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and joined the MJH Life Sciences team in February 2023. She attended Kent State University and earned a Bachelor of Science degree in journalism with minors in public relations and creative writing. She enjoys making and listening to music, reading, and spending time with her cats, Astrid and Marceline.

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Catch up on dermatology news, highlights, and insights from the past 24 hours.

Daily Derm Times: May 5, 2025

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This Melanoma Monday, we take a look at melanoma care in the US, from treatments to persistent gaps in access, early detection, and long-term outcomes.

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Researchers conducted a review of adherence behaviors for patients with dermatological diseases and provided an update on management strategies.

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Final Thoughts: The Importance of Comparative Studies in AD

Panelists offer concluding insights and emphasize the critical role of comparative studies in advancing atopic dermatitis treatment strategies.

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This week is Hidradenitis Suppurativa Awareness Week.

POLL: What Percentage of the Population Has Hidradenitis Suppurativa?

US Food and Drug Administration (FDA) officially approved prademagene zamikeracel (pz-cel)

 (Zevaskyn; Abeona Therapeutics), marking a significant advancement for individuals living with recessive dystrophic epidermolysis bullosa (RDEB). Developed by Abeona Therapeutics, pz-cel is the first autologous, cell-based gene therapy specifically designed to address the genetic cause of RDEB, offering a new therapeutic option for a disease with historically limited treatment choices.

“The past 2 years have transformed EB management, with 3 distinct FDA approvals reflecting different topical strategies—topical gene delivery, botanical pharmacologic therapy, and now autologous cell sheet-based gene therapy," said Dermatology Times Editor and Chief Christopher Bunick, MD, PhD. "Pz-cel, the first FDA-approved autologous cell sheet-based gene therapy for RDEB, expands our therapeutic toolkit, allowing dermatologists to better tailor care to EB subtype and individual patient needs.”

“Today’s approval of [pz-cel] represents a pivotal moment in the treatment of RDEB, answering the call of people living with the clinical, economic, and human impact of this devastating disease,” said Vish Seshadri, PhD, MBA, Chief Executive Officer of Abeona, in a news release. “We have heard from the RDEB community that there is a persistent unmet need to reliably address RDEB wounds, especially those that are chronic and prone to infection. Through a single surgical application, [pz-cel] can now offer people with RDEB the opportunity for wound healing and pain reduction in even the most severe wounds, as evidenced by the results from our pivotal phase 3 study.”

RDEB is a rare, inherited skin disorder characterized by mutations in the COL7A1 gene. This mutation disrupts the production of functional collagen VII, a critical protein needed to anchor the layers of the skin together. As a result, patients suffer from severe skin fragility, leading to chronic blistering, persistent wounds, debilitating pain, risk of life-threatening infections, and a heightened susceptibility to aggressive squamous cell carcinoma.

"In terms of diseases that require greater research and attention, conditions such as congenital melanocytic nevi, genetic skin diseases like epidermolysis bullosa and ichthyosis, and vascular anomalies associated with genetic syndromes remain areas of critical need," Mercedes E. Gonzalez, MD, co-chair of the Society for Pediatric Dermatology (SPD) Conference, said in a 

. "These rare disorders currently have no definitive cure, and increased research efforts could lead to improved treatments and better outcomes for affected children."

Pz-cel represents a novel therapeutic approach. It is created by harvesting a patient’s own skin cells, correcting the genetic defect ex vivo with a functional COL7A1 gene, and then expanding these corrected cells into sheets of keratinocytes. These gene-corrected cell sheets are surgically applied to chronic wound sites in a one-time procedure, where they express collagen VII locally, promoting more durable skin adhesion and wound healing.

