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Arcutis Presents Positive Patient-Reported Outcome Data for ZORYVE® (Roflumilast) Cream 0.15% in Atopic Dermatitis at American College of Allergy, Asthma and Immunology 2024 Annual Scientific Meeting

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Arcutis Biotherapeutics (ARQT) presented new patient-reported outcome data for ZORYVE® cream 0.15% in treating atopic dermatitis at ACAAI 2024. The Phase 3 INTEGUMENT-1 and -2 trials showed significant improvements across multiple metrics: 64.2% of ZORYVE-treated patients achieved meaningful improvement in SCORAD Total Score vs 36.3% for vehicle at Week 1, and 61.7% showed improvement in POEM scores vs 34.2% for vehicle. The treatment met its primary efficacy endpoint with 31.3% achieving Investigator Global Assessment Success vs 14.1% for vehicle, demonstrating rapid improvement in disease clearance, itch reduction, and quality of life measures for patients and caregivers.

Arcutis Biotherapeutics (ARQT) ha presentato nuovi dati sui risultati riferiti dai pazienti per la crema ZORYVE® 0.15% nel trattamento della dermatite atopica all'ACAAI 2024. Gli studi di Fase 3 INTEGUMENT-1 e -2 hanno mostrato miglioramenti significativi su più metriche: 64.2% dei pazienti trattati con ZORYVE ha ottenuto un miglioramento significativo nel punteggio totale SCORAD rispetto al 36.3% per il veicolo alla Settimana 1, e 61.7% ha mostrato miglioramenti nei punteggi POEM rispetto al 34.2% per il veicolo. Il trattamento ha raggiunto il suo obiettivo primario di efficacia con un 31.3% che ha ottenuto successo nella valutazione globale dell'investigatore contro il 14.1% per il veicolo, dimostrando un rapido miglioramento nella clearance della malattia, nella riduzione del prurito e nelle misure della qualità della vita per i pazienti e i caregiver.

Arcutis Biotherapeutics (ARQT) presentó nuevos datos sobre los resultados informados por los pacientes para la crema ZORYVE® 0.15% en el tratamiento de la dermatitis atópica en el ACAAI 2024. Los ensayos de Fase 3 INTEGUMENT-1 y -2 mostraron mejoras significativas en múltiples métricas: 64.2% de los pacientes tratados con ZORYVE lograron una mejora significativa en la puntuación total del SCORAD frente al 36.3% del vehículo en la Semana 1, y 61.7% mostró mejoras en los puntuajes POEM frente al 34.2% del vehículo. El tratamiento cumplió con su objetivo primario de eficacia con un 31.3% que logró el éxito en la evaluación global del investigador frente al 14.1% para el vehículo, demostrando una rápida mejora en la eliminación de la enfermedad, la reducción de la picazón y las medidas de calidad de vida para los pacientes y cuidadores.

Arcutis Biotherapeutics (ARQT)는 2024 ACAAI에서 아토피 피부염 치료를 위한 ZORYVE® 크림 0.15%에 대한 환자 보고 결과 데이터를 발표했습니다. 3상 INTEGUMENT-1 및 -2 시험은 여러 지표에서 유의미한 개선을 보여주었습니다: 64.2%의 ZORYVE 치료 환자가 1주차에 비히클의 36.3%에 비해 SCORAD 총점에서 유의미한 개선을 달성하였고, 61.7%는 비히클의 34.2%에 비해 POEM 점수에서 개선을 보였습니다. 이 치료법은 조사자 총 평가 성공률의 31.3%를 달성하여 비히클의 14.1%에 비해 주요 효능 목표를 충족했으며, 환자와 돌보는 이들을 위한 질병 제거, 가려움증 감소 및 삶의 질 측면에서 빠른 개선을 입증했습니다.

Arcutis Biotherapeutics (ARQT) a présenté de nouvelles données sur les résultats rapportés par les patients pour la crème ZORYVE® 0.15% dans le traitement de la dermatite atopique lors de l'ACAAI 2024. Les essais de Phase 3 INTEGUMENT-1 et -2 ont montré des améliorations significatives sur plusieurs métriques : 64.2% des patients traités avec ZORYVE ont constaté une amélioration significative du score total SCORAD contre 36.3% pour le véhicule à la semaine 1, et 61.7% ont montré une amélioration des scores POEM contre 34.2% pour le véhicule. Le traitement a atteint son objectif d'efficacité primaire avec un 31.3% réussissant l'évaluation globale de l'investigateur contre 14.1% pour le véhicule, démontrant une amélioration rapide de l'élimination de la maladie, de la réduction des démangeaisons et des mesures de qualité de vie pour les patients et les aidants.

