Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting
WESTLAKE VILLAGE, Calif., March 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (New Orleans, LA, March 17-21) new data from its INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase 3 studies of roflumilast cream 0.15% in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.
Both studies met the primary endpoint of 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 (INTEGUMENT-1: 32.0% roflumilast cream vs. 15.2% vehicle, P<0.0001; INTEGUMENT-2: 28.9% roflumilast cream vs. 12.0% vehicle, P<0.0001). In addition, rapid and significant improvements in v-IGA success were demonstrated as early as Week 2 (INTEGUMENT-1: 21.2% for roflumilast cream vs. 6.4% for vehicle; P<0.0001; INTEGUMENT-2: 17.7% for roflumilast cream vs 5.3% for vehicle; P< 0.0001).
Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch Numeric Scale (WI-NRS) Success at Week 4. In addition, a daily improvement in itch was observed in those treated with roflumilast cream with a significant improvement at 24 hours following the first application (P<0.05) as measured by WI-NRS.
Atopic dermatitis is a chronic skin disease common in both children and adults where pruritus, or itch, is the most reported and most burdensome symptom, and may cause substantially reduced quality of life and sleep disturbances, said Lawrence F. Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego, Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at UC San Diego School of Medicine, and study investigator. Importantly, individuals treated with roflumilast cream experienced a significant and rapid improvement in the extent and severity of their atopic dermatitis, adding further to evidence of the potential of roflumilast cream as a treatment option for this disease. Additionally, these pivotal Phase 3 data show that roflumilast cream drove a significant and rapid reduction in itch as early as the first 24 hours, which could be a helpful early indication to children and adults that the treatment is working.
Roflumilast cream also demonstrated rapid and statistically significant improvements compared to vehicle on key secondary endpoints, with more than 40% of children age 6 and older and adults treated with roflumilast cream achieving a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 compared to vehicle (INTEGUMENT-1: 43.2% vs. 22.0%, P<0.0001; INTEGUMENT-2: 42.0% vs. 19.7%, P<0.0001). Additionally, significant improvements in EASI-75 were observed with roflumilast cream as early as Week 1 in both studies compared to vehicle (INTEGUMENT-1: 14.0% vs. 5.5%, p=0.0006; INTEGUMENT-2: 13.3% vs. 7.8%, p=0.0329). In both studies, approximately 40% of children and adults treated with roflumilast cream achieved a vIGA-AD score of Clear (0) or Almost Clear (1) at Week 4 (INTEGUMENT-1: 41.5% vs. 25.2%, P<0.0001; INTEGUMENT-2: 39% vs. 16.9%, P<0.0001).
Atopic dermatitis can have a huge impact on the quality of life for those affected, and also be challenging to treat, said Julie Block, President and CEO, National Eczema Association. Thankfully, our understanding of atopic dermatitis continues to grow, and the commitment from companies, such as Arcutis, to develop new treatment options aiming to provide people living with this disease a much-needed relief, is most welcome and appreciated.
We are pleased to present these data from our pivotal Phase 3 INTEGUMENT program, which demonstrated significant improvements in atopic dermatitis in children and adults across multiple efficacy endpoints, said Patrick Burnett MD, PhD, FAAD, Chief Medical Officer of Arcutis. Roflumilast cream was also shown to be safe and well-tolerated, critical considerations for the treatment of atopic dermatitis. We look forward to the continued development of roflumilast cream 0.15% for atopic dermatitis as we prepare to file a supplemental new drug application (sNDA) with the U.S. Food & Drug Administration (FDA) in the second half of this year.
Roflumilast cream 0.15% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate in severity, and no adverse event occurring in more than 3.5% of subjects in either arm. The most common TEAEs 2% in roflumilast-treated patients were headache (INTEGUMENT-1 2.3% vs 1.4%; INTEGUMENT-2 3.5% vs 0.9%), nausea (1.8% vs 0.9%; 2.0% vs 0%), and application site pain (2.1% vs. 0.5%; 0.9% vs. 0.9%). Local tolerability was favorable with more than 90% of those treated with roflumilast cream reporting no or mild sensation across arms in both trials at any timepoint.