"This is a very exciting therapy for patients with RDEB," Bernard Cohen, MD, professor of pediatrics and dermatology, Johns Hopkins University School of Medicine, told 

. "There have been few ways to effectively treat the skin erosions in these patients that may cover more than 30% of their skin surface at one time. Pz-cel allows for the patient's own skin cells to be genetically modified to produce functional Type VII collagen sheets that allow for rapid healing of ulcerated areas of skin. This allows for a dramatic improvement in the quality of life for these patients starting in early childhood," added Cohen.

The FDA’s approval decision was supported by a 

, including results from the pivotal phase 3 VIITAL study (

). Clinical findings demonstrated significant and sustained wound healing after a single application of pz-cel. In some cases, benefits were observed for up to 8 years following treatment. Safety data from these trials indicated a favorable profile, with no new safety signals emerging during the long-term follow-up periods.

“After many years of work, it is great to see this FDA approval of [pz-cel]. The EB patients deserve all that we can do for them,” said M. Peter Marinkovich, MD, associate professor of dermatology and co-principal investigator of the VIITAL study, in the release.

Seshadri added, “We are grateful to the patients, their families, and caregivers for their support of [pz-cel]. We express our gratitude to debra of America for their unwavering support throughout the development journey, in particular, for their interactions with the FDA in support of [pz-cel] and on behalf of the EB community that have helped make today’s regulatory approval possible. We are also thankful for the clinical study investigators, study site personnel, and the entire Abeona team for their collective commitment and determination through the development process, and contribution to this milestone achievement. We look forward to providing the RDEB community access to now-approved [pz-cel].”

The approval of pz-cell represents a historic step for RDEB patients and for the field of regenerative medicine. As the first autologous gene-corrected cell therapy approved for this indication, pz-cel may not only transform the clinical management of RDEB but also pave the way for future innovations in personalized, gene-targeted treatments.

In addition to its clinical promise, pz-cel has been recognized through multiple FDA designations, including Regenerative Medicine Advanced Therapy (RMAT), Breakthrough Therapy, Orphan Drug, and Rare Pediatric Disease designations. These designations not only highlight the therapy’s potential but also underscore the urgent, unmet medical need for more effective RDEB treatments.

With the approval of pz-cel, Abeona Therapeutics may also be eligible to receive a Priority Review Voucher (PRV), a regulatory incentive designed to encourage the development of therapies for rare pediatric diseases.

Beyond pz-cel, Abeona Therapeutics is advancing a pipeline of gene therapies, including adeno-associated virus (AAV)-based programs targeting severe ophthalmic diseases. Their ongoing research and development efforts continue to focus on addressing unmet needs in rare, life-threatening conditions.

US FDA approves zevaskyn (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB). News release. Abeona Therapeutics. Published April 29, 2025. Accessed April 29, 2025. 

https://investors.abeonatherapeutics.com/press-releases/detail/303/u-s-fda-approves-zevaskyn-prademagene-zamikeracel 

Abeona Therapeutics announces FDA acceptance of BLA resubmission of pz-cel for the treatment of recessive dystrophic epidermolysis bullosa. News release. Abeona Therapeutics. Published November 12, 2024. Accessed April 29, 2025. 

https://investors.abeonatherapeutics.com/press-releases/detail/294/abeona-therapeutics-announces-fda-acceptance-of-bla

The FDA has approved prademagene zamikeracel (pz-cel), a groundbreaking autologous, cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). Developed by Abeona Therapeutics, pz-cel addresses the genetic cause of RDEB by correcting the COL7A1 gene defect in a patient's skin cells, promoting wound healing and pain reduction. Clinical trials demonstrated significant and sustained benefits, with no new safety concerns. This approval marks a significant advancement in regenerative medicine and offers hope for future personalized gene-targeted treatments for rare genetic disorders.

The FDA approved pz-cel, a groundbreaking gene therapy for recessive dystrophic epidermolysis bullosa, transforming treatment options for patients.

FDA Approves First Gene Therapy for RDEB

 (Dupixent; Regeneron and Sanofi) for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older who have not previously reached controlled disease status with H1 antihistamine treatment.

