Crisaborole ointment effective as long-term maintenance therapy for atopic dermatitis

Key takeaways:

• Median time of flare-free maintenance was 111 days in the crisaborole group vs. 30 days in vehicle group.
• Those treated with crisaborole vs. vehicle achieved more days without a flare (234 days vs. 199.4 days).

Once-daily crisaborole ointment 2% may be an effective and well-tolerated long-term maintenance therapy for pediatric and adult patients with mild to moderate atopic dermatitis, according to a study.

“Topical treatments used for AD often fail to achieve lasting disease control,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine, and colleagues wrote. “AD flares occur at variable and unpredictable intervals.”

According to Eichenfield and colleagues, many topical treatments, such as topical corticosteroids, pose safety concerns after prolonged use, leaving patients with limited options to address flares. On the other hand, crisaborole ointment 2% (Eucrisa, Pfizer), a nonsteroidal treatment option for mild to moderate AD, may be effective for long-term maintenance.

In the 8-week, open-label, run-in period of this phase 3 study, crisaborole ointment proved successful for 270 responders in managing AD flares when applied twice daily. As a result, researchers assigned the responders (mean age, 19.9 years; 56.9% female; 41% white) aged at least 3 months from the open-label period to the 52-week, double-blind, maintenance period of the study.

Each patient was randomly assigned to receive either crisaborole or vehicle once daily. If any patient experienced a flare, they were switched from their assigned dosage to twice daily crisaborole for up to 12 weeks. If the flare subsided, the patient returned to their previously assigned treatment.

In the crisaborole group, the median time of flare-free maintenance was 111 days (95% CI, 56-224) compared with 30 days in the vehicle group (95% CI, 28-56). Those treated with crisaborole saw an average of 234 days without a flare, whereas those treated with vehicle saw 199.4 days without a flare, accounting for a difference of 34.6 days (95% CI, 2.53-66.64).

Also, 35.2% of patients in the crisaborole group had only one flare compared with 25.6% of patients in the vehicle group.

According to the study, there was no clear trend in the maintenance of pruritus response between groups until the onset of the first flare.

Crisaborole was well tolerated and the researchers observed no new or unexpected findings during maintenance treatment.

“There is an unmet need for long-term topical treatment options for AD, especially considering the safety concerns and challenges in achieving lasting disease control noted with the current topical treatment options,” Eichenfield and colleagues wrote. “Crisaborole [once-daily] is effective as a long-term maintenance therapy, demonstrating a significant reduction in the incidence of AD-related flares compared to vehicle in pediatric and adult patients with mild-to-moderate AD.”