Category Archives: Dermatology

Dermatology

More Vitiligo Patients Respond with Longer Use of Opzelura – Managed Healthcare Executive

Longer-term use of Opzelura was well tolerated, with no serious treatment-related adverse events, according to a poster presented at the annual dermatology meeting.

Patients with vitiligo treated with Incytes Opzelura (ruxolitinib) largely improved or remained stable in their responses through week 52, according to a pooled analysis of two phase 3 studies. The results were presented during a poster presentation at the annual meeting of the American Academy of Dermatology Association in New Orleans, March 17 to March 20, 2023.

Vitiligo is a disease that causes the loss of skin color. Vitiligo occurs when cells that produce melanin die or stop functioning. Vitiligo affects people of all skin types, but it may be more noticeable in people with darker skin. The exact cause is unknown, but it is believed to be an autoimmune condition.

Worldwide prevalence estimates of vitiligo vary widely, ranging from 0.004% to 2.28%. One study suggests that about 40% of patients with vitiligo may be undiagnosed.

Incytes Opzelura is the first FDA-approved treatment for this condition and is the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. The approved approved it for this indication in June 2022. For patients over the age of 12. Over-activity of the JAK signaling pathway is believed to drive inflammation involved in vitiligo.

The approval was based on data from the pivotal phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), evaluating the safety and efficacy of Opzelura versus vehicle in people with vitiligo at week 24. In the studies, treatment with Opzelura resulted in improvements in Vitiligo Area Severity Index (VASI) scores, which represent improvements in facial and total body repigmentation. At week 24, about 30% of patients treated with Opzelura achieved 75% or more improvement in the facial VASI, the primary endpoint, compared with a non-medicated cream in 8% of patients in the TRuE-V1 study and 13% of patients in the TRuE-V2 study.

Investigators, led by John E. Harris, M.D., Ph.D., associate professor in the department of Dermatology at the University of Massachusetts Chan Medical School, wanted to evaluate the changes in improvement or stability of facial vitiligo among patients who used Opzelura for 52 weeks.

At week 24, about 30% of patients treated with Opzelura achieved 75% or more improvement in the facial VASI, the primary endpoint, compared with a non-medicated cream in 8% of patients in the TRuE-V1 study and 13% of patients in the TRuE-V2 study. At week 52, about 50% of Opzelura-treated patients achieved 75% or more improvement. Additionally, at week 24, more than 15% of patients treated with Opzelura achieved 90% or more improvement in the facial VASI. At week 52, about 30% of Opzelura-treated patients achieved this improvement.

Opzelura was well-tolerated through 52 weeks of treatment. A total of 58.6% of patients experienced 1 treatment-emergent adverse event (AE), most commonly COVID-19 (7.3%), application site acne (6.5%), nasopharyngitis (5.8%), and application site pruritus (5.3%). Application site reactions were the most common treatment-related adverse events; these included acne (5.6%) and pruritus (4.7%), all of which were mild or moderate. No serious adverse events were considered related to treatment. There were no clinically significant changes in hemoglobin or platelet levels.

The study was funded by Incyte.

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Dermatology

CeraVe Puts Dermatologists on Parade in New Orleans to Reinforce … – PR Newswire

All sun exposure, even indirect or unintentional, can still impact the skin. In fact, according to the International Ultraviolet Association, normal glass (as used in windows) is transparent to UV radiation, so almost all UVA light will pass through glass.3 Yet, a recent CeraVe survey of Americans4 showed that sitting near windows is one of the moments where they are least likely to apply sunscreen, with 29% citing when working indoors by a window and 28% while driving two different behaviors that expose skin to UV rays. The same survey found that 23% say they are least likely to apply sunscreen when it is cloudy, and a whopping 64% even admitted they don't think they need to wear sunscreen every day. However, like brushing teeth, it's critical to apply daily for optimal skin health.

"Wearing sunscreen every day is one of the easiest, yet most important ways to keep skin healthy, but it is often overlooked as a regular step in a skincare routine, particularly when it is not a hot, sunny day," said board-certified dermatologist Dr. Nkem Ugonabo, M.D., M.P.H. "Regardless of the season, weather, location or activities, applying SPF daily is essential to help protect skin from UV exposure which will have both short- and long-term benefits for the skin. This can be as simple as incorporating CeraVe's moisturizer with broad-spectrum SPF 30 into a skincare routine each morning."

