Funke Pickering, MD, senior medical director at Inovalon.

Social risk factors are playing a significant role in driving greater hospitalization rates and healthcare costs among patients with

. In a 2024 analysis, lower income, lower educational attainment, and greater comorbidity burden were strongly associated with increased hospitalizations and spending among patients with MDD.

Hospitalization rates were nearly twice as high among Medicaid patients compared with those with commercial insurance (29.6% vs 14.7%), with annual costs exceeding $21,000 vs $14,500, respectively. Additional findings showed that individuals living in areas with greater access to mental health specialists experienced higher short-term hospitalization rates, potentially reflecting improved identification and management of more severe disease.

In this Q&A, Funke Pickering, MD, senior medical director at Inovalon, discusses how social determinants of health influence hospitalization risk in MDD, where current risk adjustment and care models fall short, and what clinicians can do to better identify and address these upstream drivers of utilization and cost.

 How do social risk factors, such as income, education, and comorbidity burden, shape hospitalization risk among patients with MDD?

 The data is clear; patients with MDD who face greater socioeconomic disadvantage are not just harder to reach, but they’re getting sicker, cycling through higher-acuity care, and costing the system more. In our research using real-world data, hospitalization among patients with MDD was meaningfully higher for Medicaid than commercial populations.

 We also observed…lower income and educational attainment were associated with higher hospitalization rates and total costs, and a greater comorbidity burden was associated with increased hospitalization risk.

Clinically, this matches what many of us see. Depression care is rarely “just a prescription.” Many patients need both medication management and psychotherapy…but coverage for both is not always the same. Income can often decide whether a patient can sustain their treatment or if they’ll fall through the cracks.

Comorbidities add another layer of complexity because they make mental health easier to overlook. Physicians have limited time, and patients who are trying to balance diabetes, heart failure, autoimmune disease, or other chronic conditions need more than a quick wellness visit. Mental health conditions, unfortunately, are too often treated in siloes, making continuity of care a challenge for clinicians.

 What practical steps can clinicians take to identify social risk factors that may increase the likelihood of hospitalization in patients with depression?

 By screening more consistently, this communicates to patients that their mental health is an important part of their overall health, while also allowing providers to identify changes in a patient's circumstances that may place them at risk.

While most clinicians working with high-risk patients already have a sense of when something is off…they’re often at a loss for what to do next. Connecting patients to the right resources is a challenge, and navigating health plan benefits and community-based services requires coordination that many clinicians simply don't have the bandwidth for. There needs to be an intervention further upstream before they walk into the office that starts with their health plan identifying, documenting, and communicating any barriers with the patient’s care team.

Once they leave, clinicians lose visibility: Did they fill the prescription? Could they afford it? Will transportation or scheduling make follow-up possible? I’ve seen many cases where the treatment plan appeared appropriate, but we later learn, when the patient is readmitted or ends up in the emergency room, that it wasn’t feasible because they couldn’t keep up with the regimen.

It's important to be honest about access. Provider directories can be misleading, and there is evidence that even when a region appears to have mental health providers, actual appointment availability can be far lower. A 2023 study found that 81% of entries in physician directories across 5 large national health insurers contained inaccuracies or inconsistencies, raising concerns that patients may not have a reliable, legitimate referral pathway.

It shouldn’t be up to physicians alone to do the screening. Health systems, payers, government agencies, and community organizations must work together.

 How should clinicians incorporate screening for social determinants of health into routine care for patients with MDD?

 Mental health and social risk screening should be as routine as taking vital signs and medication reconciliation during a care visit.

While screenings are more common than they used to be, they’re often not embedded in a comprehensive, standardized process. Patients may be asked a few high-level questions, but the assessment rarely captures critical factors such as food security, housing stability, financial strain, or language barriers, which can change within weeks and quickly derail an otherwise sound treatment plan. That’s why screening should be integrated into the overall health assessment and diagnosis, not treated as a one-time check-the-box step.

I also wouldn’t limit screenings to wellness visits, since many patients skip routine appointments and only seek care when something is wrong. Screenings should be conducted regularly throughout the year.