About the INTEGUMENT Phase 3 Trials The INterventional Trial EvaluatinG roUMilast cream for the treatmENt of aTopic dermatitis (INTEGUMENT-1 and INTEGUMENT-2) are two identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roumilast cream 0.15% or vehicle was applied once daily for four weeks to individuals 6 years of age and older with mild to moderate AD involving 3% body surface area. A total of 1,337 individuals were randomized across both studies. The primary endpoint was IGA Success, dened as vIGA-AD score of clear or almost clear plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints were also evaluated, including itch as measured by WI-NRS as well as the proportion of subjects who attained an EASI-75 at Week 4.
After completing INTEGUMENT-1 and INTEGUMENT-2, individuals were eligible to enroll in an open-label extension study (INTEGUMENT-OLE) evaluating treatment with once-daily roflumilast cream 0.15% for up to 12 months.
Arcutis is enrolling a third pivotal Phase 3 trial, the INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients (INTEGUMENT-PED) to evaluate roflumilast cream 0.05% in children 2 to 5 years of age with mild to moderate AD. The Company plans to report topline data from this study in the second half of 2023.
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 characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms, and legs. The rash can cover significant areas of the body, in some cases half of the body or more. AD typically begins in early childhood and is chronic. It persists into adolescence and even adulthood in some individuals. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Since a large percentage of AD patients are very young children, safety is a particularly important consideration in treatment selection.
About Roflumilast Cream Roflumilast cream is a next generation topical 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 FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast cream for atopic dermatitis was evaluated at lower doses: 0.15% for adults and children 6 years of age and older and is being evaluated at 0.05% for children aged 2 to 5 years.
About ZORYVE ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
IMPORTANT SAFETY INFORMATION The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
The most common adverse reactions (1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).
Please see full Prescribing Information.
About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a 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 that harnesses 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, atopic dermatitis, seborrheic dermatitis, and alopecia areata. For more information, visit http://www.arcutis.com or follow Arcutis on LinkedIn , Facebook , and Twitter .
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 Companys current beliefs and expectations. Such forward-looking statements include, among others, statements regarding the potential for roumilast to be approved for the treatment of adults and children with AD, the potential to use roumilast cream over a long period of time, or chronically, the potential to use roumilast cream anywhere on the body, including the face and sensitive areas, timing for anticipated data of INTEGUMENT-PED, the potential sNDA ling and the potential for roumilast to advance the standard of care in AD and other inammatory dermatologic 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 U.S. Securities and Exchange Commission (SEC) on February 28, 2023, 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.
Contacts: Media Amanda Sheldon, Head of Corporate Communications asheldon@arcutis.com
Investors Eric McIntyre, Head of Investor Relations emcintyre@arcutis.com
Here is the original post:
Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase ... - InvestorsObserver
- Advancing Hidradenitis Suppurativa Care - Early Diagnosis, Biologic Therapies, and Multidisciplinary Approaches: Part 3 - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Top 5 Articles of the Month: March - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Talking to Patients on Sunscreen Application and the Effects of Visible Light - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Challenges and Unmet Needs in Treating Pediatric Atopic Dermatitis - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Clinical Experience and Diagnosis of GPP - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Gene Expression Profiling and Other Molecular Tests Utilized for Melanoma and Squamous Cell Carcinoma - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Fixed-Dose Acne Treatment Gel is Safe and Effective for Hispanic Patients, According to Post-Hoc Analysis - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- CBD and CBG Ointment Improved Skin in Patients with Atopic Dermatitis - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Utilizing Gene Expression Profiling to Avoid Unnecessary Interventions in a 72-Year-Old Woman With Melanoma - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Hims & Hers shutters Apostrophe in favor of its own tele-dermatology offerings - Fierce healthcare - March 15th, 2025 [March 15th, 2025]
