Justin Gregory, MD, MS, is the field medical director for autoimmune T1D at Sanofi.

Improving T1D Screening in Adult Men to Prevent Complications, With Justin Gregory, MD, MS

Despite the most recent standards of care in diabetes from the American Diabetes Association (ADA) emphasizing the importance of screening for 

, most men still go unscreened due to infrequent clinic visits.

In 2022, the Cleveland Clinic conducted a survey titled MENtion It, including 1000 US men aged ≥18 years. Based on this survey, roughly 55% of men do not undergo regular health screenings, and nearly 1 in 3 men have never been screened for various cancers or other diseases. This highlights the need for a significant overhaul in how screening is addressed, conducted, and discussed among male patients.

“I’d like for our field to move away from only reacting to disease once it’s apparent,” Justin Gregory, MD, MS, the field medical director for autoimmune T1D at Sanofi and a pediatric endocrinologist, told 

 in an exclusive interview. “If we get out in front of things and identify those disease processes before they’re really bad, outcomes can often improve. I’d like our field to start looking ahead, to see what we can identify at an early point to prepare for future issues.”

Despite historically being considered a childhood-onset disease, recent data have indicated the prevalence of adult-onset T1D worldwide. Adult T1D is also frequently associated with the typical 3 signs of childhood T1D, including elevated genetic risk, the presence of islet-specific autoantibodies, and progression to severe insulin deficiency. Given this wider awareness of adult T1D, recent publications have highlighted the need for more accurate methods of identifying the disease in this cohort.

Moreover, the preexisting conception of T1D as a childhood disease results in a substantial degree of misdiagnosis. Given that no individual clinical feature can fully distinguish between T1D and 

, many patients are assumed to have the latter, given the longstanding belief that the former presents solely in children. This can result in adult patients with T1D not knowing they have the disease until they eventually develop severe diabetic ketoacidosis (DKA), which can lead to significant complications later in life.

According to recent publications, T1D also presents more commonly in men versus women, indicating a greater need for improvements to screening among men. Gregory speaks to this as well, pointing out the value of optimizing the infrequent clinic visits common to a significant proportion of men. He emphasizes the value of early detection to drive home the need for further appointments and visits to manage the condition rather than allowing it to progress undetected.

“Let’s think about trying to detect that as early as possible, because if we do, we can potentially avoid a lot of the long-term consequences of having that condition and not knowing about it,” Gregory said. “I like to think in terms of getting on the same page about treatment goals, whether I’m the physician in the situation or the patient, so that the conversation can go in a productive direction from there.”

Editors’ Note: Gregory reports disclosures with Sanofi, Medtronic, vTv Therapeutics, Beckman Coulter Inc., and DRI Capital, Inc.

American Diabetes Association Professional Practice Committee; 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2025. Diabetes Care 1 January 2025; 48 (Supplement_1): S27–S49. 

Buggey H, Ely K. Cleveland Clinic Survey Reveals Men’s Top Health Concerns as They Age. 

. September 7, 2022. Accessed July 8, 2026. 

https://newsroom.clevelandclinic.org/2022/09/07/cleveland-clinic-survey-reveals-mens-top-health-concerns-as-they-age

Evans-Molina C, Oram RA. Type 1 diabetes presenting in adults: Trends, diagnostic challenges and unique features. Diabetes Obes Metab. 2025;27 Suppl 6(Suppl 6):57-68. 

Videos

Gregory discusses his strategies for optimizing adult male patients’ typically infrequent clinic visits to identify and forestall T1D progression.

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This page also hosts content previously published by EndocrinologyNetwork. 


Type 1 Diabetes

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.

 acceptance of a new supplemental New Drug Application (sNDA) has been announced by Arcutis Biotherapeutics for the company’s expansion of the indication for topical roflumilast cream 0.05% (Zoryve) to include infants aged 3 months to younger than 24 months living with mild to moderate atopic dermatitis.

FDA officials have assigned the medication a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027. Once approved, the expanded indication for roflumilast cream 0.05% would make it the first once-daily, nonsteroidal, targeted topical option specifically indicated for atopic dermatitis in this younger age bracket. Currently, the drug is approved for children in the 2 - 5 year range with mild to moderate disease.

“Infants with atopic dermatitis are particularly vulnerable to burdensome symptoms such as intense itch and sleep disruption, which can impact the whole family,” Lawrence F. Eichenfield, MD, of Rady Children’s Hospital San Diego and the University of California San Diego School of Medicine and an INTEGUMENT-INFANT clinical trial investigator, said in a statement.

