Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

New long-term data suggest once-daily roflumilast cream .05% (ZORYVE) can allow for sustained symptom control and a favorable safety profile among children aged 2 - 5 years with 

These data were announced by Arcutis Biotherapeutics, Inc., resulting from the phase 3 open-label extension INTEGUMENT-OLE trial looking at the use of once-daily roflumilast cream .05%, a topical phosphodiesterase-4 inhibitor, in young children living with atopic dermatitis. Atopic dermatitis, the most prevalent form of eczema, is estimated to impact roughly 9.6 million children across the US.

“In my clinical practice, young children with atopic dermatitis struggle with the itchy rash that can cover large portions of their bodies,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and lead author of this publication, said in a statement.

This recent extension study built upon earlier data resulting from the 4-week phase 3 INTEGUMENT‑PED trial, which initially established the safety and efficacy of roflumilast cream .05% in children between 2 and 5 years of age. Data from the INTEGUMENT-OLE study supported the 

US Food and Drug Administration (FDA) approval

 of roflumilast cream .05% in October 2025 for this age cohort.

Over as long as 56 weeks of use, the treatment demonstrated a favorable safety profile and was generally shown to be well-tolerated. Those evaluating the drug had also reported that clinical benefits persisted throughout the study and continued to improve over time.

In the latest open-label safety extension, children were recruited had previously participated in INTEGUMENT-PED and had been given either roflumilast cream .05% or a vehicle cream during that earlier 4-week analysis.

 During the extension phase, there were 562 participants given roflumilast cream .05% once each day as monotherapy for up to 52 weeks to all areas affected by atopic dermatitis except the scalp. Those involved who attained completely clear skin, defined as a Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) score of 0 at or after Week 4, were transitioned to a proactive twice-weekly maintenance regimen.

Reported efficacy outcomes included results from both individuals who remained on once-daily roflumilast cream and those who moved to the twice-weekly schedule.

 In their assessment of safety, Eichenfield and coauthors found treatment-emergent adverse events (TEAEs) appeared in 49.8% of subjects. Most were classified as mild (24.7%) or moderate (22.2%). The AEs found to have been reported most frequently included upper respiratory tract infection (8.7%), pyrexia (5.0%), and nasopharyngitis (5.0%). Gastrointestinal adverse events occurred in 4.4% of participant.

Serious AEs were documented in 3.2%, though Eichenfield et al determined that none were connected to the treatment.

 Overall, 2.5% of the 562 participants saw treatment-related adverse events, and application-site pain was reported by .7% of these children. Assessments of local tolerability by investigators suggested at least 97% of subjects showed no signs of irritation throughout the study period. In their evaluation of caregiver-reported outcomes, the data suggested minimal discomfort, with burning or stinging sensations rarely seen.

Severe symptoms took place in no more than 1.8% of those treated at any assessment point and were noted among just .3% of children by the 56-week mark. During the analysis, 55 participants reached their sixth birthday and therefore received at least a single application of roflumilast cream .15%. Safety data within this subgroup aligned with those observed in the broader study population.

Secondary endpoints identified in the analysis demonstrated sustained and gradually improving treatment responses.

 Among those who completed the full 56 weeks of treatment, 63.1% attained a vIGA-AD score of clear or almost clear (0 or 1) by the 56-week mark. The investigative team also found 71.9% of children who continued roflumilast therapy and 76.0% of those who switched from vehicle cream to roflumilast attained at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) by the study’s conclusion.

Pruritus improvements were assessed via caregiver reports using the Worst Itch Numeric Rating Scale (WI-NRS).

 By the conclusion of the trial, the team found 57.9% of children who remained on roflumilast and 66.3% of those who transitioned from vehicle treatment reported an improvement of at least 4 points on the scale. Those who saw complete skin clearance following Week 4 transitioned to a twice-weekly proactive treatment schedule. Among the 30.2% of children who entered this maintenance phase, Kaplan-Meier analysis estimated a median duration of disease control of 238 days, defined as maintaining a vIGA-AD rating of clear or almost clear with adequate symptom control while implementing the twice-weekly regimen.

“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,” Eichenfield said in his statement.

 “The publication of these data reinforces [roflumilast] cream 0.05% as a meaningful, long-term treatment option for children living with atopic dermatitis and their families.”