The approval marks the introduction of the first targeted therapy for CSU in more than a decade.

“[Dupilumab] is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over 10 years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease," said George D. Yancopoulos, MD, PhD,  board co-chair, president, and chief scientific officer at Regeneron. "With this FDA decision, [dupilumab] is now approved for 7 chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions. We look forward to bringing [dupilumab] to the more than 300,000 CSU patients in the US with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options.”

Dupilumab, an interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor, has already been approved for multiple type 2 inflammatory conditions, including atopic dermatitis, asthma, eosinophilic esophagitis, and prurigo nodularis.

The approval comes after years of research and regulatory engagement. In October 2023, the 

 for the initial supplemental Biologics License Application (sBLA),

 stating that additional efficacy data were needed to support approval. However, the agency did not identify concerns regarding dupilumab’s safety or manufacturing process.

In response to the CRL, Regeneron and Sanofi resubmitted the sBLA, which was 

 That resubmission included updated efficacy and safety data from a third phase 3 trial, LIBERTY-CUPID Study C, in biologic-naïve patients with CSU uncontrolled by antihistamines.

LIBERTY-CUPID: Building the Case for Approval

The LIBERTY-CUPID (NCT04180488) clinical development program, which supported the approval, consisted of 3 randomized, double-blind, placebo-controlled phase 3 trials.

: Conducted in biologic-naïve CSU patients whose symptoms remained uncontrolled despite H1 antihistamine therapy.

: Conducted in patients who were not only uncontrolled on H1 antihistamines but also refractory or intolerant to omalizumab (Xolair; Novartis).

Across the trials, patients receiving dupilumab experienced significant improvements in CSU symptoms. In Study C, which provided the pivotal data for approval, nearly half of participants achieved well-controlled disease status, marked by meaningful reductions in itch severity and hives, compared with placebo. These findings aligned with earlier results seen in Study A, reinforcing the drug’s efficacy.

Adverse events observed during the studies were consistent with dupilumab’s known safety profile. The most common adverse effects included injection site reactions and COVID-19 infections, which occurred in both treatment and placebo groups. No new safety signals were identified.

Filling a Decade-Long Gap in CSU Treatment

Prior to today’s approval, patients with CSU who did not respond to H1 antihistamines had limited treatment options, most notably omalizumab, an anti-IgE monoclonal antibody.

Dupilumab’s approval fills this gap as the first new targeted therapy for CSU in more than 10 years, and the only approved biologic that inhibits IL-4 and IL-13 signaling, key drivers of type 2 inflammation.

"It’s been 10 years with no innovation for chronic urticaria… now to switch gears for a new approval that the dermatology specialists are familiar with… ultimately, the patients benefit," said Jason Hawkes, MD, MS, a board-certified dermatologist and co-owner, chief scientific officer, and investigator at the Oregon Medical Research Center in Portland, Oregon, in a 

"Most of these patients—around 50%—don’t respond to antihistamines, even at high-doses," Hawkes added.

The companies are expected to launch Dupixent for CSU in the near future.

"It's going to bring patients into a specialty dermatology that hasn't really been managing these patients. We're going to pick up new observations, new insights," Hawkes said. "Dermatology specialists are familiar and comfortable with this therapy. They use it for other indications, but now they have a familiar therapy for a disease that they know how to recognize but weren't historically treating. I think [dupilumab] comes into that landscape where they
have the comfort with the therapy that's had a very good safety record having, in some indications, approval down to even 6 months of age."