 How do current risk adjustment and care models fall short when social risk factors are not adequately accounted for?

 A big limitation is that most risk adjustment models are still built around diagnosis coding. They rely on ICD-10 clinical conditions and do not meaningfully incorporate social drivers of health, even when those drivers are documented. Utilizing ICD-10 Z codes that document the context around a patient’s health, including social and environmental risk factors, is one way to track conditions over time. Though historically, the use of ICD-10 Z codes has not been incentivized or reimbursed when treating vulnerable patients.

For example, you can screen a patient and identify food or housing insecurity, but those findings often aren’t captured in a way that “counts," and reimbursement still largely follows disease-based coding.

The practical issue is that 2 patients can have the same MDD diagnosis and look similar in a model, while their real-world utilization can vary based on their life circumstances. That is exactly what our research showed. Social and economic conditions were linked with hospitalization and spending, and models that ignore those factors underestimate expected resource use.

This dynamic is most evident in value-based care settings. When caring for high social risk populations, visitation patterns can be unpredictable as there’s a higher likelihood that they won’t come in unless they’re already sick of experiencing a crisis episode. Even if clinical staff have access to social risk data, it’s often not linked to claim outputs.

 What role can data analytics and population health tools play in helping clinicians identify patients with depression who are at higher risk due to social factors?

 Population health tools help clinical staff across the care continuum identify patients with MDD who also have high comorbidity burden, repeated no-show visits, complex medication regimens, and known barriers like transportation or language needs. This visibility allows teams to route them to proper care management earlier and get ahead of crises. When implemented correctly, predictive analytics can support proactive follow-up.

When treating depression, this matters because the condition often hides in plain sight. People may be struggling to sleep enough or eat well, losing interest in activities they once enjoyed, yet still pushing through. Stigma is still real, and some people suffer in silence, meaning the data we have on MDD could actually be worse than what we see.

 What strategies should clinicians and health systems prioritize to address the social drivers of depression-related hospitalizations?

 I see 2 recurring failures that drive hospitalization. First, we too often fail to screen for and diagnose depression early enough. Without routine screening, we miss early-stage MDD and fail to identify patients at risk of admission. Second, we are not consistently screening for and documenting social drivers of health, including the barriers patients face and how those barriers impact outcomes.

Managing these barriers should be a part of the patient’s treatment plan, not an afterthought. We shouldn't have to wait until a patient arrives at the hospital during a mental health crisis when the system already knew they hadn't filled their last 3 prescriptions.

Teigland C, Mohammadi I, Agatep BC, Boskovic DH, Velligan D. Relationship between social determinants of health and hospitalizations and costs in patients with major depressive disorder. 

Butala NM, Jiwani K, Bucholz EM. Consistency of Physician Data Across Health Insurer Directories. 

Articles

Socioeconomic disadvantage materially increases hospitalization risk and total cost of care in major depressive disorder, with Medicaid populations demonstrating substantially higher admission rates and annual spending than commercially insured peers. Lower income, lower educational attainment, and higher comorbidity burden correlate with greater utilization, reflecting gaps in sustained access to combined pharmacotherapy and psychotherapy and the complexity of competing chronic disease demands. Routine, longitudinal screening for both depression and social needs is positioned as foundational, alongside payer–provider–community coordination, improved documentation (including Z codes), and analytics-enabled population health workflows to anticipate crises.

Pickering discusses data linking social risk factors to hospitalization and costs in MDD and implications for screening and care models.


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Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Social Risk Factors Drive MDD Hospitalization, With Funke Pickering, MD

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Image Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has cleared Tandem Diabetes Care’s Control-IQ+ automated insulin delivery technology for use during pregnancy complicated by type 1 diabetes, expanding the label for the company’s t:slim X2 and Tandem Mobi systems. 

According to the company, this makes Control-IQ+ the first commercially available automated insulin delivery system in the US with a pregnancy indication.

“Glycemic goals are tighter during pregnancy,” said Jordan Pinsker, MD, chief medical officer at Tandem Diabetes Care. “The higher time in the pregnancy-specific glucose range seen with Control-IQ can help improve pregnancy outcomes.”