- Closing Out AAD With Dermatology Times Editor in Chief - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Improving Patient Care in Dermatology Through Data, Innovation, Advocacy: AAD 2025 Recap - AJMC.com Managed Markets Network - March 15th, 2025 [March 15th, 2025]
- Inflammatory Arthropathy Risk Increased in Patients With Hidradenitis Suppurativa - Dermatology Advisor - March 15th, 2025 [March 15th, 2025]
- Expert Perspectives: Dermatology's Top Story to Watch in 2025 - MD Magazine - March 15th, 2025 [March 15th, 2025]
- Whats New in Dermatology for Pigmentary Disorders, with Andrew Alexis, MD, MPH - MD Magazine - March 15th, 2025 [March 15th, 2025]
- Home Phototherapy Proves Effective and Preferred in LITE Study for Psoriasis Treatment - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Efficacy, Safety, and Role in Therapy of JAK Inhibitors for Atopic Dermatitis - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Reviving the Classics: The Role of Older Medications in Modern Dermatology - AJMC.com Managed Markets Network - March 15th, 2025 [March 15th, 2025]
- Dermatology Therapeutics: Updates for Primary Care from AAD 2025 - Patient Care Online - March 15th, 2025 [March 15th, 2025]
- Advances in Dermatology Therapeutics: Key Insights from AAD 2025 - Patient Care Online - March 15th, 2025 [March 15th, 2025]
- The Impact of JAK Selectivity in Atopic Dermatitis Treatment - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Social Drivers of Health Success Stories in Dermatology | AAD 2025 - Managed Healthcare Executive - March 15th, 2025 [March 15th, 2025]
- Improving Acne Treatment Through Antibiotic Stewardship and Gut-Skin Health - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Advancing Recognition and Treatment of Allergic Contact Dermatitis - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Lebrikizumab Shows 3-Year Sustained Efficacy in AD - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- AAD 2025: Galderma to Present Extensive Updates From Across Its Dermatology Portfolio, Demonstrating Its Category Leadership and Strong Momentum -... - March 5th, 2025 [March 5th, 2025]
- What to Look Forward to at the American Academy of Dermatology Annual Meeting 2025 - MD Magazine - March 5th, 2025 [March 5th, 2025]
- Recognizing the Achievements of Women in Dermatology - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- The Solar Spectrum and Impact on Skin Health - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- The Undetectable Era: How Patients Are Shifting Towards More Natural-Looking Results at the Clinic - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- Researchers overseas: Radiology has become indispensable to dermatology - Radiology Business - March 5th, 2025 [March 5th, 2025]
- Defining Alopecia Areata Severity and Navigating Treatment Options - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- Acne and TikTok: What Do Dermatologists Need to Know? - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- Celebrating Womens History Month with Mindy Haws, MD, and the LIMITLESS Initiative - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- A Case-Based Approach to Topical and Nonsteroidal AD Management - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- Dermatology Partners Opens State-of-the-Art Dermatopathology Laboratory - citybiz - February 25th, 2025 [February 25th, 2025]
- Ethical Considerations and Guidance of Cosmeceuticals in Pediatric Care - Dermatology Times - February 25th, 2025 [February 25th, 2025]
- AI in Dermatology: Emerging Insights and Diverging Perspectives - MD Magazine - February 25th, 2025 [February 25th, 2025]
- Almirall 2024 Full-Year Results: Almirall Surpassed Guidance for 2024 - Entering an Era of Sustained Growth and Further Advancing Its Medical... - February 25th, 2025 [February 25th, 2025]
- Aesthetic Treatments: More Than Just Enhancements, A Path to Empowerment - Dermatology Times - February 25th, 2025 [February 25th, 2025]
- Samitivej to advance dermatology and aesthetic medicine in new partnership - Healthcare Asia - February 25th, 2025 [February 25th, 2025]
- Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with... - February 25th, 2025 [February 25th, 2025]
- U.S. Dermatology Partners Ranked the No. 1 Dermatology Group in the Nation by Castle Connolly - PR Newswire - February 3rd, 2025 [February 3rd, 2025]
- Alopecia Areata Risk May be Associated With Serum Vitamin D and Zinc Levels - Dermatology Advisor - February 3rd, 2025 [February 3rd, 2025]
- Age at Melanoma Diagnosis Varies by Sex, Anatomic Site, and Tumor Thickness - Dermatology Advisor - February 3rd, 2025 [February 3rd, 2025]