A clinical L'Oral study released in the Journal of Drugs in Dermatology5found that daily sun exposure not only damages skin cells, but also significantly reduces the level of ceramide 3 in the skin and impairs the quality of essential ceramides 1, 3 and 6-II in the skin barrier. Ceramides, which are lipids found in the skin barrier, are a critical component of skin barrier protection, making CeraVe AM Facial Moisturizing Lotion a key to a healthy morning skincare routine. Enriched with these essential ceramides and hyaluronic acid for hydration, this broad-spectrum sunscreen helps protect from short-term and long-term damage caused by exposure to UV rays, while simultaneously hydrating and restoring the skin barrier.

"As part of our commitment to providing therapeutic skincare for all, CeraVe is making dermatological advice more accessible and digestible so that everyone has the tools they need for achieving healthy skin," said Gene Coln, Global Senior Vice President, Medical Relations & Communications for CeraVe at L'Oral. "Dermatologists are both our biggest advocates and the most trusted resources for consumers, so by pairing them with some of the internet's most popular names, we are expanding our reach of critical sun care education and ultimately, helping people improve their daily skincare habits for healthier skin."

CeraVe goes beyond traditional marketing to educate consumers on skin health. Extensive information about the science of skin, skin types and common skin concerns is easily accessible through the brand's website and social pages. Plus, authentic collaborations with dermatologists and other healthcare professionals further help drive and empower consumers to make the best decisions for their skin. From quizzes and self-assessments to a range of resources and products all to help consumers understand their skin and choose the right products for their specific needs.

CeraVe AM Facial Moisturizing Lotion with SPF 30 is one of the many products in the full range of dermatologist-developed therapeutic skincare products with three essential ceramides, including cleansers and body moisturizers. For more skincare tips and product information, visit CeraVe at http://www.cerave.com and on Facebook, Instagram, TikTok and Twitter.

1IQVIA, ProVoice Survey, 12 months ending November 20222The American Academy of Dermatology Sunscreen FAQ: https://www.aad.org/media/stats-sunscreen3International Ultraviolet Association:https://iuva.org/UV-FAQs/4This survey was conducted online within the United States by OnePoll on behalf of CeraVe from April 16, 2020 April 21, 2020 among 2,000 U.S. adults ages 18 and older.5Barresi, Rebecca, et al. "Alteration to the Skin Ceramide Profile Following Broad-Spectrum UV Exposure." Journal of drugs in dermatology: JDD 21.1 (2022): 77-85.

About CeraVe

Founded in 2005 and developed with dermatologists, CeraVe is the first and only brand to offer a complete line of products containing essential ceramides and MVE technology to help restore the skin's natural protective barrier. CeraVe has a full line of skincare products to follow the dermatologist-recommended steps of: cleanse, treat, moisturize, and protect. The brand's mission is to provide therapeutic skincare for all. For more information, visit the brand on Facebook, Instagram or Twitter or at http://www.cerave.com.

SOURCE CeraVe

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Dermatology

FDA Approves Retifanlimab-Dlwr for the Treatment of Metastatic or … – Dermatology Times

The US Food and Drug Administration (FDA) has approved Incyte Corporations retifanlimab-dlwr (Zynyz) for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adults.1 The FDA approved Incytes Biologics License Application for MCC treatment with retifanlimab-dlwr, a humanized monoclonal antibody targeting programmed death receptor-1,under accelerated approval based on tumor response rate and duration of response (DOR). According to Incyte, continued approval of retifanlimab-dlwr for MCC may be contingent on verification and description of clinical benefit in confirmatory trials.

The FDAs approval of retifanlimab-dlwr is based on data from Incytes POD1UM-201 clinical trial (NCT03599713), an open-label, multiregional, single-arm study that evaluatedretifanlimab-dlwrin adults with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy. Out of patients who had never received chemotherapy (n=65), retifanlimab-dlwr as monotherapy demonstrated an objective response rate (ORR) of 52% (95% confidence interval: 40-65) determined by independent central reviewusing RECIST v1.1.