 “Managing these symptoms can be particularly challenging for parents and caregivers due to the very limited FDA-approved treatment options as well as concerns about the use of topical steroids on infants whose skin barrier and immune system are still developing,” 

The sNDA is supported by phase 2 open-label INTEGUMENT-INFANT trial findings as well as a phase 1 pharmacokinetic analysis looking at once-daily roflumilast cream in infants between 3 months and less than 24 months of age.

 There were 101 subjects in the phase 2 study, while the phase 1 study included 19 infants. In both studies, investigators reported safety, pharmacokinetic, and efficacy data consistent with previously observed findings in older pediatric populations using this topical agent.

Eichenfield et al found, after 4 weeks of use, approximately one-third of infants successfully attained Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success. Success was defined as clear or almost clear skin and at least a 2-grade improvement from the point of baseline. More than half reached a 75% Eczema Area and Severity Index score improvement (EASI-75). Additionally, they found one-third saw success with this endpoint by the 2-week mark.

Investigators also noted improvements in scalp, while caregivers reported rapid pruritus reductions. Specifically, nearly half of infants showed clinically meaningful improvement within 10 minutes of roflumilast cream application. The medication was generally well tolerated, and there were no new safety signals seen during the 4-week study period. Among the adverse events (AEs) reported were vomiting, diarrhea, nasopharyngitis, and upper respiratory tract infection. All such AEs were not shown to be severe.

“There is a significant unmet need in this population for therapies that can be used anywhere on the body for any duration of time, including on sensitive areas such as the face and skin folds,” Eichenfield said in a statement.

 “If approved, ZORYVE cream 0.05% could provide clinicians and caregivers with an important new steroid-free treatment option that was specifically developed for infants and very young children.”

FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months. Arcutis Biotherapeutics. July 8, 2026. 

https://investors.arcutis.com/news-releases/news-release-details/fda-accepts-supplemental-new-drug-application-arcutis-zoryver-0

Smith T. New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children. HCPLive. March 10, 2026. Accessed July 8, 2026. 

https://www.hcplive.com/view/new-long-term-data-announced-roflumilast-cream-atopic-dermatitis-in-children

Articles

FDA has accepted an sNDA from Arcutis to extend topical roflumilast cream 0.05% use to infants 3 to <24 months with mild-to-moderate atopic dermatitis, with a PDUFA date of Feb 23, 2027. Data from the open-label phase 2 INTEGUMENT-INFANT study (n=101) and a phase 1 PK analysis (n=19) showed safety, PK, and efficacy consistent with older children. At week 4, ~33% achieved vIGA-AD success and >50% reached EASI-75, with rapid pruritus relief and no new safety signals. Reported AEs were mild and primarily gastrointestinal or viral.

The supplemental New Drug Application for Arcutis’ roflumilast cream 0.05% (Zoryve) is for mild to moderate atopic dermatitis in those down to 3 months.


FDA News

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.

FDA Accepts sNDA for Roflumilast Cream 0.05% in Infants Down to 3 Months with Eczema

Segment summary: In this episode titled “Mechanisms of Action Behind Advanced CSU Therapies,” the panel dives into the underlying immunology of CSU and how each advanced therapy class intervenes in the disease pathway. The panel emphasizes that clinicians must confidently reassure patients that CSU is an autoimmune disease, not an allergy, a distinction considered foundational to patient education. Mechanistically, mast cell activation in CSU can arise from autoantibodies directed against IgE itself, against the IgE receptor on the mast cell surface, or against an as-yet-unidentified internal antigen, and unfortunately, there is no clinically useful biomarker to predict which pathway predominates in an individual patient.

Mechanisms of Action Behind Advanced CSU Therapies

Each advanced therapy class is then explained in turn. Omalizumab, an anti-IgE biologic, works by binding circulating IgE directly, making it particularly effective when autoantibody-driven IgE activity dominates, but less helpful when the receptor itself is the primary autoimmune target. Dupilumab, a biologic targeting the IL-4 receptor pathway, has a less clearly defined mechanism in CSU; possible explanations include shifting the immune response away from a Th2-skewed pattern, gradually lowering IgE levels over time, or directly blocking IL-4 receptors expressed on mast cells.

Finally, remibrutinib, an oral BTK inhibitor, works downstream of receptor activation, blocking the intracellular signaling enzyme mast cells require to degranulate regardless of which upstream trigger initiated the cascade, a mechanism described as the most intuitive of the three. It is compared to a master switch that shuts down the final common pathway leading to histamine release, offering a unifying rationale for its broad effectiveness across multiple disease drivers and a clear way to explain treatment choice to patients. In the next episode, “Trial Data and Safety of Remibrutinib for CSU,” the panel reviews pivotal trial results and addresses lingering safety questions around an oral BTK inhibitor’s labeled bleeding warning.

