Pediatric Dermatology

<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background/Objectives</jats:title><jats:p>Efficacy and safety of roflumilast cream 0.15% were demonstrated in patients aged ≥ 6 years with atopic dermatitis (AD) in two Phase 3 trials. This Phase 3 parallel‐group, double‐blind trial (INTEGUMENT‐PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2–5 years with AD.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Patients aged 2–5 years with mild‐to‐moderate AD were treated with once‐daily roflumilast cream 0.05% or vehicle for 4 weeks. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA‐AD) Success (0 [Clear] or 1 [Almost Clear] plus ≥ 2‐grade improvement from baseline) at Week 4. Other endpoints included ≥ 75% improvement in Eczema Area and Severity Index (EASI‐75) and Worst Itch‐Numeric Rating Score (WI‐NRS) Success (≥ 4‐point improvement in patients with baseline ≥ 4). Safety and tolerability were also assessed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Among 437 and 215 patients treated with roflumilast and vehicle, respectively, significantly greater proportions of the roflumilast group achieved Week‐4 vIGA‐AD Success (25.4% vs. 10.7%; <jats:italic>p</jats:italic> &lt; 0.0001), EASI‐75 (39.4% vs. 20.6%; <jats:italic>p</jats:italic> &lt; 0.0001), and WI‐NRS Success (35.3% vs. 18.0%; nominal <jats:italic>p</jats:italic> = 0.0002). Improvement in pruritus was observed within 24 h after the first application (nominal <jats:italic>p</jats:italic> = 0.0014). Treatment‐emergent adverse event (TEAE) rates were low in both groups, and 98.9% were mild or moderate. At all timepoints, stinging/burning that caused definite discomfort was reported by ≤ 0.7% of caregivers of patients in the roflumilast group.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>In this Phase 3 trial, once‐daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2–5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle.</jats:p><jats:p>
<jats:bold>Trial Registration:</jats:bold> <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="http://clinicaltrials.gov">ClinicalTrials.gov</jats:ext-link>: NCT04845620</jats:p></jats:sec>

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Long‐Term Safety and Effectiveness With Roflumilast Cream 0.15% in Patients ≥ 6 Years of Age With Atopic Dermatitis: A Phase 3 Open‐Label Extension Trial

Dermatitis

Efficacy and safety of roflumilast cream 0.15% were demonstrated in patients aged ≥ 6 years with atopic dermatitis (AD) in two Phase 3 trials. This Phase 3 parallel-group, double-blind trial (INTEGUMENT-PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2-5 years with AD.
Patients aged 2-5 years with mild-to-moderate AD were treated with once-daily roflumilast cream 0.05% or vehicle for 4 weeks. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA-AD) Success (0 [Clear] or 1 [Almost Clear] plus ≥ 2-grade improvement from baseline) at Week 4. Other endpoints included ≥ 75% improvement in Eczema Area and Severity Index (EASI-75) and Worst Itch-Numeric Rating Score (WI-NRS) Success (≥ 4-point improvement in patients with baseline ≥ 4). Safety and tolerability were also assessed.
Among 437 and 215 patients treated with roflumilast and vehicle, respectively, significantly greater proportions of the roflumilast group achieved Week-4 vIGA-AD Success (25.4% vs. 10.7%; p < 0.0001), EASI-75 (39.4% vs. 20.6%; p < 0.0001), and WI-NRS Success (35.3% vs. 18.0%; nominal p = 0.0002). Improvement in pruritus was observed within 24 h after the first application (nominal p = 0.0014). Treatment-emergent adverse event (TEAE) rates were low in both groups, and 98.9% were mild or moderate. At all timepoints, stinging/burning that caused definite discomfort was reported by ≤ 0.7% of caregivers of patients in the roflumilast group.
In this Phase 3 trial, once-daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2-5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle.
ClinicalTrials.gov: NCT04845620.

Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial.

Efficacy and Safety of Once‐Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2–5 Years With Mild‐to‐Moderate Atopic Dermatitis (<scp>INTEGUMENT</scp>‐<scp>PED</scp>): A Phase 3 Randomized Controlled Trial

Efficacy and Safety of Once‐Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2–5 Years With Mild‐to‐Moderate Atopic Dermatitis (<scp>INTEGUMENT</scp>‐<scp>PED</scp>): A Phase 3 Randomized Controlled Trial

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