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Kaitlyn Bader is the assistant managing editor of 

 and joined the MJH Life Sciences team in June 2022. She attended Otterbein University in Westerville, Ohio, and earned a Bachelor of Arts degree in literary studies with minors in creative writing and film studies. Prior to health care news, Kaitlyn worked in industrial marketing. She enjoys cooking, reading, and tending to her house plants.

Articles

At the 2024 SDPA Fall Conference, Audrey Rutherford, MD, discussed the critical role of vulvar biopsies in identifying cancer and other conditions to improve patient outcomes for underdiagnosed vulvar conditions. 

When and How to Biopsy Vulvovaginal Skin Conditions  

Zirwas spoke with Dermatology Times to share the top clinical pearls and key takeaways from his discussion on contact dermatitis.

“Don’t Touch This”: Contact Dermatitis Insights and Updates from Matthew Zirwas, MD

At the 2024 SDPA Fall Conference, Renata Block, MMS, PA-C, emphasized the power of membership, tailored education, interdisciplinary collaboration, and advocacy in shaping the future of dermatology to improve patient outcomes. 

Collaborating for Better Care: SDPA's Role in Advancing Dermatology

Post-hoc analysis demonstrated secukinumab's efficacy in addressing both HS and HS-related psychiatric symptoms. 

Poster Shows Secukinumab Improves HS Symptoms and Psychiatric Comorbidities 

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Tony Berberabe, MPH, is the Editor for Targeted Oncology. Berberabe received his Bachelor of Arts in Biology from Rutgers University and his Master of Public Health from the University of Medicine and Dentistry in New Jersey.

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.

clinical

Video Series

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Test your knowledge on the foundation leading to the development of biologics to treat atopic dermatitis.

QUIZ: What Are the Major Cytokines Driving Atopic Dermatitis?

November is Hyperhidrosis Awareness Month. Get comprehensive diagnosis, treatment, and coverage/reimbursement information through the International Hyperhidrosis Society at 

1. Walling HW. Primary hyperhidrosis increases the risk of cutaneous infection: a case-control study of 387 patients. 

2009 Aug;61(2):242-6. doi:10.1016/j.jaad.2009.02.038. Epub 2009 Apr 23. PMID: 19395123.

2. Bahar R, Zhou P, Liu Y, et al.The prevalence of anxiety and depression in patients with or without hyperhidrosis (HH). 

 2016 Dec;75(6):1126-1133. doi:10.1016/j.jaad.2016.07.001. Epub2016 Aug 25. PMID: 27567033.

3. Baker LB. Physiology of sweat gland function: The roles of sweating and sweat composition in human health. 

. 2019;6(3):211-259. Published 2019 Jul 17.doi:10.1080/23328940.2019.1632145

4. Doolittle J, Walker P, Mills T, et al. Hyperhidrosis: an update on prevalence and severity in the United States. 

2016;308(10):743-749. doi:10.1007/s00403-016-1697-9

5. American Academy of Dermatology, 2019 Annual Meeting, Prevalence of Anxiety, Depression and Attention Deficit Disorder (ADD) in Patients with Primary Hyperhidrosis, https://server.aad.org/eposters/view/Abstract.aspx?id=8424

6. Hund M, Kinkelin I, Naumann M, et al. Definition of axillary hyperhidrosis by gravimetric assessment. 

2002 Apr;138(4):539-41. doi: 10.1001/archderm.138.4.539. PMID:11939828.

7. Autism Spectrum Disorder (ASD) Data & Statistics. Centers for Disease Control and Prevention website. https/www.cdc.gov/ncbddd/autism/data.html. Feb. 12, 2018. Accessed Oct. 22, 2020.

8. Key statistics for melanoma skin cancer. American Cancer Society website. https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html. Jan 8, 2020. Accessed Oct. 22, 2020.

9. Food allergy facts and statistics. Food Allergy Research & Education website. https://www.foodallergy.org/resources/facts-and-statistics. Accessed Oct. 22, 2020.

10. Psoriasis Statistics. National Psoriasis Foundation website. https://www.psoriasis.org/psoriasis-statistics/. Oct. 8, 2020. Accessed Oct. 22, 2020.

Hyperhidrosis Awareness Month in November emphasizes the importance of understanding and managing hyperhidrosis, a condition that can lead to increased risk of cutaneous infections and is associated with anxiety and depression. Resources for diagnosis, treatment, and reimbursement are available through the International Hyperhidrosis Society. Studies highlight the prevalence and severity of hyperhidrosis, as well as its psychological impact. The condition is defined by gravimetric assessment, and its management is crucial for improving patient quality of life. Awareness efforts aim to enhance knowledge and support for affected individuals.

