Crisaborole topical ointment 2% has a good safety profile when used as a long-term treatment for patients as young as 2 years of age who have mild-to-moderate atopic dermatitis, according to results of an open-label extension study presented at the 2016 American Academy of Pediatrics (AAP) National Conference and Exhibition.
During the extension and pivotal studies of crisaborole, 65% of patients experienced more than 1 treatment-emergent adverse event, but most of these were mild or moderate, noted lead author Lawrence F. Eichenfield, MD, Rady Children's Hospital, San Diego, California, speaking here on October 24.
After completing either of 2 separate, 28-day phase 3 pivotal studies, Dr. Eichenfield and colleagues enrolled 517 patients (mean age 11.7 years) who opted to continue treatment in a multicentre, open-label, 48-week safety study. The researchers assessed these patients every 4 weeks for the severity of their atopic dermatitis using the Investigator's Static Global Assessment (ISGA) scale, and all were treated as needed with 4-week cycles of crisaborole. Investigators initiated each on-treatment period based on severity (ISGA ?2 [mild]).
Treatment-emergent adverse events (TEAEs) occurring in at least 5% of patients included atopic dermatitis (11.2%), upper respiratory-tract infection (10.3%), nasopharyngitis (7.7%), cough (6.8%), and pyrexia (5.6%).
In all, 54 patients (10.2%) reported TEAEs: 32 patients aged 2 to 11 years (10.4%), 16 patients aged 12 to 17 years (11%), and 6 patients aged 18 years or older (9.5%).
TEAEs reported by 1% or more of patients included atopic dermatitis (3.1%), application-site pain (2.3%), and application-site infection (1.2%).
There were no cutaneous adverse reactions such as application-site atrophy and telangiectasia.
Overall, 7 serious TEAEs were reported, none of which was considered related to treatment. Thirty-three patients (6.4%) interrupted or discontinued treatment because of TEAEs. Nine patients (1.7%) withdrew from the extension study because of TEAEs.
The investigators felt that the analysis of the frequency and severity of TEAEs over 4 consecutive 12-week treatment periods was well balanced, demonstrating a favourable safety profile for long-term crisaborole treatment.
Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting children and adults. Approximately 85% of patients develop AD by age 5 years, and long-term topical treatment is often required. Pharmacologic topical therapies are central to the treatment of AD, but have changed little over the past 15 years, Dr. Eichenfield observed. The primary therapies -- topical corticosteroids and topical calcineurin inhibitors -- are both associated with long-term safety concerns.
Crisaborole is an investigational non-steroidal anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor.
Funding for this study was provided by Anacor Pharmaceuticals, Palo Alto, California.
[Presentation title: Long-term Safety of Crisaborole, a Novel, Nonsteroidal, Topical, Anti-inflammatory, Phosphodiesterase 4 Inhibitor in Children and Adults with Mild to Moderate Atopic Dermatitis. Abstract 319934]