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 Biotherapteutics, Inc. March 10, 2026. 

https://investors.arcutis.com/news-releases/news-release-details/arcutis-announces-publication-positive-long-term-safety-and-0

Smith T. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years. HCPLive. October 6, 2025. Accessed March 10, 2026. 

https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years

Articles

Once-daily roflumilast cream 0.05% showed durable efficacy and favorable long-term tolerability in children aged 2–5 years with mild-to-moderate atopic dermatitis over up to 56 weeks. In an open-label extension enrolling prior phase 3 participants, most adverse events were mild-to-moderate, with low rates of treatment-related events and minimal application-site discomfort. Clinical responses were sustained and often improved over time, including vIGA-AD clear/almost clear status, EASI-75, and caregiver-reported pruritus improvement. A proactive twice-weekly maintenance strategy supported prolonged disease control.

These data, resulting from the INTEGUMENT-OLE trial, highlight the efficacy and safety of roflumilast cream (ZORYVE) 0.05% in children aged 2 - 5 years.

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New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The US Food and Drug Administration (FDA) has approved GSK’s leucovorin calcium (Wellcovorin) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1), making it the first treatment for the rare genetic condition of cerebral folate deficiency.

As described in a March 10, 2026, release from the Agency, the approval was based on a systematic review of the published literature on the topic, including published case reports with patient-level information, as well as mechanistic data.

"Today's approval represents a significant milestone for patients living with cerebral folate transport deficiency due to the FOLR1 variant, a rare genetic condition that has had no FDA-approved treatment options until today,” FDA Commissioner Marty Makary, MD, MPH, said in a statement. “This action may benefit some individuals with FOLR1- related cerebral folate transport deficiency who have developmental delays with autistic features.”

In the US, leucovorin is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. GSK marketed leucovorin under the brand name Wellcovorin from 1983 to 1997, and it is now available in the US as a generic drug.

The FDA collaborated with GSK on a process to update the labeling to include the essential scientific information needed for the safe and effective use of the drug for adults and pediatric patients with CFD-FOLR1, a neurological condition that affects folate transport into the brain.

GSK announced the submission of a supplemental New Drug Application (sNDA) for leucovorin to update the label to include an indication for the treatment of CFD on September 22, 2025. The FDA requested GSK take this action as part of the Agency’s initiative to investigate opportunities to repurpose older medications for the treatment of chronic diseases.

As described by the FDA, possible side effects associated with leucovorin include pruritus, rash, urticaria, dyspnea, rigors, and impaired thermoregulation.

"The approval of leucovorin for FOLR1-related cerebral folate transport deficiency (CFD- FOLR1) demonstrates the FDA’s commitment to rapidly identifying effective treatments for ultra rare diseases while maintaining the same evidentiary standards for approval,” said Tracy Beth Hoeg, MD, PhD, Acting Director of the FDA’s Center for Drug Evaluation and Research. “It also provides a good example of how observational or ‘real world’ evidence can lead to an FDA approval when the product is shown to provide clear clinical benefit compared with what is seen with the natural history of the disease.”

US Food and Drug Administration. FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency. March 10, 2026. Accessed March 10, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-cerebral-folate-transport-deficiency

GSK. GSK to submit label update for Wellcovorin (leucovorin) at US FDA’s request. September 22, 2025. Accessed March 10, 2026. 

https://www.gsk.com/en-gb/media/press-releases/gsk-to-submit-label-update-for-wellcovorin-leucovorin-at-us-fda-s-request/

FDA approval granted for oral leucovorin calcium (Wellcovorin) to treat cerebral folate deficiency due to confirmed FOLR1 (folate receptor 1) variants in adult and pediatric patients, marking the first FDA-approved therapy for this ultra-rare cerebral folate transport disorder. The decision relied on a systematic literature review of case reports with patient-level outcomes plus mechanistic evidence, reflecting a repurposing pathway for an older drug long used as methotrexate rescue. Labeling was updated in collaboration with GSK, with safety considerations including hypersensitivity-type reactions and thermoregulation impairment.

The approval comes after the FDA requested GSK submit an sNDA for leucovorin for the treatment of CFD-FOLR1.