"For those of us who have significant cutaneous oncology practices, the treatment of MCC has always been a challenge. Although we have treated this serious skin cancer with Mohs surgery for decades, local recurrences and metastases have always been a challenge. Incytes long-awaited FDA clearance of Zynyz for metastatic or recurrent locally advanced MCC provides our patients a long-needed adjunctive treatment approach," said David J. Goldberg, MD, JD, medical director of Skin Laser and Surgery Specialists of New York and New Jersey; director of cosmetic dermatology and clinical research at Schweiger Dermatology Group in New York, New York; and clinical professor of dermatology and past director of Mohs Surgery and Laser Research at the Icahn School of Medicine at Mount Sinai in New York, New York.

Complete response was observedin 12 patients (18%), and 22 patients (34%) showed partial response. Among the responding patients, the DOR ranged from 1.1 to 24.9+ months,76% (26/34) experienced a DOR of 6months or longer, and 62% (21/34) experienced a DOR of 12 months or longer by landmark analysis.

Some serious adverse events (AE) were observed in 22% of patients who received retifanlimab-dlwr. The most frequent serious AEs ( 2% of patients) were fatigue, arrhythmia, and pneumonitis. Due to AEs, 11% of patients discontinued retifanlimab-dlwr. The most common AEs (10%) observed in patients were fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea.

Patients receivedretifanlimab-dlwr 500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, for up to 24 months. Tumor response assessments were performed every 8 weeks for the first year of therapy and 12 weeks afterward.

The primary endpoint of POD1UM-201 was ORR determined by an independent central radiographic review using RECIST v1.1. Secondary endpoints included DOR, disease control rate, progression-free survival, and overall survival, as well as observed safety and pharmacokinetics.

Retifanlimab is also being studied in other POD1UM clinical trials for the treatment of squamous cell carcinoma of the anal canal.

Reference

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Dermatology

Cancer Treatment’s Checkpoint Inhibitors Are Causing Skin-Related … – Managed Healthcare Executive

Checkpoint inhibitors, such as Keytruda (pembrolizumab) and Opdivo (nivolumab), are playing a major role in cancer treatment. But they also produce side effects that affect the skin. Steven Chen, M.D., M.P.H., M.H.P. Ed., said dermatologists need to work with oncologists to manage the side effects so patients can stay on checkpoint inhibitors.

Immunotherapies, specifically immune checkpoint inhibitors, have provided patients with a life-saving option for many cancers. Checkpoint proteins are part of the normal immune system, and they work to keep the immune response measured and controlled. But checkpoint proteins also steer the immune system away from attacking cancer. Drugs that block checkpoint proteins unleash the immune system's T cells so they identify and kill cancer cells.

Several different types of checkpoint inhibitor drugs are now being used to treat many types of tumors and blood cancers, including Keytruda (pembrolizumab), Opdivo (nivolumab) and Tecentriq (atezolizumab). But toxicity from these therapies can affect almost every organ system. Skin conditions, such as dermatitis, psoriasis, eczema, pruritus (itchy skin), are one of the most common adverse events related to checkpoint inhibitors.

Skin-related adverse events are likely to increase as the number of FDA- approved checkpoint inhibitors increase and as various combinations get used, Steven T. Chen, M.D., M.P.H., M.H.P. Ed., vice chief of education in the Department of Dermatology at Massachusetts General Hospital in Boston, said today at a presentation at the annual meeting of the American Academy of Dermatology.

Since the approval of the first checkpoint inhibitor Yervoy (ipilimumab) in 2011 to treat patients with advanced melanoma approvals have steadily increased. New combinations especially for solid tumor and next-generation checkpoint inhibitors are in development.

But there is also likely to be variability in patient response to the various therapies and the type of reactions patients have, said Chen. In fact, of the patients with melanoma who are treated with Yervoy, 44% had a dermatological adverse event whereas only 12% of patients with non-small cell lung cancer patients who are treated with Keytruda had dermatological adverse event.

Toxicities most often occur in the first three months of treatment with checkpoint inhibitors, but can arise at any time during or even several months after treatment stops. Some patients experience rashes after just one dose of a checkpoint inhibitor. For other patients, the adverse event could occur after treatment stops. Patients can also experience more severe forms of skin adverse events such as Stevens-Johnson syndrome/toxic epidermal necrolysis, which can be life-threatening

As we see this increase in the use of checkpoint inhibitors, the toxicities that can occur from them are becoming more and more obvious for us as dermatologists who have to understand how to treat these patients, Chen said.