The clearance was based on the CIRCUIT randomized clinical trial, published in 

 in 2025. In the multicenter study, pregnant individuals with type 1 diabetes were assigned either to a t:slim X2 pump using Control-IQ technology or to standard therapy consisting of multiple daily injections or insulin pump therapy with continuous glucose monitoring. 

From 16 weeks’ gestation to the end of pregnancy, participants using Control-IQ spent 12.6% more time in the prespecified pregnancy glucose target range of 63 to 140 mg/dL, about 3 additional hours per day, than those receiving standard care, according to the press release and trial publication.

Type 1 diabetes in pregnancy remains a high-risk clinical setting. Current guidelines recommend stringent glucose targets during gestation because hyperglycemia is associated with congenital anomalies, preeclampsia, large-for-gestational-age birthweight, neonatal hypoglycemia, and other complications.^2 Continuous glucose monitoring has improved management in this population and is recommended by major professional societies, but achieving targets remains difficult for many patients despite intensive insulin therapy.^2,3

Automated insulin delivery has been increasingly adopted outside pregnancy, supported by randomized trials showing improved time in range and lower mean glucose levels compared with sensor-augmented pump therapy or standard care in children and adults with type 1 diabetes.^4 

However, pregnancy has posed a specific regulatory and clinical gap because algorithms developed for nonpregnant users may not reflect gestational insulin resistance, tighter glucose thresholds, and fetal safety considerations. The new clearance helps to address this gap, although its use remains contingent on pairing the pump with a continuous glucose monitoring system suitable for pregnancy, according to the updated indication in the company announcement.

Control-IQ+ is an advanced hybrid closed-loop system that adjusts basal insulin based on continuous glucose monitor readings and predicted glucose values and can deliver correction boluses when glucose is expected to exceed a set threshold. Before this pregnancy expansion, the technology was already indicated for management of type 1 diabetes in patients aged 2 years or older and type 2 diabetes in adults, according to the release.

Important questions remain. The company said maternal and neonatal outcomes were similar overall between groups, although they favored Control-IQ; detailed outcome data and absolute event rates are best interpreted from the published trial rather than the press release alone.

Donovan LE, Lemieux P, Dunlop AD, et al. Closed-loop insulin delivery in type 1 diabetes in pregnancy: the CIRCUIT randomized clinical trial. 

. 2025;334(24):2176-2185. doi:10.1001/jama.2025.19578  

American Diabetes Association Professional Practice Committee. 15. Management of diabetes in pregnancy: Standards of Care in Diabetes. 

Feig DS, Donovan LE, Corcoy R, et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. 

. 2017;390(10110):2347-2359. doi:10.1016/S0140-6736(17)32400-5  

Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. 

. 2019;381(18):1707-1717. doi:10.1056/NEJMoa1907863

FDA clearance expands Tandem Diabetes Care’s Control-IQ+ automated insulin delivery label to include pregnancy complicated by type 1 diabetes on t:slim X2 and Tandem Mobi, positioning it as the first US commercial AID system with a pregnancy indication. The decision is supported by the CIRCUIT randomized trial showing a 12.6% absolute increase in time-in-range for 63–140 mg/dL (≈3 additional hours/day) from 16 weeks’ gestation through delivery versus standard therapy. Benefits appeared within one week and were consistent across baseline HbA1c and prior therapy.

FDA cleared Control-IQ+ for pregnancy in type 1 diabetes, expanding automated insulin delivery options during gestation.

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The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Type 1 Diabetes

FDA News

FDA Clears Control-IQ+ for Use in Pregnancy With Type 1 Diabetes

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A single dose of lonvoguran ziclumeran (lonvo-z) reduced 

attack rates by 87% compared with placebo in the phase 3 HAELO trial, according to topline 6-month efficacy data released by Intellia Therapeutics.¹

“The results we are seeing from lonvo-z demonstrate its potential to eliminate the need for chronic medication and related challenges,” said HAELO lead investigator Aleena Banerji, MD, professor at Harvard Medical School and director of clinical care at the Center for Drug and Vaccine Allergy at Massachusetts General Hospital, in a statement.1 “If approved as a one-time treatment, I would expect lonvo-z to be an appealing option for many patients.”