Dupixent® (dupilumab) approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU). News release. Globe Newswire. April 18, 2025. Accessed April 18, 2025. 

https://www.globenewswire.com/news-release/2025/04/18/3064133/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-New-Targeted-Therapy-in-Over-a-Decade-for-Chronic-Spontaneous-Urticaria-CSU.html

Regeneron and Sanofi provide update on Dupixent (dupilumab) SBLA for chronic spontaneous urticaria. News release. Regeneron Pharmaceuticals Inc. October 20, 2023. Accessed April 18, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-provide-update-dupixentr-dupilumab-sbla

Dupixent (dupilumab) sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria (CSU). News release. Regeneron. November 15, 2024. Accessed April 18, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-review-treatment-chronic

Dupilumab for the treatment of chronic spontaneous urticaria in patients who remain symptomatic despite the use of H1 antihistamine and who are naïve to, intolerant of, or incomplete responders to omalizumab (LIBERTY-CSU CUPID). ClinicalTrials.gov ID NCT04180488. Last updated December 11, 2024. Accessed April 18, 2025. 

https://clinicaltrials.gov/ct2/show/NCT04180488

Dupilumab becomes the first targeted therapy approved for chronic spontaneous urticaria in more than a decade.

FDA Approves Dupilumab for Adolescents and Adults With H1 Antihistamine-Refractory Chronic Spontaneous Urticaria

Dermatology Times Case-Based Peer Perspectives

vancing Approaches to Atopic Dermatitis Management

, Naiem Issa, MD, PhD, reviewed 3 complex patient cases of atopic dermatitis (AD). Issa is a board-certified dermatologist and the medical director of research and academics at Forefront Dermatology in Vienna, Virginia, and an assistant professor of dermatology at the University of Miami Miller School of Medicine in Florida, George Washington School of Medicine and Health Sciences in Washington, DC, and West Virginia School of Osteopathic Medicine in Lewisburg. He took a deep dive into how to select between topical, biologic, and systemic therapies for individual patients with varying severity of AD.

Issa first reviewed the case of an Asian girl aged 10 years with a long-standing history of moderate to severe AD and comorbid mild asthma. Diagnosed with AD when she was 2, she had previously responded to emollients and topical corticosteroids but experienced worsening flares over the past year, particularly during colder months. Her physical examination revealed erythematous, scaly, excoriated patches on classic AD sites, including the elbows, knees, face, and neck, with notable lichenification.

Despite consistent topical use, including corticosteroids, her condition remained uncontrolled. The disease significantly impacted her quality of life with disruptive sleep, emotional distress, and social embarrassment due to facial involvement. Given the severity, chronicity, comorbidity (asthma), and failure of topical monotherapy, the patient was considered a strong candidate for systemic treatment.

Dupilumab (Dupixent; Sanofi and Regeneron) was selected due to its age-appropriate approval of as young as 6 years and mechanism of action targeting IL-4 and IL-13 via IL-4 receptor alpha blockade. Dupilumab provides systemic immunomodulation without the safety concerns associated with traditional immunosuppressants or systemic corticosteroids. Issa emphasized dupilumab’s favorable safety profile: no boxed warning, no lab monitoring, and low rates of adverse events such as conjunctivitis or arthralgia. Topicals may still be used adjunctively, and for this age group, nonsteroidal options such as tapinarof (Vtama; Dermavant) and roflumilast (Zoryve; Arcutis Biotherapeutics) are viable. Overall, dupilumab was chosen based on its targeted mechanism, pediatric indication, and ability to address systemic atopic disease with minimal safety trade-offs.

Issa presented a case of an African American man aged 24 years with mild AD and allergic rhinitis. He was diagnosed with AD when he was 8. The patient’s symptoms had been well controlled with emollients and over-the-counter hydrocortisone. However, over the past 6 months, he experienced worsening pruritus and lesion spread to additional flexural sites (elbows, knees, ankles), now involving 5% to 10% of body surface area (BSA). New occupational stress and increased physical activity appeared to be exacerbating factors. Exam findings included dry, hyperpigmented lesions with mild excoriation.

The patient expressed dissatisfaction with his current regimen, citing persistent itch and sleep disturbance. Notably, he preferred to avoid systemic therapy, indicating a desire for an effective topical option.

