Acne 

Actinic Keratosis 

Aesthetics

Alopecia

Biologic Treatments for Moderate to Severe Atopic Dermatitis 

Atopic Dermatitis 

COVID-19

Drug Watch

Eczema

General Dermatology 

Hidradenitis Suppurativa

Melasma

NP and PA

Pediatric Dermatology

Pigmentary Disorders 

Practice Management 

Precision Medicine and Biologics

Prurigo Nodularis

Emerging Therapies Plaque Psoriasis

Treatments for Plaque Psoriasis 

Psoriasis 

Psoriatic Arthritis 

Rare Disease

Rosacea 

Skin Cancer (Nonmelanoma)

Skin Cancer

Vitiligo

Wound Care

News

Media

Around the Practice

Between The Lines

Case-Based Peer Perspective

Clinical Case Collective

DermView

Expert Perspectives

Fellows Face Off

Frontline Forum

Medical World News

Patient Perspectives

Podcasts

Readout360

Recognize and Refer

Conferences

Conference Coverage

Conference Listing

Events

Case-Based Roundtable

Publication

Dermatology Times

CME/CE

Resources

DermIQ

Interactive Tools

Job Board

Partner Perspectives

Polls

Editorial Advisory Board

Partners

Subscribe

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.

Articles

The conference aimed at providing dermatology NPs and PAs clinicians with the latest updates in the specialty begins today in Nashville, Tennessee.

Previewing Maui Derm NP+PA Fall 2024: Will You Be There?

Keep up with the latest headlines in dermatology from the past week, including the use of AI in a dermatology clinic to enhance gun safety, decreased rates of melanoma in Swedish adults under 50, and more.

Derm In The News: September 8-14

Ebglyss is now approved for children and adults aged 12 years and older.

FDA Approves Lebrikizumab-lbkz for Moderate to Severe Atopic Dermatitis

Maddi Hebebrand is an associate editor of 

and joined the MJH Life Sciences team in May 2024. She attended Baldwin Wallace University, studying Media Production and Film, and is now finishing her Masters in Digital Media through Ohio University. When she's not writing, Maddi loves to read, attend concerts and spend time with her family.

In case you missed it, this week we had news about adverse event profiles among pediatric patients treated with JAK inhibitors, positive results from a phase 3 trial of dupilumab for chronic spontaneous urticaria, and the impact of tropical weather on patients with atopic dermatitis.

The Weekly Roundup: September 9-13

About

Advertise

Contact Us

Do Not Sell My Information

Terms and Conditions

Privacy Policy

Dermatology Times and Multimedia Medical, LLC

Twitter

Facebook

Linkedin

Topics

Acne

Pigmentary Disorders

Practice Management

Psoriasis

Psoriatic Arthritis

Rosacea

1rem

Authors

A central goal of Hacking Dermatology, one of the first ever dermatology-focused hackathons, is to build a community of people interested in collaborating to improve the current standards of care for patients with skin disease. Learn how to get involved in this article.

The case for hackathons in dermatology

The US Food and Drug Administration (FDA) has approved Eli Lilly and Company's lebrikizumab-lbkz (Ebglyss)

 for children and adults aged 12 years and older with moderate to severe atopic dermatitis (AD).

The IL-13 inhibitor is intended for adults, as well as pediatric patients who weigh at least 88 pounds (40 kg), and whose AD has not yet been controlled through the use of topical therapies.

The approval is supported by positive data stemming from the ADvocate 1, ADvocate 2, and ADhere studies.

"Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, in a news release.

 Silverberg is also the first author of the manuscript for the clinical trials related to lebrikizumab. 

The studies, involving over 1,000 patients with moderate to severe eczema who didn't respond to topical treatments, primarily measured clear or almost clear skin at the 16 week mark. 

In an average of the ADvocate 1 and ADvocate 2 studies, 38% of those using lebrikizumab achieved clear skin at 16 weeks, compared to 12% with placebo, and 10% saw results as early as 4 weeks. Of those who achieved clear skin, 77% maintained it for a year with monthly doses, and 48% maintained it even after switching to placebo.