In this episode titled “Mechanisms of Action Behind Advanced CSU Therapies,” the panel dives into the underlying immunology of CSU and how each advanced therapy class intervenes in the disease pathway.

Video Series

Segment summary: This episode titled “Updated Guidelines and the Current CSU Treatment Landscape,” reviews the recently updated international CSU treatment guideline and how it has changed clinical practice. While one-size-fits-all dermatology guidelines are viewed with some skepticism, this update is considered practical because it elevates all three advanced therapy classes to parity rather than ranking them sequentially. The stepwise approach is outlined: minimal workup, a thorough history, and first-line treatment with a second-generation H1 antihistamine dosed up to four times the standard amount, with a caution to avoid combination antihistamine-decongestant formulations at high doses due to hypertension risk.

Updated Guidelines and the Current CSU Treatment Landscape

When antihistamine monotherapy fails, roughly half of patients by the panelist’s estimate, the guideline now recommends moving to one of three advanced therapy classes: an injectable anti-IgE biologic, an injectable biologic targeting the IL-4 receptor pathway, or an oral BTK inhibitor, with cyclosporine reserved as a later option for refractory cases. Rather than a fixed hierarchy, choosing among the three advanced options is described through structured shared decision-making, presenting patients with no more than two choices at a time, starting with questions about comorbid asthma or other atopic conditions, since certain biologics carry additional approvals for those indications.

For patients without such comorbidities, the choice is framed around route of administration and speed of relief: a fast-acting oral pill taken twice daily versus an injectable that works somewhat more slowly but requires dosing only monthly or every two weeks. By the time most CSU patients reach a specialist after a diagnostic delay of two or more years, they have typically exhausted first-line therapy, making this discussion of advanced options especially timely. In the next episode, “Mechanisms of Action Behind Advanced CSU Therapies,” the panel breaks down the autoimmune pathways driving CSU and explains exactly how each of the three advanced therapy classes interrupts the disease process.

This episode titled “Updated Guidelines and the Current CSU Treatment Landscape,” reviews the recently updated international CSU treatment guideline and how it has changed clinical practice.

JAK Inhibitors, Oral Minoxidil Reshape Hair Loss Care

Benjamin Ungar, MD, director of the Alopecia Center of Excellence at the Kimberly and Eric J. Waldman department of dermatology at Mount Sinai, said the emergence of Janus kinase (JAK) inhibitors has been the single biggest advance in 

treatment over the past 2 years, reshaping care for both alopecia areata (AA) and scarring alopecia.

Ungar discussed the shift during his session, “Hair Update 2026,” at the Maui Derm NP+PA Summer 2026 conference in Colorodo Springs.

Currently, 3 oral JAK inhibitors are approved in the US for severe AA: baricitinib (Olumiant), ritlecitinib (Litfulo), and deuruxolitinib (Leqselvi).

 Ungar noted that newer anti-inflammatory approaches, including topical and off-label oral JAK inhibitors, are also beginning to move the needle on scarring alopecia, a historically difficult subtype to treat.

Ungar has published research characterizing the long-term safety of JAK inhibitors in AA, an important consideration given that treatment is typically ongoing rather than time limited. His findings, along with data from other groups, suggest that JAK inhibitor use in AA does not meaningfully increase the risk of major adverse cardiovascular events (MACE) or thromboembolic events beyond background population rates, even over several years of follow-up.

All 3 approved agents carry a US Food & Drug Administration (FDA) boxed warning for class-wide risks, including serious infection, malignancy, MACE, and thrombosis, based largely on post-marketing data from rheumatoid arthritis populations treated with a different JAK inhibitor.

 Ungar's data adds to a growing body of AA-specific evidence that has not shown new or unexpected safety signals to date.

Low-dose oral minoxidil (LDOM) has become an increasingly common option across hair loss subtypes, according to Ungar. He uses it as monotherapy in some patients and in combination with other treatments in others, applying it broadly to androgenetic alopecia and telogen effluvium alike.

Dosing typically starts at 1.25 mg for women and 2.5 mg for men, with titration upward as tolerated, Ungar said. Cardiovascular effects such as hypotension and tachycardia, along with rare pericardial effusion, remain the primary safety concerns, though Ungar noted that large-scale clinical experience has shown these events to be uncommon and that LDOM is generally well-tolerated.

The most frequent adverse effect is hypertrichosis, which Ungar counsels patients to expect before starting treatment. In his experience, most patients who develop unwanted hair growth still choose to continue therapy because of the benefit to scalp hair.

