The Benefits of Crisaborole for the Quality of Life of Patients With Atopic Dermatitis and Their Caregivers

This Thursday, at the 25th European Academy of Dermatology and Venereology Congress in Vienna, 2 presentations focused on the effects of crisaborole topical ointment, 2%, in treating atopic dermatitis (AD). The first presenter, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, professor of pediatrics and medicine (Dermatology) at UC San Diego School of Medicine, director of the Eczema & Inflammatory Disease Center, and the Vascular Lesion & Birthmark Center, discussed the safety profiles of study participants who took crisaborole to treat mild to moderate AD. Later, Amy S Paller, MD, chair, department of dermatology and professor of dermatology and pediatrics (dermatology) at Northwestern University, and director, Northwestern University Skin Disease Research Center, demonstrated the benefits of crisaborole on the quality-of-life (QOL) of patients suffering from AD.

Crisaborole is a novel nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor, the safety and efficacy of which is currently being tested by Eichenfield and Paller and their colleagues for use in long-term treatment. According to Eichenfield, the viability of using a PDE4 inhibitor as a treatment option for AD is validated by the initial studies of PDE4 30 years ago.

“We know that PDE4 is important in the processing of inflammatory cells, and that PDE4 activity was increased in atopic dermatitis,” Eichenfield explained.

Eichenfield presented the findings of a 48-week open label, extension study involving 517 patients with mild to moderate AD. Patients included children and adults from a number of demographic profiles, and were all part of a previous 28-day double-blind, vehicle-controlled pivotal study for safety and efficacy. The Phase 3 study looked for treatment-emergent adverse events (TEAEs) associated with the crisaborole, which was administered every 4 weeks.

The pooled results revealed a low frequency of treatment-related TEAEs across all age groups. Overall, 10.2% of patients reported TEAEs, including atopic dermatitis (3.1%), application site pain (2.3%), and application site infection (1.2%). The severity of these TEAEs was mostly mild (51.2%) or moderate (44.6%).

Continuing Eichenfield’s presentation, Paller later went on to describe how crisaborole could potentially improve the QOL of both patients with AD and their caregivers. Using the patients included in the initial 28-day, double-blind, vehicle-controlled Phase 3 study discussed in Eichenfield’s lecture, QOL evaluations were conducted using 2 common scales: the Children’s Dermatology Life Quality Index for children ages 2-15, and the Dermatology Life Quality Index for persons ages 16 and older. The QOL of family and caregivers of children ages 2-17 was measured using the Dermatitis Family Impact Questionnaire.

The results were encouraging. Patients treated with crisaborole showed greater improvement in QOL than those in the vehicle-controlled groups, as shown by each group’s respective questionnaire.

“If approved, crisaborole may represent a promising new topical atopic dermatitis treatment that could improve quality of life for patients with mild to moderate atopic dermatitis," Paller said.