For itch relief, 43% of lebrikizumab users experienced relief at 16 weeks, versus 12% with placebo, with 5% feeling relief as early as 2 weeks. Among those with itch relief at week 16, 85% continued to feel relief after a year on monthly maintenance, and 66% maintained relief after switching to placebo.

"Today's FDA approval of Ebglyss is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren't enough," he said.

Kristin Belleson, president and CEO of the 

, weighed in on the approval's significance for patients.

"Eczema can affect people of all skin tones, ethnicities, genders and ages. Nearly 16.5 million adults in the US have eczema, with 6.6 million experiencing moderate-to-severe symptoms like itchiness, dry and scaly skin, discoloration and rashes, which can lead to more scratching that may cause skin to crack and bleed," Belleson said. "The approval of Ebglyss provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms."

Lebrikizumab was approved by the European Commission in 2023,

 Japan in January 2024, and Canada in June 2024.

Lebrikizumab will be available as a 250 mg/2 mL injection and may be used with or without topical corticosteroids. Lilly anticipates the drug will become available in the US in a matter of weeks. 

FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. News release. Lilly. September 13, 2024. Accessed September 13, 2024. 

https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and#:~:text=INDIANAPOLIS%20%2C%20Sept.%2013%2C%202024,88%20pounds%20(40%20kg)%20with

Almirall. Almirall receives European Commission approval of Ebglyss (lebrikizumab) for moderate-to-severe atopic dermatitis. News release. November 17, 2023. Accessed September 13, 2024. 

https://www.almirall.com/newsroom/news/almirall-receives-european-commission-approval-of-ebglyss-lebrikizumab-for-moderate-to-severe-atopic-dermatitis

Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older. News release. Cision; Eli Lilly Canada Inc. June 25, 2024. Accessed September 13, 2024. 

https://www.newswire.ca/news-releases/health-canada-authorizes-lilly-s-ebglyss-tm-lebrikizumab-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-in-adults-and-adolescents-12-years-and-older-833722064.html

News 

clinical

Hyperhidrosis is not rare. According to the 

, approximately 385 million people worldwide live with hyperhidrosis.

In fact, they note that the amount of people living with chronic, excessive sweating is even higher than the amount of people living with other dermatologic conditions like psoriasis.

Just how common is hyperhidrosis in real-world comparisons?

The prevalence of hyperhidrosis is much higher in younger populations than in the general population, with 8.8% of individuals between the ages of 18 to 39 years old living with the condition. 

When comparing these statistics to everyday, common occurrences like hair color, the number of people with hyperhidrosis is greater than the 1% of individuals with natural red hair and 2% of individuals with natural blond hair. 

Despite how common hyperhidrosis is, it is estimated that 27% of those with the condition never receive a diagnosis.

 wants to hear from you. What percentage of the global population is estimated to have hyperhidrosis?

 to share your hyperhidrosis insights or research.

Albert. Fact check: Hyperhidrosis - International Hyperhidrosis Society: Official site. Home - International Hyperhidrosis Society. October 24, 1970. Accessed November 16, 2023. 

https://www.sweathelp.org/home/news-blog/542-fact-check-hyperhidrosis.html

Click here to answer this week's poll for Hyperhidrosis Awareness Month.

Polls 

POLL: What Percent of the Global Population is Estimated to Have Hyperhidrosis?

Combination therapy (eg, topical agents + procedures)

Lilit Garibyan, MD, PhD, and Sara Moradi Tuchayi, MD, MPH, of 

, topical agents such as kojic acid, cysteamine, and rucinol should be avoided among patients who are pregnant. 

Share your recommended melasma treatment pearls or additional methods not mentioned above with us by emailing 

Click here to answer this week's melasma poll. 