Chen said more research and a better understanding is needed to identify the dermatology adverse events caused by checkpoint inhibitors. It will be important, he said, for dermatologists to work with oncologists to address the toxicities in a way that allows patients to remain on their oncology treatments.

When treating patients with dermatology adverse events from checkpoint inhibitors, Chen said dermatologist should avoid immunosupression and possibly limit the strength of systemic steroids.

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Dermatology

19th Annual Bouchet Conference Recognizes Diversity and … – Yale University

The 19th Annual Bouchet Conference on Diversity and Graduate Education, hosted by the Office for Graduate Student Development and Diversity in the Graduate School of Arts and Sciences, will take place on March 31-April 1, 2023. This years theme The Role of the Academy in Preserving a Democracy will delve into the ways in which the academy, and graduate education in particular, prepares future leaders for service tosociety.

Named for Edward Alexander Bouchet, the first African American doctoral recipient in the United States, the Edward Alexander Bouchet Graduate Honor Society recognizes outstanding scholarly achievement and promotes diversity and excellence in doctoral education and the professoriate. The Bouchet Society was inaugurated on Thursday, September 15, 2005, with a simulcast ceremony held at Yale University and Howard University. There will be 122 inductees this year from 19 Bouchet Graduate Honor Society chapterinstitutions.

Yales Graduate School hosts an annual induction ceremony and simultaneous conference featuring panel presentations and poster sessions from members of the honor society on topics ranging from artificial intelligence to Black feminist literature. The conference will feature a keynote address by this years Bouchet Leadership Award Medal recipient David A. Thomas, President of Morehouse College. Yale will induct six new members to its chapter during the ceremony: William D. Shipman II, MD, PhD, dermatology resident and postdoctoral fellow in the Yale Department of Dermatology; Eric Glover, MMUF PhD, assistant professor adjunct at Yale David Geffen School of Drama; Ngozi Akingbesote, PhD candidate in cellular and molecular physiology; Sandy Chang, MD, PhD, professor of laboratory medicine, pathology, and molecular biophysics and biochemistry; Mariam O. Fofana, MD, PhD, postdoctoral associate in the Department of Epidemiology of Microbial Diseases at the Yale School of Public Health and clinical instructor in emergency medicine at the Yale School of Medicine; and Paola Figueroa-Delgado, PhD candidate in the Department of CellBiology.

The conference will also feature an award ceremony honoring this years Bouchet Graduate Honor Society Distinguished Service Award recipient Karen P. DePauw, Vice President and Dean for Graduate Education at VirginiaTech.

Brief bios of this years Yale Bouchet Graduate Honor Society inductees can be foundbelow:

William D. ShipmanDermatology

William D. Shipman III MD, PhD is a Dermatology resident and postdoctoral fellow in the Yale Department of Dermatology. His research and clinical interests focus on skin of color, wound healing, and hidradenitis suppurativa. He is originally from North Carolina and is a proud graduate of Morehouse College in Atlanta, GA, obtaining a Bachelor of Science degree in Biology. From there, he completed an MD-PhD program at the Weill Cornell/Rockefeller/ Sloan-Kettering Tri-Institutional program in NYC, receiving a PhD in Immunology- studying autoimmune skin diseases and specially discovering that immune cells are dysfunctional in lupus skin, working with Dr. Theresa Lu- a Yale Medicine MD/PhD alumna. During graduate school he also worked on projects in skin fibrosis and lymph node fibroblast function in immunity. At Weill Cornell he was involved in creating the Black and Latino Men in Medicine organization, which has since resulted in consultation from other academic centers. He completed a preliminary year in Internal Medicine at Yale-New Haven Hospital and is currently completing his residency in Dermatology with a combined postdoctoral fellowship component. His postdoctoral work will be done with Dr. Henry Hsia- Professor of Plastic Surgery and Founder of Yale Regenerative Wound Healing Center, studying the role of extracellular vesicles in wound healing and hidradenitis suppurativa. In addition to his clinical and research efforts, Dr. Shipman serves as an advocate to promote diversity, equity, and inclusion within his department and within Dermatologynationally.

