Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data with ZORYVE® (roflumilast) Cream 0.05% for Treatment of Mild-to-Moderate Atopic Dermatitis in Children Ages 2–5 in Pediatric Dermatology
Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data with ZORYVE® (roflumilast) Cream 0.05% for Treatment of Mild-to-Moderate Atopic Dermatitis in Children Ages 2–5 in Pediatric Dermatology
Arcutis (Nasdaq: ARQT) reported long-term Phase 3 open-label extension data for ZORYVE cream 0.05% in children ages 2–5 with mild-to-moderate atopic dermatitis, showing durable and improving efficacy through 56 weeks and a favorable safety/tolerability profile.
Key results: 63.1% achieved vIGA-AD Clear/Almost Clear at Week 56; EASI-75 reached 71.9–76.0% at Week 56; median disease-control duration on twice-weekly proactive dosing ~238 days. Overall TEAEs were mostly mild/moderate; SAEs 3.2% (none treatment-related).
Loading...
Loading translation...
Positive
vIGA-AD Clear/Almost Clear 63.1% at Week 56
EASI-75 achieved by 71.9%–76.0% of children at Week 56
Median disease-control duration ~238 days on twice-weekly proactive dosing
High local tolerability: ≥97% with no evidence of local irritation
Negative
Treatment-Emergent Adverse Events reported in 49.8% of participants
Serious Adverse Events occurred in 3.2% of participants (none treatment-related)
News Market Reaction – ARQT
-0.93%
-0.93%Session close to close
In the Mar 10 session, ARQT declined 0.93%, reflecting a mild negative market reaction.
This announcement highlights robust long-term safety and efficacy of ZORYVE cream 0.05% in children ...
Analysis
This announcement highlights robust long-term safety and efficacy of ZORYVE cream 0.05% in children aged 2–5, with sustained responses through 56 weeks and meaningful itch and disease-control metrics. It builds on prior Phase 3 data and FDA approval in this age group, reinforcing Arcutis’ pediatric focus. Recent history shows strong commercial traction for ZORYVE. Investors may monitor further pediatric label expansions, real-world uptake, and any future use of the effective S-3ASR shelf registration.
Key Figures
Participants:562 childrenTEAEs incidence:49.8%Serious AEs:3.2%+5 more
8 metrics
Participants562 childrenINTEGUMENT-OLE Phase 3 open-label extension population aged 2–5 years
TEAEs incidence49.8%Treatment-Emergent Adverse Events in 280 of 562 participants
Serious AEs3.2%18 participants with Serious Adverse Events, none treatment-related
vIGA-AD 0/163.1%Clear or Almost Clear at Week 56 among 377 completers
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Pattern Detected
Recent ARQT news, including strong earnings and R&D updates, often saw muted or negative next-day moves, with only the marketing campaign showing a clear positive alignment.
Recent Company History
Over the last several weeks, Arcutis released multiple updates spanning earnings, clinical development, and corporate activities. On Feb 25, 2026, strong ZORYVE revenue growth and raised 2026 guidance produced only a modest +0.11% move. A seborrheic dermatitis awareness campaign on Feb 24 aligned with a +2.55% gain. However, a Phase 1 start for ARQ-234, a TD Cowen conference appearance, and a senior legal promotion all saw negative next-day reactions. Today’s positive long-term pediatric ZORYVE data fits the pattern of fundamentally constructive news against mixed short-term trading responses.
Key Terms
atopic dermatitis, phase 3, open-label extension, validated investigator global assessment, +3 more
7 terms
atopic dermatitismedical
"atopic dermatitis is the most common type of eczema, affecting approximately"
A chronic inflammatory skin condition, often called eczema, that causes dry, itchy, red patches and recurring flare-ups; think of it as a persistent rash that can come and go over a person’s life. It matters to investors because its chronic nature and large patient population create steady demand for treatments, influence drug development and approval decisions, affect healthcare costs and reimbursement, and can drive revenue and valuation shifts for companies working on therapies and diagnostics.
phase 3medical
"published data from the Phase 3 open-label extension (INTEGUMENT-OLE) study"
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
open-label extensionmedical
"Phase 3 open-label extension (INTEGUMENT-OLE) study evaluating once-daily"
An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.
validated investigator global assessmentmedical
"or a Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) = 0"
A validated investigator global assessment is a clinician’s standardized rating of a patient’s overall disease condition, using a scoring method that has been tested for consistency and accuracy. Think of it like a trusted referee’s overall score in a game: it summarizes how well a treatment is working from a medical expert’s viewpoint. Investors care because it’s a commonly used, regulator-accepted measure of efficacy that can influence clinical trial success, labeling decisions, and commercial prospects.