Arcutis Biotherapeutics (ARQT) präsentierte neue patientenberichtete Ergebnisdaten zur ZORYVE® Creme 0.15% zur Behandlung der atopischen Dermatitis auf dem ACAAI 2024. Die Phase-3-Studien INTEGUMENT-1 und -2 zeigten signifikante Verbesserungen in mehreren Messgrößen: 64.2% der mit ZORYVE behandelten Patienten erreichten eine bedeutende Verbesserung des SCORAD-Gesamtwerts im Vergleich zu 36.3% für das Vehikel in Woche 1, und 61.7% zeigten Verbesserungen in den POEM-Werten im Vergleich zu 34.2% für das Vehikel. Die Behandlung erreichte ihren primären Wirksamkeitsendpunkt mit 31.3% Erfolg bei der globalen Bewertung des Untersuchers gegenüber 14.1% für das Vehikel und zeigte eine schnelle Verbesserung der Krankheitsbeseitigung, der Juckreduktion sowie der Lebensqualitätsmessungen für Patienten und Betreuer.

Positive
  • Met primary efficacy endpoint with 31.3% IGA Success vs 14.1% for vehicle (P<0.0001)
  • 64.2% achieved meaningful SCORAD improvement vs 36.3% for vehicle at Week 1
  • 61.7% achieved meaningful POEM score improvement vs 34.2% for vehicle at Week 1
  • Demonstrated rapid itch reduction within 24 hours of first application
Negative
  • Reported adverse reactions including headache, nausea, application site pain, diarrhea, and vomiting

Insights

The patient-reported outcome data from INTEGUMENT-1 and -2 trials demonstrates compelling efficacy for ZORYVE cream in treating atopic dermatitis. Key highlights include 64.2% of patients achieving meaningful improvement in SCORAD scores at Week 1 versus 36.3% for vehicle, showing rapid onset of action. The drug also improved quality of life metrics across multiple validated scales.

The data is particularly significant as it addresses both clinical efficacy and patient experience - two critical factors for market adoption. The improvement in Dermatitis Family Impact scores (3.12 vs 1.74) suggests broader benefits beyond individual patient care, which could drive preference among prescribing physicians and payers.

The robust safety profile, combined with once-daily dosing and demonstrated rapid itch reduction within 24 hours, positions ZORYVE competitively in the $20+ billion atopic dermatitis market. These results should support continued commercial uptake and market share gains.

  • New patient-reported outcome data from INTEGUMENT-1 and -2 demonstrate that ZORYVE cream 0.15% rapidly decreased the impact of atopic dermatitis (AD), including sleep loss and daily activities, on patients and families
  • ZORYVE cream 0.15% resulted in significant improvements across all efficacy endpoints, including validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Success and rapid itch reduction within 24-hours of first application
  • Data presented as an oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting

WESTLAKE VILLAGE, Calif., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new patient-reported outcome data demonstrating that ZORYVE cream 0.15% improved the impact of AD on patients, families, and caregivers. These results, along with efficacy, safety, and tolerability data from Phase 3 INTEGUMENT-1 and -2, will be shared in an oral presentation at the ACAAI 2024 Annual Scientific Meeting held October 24-28, 2024, in Boston, MA.

Improvement with ZORYVE cream 0.15% was seen across multiple patient-reported outcomes including SCORing AD (SCORAD) total scorei, Patient-Oriented Eczema Measure (POEM), and Dermatitis Family Impact (DFI) compared to vehicle at 4 weeks, with improvement reported as early as Week 1, the first timepoint measured. These assessments score the improvement of physical symptoms such as redness and itchiness, as well as impact on loss of sleep, emotional distress, and daily activities (such as schoolwork, housework, or social activities).

“AD is a chronic, complex disease that can negatively affect the individual and the broader family unit, impacting relationships, sleep, and basic functions in life, like school attendance, housework, food preparation, and more,” said Mark Boguniewicz, MD, professor in the Division of Allergy-Immunology, Department of Pediatrics, at National Jewish Health and University of Colorado School of Medicine , and presenting author. “These new data show that treatment with ZORYVE not only provides rapid disease clearance and significant reduction in itch for the patient, but extends beyond that, reducing the impact of quality of life challenges that families and caregivers experience as a result of having a loved one living with a chronic skin disease like AD.”