Eric M. GloverDramaturgy and DramaticCriticism

Eric M. Glover, MMUF PhD, is an assistant professor adjunct at Yale David Geffen School of Drama, where he practices dramaturgy and dramatic criticism. Glover is the author of African-American Perspectives in Musical Theatre (London: Bloomsbury Publishing Plc, 2023), where he reads representative musicals by and about Black peoplefrom Pauline Elizabeth Hopkins to Stewclosely. Glover is also editing Manifestos for BlackTheatre, Then and Now, a special section of TheatreHistory Studies, with Isaiah Matthew Wooden at Swarthmore. A member of the advisory board for the Web site Extended Play: TheaterBeyond the Theater and also a member of the editorial board for the scholarly journal Studies in Musical Theatre. Glover is also serving as a production dramaturg at Yale Repertory Theatre for Christina Anderson's play the ripple, the wave thatcarried me home. Black Theater History in the Making at Yale School of Drama, Black Women Playwrights, Race and the American Musical from Jerome Kern to Jay Kuo, and Topics in Casting comprise courses taught. Glover is also proud to be the first-ever self-identified African-American dramaturgy and dramatic criticism faculty member at the School of Drama in itshistory.

Ngozi AkingbesoteCellular and MolecularPhysiology

Ngozi is a candidate for the Ph.D. in Cellular and Molecular Physiology with a concentration in Cancer Metabolism at Yale University. Her research focuses on uncovering the mechanisms by which exercise improves therapeutic responses to immunotherapy in triple-negative breast cancer preclinical models. Her first author paper revealing, A precision medicine approach to metabolic therapy for breast cancer in mice, is published in Communications Biology. Ngozi was awarded the Yale Presidents Public Service Fellowship in 2021, where she got the opportunity to work with the Sickle Cell Disease Association of America (Michelles House), a Connecticut-based organization that seeks to use prevention strategies to enhance the quality of life and well-being of the community affected by sickle cell disease (SCD). Additionally, Ngozi was awarded one of the Yale Deans Emerging Scholars Research Awards in 2022. Currently, Ngozi serves as the Outreach chair for the Yale BBS Diversity and Inclusion Collective (YBDIC) where she works to leverage resources within Yales network to create STEM education opportunities for minority undergraduate, community school, and post-baccalaureate students. Ngozi also serves as a Public Service Fellow with Yale McDougal Graduate Student Center, where she helps create opportunities for graduate students to interact with the New Haven community through communityservice.

Sandy ChangTelomere Biology and MolecularDiagnostics

Dr. Sandy Chang is a physician-scientist with a research focus on telomere biology and a clinical interest on molecular diagnostics. He has been an important contributor for over two decades in advancing our understanding of how telomeres, repetitive sequences that cap the ends of eukaryotic chromosomes, protect chromosomal ends from being recognized as damaged DNA. The Chang lab has generated many unique mouse models of telomere dysfunction to address innovative questions in both the aging and cancer fields. For example, his lab was the first to generate a mouse model of human Werner Syndrome that recapitulated many of its clinical aging phenotypes. His lab has published their findings in prestigious scientific journals including Nature, Science and Cell. Dr. Chang has been a direct mentor to many PhD students who have gone on to have productive academic research careers. At Yale College, he teaches two First Year Seminars, Topics in Cancer Biology and Perspectives in Biological Research. In both classes, students learn to read and present primary scientific literature and write research proposals that they use to secure summer research funding. As the Associate Dean of STEM Education at Yale College, Dr. Chang is also the director of the Science, Technology and Research (STARS) Programs. STARS supports successful integration of women and underrepresented minorities into Yale STEM classes and laboratories through peer mentorship, professional development workshops and experiential research opportunities. In this capacity, Dr. Chang has increased by over 300% the number of URM and FGLI undergraduates participating in STARSPrograms.

