Crisaborole safe, effective in infants with atopic dermatitis in late-stage study

Crisaborole ointment was well tolerated and effective in treating infants with mild to moderate atopic dermatitis, according to findings published in American Journal of Clinical Dermatology.

“AD affects patients of all ages and is one of the most common, chronic, relapsing childhood dermatoses, impacting 15% to 30% of the pediatric population in the United States,” Joel Schlessinger, MD, of Advanced Skin Research Center in Omaha, Nebraska, and colleagues wrote. “Approximately 60% of patients experience first signs and symptoms before 1 year of age, and disease activity for many persists well into adulthood.”

The multicenter, open-label, single-arm, phase 4 CrisADe CARE 1 study evaluated the safety, efficacy and pharmacokinetics of nonsteroidal phosphodiesterase 4 inhibitor crisaborole ointment 2% (Pfizer) in 137 infants between the ages of 3 months and 24 months who received treatment twice daily for 28 days. While receiving treatment, patients were evaluated at baseline day 1 and days 8, 15, 22 and 29; on days 26 and 57, follow-up occurred by telephone visits.

All-cause treatment-emergent adverse events were reported in 64.2% of patients, with 98.9% rated as mild or moderate. Treatment-related events were reported for 16.1% of patients, with application site pain reported in 3.6% of patients, application site discomfort in 2.9% and erythema in 2.9%.

Crisaborole ointment was well tolerated and effective in treating infants with mild to moderate atopic dermatitis, according to findings published in American Journal of Clinical Dermatology.

Investigator’s Static Global Assessment success of clear or almost clear atopic dermatitis with an improvement of two grades or more was achieved by 20% of patients at day 8 and 30.2% of patients at day 29.

Additionally, improvements in sleep and itch were sustained through the entirety of the study.

Regarding pharmacokinetics, “crisaborole exposure was comparable with that in patients aged 2 years [and older] observed in previous studies,” the study said.

“Safety and efficacy were consistent with that observed in previous studies of crisaborole in patients aged 2 years [and older],” the researchers wrote. “Overall, the results of this study show that crisaborole may be a safe and efficacious treatment option for infants aged 3 to [younger than] 24 months.” – by Kate Burba

Disclosures: Schlessinger reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.