Given the mild to moderate severity and patient preference, the discussion focused on newer nonsteroidal topical therapies. Among the options—roflumilast 0.15%, ruxolitinib 1.5% (Opzelura; Incyte), and tapinarof 1% cream—the patient chose tapinarof. The patient’s reasoning centered on tapinarof’s remittive effect: Data from clinical trials demonstrate sustained disease control for approximately 83 days after discontinuation. According to Issa, this aligned well with the patient’s desire to reduce application burden and manage flares more effectively over time.

Tapinarof’s mechanism as an aryl hydrocarbon receptor agonist, along with its steroid-sparing potential and efficacy in patients with skin of color, made it a suitable choice. The patient chose treatment with tapinarof cream and achieved favorable results.

The third case involved a White female hairstylist aged 32 years with asthma, allergic rhinitis, and moderate to severe AD with worsening disease. She has 20% BSA across her hands, elbows, knees, ankles, neck, and face—placing her in the severe category. Her current regimen includes daily emollients and tralokinumab (Adbry; LEO Pharma), which she started 6 months ago, but she reports persistent itch, sleep disruption, and diminished quality of life. Occupational exposure to irritants in the salon environment, especially given her hand involvement, adds complexity to management.

Despite being on a biologic agent, her disease remains uncontrolled, and she expresses a desire to switch therapies while remaining on a biologic. Given her full atopic triad of AD, allergic rhinitis, and asthma, dupilumab was selected as the next-line treatment. According to Issa, its efficacy across the atopic spectrum and specific data from the 

, which demonstrated statistically significant improvement in hand and foot AD, made it an appropriate choice, especially considering her occupational hand involvement.

Other systemic options, including JAK1 inhibitors (abrocitinib [Cibinqo; Pfizer] and upadacitinib [Rinvoq; AbbVie]), were discussed but declined by the patient. Nemolizumab (Nemluvio; Galderma), an IL-31 inhibitor, lacked the data this patient prioritized. Additionally, ruxolitinib cream was ruled out due to her greater than 20% BSA and the associated boxed warning.

The case discussion also reviewed transitioning between biologics. Clinical trial protocols recommend a 5–half-life washout, but in practice overlapping therapies can be considered, depending on safety profiles and patient burden, according to Issa. In this case, dupilumab was initiated, aiming for broader disease control and occupational relief.

register to attend the Revolutionizing Atopic Dermatitis (RAD) conference

 in Nashville, Tennessee, June 6-7. Use code DT40 for 40% off your RAD 2025 registration.

Naiem Issa, MD, PhD, reviewed three complex atopic dermatitis (AD) cases, focusing on personalized treatment strategies. The first case involved a 10-year-old Asian girl with moderate to severe AD and asthma, where dupilumab was chosen for its systemic benefits and safety profile. The second case featured a 24-year-old African American man with mild AD, opting for tapinarof cream due to its remittive effect and patient preference. The third case involved a 32-year-old White female hairstylist with severe AD, where dupilumab was selected for its efficacy across the atopic spectrum and occupational considerations.

In a recent Dermatology Times Case-Based Peer Perspectives custom video series, Naiem Issa, MD, PhD, reviewed 3 complex patient cases of atopic dermatitis. 

Using Real-World AD Cases to Pick the Right Therapy for Each Patient

Vitiligo is a condition that presents unique challenges for both patients and clinicians alike. A recent 

Case-Based Roundtable custom event, “Vitiligo in Focus: Case-Based Insights and Strategies for Optimizing Treatment,” explored various aspects of vitiligo management through case-based presentations and shared clinical experiences. Led by Michael Cameron, MD, FAAD, founder of Cameron Dermatology PLLC and an assistant clinical professor in the department of dermatology at Mount Sinai in New York City, experts discussed ways to better understand the condition, focusing on treatment strategies, patient care considerations, and emerging therapies.