November is Hyperhidrosis Awareness Month - test your knowledge on the subject.

Quizzes

Test Your Knowledge: Hyperhidrosis and Sweat

Jenny Murase, MD, covered topics and pearls related to women’s health in a series of 3 presentations at the 

. One of her sessions, titled, “Baby Bumps: Understanding the Dermatoses of Pregnancy,” outlined how to safely and effectively treat the primary dermatoses exhibited or exacerbated during pregnancy.

Murase identifies 4 main pregnancy dermatoses—atopic eruption, polymorphic eruption, extrahepatic cholestasis, and pemphigoid gestationis—as "baby bumps."

"Baby Bumps": Jennifer Murase, MD, on Dermatoses During Pregnancy

My name is Dr Jenny Murase, and I am the director of medical consultative dermatology at the Palo Alto Foundation Medical Group, and I'm associate clinical professor at UCSF. I just presented at NP Elevate in Arizona over the past few days on 3 presentations related to women's health and dermatology.

What did you cover during your session titled, "Baby Bumps: Understanding the Dermatoses of Pregnancy"?

Now there are 4, it kind of depends if you're a lumper or a splitter, but there are 4 primary dermatoses of pregnancy, that we call the baby bumps right of pregnancy. Then there's 1 that's a little bit more controversial, but it's thought it to be the fifth pregnancy dermatosis. The way that I think about them, I always think about what's causing it, and it helps me to remember what I need to do. The most common would be atopic eruption of pregnancy. I'll draw a little yin yang for my patients, where I have the cell mediated immunity on TH1 side. That's the soldiers of our immune system, fighting bacteria, viruses, and fungus.Then we haveTH2 on the other, the allergic arm of the immune system, estrogen causes a shift so that you become more TH2 and allergic dominant. I remember I was pregnant with my daughter, and I was talking about how you become more allergic, and you get atopic dermatitis more easily in pregnancy, and I was just sneezing like crazy, so allergic at the time. That conditionis by far and away, the most common. Polymorphic eruption of pregnancy, which is when the skin is being stretched. That's why it's going to occur later in pregnancy, and it's going to occur in areas where the skin is stretched, like the abdomen and the thighs, and both those have any implications to the fetus. Then we have extrahepatic cholestasis of pregnancy, and that is a condition that there is a strong genetic component, but there's no primary lesions in the skin. Everything is secondary. Everything is from scratching, and that's related to bile acids being high, and bile acids can affect the placenta. There are implications to the baby. And finally, there is a condition, herpes gestationis, or pemphigoid gestationis - there's 2 names for it. It has nothing to do with the herpes virus, and it's an autoimmune disease where the antibodies will attack the junction between the epidermis and the dermis, because the placenta and the skin are both epidermal in origin. The antibodies that are created that are attacking the skin can also affect the placenta and that could affect the pregnancy. We detect that by doing a biopsy. So when in doubt, you want to do bile acids and a biopsy, because those are the 2 that could have implications. There's also a condition, as I mentioned, this fifth dermatosis, a psoriatic condition. It's called impetigo herpetiformis, even though it has nothing to do with staphylococcus aureus and nothing to do with the herpes virus. That condition is, there is a new agent on the market, spesolimab, that is an IL-36 antagonist that's used for generalized pustular psoriasis of pregnancy. That is a newer therapeutic that can help with this, this, this pustule based rare eruption that occurs in pregnancy.

How can clinicians work together to provide holistic care for new mothers?

I think that there really has been a paradigm shift over the course of the past 10 to 15 years where we are developing a very patient-centric approach. It's almost like there's a whole care team that's surrounding the patient and providing many, many different facets of care. Whether it's nutritional care or obstetric care or dermatologic care, the specialist, the primary care, and then different forms of nursing that might be required, as well as acupuncturists and herbalists.We're all a team caring for the patient in terms of their particular needs and their desires for how they want to approach their care.When I think of holistic care, I think about how our electronic medical records are making it much easier for us to communicate, and I think that that's1 of the reasons why we can be more effective with this holistic care and be copying each other on the notes more easily and communicating. I know that patients really appreciate it when I'm in the room and I'm calling their doctor, or I'm typing a note to their doctor or their provider, the nurse, whatever it might be, so that they can see that communication is taking place. Then I feel like they feel like they're part of this team, and everyone's talking. I think 1 thing that the providers can do is kind of make that effort to make a point that they're reaching out.It doesn't have to be done later in the day when they don't even know you're communicating, show that you are kind of bringing in the troops and calling in the team and communicating with the team so that they know that they're the center of that team. It's also very important, I think, for all dermatology providers, to have a lactation consultant in the area that they know. Because lactation, the nursing, I should say, is an art. It really is just the exact latch, which is the position of the baby's mouth and head. It's a very subtle art and limiting the trauma to the nipples in our patients with sensitive skin, whether they have atopic dermatitis or psoriasis, because psoriasis can koebnerize, meaning it forms in areas of trauma on the nipple. The nipples need to be in very excellent shape, especially atopic dermatitis, right before delivery, in order to limit pain and lactation, consultants can certainly help you.