HAELO was a randomized, double-blind, placebo-controlled trial evaluating a single 50 mg intravenous dose of lonvo-z, an in vivo CRISPR-based gene editing therapy formerly known as NTLA-2002, in 80 patients aged ≥16 years with type I or II HAE.¹ A total of 52 patients received lonvo-z and 28 received placebo; 71% were receiving long-term prophylaxis (LTP) at baseline and discontinued these therapies before dosing.¹ The primary endpoint assessed the mean monthly attack rate during weeks 5 through 28.

During the 6-month efficacy period, the mean monthly attack rate was 0.26 in the lonvo-z arm compared with 2.10 in the placebo arm (

 <.0001), meeting the primary endpoint.¹ All key secondary endpoints were also met, including a 62% rate of patients who were both attack-free and LTP-free, compared with 11% in the placebo group (

 <.0001).¹ At data cutoff, all patients treated with lonvo-z, including those who crossed over after week 28, remained off prophylactic therapy.¹

Safety findings were consistent with earlier-stage data. The most common treatment-emergent adverse events, all reported as mild or moderate, included infusion-related reactions, headache, and fatigue. No serious adverse events were observed in the treatment arm during the primary observation period.¹

HAE, a condition characterized by recurrent, potentially life-threatening angioedema attacks driven by dysregulated bradykinin production, remains a rare genetic disorder affecting approximately 1 in 50,000 individuals.² Despite the availability of targeted therapies, including plasma kallikrein inhibitors such as lanadelumab and berotralstat, management often requires chronic administration and does not fully eliminate breakthrough attacks.³

⁴ The need for frequent injections or daily oral therapy contributes to treatment burden and adherence challenges.

Lonvo-z is designed to address this unmet need through in vivo gene editing. Using CRISPR/Cas9 technology, the therapy targets and inactivates the KLKB1 gene in hepatocytes, reducing kallikrein production and downstream bradykinin generation.¹ This mechanism builds on established clinical validation of kallikrein inhibition in HAE but introduces the possibility of sustained effect after a single administration.

The program has received multiple regulatory designations, including Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations from the US Food and Drug Administration, as well as PRIME designation in the European Union.¹ Intellia has initiated a rolling biologics license application (BLA) submission, with completion anticipated in the second half of 2026 and potential US launch in 2027 if approved.

Although the magnitude of effect observed in HAELO is notable, interpretation remains constrained by the limited follow-up duration of 6 months for the primary endpoint. Longer-term durability, potential delayed adverse effects, and real-world generalizability remain key unanswered questions, particularly given the permanent genomic modification underlying the therapy. In addition, the trial required discontinuation of baseline prophylaxis before dosing, which may not fully reflect clinical practice patterns.

If confirmed and approved, lonvo-z would represent a new therapeutic paradigm in HAE, shifting from chronic suppression of disease pathways to potentially durable modification of the underlying biology.1 However, clinicians will likely weigh efficacy against uncertainties related to long-term safety, reversibility, and patient selection in considering integration into practice.

“As the first phase 3 data reported for an in vivo gene editing therapy, today’s HAELO results represent a profound milestone for Intellia, the broader CRISPR and precision medicine fields, and most importantly, the HAE community,” said Intellia President and Chief Executive Officer John Leonard, MD, in the press release.

“These data affirm lonvo-z’s potential, with one dose, to offer prolonged freedom from both attacks and the need for ongoing therapy.”

Intellia Therapeutics. Intellia Therapeutics reports positive phase 3 results in hereditary angioedema, marking a global first for in vivo gene editing. April 27, 2026. 

https://ir.intelliatx.com/news-releases/news-release-details/intellia-therapeutics-reports-positive-phase-3-results

Learn About Hereditary Angioedema. DiscoverHAE. 

https://www.discoverhae.com/what-is-hereditary-angioedema

Lanadelumab Cuts Monthly HAE Attack Rates in Real-World 3-Year Study. HCPLive. Published on July 22, 2025. Accessed April 27, 2026. 

