100302 - Improvement in Atopic Dermatitis Signs and Symptoms With Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.15% or 0.05%: 52-Week Phase 3 INTEGUMENT-OLE Trial Outcomes in Patients Aged ≥2 Years

Roflumilast cream 0.15% and 0.05% demonstrated efficacy and safety in patients aged ≥6-years and 2–5 years, respectively, with mild-to-moderate atopic dermatitis (AD) in randomized, vehicle-controlled, 4-week, phase 3 trials (INTEGUMENT-1/2 and INTEGUMENT-PED).  

Patients completing INTEGUMENT-1/2 or INTEGUMENT-PED could enroll in a phase 3, open-label extension trial (INTEGUMENT-OLE/NCT04804605). Roflumilast cream 0.15% (≥6 years) or 0.05% (2–5 years) was applied once daily for ≤52 weeks. Patients achieving Validated Investigator Global Assessment for AD (vIGA AD) 0 (clear) at/after OLE week 4 transitioned to twice-weekly (BIW) application, which was continued as long as ‘disease control’ (vIGA-AD 0/1 [clear/almost clear] and adequate AD sign/symptom control) was maintained. Efficacy endpoints, assessed from parent-study baseline, included vIGA-AD 0/1, Worst Itch-Numeric Rating Scale (WI NRS) 0/1 (no/minimal itch in patients with baseline score ≥2) and success (≥4-point improvement in patients with baseline score ≥4), and mean body surface area affected (BSA). Safety and application-site tolerability were also assessed.

Among 658 patients from INTEGUMENT-1/2 and 562 from INTEGUMENT-PED, week-52 rates for vIGA-AD 0/1 were 55.7% (117/210) and 63.1% (234/371); WI-NRS 0/1 were 41.4% (53/128) and 40.7% (116/285); and WI-NRS success were 55.3% (57/103) and 60.7% (148/244). In addition, mean BSA decreased from baseline to week 52 (14.8% to 3.7%; 22.3% to 4.9%). At/after OLE week 4, 19.8% (130/658) of patients from INTEGUMENT-1/2 and 30.2% (170/562) from INTEGUMENT-PED transitioned to BIW application and had median durations of ‘disease control’ of 281 and 238 days, respectively (Kaplan-Meier estimates). Application-site dermatitis and pain AEs, respectively, were reported for 0.8% and 0.5% of patients from INTEGUMENT-1/2, and 0.7% and 0.5% of patients from INTEGUMENT-PED. During any OLE visit, 0.4%–2.1% of patients and 0.4%–1.8% of caregivers, respectively, reported stinging and/or burning that caused definite discomfort.

In patients aged ≥2 years, roflumilast cream decreased AD signs/symptoms, including BSA, and maintained improvements during long-term treatment. Proactive BIW application maintained ’disease control’ for >200 days. Roflumilast cream was well tolerated and is an appropriate alternative to topical corticosteroids and calcineurin inhibitors for AD treatment.