FDA News

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FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

Nicole Negbenebor, MD, is a clinical assistant professor of dermatology and the director of the Skin of Color Clinic for the University of Iowa, as well as a Skin of Color Society (SOCS) member.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Skin of Color Savvy: Challenges and Successes in a Dermatologist’s Career, With Nicole Negbenebor, MD

 leaders, Nicole Negbenebor, MD, clinical assistant professor of dermatology and director of the Skin of Color Clinic at the University of Iowa, discusses her professional journey in 

, highlighting her clinical interests, research advocacy, and commitment to improving care for diverse patient populations.

Negbenebor reflects on the factors drawing her to dermatology back during medical school, citing the specialty’s breadth, diagnostic complexity, and ability to reveal systemic disease through cutaneous findings. She notes that dermatology’s combination of medical management, surgery, pathology, and patient education allows physicians to pursue varied interests while maintaining a strong investigative component. This multidimensional nature of the specialty continues to shape her clinical and research pursuits.

A significant portion of Negbenebor’s work centers on her leadership of the Skin of Color Clinic at the University of Iowa, originally established by a mentor. In this role, she treats a wide spectrum of conditions affecting patients with diverse skin types, including vitiligo, hidradenitis suppurativa (HS), acne keloidalis nuchae, scarring alopecias, and postinflammatory hyperpigmentation.

The clinic also addresses cosmetic dermatology concerns and provides education to dermatology residents rotating through the program. Negbenebor emphasizes the importance of culturally informed care, noting that treatment strategies must often account for hair-care practices, product use, and other cultural considerations not extensively addressed in traditional dermatology training.

Throughout the discussion, she highlights ongoing improvements in awareness of skin of color dermatology but describes some patients as still feeling unheard in clinical settings. Creating spaces where patients feel comfortable discussing concerns, including hair care practices or culturally specific skincare routines, can improve trust and treatment outcomes. Integrating such knowledge into dermatologic care, she adds, is essential to delivering effective and patient-centered management.

Negbenebor also shares examples from her clinical practice illustrating the complexity of dermatologic care. In one case, she describes treating a patient with dermatofibrosarcoma protuberans requiring Mohs surgery, multidisciplinary collaboration, and coordination of social support services, including interpretation and childcare. Experiences such as these underscore the importance of teamwork across specialties to optimize patient outcomes.

Beyond clinical practice, Negbenebor highlights writing and research as key avenues for advocacy. She describes academic writing as a way to document patient experiences, address barriers such as insurance restrictions for biologic therapies, and contribute to broader systemic improvements in care.

Reflecting on her experiences with SOCS, Negbenebor credits the organization’s mentorship programs and educational resources with fostering community and advancing expertise in dermatologic care for patients with skin of color. She concludes by encouraging trainees to seek mentorship, remain persistent in pursuing dermatology, and maintain a strong sense of purpose in caring for patients whose dermatologic conditions significantly affect quality of life.

To learn more about SOCS’s programs and initiatives, visit 

Editor’s note: This summary was edited with the help of AI tools.

Podcasts

This March episode highlights one SOCS member’s journey in dermatology, covering clinical and research passions as well as lessons learned along the way.

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Videos

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

The expert faculty explore how clinicians approach rectal bleeding and surveillance decisions in colorectal cancer screening.

Colorectal Cancer Screening and Surveillance Decisions

In this episode, ‘Colorectal Cancer Screening and Surveillance Decisions’, the expert faculty explore how clinicians approach rectal bleeding and surveillance decisions in colorectal cancer screening. The discussion highlights rectal bleeding as a key presenting symptom in early-onset colorectal cancer, particularly among younger patients, and examines when colonoscopy is warranted even in the presence of suspected benign causes such as hemorrhoids. Faculty emphasize the importance of follow-up and individualized clinical judgment, especially when recent screening has been performed. The conversation also addresses post-polypectomy management, clarifying differences between hyperplastic polyps and adenomas and how these findings influence future screening strategies. Ultimately, the speakers reinforce that the most effective screening approach is one that aligns with risk profile and ensures patient adherence.

The next episode in this series, ‘Shared Decision-Making in Colorectal Cancer Screening,’ features the panelists highlighting the challenges of engaging patients in colorectal cancer screening and emphasizes the importance of pragmatic, shared decision-making conversations. The faculty discuss how presenting the risks and benefits of colonoscopy and stool-based options can improve patient buy-in and follow-through, while reinforcing the impact of early detection on mortality and quality of life.