Direct-to-consumer marketing of hair growth nutraceuticals continues to expand, but Ungar said evidence should guide how clinicians position these products. Some formulations have data supporting benefit, particularly in patients with underlying nutrient deficiencies or insufficiencies that can affect the hair cycle. Ungar generally views nutraceuticals as adjunctive rather than core therapy, noting that aside from cost, there is typically little downside to their use alongside evidence-based treatment.

Ungar said severity remains the primary driver of treatment selection in AA. Mild disease is generally managed with intralesional steroid injections, while severe disease warrants systemic therapy. Moderate disease occupies a gray zone in which injections alone may be insufficient.

“Once someone is determined to be a candidate for systemic treatment, in most cases, oral JAK inhibitors are the first-line treatment,” Ungar said. “I think that we as a field should be shifting away from more traditional immunosuppressants like systemic steroids… and really should be using oral JAK inhibitors to treat patients who are systemic candidates because of the higher degree of efficacy and overall better safety profile.”

Ungar B. Hair Update 2026. Presented at Maui Derm NP+PA Summer 2026 in Colorado Springs.

FDA-approved JAK inhibitors. National Alopecia Areata Foundation. Accessed July 8, 2026. 

https://www.naaf.org/navigation-toolkit/fda-approved-jak-inhibitors/

Green L, Guttman E, Lebwohl M, et al. Exploring novel management options for alopecia areata

Published on March 3, 2026. Accessed July 8, 2026. 

https://www.ajmc.com/view/exploring-novel-management-options-for-alopecia-areata

At Maui Derm NP+PA Summer 2026, Benjamin Ungar, MD, detailed how JAK inhibitors and oral minoxidil are reshaping hair loss treatment strategy.

Dermatology

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.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Alopecia

Strategic Alliance Partnership

This review highlights the most notable dermatology news stories covered by HCPLive during the second quarter of 2026.

Plaque Psoriasis

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

Q2 2026 Recap: Dermatology News & Updates

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.

New Phase 3 COMP006 data show durable MADRS improvement in treatment-resistant depression following two doses of synthetic psilocybin.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

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COMP360 Psilocybin Sustains Depression Benefit Through 26 Weeks

In the final episode, ‘Hypercortisolism Recognition and Action in Resistant Hypertension,’ the panelists explored key takeaways from their discussion on the evolving role of hypercortisolism in resistant hypertension and cardiometabolic disease.

Hypercortisolism Recognition and Action in Resistant Hypertension

In this episode, ‘The Future of Hypercortisolism Care in Cardiology,’ the panelists explore how increasing awareness of hypercortisolism may reshape cardiovascular practice, education, and multidisciplinary care models.

The Future of Hypercortisolism Care in Cardiology

This episode, titled ‘Emerging Therapies for Hypercortisolism,’ features panelists discussing the evolving treatment landscape for hypercortisolism and the growing body of research aimed at improving outcomes for patients with resistant hypertension, diabetes, and other cardiometabolic complications.

Emerging Therapies for Hypercortisolism

In ‘Management and Treatment Goals in Hypercortisolism,’ our panel explores practical approaches to managing patients with hypercortisolism-associated hypertension following diagnosis and discusses the importance of addressing the underlying cause of disease.

Management and Treatment Goals in Hypercortisolism

In this episode, ‘Hypercortisolism Insights from MOMENTUM and CATALYST Trials,’ the panelists explore the design, findings, and clinical implications of the MOMENTUM and CATALYST studies and discuss how emerging evidence is reshaping the understanding of hypercortisolism in resistant hypertension and difficult-to-control type 2 diabetes.

Hypercortisolism Insights from MOMENTUM and CATALYST Trials

This episode, titled ‘Guidelines and Barriers to Hypercortisolism Screening in Cardiology,’ features panelists discussing how recent clinical evidence and updated expert recommendations may influence the recognition and screening of hypercortisolism in patients with resistant hypertension and cardiovascular disease.

Guidelines and Barriers to Hypercortisolism Screening in Cardiology

In ‘Hypercortisolism Screening in Cardiology Practice,’ our panel explores the evolving role of cardiologists in identifying patients at risk for hypercortisolism and initiating appropriate screening evaluations.

Hypercortisolism Screening in Cardiology Practice

In this episode, ‘Hypercortisolism and Other Secondary Causes of Hypertension,’ the panelists explore how cardiologists should think about hypercortisolism in the context of other secondary causes of hypertension, particularly primary aldosteronism.

Latest News

Improving T1D Screening in Adult Men to Prevent Complications, With Justin Gregory, MD, MS

FDA Accepts sNDA for Roflumilast Cream 0.05% in Infants Down to 3 Months with Eczema

Mechanisms of Action Behind Advanced CSU Therapies

Updated Guidelines and the Current CSU Treatment Landscape

JAK Inhibitors, Oral Minoxidil Reshape Hair Loss Care