https://www.hcplive.com/view/lanadelumab-cuts-monthly-hae-attack-rates-in-real-world-3-year-study

Derman C. FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE. HCPLive. Published on December 12, 2026. Accessed April 27, 2026. 

https://www.hcplive.com/view/fda-approves-oral-berotralstat-children-aged-2-11-years-hae

Intellia Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for Lonvoguran Ziclumeran (lonvo-z) as a One-Time Treatment for Hereditary Angioedema - Intellia Therapeutics. Intellia Therapeutics. Published on April 27, 2026. Accessed April 27, 2026. 

https://ir.intelliatx.com/news-releases/news-release-details/intellia-therapeutics-initiates-rolling-submission-biologics

Phase 3 HAELO topline data show a single 50 mg IV dose of lonvoguran ziclumeran achieved an 87% reduction in mean monthly hereditary angioedema attack rates versus placebo through weeks 5–28 (0.26 vs 2.10; P<.0001). Most participants discontinued baseline long-term prophylaxis pre-dose, and 62% became both attack-free and prophylaxis-free versus 11% with placebo. Safety was consistent with prior studies, with mainly mild-to-moderate infusion reactions, headache, and fatigue, and no treatment-arm serious adverse events in the primary period.

Phase 3 HAELO data show significant reductions in attack rates and treatment burden with a single-dose in vivo CRISPR therapy; BLA submission underway with FDA.

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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.

Single-Dose Lonvoguran Ziclumeran Cuts HAE Attacks by 87% in Phase 3 Trial

Michelle Bichchau Nguyen, MD, MBA, MPH, is an associate professor of dermatology at Tufts University School of Medicine and the director of Mohs Micrographic Surgery.


Dermatologic surgeries require clear communication and guidance by those performing the procedure, with patient satisfaction being an invaluable consideration in such circumstances.

A positive experience among patients treated in outpatient dermatology clinics is not only based on rapport with clinicians but also on such elements as optimal utilization of space, the support of staff members, and optimal wait times. In a review of best practices related to patient experience, Michelle Nguyen, MD, MBA, MPH, associate professor of dermatology at Tufts University School of Medicine and director of Mohs Micrographic Surgery, touched on this topic in an interview following a session presented at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

The following Q&A interview transcript summarizes her responses to inquiries by 

 In your talk, you gave several pearls to improve patient satisfaction and enhance patient experience in dermatology. What were the notable takeaways from your portion of this session regarding surgery?

Correct, and I'm currently the director of dermatology surgery at Tufts Medical Center, which is part of Tufts University School of Medicine. So my portion covered some of the top tips for providing the optimal patient experience for people undergoing surgical procedures. And you know, we always think that it's the surgical outcomes that matter the most for patients, like how things look, making sure there are no complications, and, obviously, that's very important.

But what patient care even more than that is how they are treated before, during, and after the visit. Clear explanation of what the procedure is, a detailed, step-by-step, explanation, giving them the opportunity to ask questions, raise their concerns, and set realistic expectations [is key]. There are no scarless surgeries. We always tell patients that we use the best techniques. But [then we say] here are the things that you can do at home to help your scars look better and in the in the future, if you have any concerns at all about how your scar looks or feel, we're happy to see you back anytime, and patients are really comforted by knowing that you're there for them throughout the surgical procedure, but also the post op care and beyond.

So having that relationship that extends beyond the actual procedure is really important, and having well-trained staff that can comfort and care for the patient, as you're doing the procedures, answering common patient questions, and doing patient education when you're not there are also a very key part of that optimal patient experience for surgery.

These do sound like important strategies for improving patient experiences, especially with regard to your comments about staff guidance.

Yes, and you know, people underestimate the role of staff in crafting that optimal surgical experience, because our staff actually spends way more time with the patients than we do. Oftentimes, our surgical procedures take is actually a very small part of that care experience. So you should treat your staff well, train them well. Empower them to help patients whenever they can, without your input.

If you were looking at only one of these pearls you provided, what would you say you've seen in your practice that has really worked for patients?