Video Series

 In this episode title, ‘Shifting Epidemiology and Risk Factors in Colorectal Cancer,’ the moderator introduces the evolving landscape of colorectal cancer screening and highlights the growing importance of early detection.

Shifting Epidemiology and Risk Factors in Colorectal Cancer 

Welcome back to another HCP Live Peers and Perspectives series. In this episode title, ‘Shifting Epidemiology and Risk Factors in Colorectal Cancer,’ the moderator introduces the evolving landscape of colorectal cancer screening and highlights the growing importance of early detection. The faculty review current epidemiologic trends, noting declining incidence in adults over 50 alongside a concerning rise in cases among individuals aged 40 to 49. They discuss potential contributing factors, including obesity, sedentary lifestyle, dietary habits, and the possibility of a birth cohort effect. The conversation also underscores disparities in incidence and mortality among certain racial and ethnic populations, emphasizing the role of access to care and social determinants of health. Finally, the expert faculty highlight the importance of family history assessment and risk stratification in guiding appropriate screening strategies in clinical practice.

In the next episode, ‘Colorectal Cancer Screening and Surveillance Decisions,’ expert faculty emphasize that rectal bleeding in younger patients warrants a low threshold for colonoscopy, while prior polyp type (eg, hyperplastic, adenomatous) guides whether continued colonoscopy surveillance or noninvasive screening is appropriate.

 In this episode titled, ‘Shifting Epidemiology and Risk Factors in Colorectal Cancer,’ the moderator introduces the evolving landscape of colorectal cancer screening and highlights the growing importance of early detection.

Wood discussed the latest long term data from OUtMATCHat AAAAI 2026.

Conference

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Food Allergy

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Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

OUtMATCH: Omalizumab and OIT Similarly Enable Allergenic Food Consumption, With Robert Wood, MD

Brajan Budini is a medical student at the School of Clinical Medicine and Trinity College, University of Cambridge.

Budini discusses his recent study investigating the trajectory of weight regain after GLP-1 cessation, given current high discontinuation rates.

Obesity Management

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Discontinuing GLP-1 Treatment Associated With Up to 60% Weight Regain, With Brajan Budini

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

February 2026 saw new data and expert interviews from AAAAI 2026.

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6 Pulmonology Headlines You Missed in February 2026

The FDA accepted Mineralys Therapeutics’ NDA for lorundrostat in hypertension, but the selective aldosterone synthase inhibitor fell short in a phase 2 obstructive sleep apnea trial.

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Lorundrostat Secures FDA NDA Acceptance for Hypertension, Falls Short in Phase 2 OSA Trial

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

Phase 3 RAINIER exhibits positive results for povetacicept in adults with IgA Nephropathy in a 36 week interim analysis.

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RAINIER: Povetacicept Reduces Proteinuria By 52.0%

Shahinian is a Dr. Robert H and Eva M Moyad Research Professor of UrologyCo-Chief of Dow Division of Health Services ResearchProfessor of Internal Medicine, and Professor of Urology at the University of Michigan Medical School. 

Having a primary care provider may be associated with reduced emergency department utilization for patients with ESKD receiving dialysis, according to new research. 

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Having a Primary Care Provider Linked to Reduced ED Visits for ESKD, With Vahakn Shahinian

A trio of experts discuss how simplifying hepatitis B guidance could help more clinicians diagnose, treat, and support patients living with chronic infection.

Hepatology

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Empowering More Clinicians to Treat Hepatitis B

Désirée Larenas-Linnemann, MD, from Hospital Médica Sur

At AAAAI 2026, Larenas-Linnemann discusses evidence, safety, and long-term benefits of sublingual immunotherapy for allergic rhinitis and asthma.

Seasonal Allergy

Sublingual Immunotherapy for Allergy in 2026, With Désirée Larenas-Linnemann, MD

Williams explains colorectal cancer screening options, persistent barriers to uptake, and strategies to improve screening rates.

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Colorectal Cancer Screening in 2026: Progress, Gaps, and What Comes Next, With Renee Williams, MD

An economic model suggest using lower quality, but acceptable kidneys for older adults may be cost efficective and clinically valuable.

Latest News

New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children

FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

Skin of Color Savvy: Challenges and Successes in a Dermatologist’s Career, With Nicole Negbenebor, MD

Colorectal Cancer Screening and Surveillance Decisions

Shifting Epidemiology and Risk Factors in Colorectal Cancer