Roflumilast cream 0.15% addresses unmet needs of adults, children with atopic dermatitis
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Key takeaways:
- More patients treated with roflumilast vs. vehicle achieved a validated IGA-AD score of 0/1.
- More than 95% of roflumilast-treated patients reported no signs of application site irritation.
Roflumilast cream 0.15% showed high efficacy rates among patients aged 6 years and older with mild to moderate atopic dermatitis, according to a study.
“Although the current therapeutic landscape for AD comprises topical steroidal and nonsteroidal medications, unmet treatment needs persist,” Eric L. Simpson, MD, MCR, Frances J. Storrs Medical Dermatology Professor at Oregon Health & Science University, and colleagues wrote.
According to the authors, some of the top unmet needs include a lack of creams over ointments, adherence with medications that require twice-daily dosing, a lack of effective nonsteroidal options and too many application site reactions while using topicals.
In this randomized, phase 3 study, Simpson and colleagues evaluated the efficacy and safety of once-daily roflumilast 0.15% cream, a highly potent, once-daily topical PDE4 inhibitor, for the treatment of mild to moderate AD in patients aged 6 years or older. The primary endpoint was success in validated IGA-AD at week 4, which the authors defined as a score of 0/1 and a 2-grade or more improvement from baseline.
The study included 1,337 patients (mean age, 27.7 years; 56.9% female) — 654 from INTEGUMENT-1 and 683 from INTEGUMENT-2 — that were treated 2:1 with roflumilast 0.15% cream or vehicle once daily for 4 weeks. Patients had a mean body surface area involvement of 13.6% (range, 3%-88%).
Result showed that by the end of the study, more patients treated with roflumilast vs. vehicle achieved the primary endpoint in INTEGUMENT-1 (32% vs. 15.2%, respectively; P < .001). Data from INTEGUMENT-2 were similar, with 28.9% of the roflumilast group reaching this endpoint vs. 12% of the vehicle group (P < .001).
In INTEGUMENT-1, 43.2% of roflumilast-treated patients achieved the secondary endpoint of EASI 75 vs. 22% of the vehicle group by week 4 (P < .001). In INTEGUMENT-2, 42% of the roflumilast group also achieved EASI 75 compared with 19.7% of the vehicle group in the same period (P < .001).
According to investigators, roflumilast was well tolerated with a low incidence of treatment-emergent adverse events, the majority of which were mild to moderate in severity. Four patients experienced serious treatment-emergent adverse events, with one being deemed possibly related to treatment and one as probably related to treatment.
At each time point, more than 95% of roflumilast-treated patients reported no signs of application site irritation.
“The INTEGUMENT-1 and INTEGUMENT-2 phase 3 randomized clinical trials of patients with AD treated with roflumilast cream 0.15% demonstrated improvement across multiple efficacy end points, including reducing pruritus within 24 hours after application, with favorable safety and tolerability,” the authors concluded. “This once-daily nonsteroidal cream addresses several unmet needs in the treatment of AD and thus has the potential to substantially improve treatment.”