Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT
Arcutis Biotherapeutics — American Academy of Dermatology Annual Meeting 2024
16 slides from Arcutis Biotherapeutics's conference presentation, March 2024
Slide 1: Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients 2 to 5 (INTEGUMENT-PED)
Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients 2 to 5 Years of Age with Mild to Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial Lawrence Eichenfield,1 John Browning,2 Tracy Funk,3 Mercedes E. Gonzalez,4 Adelaide A. Hebert,5 Mark Lee
Slide 2: Introduction
Copyright ARCUTIS 2022 Introduction • Current topical atopic dermatitis (AD) treatments are limited by dosing frequency, local tolerability issues, restrictions on application to the face/eyelids, use on large body surface areas, and use long-term • Topical roflumilast, a potent PDE4 inhibitor, is f
Slide 3: Study Design
Study Design INTEGUMENT-PED: Phase 3 multicenter trial Endpoints 2:1 Primary Roflumilast cream • vIGA-AD Success at Week 4 0.05% QD Eligibility Key Secondary n=437 Randomized • Age 2-5 years • vIGA-AD = Clear (0) or Almost Clear (1) at Weeks • vIGA-AD score 2 or 3 1, 2, 4 • vIGA-AD Success at Weeks
Slide 4: Baseline Demographics
Baseline Demographics ITT population Roflumilast 0.05% Vehicle (n=436) (n=215) Age in years, mean (SD) 3.3 (1.1) 3.2 (1.1) Male, n (%) 225 (51.6) 116 (54.0) Race, n (%) Asian 37 (8.5) 17 (7.9) Black or African American 68 (15.6) 32 (14.9) White 294 (67.4) 156 (72.6) Other or More than 1 race 37 (8.5
Slide 5: Baseline Demographics (cont'd)
Baseline Demographics (cont’d) ITT population Roflumilast 0.05% Vehicle n (%) (n=436) (n=215) Key body areas involved Face 226 (51.8) 119 (55.3) Eyelids 90 (20.6) 51 (23.7) Prior inadequate response, intolerance, or contraindication to: Topical corticosteroids 226 (51.8) 114 (53.0) Topical calcineur
Slide 6: Baseline Disease Characteristics
Baseline Disease Characteristics ITT population Roflumilast 0.05% Vehicle (n=436) (n=215) Baseline vIGA-AD, n (%) 2 (mild) 99 (22.7) 43 (20.0) 3 (moderate) 337 (77.3) 172 (80.0) EASI Mean (SD) 12.2 (6.9) 11.6 (6.2) Median (min, max) 10.2 (4.6, 42.0) 9.5 (5.0, 32.9) BSA Mean (SD) 22.5 (16.4) 21.2 (15
Slide 7: vIGA-AD Success
vIGA-AD Success ITT: intent-to-treat population vIGA-AD Success = Clear or Almost Clear with at least a 2-grade improvement from baseline 7 CI: confidence interval; vIGA-AD: Validated Investigator Global Assessment for Atopic Dermatitis PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING
Slide 8: vIGA-AD Clear or Almost Clear
vIGA-AD Clear or Almost Clear 8 CI: confidence interval; vIGA-AD: Validated Investigator Global Assessment for Atopic Dermatitis PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING, MARCH 8–12, 2024, SAN DIEGO, CA, USA
Slide 9: EASI-75
EASI-75 9 CI: confidence interval; EASI-75: 75% reduction in EASI score from baseline PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING, MARCH 8–12, 2024, SAN DIEGO, CA, USA
Slide 10: WI-NRS Success
WI-NRS Success WI-NRS Success = ≥4-point reduction in weekly average WI-NRS score with WI-NRS ≥4 at baseline 10 CI: confidence interval; WI-NRS: Worst Itch Numerical Rating Scale PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING, MARCH 8–12, 2024, SAN DIEGO, CA, USA
Slide 11: LS Mean Change from Baseline in Daily WI-NRS Score
LS Mean Change from Baseline in Daily WI-NRS Score† †Evaluated in all patients, not just those with baseline WI-NRS ≥4 11 CfB: change from baseline; LS: least squares; SE: standard error; WI-NRS: Worst Itch Numerical Rating Scale PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING, MARCH
Slide 12: Treatment with Roflumilast Cream 0.05% Once Daily
Treatment with Roflumilast Cream 0.05% Once Daily Baseline Week 1 Week 4 vIGA-AD=3 vIGA-AD=1 vIGA-AD=1 EASI=24.6 EASI=2.6 EASI=1.3 BSA=39.0% BSA=35.5% BSA=7.0% WI-NRS=5 WI-NRS=5 WI-NRS=0 3-year-old White Male, Hispanic or Latino BSA: body surface area; EASI: Eczema Area and Severity Index; QD: once
Slide 13: Treatment with Roflumilast Cream 0.05% Once Daily
Treatment with Roflumilast Cream 0.05% Once Daily Baseline Week 1 Week 4 vIGA-AD=3 vIGA-AD=3 vIGA-AD=1 EASI=11.4 EASI=9.0 EASI=0.2 BSA=28.0% BSA=16.0% BSA=2.0% WI-NRS=8 WI-NRS=3 WI-NRS=1 3-year-old White Female, Hispanic or Latino BSA: body surface area; EASI: Eczema Area and Severity Index; QD: onc
Slide 14: Safety
Safety Roflumilast 0.05% Vehicle n (%) (n=437) (n=215) Patients with at least one TEAE 130 (29.7) 47 (21.9) Patients with any treatment-related TEAE 15 (3.4) 6 (2.8) Patients with at least one treatment-emergent serious AE† 1 (0.2) 0 Patients with at least one TEAE leading to IP discontinuation†† 5
Slide 15: Investigator and Patient-Rated Local Tolerability
Investigator and Patient-Rated Local Tolerability 59 (9%) of patients reported prior inadequate response, intolerance, or contraindication to crisaborole 35 of the 59 patients reported stinging, burning, and/or poor tolerability as a reason for stopping crisaborole 2 of 21 roflumilast-treated and 2
Slide 16: Conclusions
Conclusions • Once-daily, nonsteroidal roflumilast cream 0.05% significantly improved AD in children 2-5 years of age • Significant improvement in AD was observed as early as 1 week after treatment initiation • Reduction in pruritus was observed 24 hours (P=0.0014) following the first application •
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