Treatment with ZORYVE improved all patient-reported outcomes measured compared to vehicle including:

  • 64.2% of individuals treated with ZORYVE cream achieved a clinically meaningful improvement in SCORAD Total Score compared to 36.3% treated with vehicle at Week 1 i,ii (P<0.0001).
  • 46.2% of individuals treated with ZORYVE cream demonstrated improvement in SCORAD Total Score compared to 26.6% of patients treated with vehicle at Week 4 (P<0.0001).
  • 61.7% of ZORYVE cream treated individuals achieved a clinically meaningful improvement in POEM scores compared to 34.2% treated with the vehicle at Week 1 (P<0.0001).
  • Greater improvement in POEM scores were seen with ZORYVE cream compared to vehicle at Week 4 (7.5 vs. 3.9; P<0.0001).
  • Greater improvement in DFI scores were seen with ZORYVE cream treated patients compared to vehicle at Week 4 (3.12 vs. 1.74; P<0.0001).

"When evaluating different treatment options for chronic skin conditions we often focus on the clinical efficacy outcomes, like disease clearance or reduction in symptoms like itch. However, this is just one piece of the puzzle and it’s just as important to understand the improvement in other aspects of patients’ lives that are impacted by this chronic disease,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. “We’re proud to share these data showcasing rapid improvement in patient reported outcomes, which translate to meaningful relief with ZORYVE cream for those with AD their families, and caregivers.”

As previously reported and published in JAMA Dermatology, across both studies (INTEGUMENT-1 and INTEGUMENT-2) ZORYVE cream 0.15% met the primary efficacy endpoint of Investigator Global Assessment (IGA) Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear plus a 2-grade improvement from baseline at Week 4 (31.3% ZORYVE cream vs. 14.1% vehicle, P<0.0001). ZORYVE cream 0.15% was safe and well tolerated. The Incidence of Treatment Emergent Adverse Events (TEAEs) was low in both ZORYVE- and vehicle-treated patients. The most common adverse reactions were headache, nausea, application site pain, diarrhea, and vomiting.

INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of ZORYVE cream 0.15% or vehicle applied once-daily for four weeks to 1,337 adults and children 6 years of age and older with mild to moderate AD.

Presentation Details
“Patient-reported Outcomes and Family Impact With Roflumilast Cream in Atopic Dermatitis: Pooled Phase 3 Results”
Session: Distinguished Industry & Late-breaking Oral Abstracts - Session 2
Room: 311311
Saturday, Oct. 26, 2024; 4:30 PM (ET) session; 5:13 PM (ET) presentation
Presenter: Mark Boguniewicz, MD

About Atopic Dermatitis
AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.

AD is a chronic, relapsing inflammatory skin disease that is genetically pre-disposed and presents across the lifespan. The disease may appear as a red, intensely itchy rash that can occur anywhere on the body and may present differently in children and adults. AD presentation can rapidly fluctuate and vary based on geographic location and environment.

About ZORYVE Cream
ZORYVE (roflumilast) cream is a next generation topical phosphodiesterase-4 (PDE4) inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE®) is approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. Roflumilast cream 0.15% (ZORYVE®) is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis, in patients 6 years of age and older. A lower dose, roflumilast cream 0.05%, was evaluated for children aged 2 to 5 years and based on the positive data Arcutis intends to submit a supplemental New Drug Application.

Indications
ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

Please see full prescribing information for ZORYVE cream.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, AD, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedInFacebook, Instagram, and X.

Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential of real-world use results of ZORYVE cream in AD, including patient reported outcomes, and the potential for ZORYVE cream to advance the standard of care in AD and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Latha Vairavan, Vice President, Finance and Corporate Controller
ir@arcutis.com

i SCORAD (Scoring Atopic Dermatitis) combines investigator-assessed objective symptoms such as extent and intensity of redness, swelling and ozzing with patient reported subjective criteria such as itch and sleeplessness
ii As measured by Minimal Important Difference (MID), representing the point at which a difference in an outcome measure is important enough to warrant a change in treatment


FAQ

What were the efficacy results for ZORYVE cream 0.15% in the INTEGUMENT trials for atopic dermatitis?

ZORYVE cream 0.15% achieved 31.3% IGA Success compared to 14.1% for vehicle (P<0.0001), with 64.2% of patients showing SCORAD improvement at Week 1 versus 36.3% for vehicle.

What are the main side effects reported for ZORYVE cream 0.15% in atopic dermatitis treatment?

The most common adverse reactions reported for ZORYVE cream 0.15% were headache, nausea, application site pain, diarrhea, and vomiting.

How quickly does ZORYVE cream 0.15% (ARQT) show improvement in atopic dermatitis symptoms?

ZORYVE cream 0.15% demonstrated rapid itch reduction within 24 hours of first application, with significant improvements in patient-reported outcomes observed as early as Week 1.

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