- Dermatology Medications and Solutions Market Poised to Growth USD 51.7 Billion by 2032 with Thriving CAGR of - EIN News - January 23rd, 2025 [January 23rd, 2025]
- Optimizing Care for Patients with Urticaria - Dermatology Times - January 23rd, 2025 [January 23rd, 2025]
- Advancing Care With Laser and Light-Based Technology in Dermatology - Dermatology Times - January 23rd, 2025 [January 23rd, 2025]
- Online Dermatology Consultation Market: CAGR of 15.4% Expected by 2025 Due to Increasing Skin Health Awareness - openPR - January 23rd, 2025 [January 23rd, 2025]
- VP-315 Demonstrates Positive Topline Results in Basal Cell Carcinoma - Dermatology Times - January 23rd, 2025 [January 23rd, 2025]
- AI and the Future of Cosmetic Dermatology: Experts Weigh in - Medscape - January 23rd, 2025 [January 23rd, 2025]
- When and How to Employ the Buy and Bill Model - Dermatology Times - January 23rd, 2025 [January 23rd, 2025]
- Innovating Scalp Care: How Research and Education Drive Solutions - Dermatology Times - January 15th, 2025 [January 15th, 2025]
- Rare Overlap of 2 Autoinflammatory Keratinization Diseases Observed in Single Lesion - Dermatology Times - January 15th, 2025 [January 15th, 2025]
- Expanding Laser Benefits for Diverse Patient Populations - Dermatology Times - January 15th, 2025 [January 15th, 2025]
- LEO Pharma and Gilead Will Develop STAT6 Program for AD and Other Inflammatory Diseases - Dermatology Times - January 15th, 2025 [January 15th, 2025]
- Kwon Min-ah, a former member of the group AOA, became the head of the dermatology consultation offic.. - - January 15th, 2025 [January 15th, 2025]
- Top 5 Dermatology Articles of 2024 - Managed Healthcare Executive - January 1st, 2025 [January 1st, 2025]
- DEI programs, sun safety: Read this years top practice management articles in dermatology - Healio - January 1st, 2025 [January 1st, 2025]
- Cutaneous Connection 2024: Top Dermatology Podcast Episodes and Insights of the Year - Dermatology Times - January 1st, 2025 [January 1st, 2025]
- Top Insights and Highlights from Dermatology Times' Interview Intersection: 2024 - Dermatology Times - January 1st, 2025 [January 1st, 2025]
- Providing Support for Comorbidities and Psychological Health in Patients with Atopic Dermatitis - Dermatology Times - January 1st, 2025 [January 1st, 2025]
- Reviewing Major Dermatologic Studies of the Year: 2024 - Dermatology Times - January 1st, 2025 [January 1st, 2025]
- Peak Dermatology in Visalia hopes to provide more skin services and treatment to the area - KFSN-TV - December 23rd, 2024 [December 23rd, 2024]
- Krystal Tawney of Pinnacle Dermatology celebrates 10 years of business in the Greenbrier Valley - Real WV - December 23rd, 2024 [December 23rd, 2024]
- Supporting Pediatric Patients With AD and Their Caregivers - Dermatology Times - December 23rd, 2024 [December 23rd, 2024]
- Photodynamic Therapy is an Effective, Long-Term Treatment for Actinic Keratosis - Dermatology Times - December 23rd, 2024 [December 23rd, 2024]
- InflaRx Advances INF904 for CSU and HS with Phase 2a Study - Dermatology Times - December 23rd, 2024 [December 23rd, 2024]
- Advanced Dermatology to pay $15G fine after doctor refused to perform procedure on HIV-infected patient - Newsday - December 9th, 2024 [December 9th, 2024]
- Efficacy of Combining Postbiotic Formulation with Microneedling for Acne - Dermatology Times - December 9th, 2024 [December 9th, 2024]
- Burden of Hidradenitis Suppurativa on Patients and Diagnostic Challenges - Dermatology Times - December 9th, 2024 [December 9th, 2024]
- Opioid-Prescribing Trends in Dermatology From 2014 to 2020 in the United States - Cureus - November 28th, 2024 [November 28th, 2024]
- Amid challenges, the Baton Rouge dermatology industry is evolving - Greater Baton Rouge Business Report - November 28th, 2024 [November 28th, 2024]
- Polynucleotide Therapy Shows Promise in Scar and Burn Management - Dermatology Times - November 28th, 2024 [November 28th, 2024]
- Revolutionizing Dermatology: How Emerging Technologies are Shaping the Future of Skin Care - Spherical Insights - November 28th, 2024 [November 28th, 2024]
- Dermatology OTC Medications Market Size, Scope Analysis, Key Insights, Leading Key Players, And Forecast To 2033 - openPR - November 28th, 2024 [November 28th, 2024]
- Jeff Stark, MD: Insights on the Approval of Bimekizumab for HS - Dermatology Times - November 28th, 2024 [November 28th, 2024]
- Exploring the Atopic Dermatitis Treatment Paradigm and Challenging Cases: Part 2 - Dermatology Times - November 28th, 2024 [November 28th, 2024]
- Patient Education and Novel Topical Therapies for AD - Dermatology Times - November 28th, 2024 [November 28th, 2024]
- TikTok dermfluencers have medical students flocking to dermatology, where they can make half a million dollars a year and work four days a week -... - November 20th, 2024 [November 20th, 2024]