[Transcript has been edited for clarity.]

Dr. Jennifer Murase presented on the dermatoses of pregnancy at the 2024 Elevate-Derm West Conference, focusing on conditions like atopic eruption, polymorphic eruption, extrahepatic cholestasis, and pemphigoid gestationis. She emphasized the importance of understanding the underlying causes and potential fetal implications. Murase also highlighted the significance of holistic care for new mothers, advocating for a patient-centric approach involving a multidisciplinary team. Effective communication among healthcare providers, facilitated by electronic medical records, enhances patient care and ensures comprehensive support for new mothers.

Murase identifies 4 main pregnancy dermatoses—atopic eruption, polymorphic eruption, extrahepatic cholestasis, and pemphigoid gestationis—as "baby bumps." 

"Baby Bumps": Jenny Murase, MD, on Dermatoses During Pregnancy

In her second presentation at the 2024 Elevate-Derm West Conference, Jenny Murase, MD, talked about the Dermatologic Care of New Mothers. Her lecture covered important topics such as differential diagnosis, safety of medications, and conditions commonly found in breastfeeding mothers.

Murase discussed safe dermatologic treatments during lactation, especially for chronic conditions needing biologics.

Jenny Murase, MD: Providing Dermatologic Support in Postpartum Care

What did you cover during your session titled, "Dermatologic Care of New Mothers"?

I think that lactation is an area where there really, in the past, hasn't been a lot of attention in the field. I remember 18 years ago when I was looking at how to redesign the women's health curriculum for the American Academy of Dermatology, I realized that there was literally no education on new mothers and issues regarding breastfeeding and really even safety of medications and lactation as well. That was definitely an area that I wanted to make sure was addressed at our academy meetings, because it's such a relevant issue for patient care. In the session that I gave, I talked about the differential diagnosis and the things we have to think about when a patient presents with mastitis, meaning inflammation of particularly the areola or nipple when breastfeeding. Those conditions include things like irritant contact dermatitis, allergic contact dermatitis, to things like lanolin, for example, that is in wool alcohol ointment or Aquaphor, that's oftentimes used to emulate the skin and protect the nipples. In addition, it can get secondarily infected with both Candida, a yeast, as well as Staphylococcus aureus, a bacterial infection. Finally, there's a condition called Raynaud phenomena. We were actually the first to develop an article on Raynaud phenomena summarizing patient data.There is a nursing center, and I work with Honor Fullerton Stone in Northern California to summarize patient data. We found that 20% of patients developed Raynaud phenomena, which means that there was a pain that was caused due to vasoconstriction. In the general population, about 20% of women have Raynaud phenomena, so it was interesting that it was kind of the same statistic when we looked at the mastitis patient. It's important to consider warming techniques. There's also a medicine called nifedipine that can be tried, particularly if there are color changes seen in the nipple and areola, such as from vasoconstriction. You can get both cyanosis, meaning a bluish color forming, or pallor, meaning a white color. Then also you can get vasodilation in response where the blood vessels open up, where it becomes more red, so it'skind of a red, white and blue, and so those are the main things on the differential diagnosis that should be considered when treating mastitis.

 What advice can clinicians give to new mothers facing debilitating skin conditions?

I have 3 children, and I can only imagine how hard it would be to have an underlying medical condition like bad atopic dermatitis with horrible itch or bad psoriasis, and be juggling that, in addition to the sleep deprivation from having to wake up every 3 to 4 hours to breastfeed. Families are wonderful if you have support. But for the mothers that don't have that support, hats off. It must be so difficult. One thing that I do really want to emphasize, because I just finished working with George Martin and running the Delphi consensus for the National Psoriasis Foundation. Phil Anderson is 1 of the people on our Delphi consensus. He's the founder of LactMed, so he knows more about lactation safety and medications, more than maybe anyone in the country. He really made the point that biologics, even including rituximab now, because before they were worried about B cell development with the rituximab, but even with rituximab, are safe in lactation. So certainly, any provider that's making a recommendation to stop a biologic in lactation, I really think that that is not doing the patient good service, especially if they're struggling to manage a chronic, debilitating condition that itch. Having chronic itch has a quality of life impact between having cystic fibrosis and having a kidney transplant, and you put that on top of being a new mother and waking up every 3 to 4 hours and having to care for a little creature that doesn't even know where their thumbs areand have to do everything for them. I mean, it's just ridiculous to me. I really think we need to be making sure that the dermatologic medication safety discussions are being held in a in a responsible manner that's giving them the care that they need.