Mariam FofanaEpidemiology of MicrobialDiseases

Mariam O. Fofana is a Postdoctoral Associate in the Department of Epidemiology of Microbial Diseases at the Yale School of Public Health and a Clinical Instructor in Emergency Medicine at the Yale School of Medicine. Her research focuses on the application of quantitative epidemiologic methods such as mathematical modeling to guide the control of infectious disease threats in under-resourced settings and marginalized populations. Her previous work includes estimating the cost-effectiveness of interventions to prevent and treat HIV in South Africa and quantifying the impact of changes in tuberculosis treatment delivery on transmission. Her current work focuses primarily on immune responses, transmission dynamics and socioeconomic impact of SARS-CoV-2 in an urban informal settlement in Brazil. She is determined to make global health more equitable and sustainable through her research as well as education and advocacyefforts.

Paola Figueroa-DelgadoCellBiology

Paola Figueroa-Delgado is a Ph.D. Candidate in the Department of Cell Biology at the Yale School of Medicine. Her research focuses on studying the underlying mechanisms mediating neuronal remodeling in Caenorhabditis elegans. Her thesis work will increase our understanding of fundamental processes that shape the nervous system and will provide insights into how neurodevelopmental disorders may arise. Paola is a recipient of the National Institutes of Health National Research Service Award Predoctoral Fellowship which supports her thesis work and training. In addition, she is the recipient of Yales Annie Le Fellowship for her contributions to science and to the Yale community. Beyond her thesis work, Paola serves as the Director for the Yale Biological and Biomedical Sciences Diversity and Inclusion Collective (YBDIC), an initiative that aims to engage, empower, and advance underrepresented minorities in the biological and biomedical sciences. Through YBDIC, Paola developed and launched programs that provide science education and communication opportunities to community college, undergraduate, and post-baccalaureate students. Among them: mentoring programs (matching over 70 local and national students with current Yale students); a science communication series; and, most notably, a research symposium which hosted 60 local and national students at Yale. In addition, Paola is Student Coordinator for the Yale BioMed Amgen Scholars Program, where she has mentored and supported over 40 undergraduates pursuing a summer research experience at Yale. Her work in service to Yale and her community have awarded her the Yale-Jefferson Award for Public Service and the Vanderbilt Basic Sciences Hispanic and Latin Heritage Graduate LeaderAward.

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Dermatology

Top MEIDAM Dermatologists took Center Stage at AAD Conference discussing the 13 Billion Dollar Medical – EIN News

Dr. Saad Sami AlSogair presenting at AAD Global Education Day

MEIDAM at AAD Global Education Day

Middle East International Dermatology and Aesthetic Medicine

During the MEIDAM session, attendees gleaned information on subjects ranging from the business side of dermatology to mental health awareness. Topics included: * The origins and growth of dermatology * Evaluation of pruritus * Personality disorders in dermatological disorders * WhatsApp Dermatology * Alternatives to topical steroids

Dr. Khaled Al Nuaimi, President of MEIDAM, remarked, This was a great occasion where medical professionals gathered together from all around the world to share insights and breakthroughs in our field. MEIDAM is excited to be a part of this venture and to show our international colleagues the cutting-edge techniques developed by our members.

Global Newswire states that the 13.9 billion dollar medical aesthetics market is expected to triple in less than a decade. This innovative group of physicians is at the cusp of this wave. Dr. Saad Sami AlSogair, a preeminent speaker, conference facilitator, and renowned dermatologist, is at the helm of this growing organization. As the new general secretary of MEIDAM, the sought-after doctor and his esteemed colleagues offered the latest in dermatological advancement at the ADD conference.

In honor of the AAD Global Education Day, Dr. AlSogair presented his findings in Rheology of Hyaluronic Acid Dermal Fillers. His keynote speech addressed the effects of aging and the ongoing debate about surgery versus dermal fillers. Dr. AlSogair concluded that surgical interventions might make the apparent volume loss more evident. However, he encouraged using fillers because of their growing popularity amongst clients looking for a biodegradable and non-invasive approach. His well-attended talk led colleagues to rethink their stance and see the growth possibilities in this sector.

In response to the event, Dr. AlSogair says, This joint session began a beautiful partnership where MEIDAM and ADD can continue to increase awareness around our clienteles needs and the industrys growth. As the co-chair of this session, it was a privilege to share in this moment where medical professionals learned from one another, says AlSogair.

Newly elected AAD president, Dr. Seemal R. Desai, acknowledges the contributions of his 20,000-member group. As a leader in pigmented skin disorders, Dr. Desai understands the need to have many voices at the tables. The Texas-based doctor applauds the event saying, The addition of the MEIDAM session was a boost for our annual event. This group of internationally recognized physicians brought time-sensitive topics such as the correlation between mental health and dermatological issues and ideas around alternatives to steroids to the forefront.