Experts started by discussing the prevalence of the condition, stating that vitiligo is more prevalent than many clinicians realize. The condition can manifest across all age groups and skin types, often presenting as a cosmetic concern that can significantly impact patients' quality of life. The roundtable participants emphasized the importance of recognizing the emotional and psychological aspects of vitiligo. One participant noted, “I think the burden is really on us for kids, particularly. I don't think a 30-year-old with vitiligo I'm spending 10 minutes talking about their feelings about it”. This highlights the need for tailored approaches that acknowledge the variable impact of vitiligo on different patient populations.

The treatment of vitiligo is complex, particularly in non-facial areas such as the hands. The discussion underscored several treatment modalities, including topical therapies, phototherapy, and systemic agents.

 Tacrolimus, a topical calcineurin inhibitor, has been used in vitiligo treatment, but its greasiness, potential for skin burning, and perceived lack of efficacy were noted as drawbacks.

 Narrowband UVB phototherapy, alone or in combination with topical treatments, was identified as a valuable therapeutic option. However, access to phototherapy can be limited by insurance coverage and the availability of specialized equipment.

Ruxolitinib cream, a topical Janus kinase (JAK) inhibitor, has emerged as a promising first-line treatment for vitiligo. The roundtable participants shared positive experiences with ruxolitinib cream, noting its tolerability and efficacy. One clinician stated, "If it's covered, it's always my first line option.”

For widespread or rapidly progressing vitiligo, oral JAK inhibitors like upadacitinib were considered, although their use is currently off-label. Access to these medications can be challenging due to insurance restrictions, with some insurers considering them as biologics and imposing stringent prior authorization requirements.

Effective patient communication is crucial in vitiligo management. Clinicians emphasized the importance of setting realistic expectations, as repigmentation is a slow process that can take months to achieve. Regular follow-up appointments are essential to monitor treatment response, manage potential adverse effects, and provide ongoing support.

The roundtable discussion also highlighted the significance of proper application techniques for topical medications. One participant described using a white pencil to delineate the treatment area and instructing patients to take a photo to ensure correct application. This meticulous approach underscores the importance of addressing compliance issues, which can be a common reason for treatment failure.

Special Populations and Global Perspectives

The roundtable discussed that the management of vitiligo in pediatric patients and individuals with skin of color requires special consideration. The emotional impact of vitiligo can be particularly profound in children, necessitating a sensitive and supportive approach. In patients with skin of color, vitiligo can present unique diagnostic and therapeutic challenges.

The roundtable also shed light on the global disparities in vitiligo care. Participants discussed the stigma associated with vitiligo in certain cultures, as well as the limited access to effective treatments in resource-poor settings. One clinician shared their experience of practicing in Nigeria, where vitiligo is often heavily stigmatized: “It's very interesting how they treat people, especially kids, with vitiligo or albinism. It's like a curse to the family if kids have this.”

The roundtable discussion provided valuable insights into the multifaceted management of vitiligo. By sharing clinical experiences and discussing treatment strategies, the participating clinicians highlighted the importance of individualized patient care, effective communication, and a comprehensive approach that addresses both the physical and emotional aspects of this challenging condition. As research in vitiligo continues to advance, the insights from this discussion can help inform clinical practice and improve outcomes for patients worldwide.

Vitiligo presents significant challenges in management, impacting patients' quality of life and requiring tailored treatment strategies. Experts emphasize the importance of understanding the emotional and psychological aspects, especially in children. Treatment options include topical therapies, phototherapy, and emerging agents like ruxolitinib cream. Systemic JAK inhibitors are considered for extensive cases, though access is limited. Effective patient communication and follow-up are crucial for successful outcomes. Special considerations are necessary for pediatric patients and individuals with skin of color, with global disparities in care highlighting the need for comprehensive, individualized approaches.

The significance of patient education and setting realistic expectations for the often-slow process of repigmentation in vitiligo treatment was a key focus of the discussion.

Matthew Salois, PhD

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