The investigational topical ointment crisaborole improves mild to moderate atopic dermatitis (AD) in both children and adults, according to a study presented here on October 24 at the 2016 American Academy of Pediatrics (AAP) National Conference and Exhibition.
Crisaborole topical ointment (2%) is a non-steroidal anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor.
By selectively inhibiting PDE4, an enzyme that degrades cyclic adenosine monophosphate (cAMP), crisaborole increases intracellular cAMP, thereby suppressing the activity of the pathways responsible for the production of inflammatory cytokines.
Lawrence F. Eichenfield, MD, Rady Children's Hospital, San Diego, California, and colleagues conducted 2 phase 3 clinical studies in patients aged 2 years and older with mild to moderate AD affecting ? 5% of body surface area (BSA).
Study participants were randomised in a 2:1 ratio to treatment with twice-daily crisaborole or vehicle for 28 days.
The primary endpoint was success in the investigator's Static Global Assessment (ISGA), as clear/0 or almost clear/1 with ?2-grade improvement from baseline at day 29.
The intent-to-treat population of studies AD-301 and 302 included 503:256 and 513:250 crisaborole:vehicle patients, respectively. The mean age of the stud population was about 12 years.
Significantly more patients achieved success in ISGA with crisaborole than vehicle at day 29 (P = .038 and P < .001 for studies 301 and 302, respectively), with a greater percentage of clear/0 or almost clear/1 ISGA scores (P = .005 and P < .001).
Significantly more patients treated with crisaborole achieved success in ISGA earlier than those treated with vehicle, determined by Kaplan-Meier analysis (log-rank P < .001).
Crisaborole had a favourable safety profile, and most treatment-related adverse events were mild. Overall, more crisaborole-treated patients (4.4%) reported application site pain than vehicle-treated patients (1.2%). No treatment-emergent serious adverse events were reported in crisaborole-treated patients.
In addition, no clinically meaningful differences were observed between crisaborole- and vehicle-treated patients in vital signs, electrocardiogram, and clinical laboratory parameters.
The rate of study discontinuations because of adverse events was 1.2% in both groups.
Funding for this study was provided by Anacor Pharmaceuticals.
[Presentation title: Phase 3 Studies Treating Children and Adult Patients With Mild to Moderate Atopic Dermatitis With Crisaborole Ointment, a Novel, Nonsteroidal, Topical Anti-Inflammatory, Phosphodiesterase 4 Inhibitor. Abstract 319937]