For more information, contact Media Relations at mediarelations@aad.org.

AAD MediaMiddle East International Dermatology & Aesthetic Medicine +1 847-240-1714mediarelations@aad.org

MEIDAM at AAD Global Education Day

Middle East International Dermatology and Aesthetic Medicine

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Dermatology

Investigational Gene Therapy Expected to Improve QoL for Patients … – Dermatology Times

Alexander Limbach/Adobestock

There is a promising treatment on the horizon for patients with dystrophic epidermolysis bullosa (DEB), according to Isin Sinem Bagci, MD, a presenter in the New Technologies of Dermatological Science and Practice session at the 2023 Annual Meeting of the American Academy of Dermatology in New Orleans, Louisiana.1

Bagci, who is a research scientist in dermatology operations at Stanford University School of Medicine, highlighted data from a recent study of beremagene geperpavec (B-VEC) for DEB.2 Bagci was one of the investigators on that study, which found that B-VEC was more likely associated with complete wound healing in comparison with placebo. Based on this data, Bagci expected a redosable/in vivo/topical gene therapy [would be] emerging this year in the genetic disease field, she told attendees.

DEB is caused by mutations in COL7A1, a gene involved in assembling type 7 collagen and plays a crucial role in stabilizing the skin, Bagci explained. As a result, patients with DEB have blisters and scars over much of their bodies. B-VEC is a topical investigational herpes simplex virus type 1-based gene therapy that delivers COL7A1 and therefore restores C7 protein. Because there are no currently approved corrective therapies for DEB, B-VECs success to date brings hope for many patients, she said. For the treatment of DEB, B-VEC received orphan drug designation, was granted fast track designation and rare pediatric designation, and was granted Regenerative Medicine Advanced Therapy by the US Food and Drug Administration.

The results from this phase 3, double blind, intrapatient randomized, placebo-controlled trial were published in The New England Journal of Medicine, Bagic said.2 She explained participants included adults and children at least 6 months old with genetically confirmed clinical diagnosis of DEB and were recruited across 3 US sites. Although participants from phase 1 and 2 trials were not excluded, patients were excluded if they were actively receiving treatment with immunotherapy, chemotherapy, or other investigations agents. Evidence or history of squamous cell carcinoma and infections disqualified wound sites.

Over a 26-week period, 2 wounds on each patient that were of similar size, anatomical region, and appearance were randomized to receive application of B-VEC or placebo once per week until the wound closed (treatment was resumed if the wound reopened). Response was defined as at least 2 consecutive weeks of wound healing; total wound closure was required for wounds to be considered healed. Bagci noted she and her colleagues set a high bar for the primary end point, which was complete wound healing at 6 months; secondary end point was complete wound healing at 3 months. Bagci said safety end points looked at adverse events.

The results were quite impressive, she told attendees. Complete wound healing occurred in 67% of the wounds exposed to B-VEC, in comparison to 22% of those exposed to placebo. Similarly, she noted 71% of the wounds were deemed completely healed at 3 months for those exposed to B-VEC as opposed to 20% of those wounds exposed to placebo.

Subgroup analysis also uncovered some interesting data, Bagci reported. Younger patients had a better treatment response than older patients, she said, so its important to start the treatment early.

Bagci and colleagues also found B-VEC had positive effects on larger and chronic wounds. She shared the example of a 21 year old patient who had a large (>100 cm2) wound on his back for more than 10 years. It was decreasing his quality of life; it was a major problem, she told attendees.

After treatment, she said the patient reportedly could shower as well as lay on their back without significant pain. The wound has remained closed for more than a year, and the patient reports increased quality of life.

Adding to the hopeful news was the safety results, Bagci said. Of the 45 reported adverse events, 58% were considered mild and 48% were considered moderate. She added only 1 adverse event (mild erythema) was considered related to B-VEC, and no adverse events led to discontinuation of either B-VEC or placebo. Bagci said 3 patients experienced 5 serious adverse events, but they were not related to B-VEC or placebo. In addition, a post-hoc analysis found B-VEC treatment response was not associated with baseline HSV-1 serostatus or C7 seroconversion.