We like to give information. We like to educate, and we think that the more we talk, the more information we're providing, but that might not be the information that the patient is looking for. I think a key part of crafting the optimal patient experience is actually asking the patient what their concerns are, what they worry about in the aftercare, and then actually hearing about their concerns and finding ways to address them. So, my number one tip is to ask and listen.

How much does clear communication about treatment expectations influence patient satisfaction, especially for chronic skin conditions?

It’s hugely important because when there's a mismatch between what the patient expects and reality, that is when the patient gets unhappy. Part of our job as clinicians, as with educators, is to set realistic expectations, especially in this age of social media and ChatGPT, where people get information from a very diverse range of sources of information. Some are correct, and some are not.

You just want to be clear that this is a chronic condition, we will manage it for you. These are the options. These are the escalating treatments that we will try. And it takes time. Oftentimes, these are things that you struggle with for years. It's going to take us a bit of time to put you on the right regimen, for your skin condition, for your quality of life, for your goals of care, and so establishing that treatment plan and milestones ahead really helps set expectations so that the patients feel like you understand and that you're there for them for the long term.

What would you say is the biggest driver of patient dissatisfaction in dermatology practices?

 We are a high-volume practice. We see many patients in a relatively short period of time. Therefore, it is very crucial for us to take the time to make patients feel like they are listened to, and that we are spending adequate time to provide the care and listen to them. I always tell my colleagues to sit down. You know, just the fact that you're sitting down and having a conversation instantly makes patients feel like you are spending the time, and it's worth it to wait three months to see you right, and paying the co-pays and all of that. Establishing that rapport and sitting down and giving the patient the time and space to talk and express that concern is very important.

What would you what advice would you give to an early-career dermatologist who wants to build a more patient-centered practice?

To build on what I said about listening to the patient, don't take it personally. You know, when we were first starting out, whenever we have a suboptimal patient review, it really hurt. You take it as a bad note on your performance and who you are as a clinician, and your worth as a doctor. I would say that's not true, right?

Patients respond because they're hurt before they felt let down, and some of those words can hurt because we're people too, but don't let don't take that so personally. It's a learning opportunity, and you try to take every negative comment as a small grain of truth. You should focus on that grain of truth; you get better. And eventually, you find that your interactions with patients just automatically get better over time.

The quotes contained in this summary were edited for the purposes of clarity.

Nguyen had no relevant financial disclosures of note.

Nguyen M, et al. U005 Top Tips from Top Docs: Pearls to Improve Patient Satisfaction and Enhance Patient Experience. Session presented at: 2026 American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, CO.

Queen D, Trager MH, Samie FH, et al. Patient Satisfaction of General Dermatology Providers: A Quantitative and Qualitative Analysis of 38,008 Online Reviews. JID Innov. 2021 Aug 19;1(4):100049. doi: 10.1016/j.xjidi.2021.100049. PMID: 34909746; PMCID: PMC8659734.

Optimizing dermatologic surgery experience depends as much on process and communication as on clinical outcomes. Pre-, intra-, and post-procedure counseling should include stepwise explanations, opportunities for questions, and realistic expectations, including unavoidable scarring and practical scar-optimization strategies. Longitudinal availability for postoperative concerns reassures patients and reinforces trust. Staff training and empowerment are central, given their disproportionate patient-facing time. In high-volume settings, perceived attentiveness—asking about patient concerns, actively listening, and even sitting during conversations—mitigates dissatisfaction and strengthens rapport.

In this interview, Nguyen discusses improving patient experiences during surgical procedures in dermatology practices, such as Mohs surgery.

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The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

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Q&A: Tips to Improve Dermatologic Surgery Experience, With Michelle Bichchau Nguyen, MD, MBA, MPH

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.

A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration (FDA) for the broadening of roflumilast cream 0.05% (Zoryve) to treat mild to moderate atopic dermatitis in infants down to the age of 3 months.

The sNDA submission, announced on April 27 by Arcutis Biotherapeutics, was backed by data from a pair of open-label studies assessing once-daily roflumilast cream 0.05% in infants aged 3 to less than 24 months with mild to moderate atopic dermatitis. The disease itself is the most prevalent form of eczema in the US, impacting an estimated 9.6 million children and 16.5 million adults.