treatment-emergent adverse eventsmedical
"The primary endpoint of the OLE study was safety. Treatment-Emergent Adverse Events (TEAEs)"
Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.
serious adverse eventsmedical
"Serious Adverse Events (SAEs) occurred in 18 (3.2%) participants, none"
Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.
eczema area and severity indexmedical
"achieved at least a 75% reduction in Eczema Area and Severity Index (EASI-75)"
A standardized clinical score that measures how much skin is affected by eczema and how severe the lesions are, combining area and intensity into one number much like a report card for a skin condition. Investors care because changes in this score are often used as a primary measure of a treatment’s effectiveness in clinical trials, influencing regulatory approval chances, market potential, and the perceived value of companies developing eczema therapies.
ZORYVE cream 0.05% was safe and well-tolerated, with efficacy that was maintained and improved over time up to 56 weeks of treatment
Children ages 2-5 who achieved disease clearance and who switched to proactive twice-weekly application sustained disease control for a median duration of ~8 months
These results further support the Company’s focus on expanding options for pediatric populations
WESTLAKE VILLAGE, Calif., March 10, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Pediatric Dermatologypublished data from the Phase 3 open-label extension (INTEGUMENT-OLE) study evaluating once-daily ZORYVE® (roflumilast) cream 0.05% in children aged 2 to 5 years with mild-to-moderate atopic dermatitis. Data from the INTEGUMENT-OLE trial, which supported the FDA approval of ZORYVE cream 0.05% in October 2025, demonstrated that ZORYVE cream 0.05% is safe and well-tolerated, and efficacy was not only maintained but continued to improve with up to 56 weeks of treatment.
Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children in the United States. These data expand upon findings from the pivotal four-week Phase 3 trial INTEGUMENT-PED (INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis), which first established the efficacy and safety of ZORYVE cream 0.05% in this pediatric population.
“In my clinical practice, young children with atopic dermatitis struggle with the itchy rash that can cover large portions of their bodies,” said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and lead author of the publication. “Providing safe, effective nonsteroidal treatment options for young patients—who can have substantial disease burden but have limited available therapies—remains an important goal in pediatric dermatology. The publication of these data reinforces ZORYVE cream 0.05% as a meaningful, long-term treatment option for children living with atopic dermatitis and their families.”
This Phase 3, open-label safety trial was conducted in children aged 2 to 5 years with mild-to-moderate atopic dermatitis who had previously been treated with ZORYVE cream 0.05% or vehicle cream in the preceding four-week INTEGUMENT-PED study. During the 52-week OLE study, all participants (n=562) initially applied ZORYVE cream 0.05% once daily as a monotherapy to all areas of the body impacted by atopic dermatitis, excluding the scalp. Per study protocol, children who achieved clear skin, or a Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) = 0 at or after Week 4, were transitioned to a proactive twice-weekly (BIW) regimen, and the efficacy results reported in this publication include data from both once-daily and BIW participants.
The primary endpoint of the OLE study was safety. Treatment-Emergent Adverse Events (TEAEs) were reported for 280 (49.8%) participants, and most events were mild (n=139; 24.7%) or moderate (n=125; 22.2%). The most common TEAEs (≥4%) included upper respiratory tract infection in 8.7% of participants, nasopharyngitis in 5.0%, and pyrexia in 5.0%. Gastrointestinal adverse events (AEs) were reported for 4.4% of participants, most commonly vomiting (2.7%) and diarrhea (1.1%). Serious Adverse Events (SAEs) occurred in 18 (3.2%) participants, none of which were considered treatment-related. Overall, 14 of 562 participants (2.5%) experienced treatment-related AEs, and 4 participants (0.7%) experienced application site pain.
Based on investigator-rated local tolerability assessments, ≥97% of study participants had no evidence of local irritation across time points. For caregiver-reported local tolerability assessments, reports of burning or stinging sensations were low, with severe sensations occurring in ≤1.8% of participants at any time point and 0.3% at Week 56. Over the 56-week period, 55 participants attained their 6th birthday and were transitioned to ZORYVE cream 0.15% for at least one application; safety outcomes observed in this subgroup were consistent with the overall study population.