Based on the data, Krystal Biotech announced a home dosing extension study in April 2022, she said. The doses would be administered by a health care provider and would be a convenience for patients.

Meanwhile, Bagci said she is looking forward to good news about B-VEC later this year, with the PDUFA expected in May 2023.

Are you attending the annual meeting? Share your highlights with us via email: DTEditor@mmhgroup.com.

References

1. Bagci IS. Gene therapy of the skin and its integration into clinical practice. Presented at the 2023 Annual Meeting of the American Academy of Dermatology. March 17-21; New Orleans, Louisiana.

2. Guide SV, Gonzalez ME, Bac IS, et al. Trial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa. N Engl J Med. 2022;387(24):2211-2219. doi:10.1056/NEJMoa2206663

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Dermatology

Treatment of Atopic Dermatitis and Psoriasis in People Who Are … – Managed Healthcare Executive

Women who are pregnant dont have to stop all of their treatments during pregnancy. Some can be safely treated for their psoriasis or eczema, according to a presentation today at the annual meeting of the American Academy of Dermatology.

Women who are pregnant and who have psoriasis or eczema often have limited options. The evidence about the effect that the systemic medications might have on pregnant women and their fetuses is limited.

But women deserve more than just topical treatment and moisturizers, and doctors may be more restrictive than necessary, Elizabeth Kiracofe, M.D., a dermatologist in private practice in Chicago, said during a presentation today at the annual meeting of the American Academy of Dermatology in New Orleans.

We are more restrictive with both systemics and topical medications in our patients who have atopic dermatitis and psoriasis in a way that is not scientifically backed, she said. We may be doing a disservice to patients by being too restrictive in our prescribing patterns. We may have concerns, and there are uncertainties, but these patients deserve to be treated because there's also risk of nontreatment. These patients have a chronic immune-mediated inflammatory disease and theyre pregnant. Having an uncontrolled chronic immune mediated inflammatory disease is also not healthy in pregnancy.

Inadequate control of disease can lead to flares and infections and even septicemia, Kiracofe said. Additionally, she said, depression is more common in women with psoriasis than in healthy women without psoriasis. And 21% of pregnant women who have psoriasis suffer from depression, compared with 10% of non-psoriasis patients.

In the United States, 4.6% of women have atopic dermatitis, and 3.2% of women have psoriasis. About 75% of women are diagnosed before the age of 40. At the same time, the representation of women in psoriasis studies has decreased. In a recent JAMA study, investigators found that clinical studies with least 45% of women in the enrolled population decreased from 87.2% in the 2010 to 2015 timeframe to 29.5% in the 2015 to 2020 timeframe.

Kiracofe acknowledged the treatment choices for pregnant patients with atopic dermatitis are complicated. There are no large clinical studies on the possible effects and side-effect of biologics on conception, pregnancy and lactation.

When treating pregnant women, its important to use the science, Kiracofe said. We cant just base decisions on just the label; we need to know the pathophysiology, we need to know how the body works. And we need to have a shared decision-making process and talk with our patients because that is a really important conversation.

An important piece of the puzzle in the use of biologics in psoriasis and atopic dermatitis during pregnancy is the degree of immune suppression the infant experiences within the few first few months of life.

Its important to think about the impact of using biologics in the second and third trimester. Thats a really big frameshift when thinking about medication interacting with our patients. Were taught from medical school to think about the first trimester fetal malformations. But for these type of systemic medications, we actually want to be thinking in the second and third trimester.

Kiracofe described how the placental Fc receptor "grabs." The Fc receptor is instrumental in allowing medications to cross the placenta. Cimzia (certolizumab) is the only biologic with a confirmed safety profile during pregnancy and lactation with no increased mortality rate for the fetus, Kiracofe told an audience at the dermatology organization's annual meeting. Cimzia is a TNF-alpha inhibitor that doesnt bind to the placental Fc receptor.

Cimzia was approved in September 2013 by the FDA as a treatment of active psoriatic arthritis and in May 2018 as a treatment of moderate-to-severe psoriasis in adults. It is also approved for treating rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

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Treatment of Atopic Dermatitis and Psoriasis in People Who Are ... - Managed Healthcare Executive