“Atopic dermatitis often begins within the first year of life, yet treatment options for infants are extremely limited,” Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC and INTEGUMENT-INFANT clinical trial investigator, said in a statement.

Parents and caregivers are often faced with difficult decisions around managing these symptoms, including concerns about the long-term use of topical steroids. Because their immune system and skin barrier are still developing, infants are particularly vulnerable to the burdensome symptoms of atopic dermatitis, including visible disease and intense itch that can disrupt sleep and significantly impact both infants and their caregivers.”

The disease often manifests during infancy, imposing considerable burden on both patients and their caregivers. The disease presents unique treatment considerations among infants, including a higher body surface area-to-body mass ratio heightening systemic exposure risk from topical medications.

The data leading to this sNDA first included a phase 1 pharmacokinetic study in 19 infants demonstrating a safety, efficacy, and pharmacokinetic profile over 4 weeks. These findings aligned with data from prior research in older pediatric populations. In the larger phase 2 INTEGUMENT-INFANT trial, 101 infants were recruited and roflumilast cream’s safety, tolerability, and efficacy were evaluated across 4 weeks of treatment.

The medication was shown by Gonzalez and colleagues to be well tolerated, with patients’ most commonly reported adverse events (AEs) being nasopharyngitis, diarrhea, upper respiratory tract infection, and vomiting.

 These AEs were described as consistent with the broader INTEGUMENT program experience.

In the infants completing the full 4-week treatment course (n=96), investigators found 34.4% attained success in their Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score, defined as a ‘clear’ or ‘almost clear’ score with at least a 2-grade improvement from baseline.

 The team further noted 49% succeeded in achieving a vIGA-AD score at the 4-week mark.

Improvements were observed by Gonzalez et al as early as Week 1. Among infants showing scalp involvement at baseline, 67.5% saw vIGA-scalp success at the 4-week mark, and 58.3% attained an EASI-75 score at Week 4.

 The team further noted notable caregiver-reported itch outcomes, including that 72.7% of infants met the threshold for Worst Scratch Itch Numeric Rating Scale success at Week 4. Rapid onset was observed in these infants, as suggested by a 46.6% response rate on the Dynamic Pruritus Scale by 10 minutes post-application.

Roflumilast cream 0.05% is already FDA-approved for mild to moderate AD in patients aged 2 to 5 years.

 This new move could expand its indication if it receives approval by FDA officials for this newer age range.

“Safe and effective long-term therapies suitable for use anywhere on the body, including sensitive regions such as the face and skin folds, remain an important unmet need for infants with atopic dermatitis,” Gonzalez said in her statement.

 “If approved, [roflumilast] cream 0.05% could offer a much-needed, non-steroidal treatment option developed specifically for very young children, including infants.”

Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months. Arcutis Biotherapeutics, Inc. April 27, 2026. 

https://investors.arcutis.com/news-releases/news-release-details/arcutis-submits-supplemental-new-drug-application-fda-zoryver

Smith T. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years. HCPLive. October 6, 2025. Accessed April 27, 2026. 

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

Arcutis submitted an sNDA to expand roflumilast cream 0.05% for mild-to-moderate atopic dermatitis to infants aged ≥3 months. The filing is supported by open-label phase 1 PK (n=19) and phase 2 INTEGUMENT-INFANT (n=101) data over 4 weeks, addressing infant-specific exposure concerns. Treatment was well tolerated, with AEs including nasopharyngitis, diarrhea, URTI, and vomiting. Efficacy signals included vIGA-AD success in 34.4% (n=96), early improvement by Week 1, EASI-75 in 58.3%, and rapid caregiver-reported itch relief.

This supplemental New Drug Application for roflumilast cream (Zoryve) to the FDA was supported by the INTEGUMENT-INFANT open-label study.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Roflumilast Cream 0.05% sNDA Submitted to FDA for Infants Down to 3 Months with Atopic Dermatitis

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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.

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Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


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Andrea Cipriani, MD, PhD, from the University of Oxford.

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Roflumilast Cream 0.05% sNDA Submitted to FDA for Infants Down to 3 Months with Atopic Dermatitis