Durable and continuously improving efficacy, assessed via prespecified secondary endpoints, was observed in the study. In participants who completed 56 weeks of treatment (n=377), 63.1% achieved a vIGA-AD score of Clear or Almost Clear (0 or 1) at Week 56. At Week 56, 71.9% of children who continued treatment with ZORYVE cream 0.05% and 76.0% of children who switched from vehicle to ZORYVE cream 0.05% achieved at least a 75% reduction in Eczema Area and Severity Index (EASI-75). Itch improvement, as assessed by caregivers using the Worst Itch Numeric Rating Scale (WI-NRS)—a measure validated in patients aged 12 years and older—showed that 57.9% of children who continued treatment with ZORYVE cream 0.05% and 66.3% of children who switched from vehicle to ZORYVE cream 0.05% achieved a ≥4-point improvement at the end of the study. Efficacy assessments excluded palms, soles, and the scalp.
Children who achieved clear skin (vIGA-AD = 0) at or after Week 4 were transitioned to a proactive twice-weekly application schedule. Of the 170 participants (30.2%) who entered twice-weekly dosing, the median Kaplan-Meier duration of disease control (maintaining vIGA-AD of ‘Clear’ or ‘Almost Clear,’ with adequate control of signs and symptoms on the twice-weekly schedule application) was 238 days.
“Atopic dermatitis often begins early in life, during a time when the immune system is developing and the skin is vulnerable. For this young age group, long-term treatment options have historically been limited, making it especially important to have therapies that are both safe and effective,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis Biotherapeutics. “The publication of these long-term data reinforces the strong safety profile and durable efficacy of ZORYVE cream 0.05% and highlights our commitment to providing clinicians, families, and young children with treatment options that can be used confidently over time.”
About Atopic Dermatitis Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Atopic dermatitis is a chronic, relapsing, and genetically predisposed inflammatory skin disease that has unique clinical presentations across the lifespan. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. It presents differently in infants, children, and adults. Younger children typically have more widespread atopic dermatitis, including on the face, neck, and areas around the knees and elbows.
Atopic dermatitis is often initially diagnosed during childhood with approximately 90% of people with atopic dermatitis developing symptoms by age 5. Pediatric atopic dermatitis can negatively impact the entire family by significantly disrupting sleep, increasing the risk of skin infections, and leading to developmental and emotional strain for both the child and caregivers.
About ZORYVE® (roflumilast) ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.
Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards and recommendations. ZORYVE was awarded by Allure with the "2025 Best of Beauty Breakthrough Award," making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and ZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal of Recognition—the first FDA-approved prescription brand to receive the honor. Additionally, the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adult patients with mild to moderate atopic dermatitis, according to updated guidelines released in June 2025. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.”
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 of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.
INDICATIONS ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.
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.
IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).
The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, 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 for ZORYVE cream 0.05% to advance the standard of care in atopic dermatitis for pediatric patients aged 2 to 5 years old, and real world treatment results. 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 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, 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 media@arcutis.com
Investors Brian Schoelkopf, Head of Investor Relations ir@arcutis.com
FAQ
What long-term efficacy did ARQT report for ZORYVE cream 0.05% in children ages 2–5 (March 10, 2026)?
ZORYVE showed durable and improving efficacy through 56 weeks, with 63.1% achieving vIGA-AD Clear/Almost Clear. According to the company, EASI-75 rates were 71.9%–76.0% at Week 56 and itch improvements were substantial by caregiver reports.
What safety outcomes did Arcutis report for ZORYVE cream 0.05% in the 52-week INTEGUMENT-OLE study (ARQT)?
ZORYVE was generally safe and well-tolerated, with mostly mild or moderate TEAEs reported. According to the company, TEAEs occurred in 49.8% of participants and SAEs in 3.2%, none deemed treatment-related.
How long did disease control last on twice-weekly proactive ZORYVE dosing for ARQT pediatric patients?
Median duration of disease control on proactive twice-weekly dosing was approximately 238 days. According to the company, 170 participants entered twice-weekly dosing and maintained control for a median of ~8 months.
What proportion of children reached EASI-75 and itch improvement at Week 56 in ARQT's study?
At Week 56, 71.9%–76.0% achieved EASI-75 and 57.9%–66.3% met ≥4-point itch improvement thresholds. According to the company, rates varied by prior treatment group but showed strong end-of-study responses.
Did the INTEGUMENT-OLE study report local tolerability findings for ZORYVE cream 0.05% (ARQT)?
Local tolerability was high, with ≥97% of participants showing no investigator-rated local irritation. According to the company, caregiver-reported severe burning or stinging was ≤1.8% at any time and 0.3% at Week 56.
