1990]).

Those receiving pimecrolimus only required topical corticosteroids for a median 7 days, compared to 178 days in the corticosteroids group over the 5-year period. Just over a third (36%) of pimecrolimus patients never used topical corticosteroids.

Both groups experienced similar rates of adverse events, and neither showed negative effects on children’s humoral or cellular immunity, with similar antibody responses in both groups to routine vaccinations. Both groups also had similar growth rates, the investigators reported.