A recent study assessing the long-term safety of crisaborole ointment found that it was a safe treatment for atopic dermatitis (AD), with a low frequency of treatment-related adverse events (TRAE), according to a study published online in the Journal of the American Academy of Dermatology.
In an open-label study conducted over 48 weeks, researchers evaluated 517 patients age 2 years and older with mild to moderate AD who continued using crisaborole after completing an initial 28-day trial of the treatment.
Overall, 10.2% of patients reported TRAEs. The most often reported TREA was dermatitis atopic, defined as worsening, exacerbation, flare, or flare-up of AD (3.1%). Participants also reported experiencing application-site pain (2.3%) and application-site infection (1.2%). Nine patients discontinued the treatment because of TRAEs (1.7%). In total, 65% of patients reported ≥1 TRAE, although 93.1% were considered unrelated to the treatment, and most were mild (51.2%) or moderate (44.6%). Most patients (77.8%) did not need rescue therapy.
“In this long-term safety study, crisaborole was used predominantly as monotherapy and did not result in cutaneous side effects,” the investigators noted. “These data indicate that crisaborole could be applied as maintenance therapy without unwanted side effects.”
The study did not examine the long-term efficacy of crisaborole.
Eichenfield LF, Call RS, Forsha DW, et al. Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis. J Am Acad Dermatol. 2017;77:641-649.