Jennifer Murase, MD, emphasized the importance of dermatologic care for new mothers, particularly in the context of lactation. She highlighted the lack of attention historically given to this area and discussed differential diagnoses for conditions like mastitis, including irritant and allergic contact dermatitis, infections, and Raynaud phenomena. Murase also stressed the safety of biologics during lactation, advocating against discontinuation for breastfeeding mothers with chronic conditions. She underscored the need for responsible discussions on medication safety to ensure comprehensive care for new mothers.

 that the US Food and Drug Administration (FDA) has accepted its resubmitted Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) for the treatment of recessive dystrophic epidermolysis bullosa.

The FDA has established a Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025.

Abeona's initial BLA for the COL7A1 gene-corrected epidermal sheets was submitted to the FDA in September 2023.

 The FDA accepted the BLA and granted it priority review the following month, establishing an initial PDUFA date of May 24, 2024.

However, earlier this year, the FDA issued a Complete Response Letter in response to the BLA

 just one month shy of the anticipated target action date.

The FDA identified the need for additional Chemistry, Manufacturing, and Controls information, including validation for specific manufacturing and release testing methods noted during the pre-license inspection. However, the CRL did not find deficiencies in the clinical efficacy or safety data of pz-cel.

The BLA's acceptance is based on positive data from the pivotal phase 3 VIITAL study (NCT04227106) and supporting phase 1/2a data (NCT01263379), which demonstrated sustained wound healing and pain reduction with pz-cel. 

"The FDA acceptance of our BLA resubmission moves us one step closer to providing pz-cel as a differentiated treatment option to address the persistent unmet needs of people with RDEB in the US," said Vish Seshadri, chief executive officer of Abeona, in a news release.

 "We look forward to continuing to work with the FDA to finalize the review of the pz-cel application."

Abeona Therapeutics announces FDA acceptance of BLA resubmission of Pz-cel for the treatment of recessive dystrophic epidermolysis bullosa. News release. Globe Newswire. November 12, 2024. Accessed November 12, 2024. 

https://www.globenewswire.com/news-release/2024/11/12/2978973/0/en/Abeona-Therapeutics-Announces-FDA-Acceptance-of-BLA-Resubmission-of-Pz-cel-for-the-Treatment-of-Recessive-Dystrophic-Epidermolysis-Bullosa.html

Abeona Therapeutics submits Biologics License Application to US FDA seeking Priority Review and approval of EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa. Abeona Therapeutics Inc. September 26, 2023. Accessed November 12, 2024. 

https://investors.abeonatherapeutics.com/press-releases/detail/265/abeona-therapeutics-submits-biologics-license-application.

Abeona Therapeutics announces FDA accepts and grants Priority Review for pz-cel biologics license application (BLA). Abeona Therapeutics. News release. November 27, 2023. Accessed November 12, 2024. 

https://investors.abeonatherapeutics.com/press-releases/detail/268/abeona-therapeutics-announces-fda-accepts-and-grants

Abeona Therapeutics provides regulatory update on pz-cel. News release. Abeona Therapeutics. April 22, 2024. Accessed November 12, 2024. 

https://investors.abeonatherapeutics.com/press-releases/detail/276/abeona-therapeutics-provides-regulatory-update-on-pz-cel

Abeona Therapeutics completes pz-cel Biologics License Application resubmission to US Food and Drug Administration. News release. Abeona Therapeutics. October 29, 2024. Accessed November 12, 2024. 

https://investors.abeonatherapeutics.com/press-releases/detail/291/abeona-therapeutics-completes-pz-cel-biologics-license

Abeona Therapeutics' resubmitted Biologics License Application for prademagene zamikeracel (pz-cel) has been accepted by the FDA for treating recessive dystrophic epidermolysis bullosa. The FDA set a new PDUFA target action date for April 29, 2025, following a Complete Response Letter requesting additional Chemistry, Manufacturing, and Controls information. The resubmission is supported by positive data from the pivotal phase 3 VIITAL study and phase 1/2a data, demonstrating sustained wound healing and pain reduction. Abeona aims to address unmet needs in this patient population.

Abeona's pz-cel has been granted a April 29, 2025, PDUFA date.

Tony Berberabe, MPH

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