Roflumilast may improve atopic dermatitis symptoms, pruritus

Key takeaways:

• Safety and tolerability were similar in both treatment groups.
• Roflumilast showed significant improvement across all test measures.

BOSTON — Roflumilast cream improved signs and symptoms of atopic dermatitis, according to a presentation at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.

“Atopic dermatitis is the most common chronic inflammatory skin condition on the planet,” Mark Boguniewicz, MD, allergist-immunologist at National Jewish Health in Denver, said during his presentation.

“It’s so much more than just this inflammatory itchy skin condition that patients are suffering and, by extension, their family members, caregivers. It is negatively impacting the quality of life,” Boguniewicz said.

Roflumilast is a phosphodiesterase 4 inhibitor, and the 0.15% cream was recently approved for patients aged 6 years or older with mild to moderate AD.

This study included two identically designed parallel phase 3 multicenter trials. Eligible patients had a diagnosis of mild to moderate AD and had to be aged 6 years or older. They also had to have body surface area involvement of 3% or greater and an eczema severity grade of 5 or greater.

Patients were randomly assigned in a 2:1 ratio to either a once-daily roflumilast cream 0.15% (n = 884; mean age, 27.9 years; 59.3% female; 59.8% white) or vehicle (n = 453; mean age, 27.3 years; 60% female; 58.9% white). The primary endpoint of the study was the validated Investigator Global Assessment for AD (vIGA-AD) success, defined as a score of a 0 (clear) or 1 (almost clear) and at least a two-grade improvement from baseline at week 4.

Other endpoints included the Worst-Itch Numeric Rating Scale (WI-NRS), SCORing AD (SCORAD), Patient-Oriented Eczema Measure (POEM) and Dermatitis Family Impact (DFI) in patients aged 17 years or older. Percentages of patients who achieved 75% improvements in their Eczema Area and Severity Index (EASI 75) scores were assessed as well. The safety and tolerability of roflumilast were also tested.

Patients taking roflumilast vs. vehicle had higher proportions who achieved vIGA-AD success (31.3% vs. 14.1%), vIGA-AD scores of either 0 or 1 (41.1% vs. 21.4%), EASI 75 (42.7% vs. 20.6%) and WI-NRS success (31.9% vs. 16.6%; P < .0001 for all).

Improvement of pruritus from baseline after 1 day of roflumilast treatment showed a significant change in daily WI-NRS score compared with the vehicle group (P < .0001). The proportion of roflumilast patients achieving a WI-NRS score of 0 or 1 was also higher vs. the vehicle group (28.8% vs. 18.5%, respectively; P .01).

SCORAD scores were significantly improved for patients taking roflumilast vs. vehicle by week 1 (29.7% vs. 14.1%), week 2 (39.6% vs. 23.4%) and week 3 (46.2% vs. 26.6%; P < .0001 for all).

POEM scores showed higher least squares mean improvement in the roflumilast group compared with the vehicle group in week 1 (5.8 vs. 2.3), week 2 (7.2 vs. 3.6) and week 4 (7.5 vs. 3.9; P < .0001 for all).

DFI scores also showed improvements in least square means in roflumilast patients at week 1 (2.49 vs. 1.46; P = .0003), week 2 (3.04 vs. 1.82; P = .0001) and week 4 (3.12 vs. 1.74; P < .0001) compared with vehicle patients.

Safety and tolerability were similar in both treatment groups. Treatment-related treatment-emergent adverse events occurred in 6% (n = 53) of roflumilast patients and 2.7% (n = 12) of vehicle patients. A treatment-emergent adverse events that led to discontinuation of the trial happened in 1.6% (n = 14) of roflumilast patients and 1.1% (n = 5) of vehicle patients. Across both treatment groups, more than 95% of patients had no signs of irritation, and more than 90% reported no or mild sensation.

“Once daily nonsteroidal roflumilast cream 0.15% provided meaningful improvements in signs and symptoms of atopic dermatitis, including improvement in pruritus within 24 hours of application,” Boguniewicz said.

“The cream also improved the impact of AD on patients, families and patient-reported measures,” he continued. “It was well tolerated with low rates of discontinuation because of adverse events occurring in both groups, and local tolerability was generally like that of patients treated with the vehicle.”