POLL: What Treatment Approach Do You Find Most Successful for Improving Melasma?

 approximately 2% of people worldwide will experience hair loss due to alopecia areata in their lifetime. 

When taking this statistic into account, approximately 160 million people globally have had, currently have, or will have alopecia areata, including approximately 6.7 million in the US. 

At this moment in time, it can be approximated that 700,000 people in the US, both children and adults, currently have some form of alopecia areata.

Alopecia areata - National Alopecia Areata Foundation. NAAF. June 23, 2023. Accessed August 11, 2023. 

This Hair Loss Awareness Month, test your knowledge of hair loss conditions. Click here to answer this week's poll.

POLL: What Percentage of People Worldwide Will Experience Alopecia in Their Lifetime?

Shauna Jardon, PharmD, Amgen’s US medical lead for Otzela, spoke with Dermatology Times on the efficacy, safety, and future of apremilast. 

SPROUT Trial Highlights Benefits of Apremilast for Pediatric Psoriasis

Amgen’s US medical lead for Otezla, spoke with 

 on the efficacy, safety, and future of apremilast.

 My name is Shauna Jardon, and I am the US medical lead for Otezla.

 What are the key takeaways from the SPROUT trial?

 The key takeaways that were most important to us is finding out that we have an oral option for these burdened pediatric patients and finding out that Otezla is a safe and effective systemic therapy for pediatric patients ages 6 to 17 years old. We saw statistically significant, and perhaps more importantly, clinically relevant improvements in the pediatric patients, inclusive of their plaques, of their itch, of their high impact areas, which are just as burdensome for pediatric patients as we know they are for adults. When we think about the cumulative life course impairment that goes on with psoriasis, when we think about kids growing up and dealing with a skin forward disease such as psoriasis, having an oral option is incredibly important, and we're proud. Amgen is proud to bring that forward for these patients.In the current treatment milieu out there for pediatric psoriasis, what we know through much research that's been done with this patient population is that it's not just burdensome for the pediatric patients, but as well, for caregivers. If you think about the application of topical therapies and the time that that takes, and then if we think about injectable therapies and the needle phobia that can come along with that, as well as laboratory monitoring.With Otezla being oral, with no need for laboratory monitoring, and having you know the safety and efficacy that goes along with it, I think that we're just happy to be able to bring that to the pediatric population.

 Were there any differences in the safety profile of apremilast when comparing adult and pediatric populations?

 Speaking from an Otezla point of view, what we found is that it is remarkably similar. In terms of there being any new safety signals, that was not seen.Children are resilient, and so something that is a little different than what we have seen in our adult population with apremilast is some of the GI adverse effects that can be experienced in the beginning of use, perhaps over the first 1 to 2 weeks. What we saw was diarrhea and abdominal pain for over 70% of the pediatric population attenuated over the first 72 hours. I think it's just a real call out to the resilience that we see in children. And, we had 21 pediatric patients in this trial that received immunizations. When you think about systemic therapy and immunizations, what we saw was no safety signals there as well. There were no, just like our adult population, restraints around patients receiving immunizations. These pediatric patients went ahead with immunizations, and in fact, COVID-19 vaccines, and we saw no safety issues with that as well. It's nice to have that background knowledge when we think about children being in any sort of stage for receiving immunizations.

 Can you speak to the long-term efficacy of apremilast?

 If we think about from that first 16-week data out to the 52-week, we continue to see an increase in efficacy and the maintenance of effect that was important to see, and the safety profile held.That's the important piece. We presented that 1-year data at AAD (American Academy of Dermatology meeting), and we are working on presenting unpublished 2-year data that's going to be coming up.

What are the next steps in your team’s research?

We look forward to bringing that data forward, because we're always concerned as children are growing. Safety is king when we think about the pediatric population.As we follow along the lines of research that we have done in the adult population with psoriasis and psoriatic disease, we will also be looking at any sort of important metabolic improvements that might be possible in the pediatric population. We've done a body of research in that for adult patients of improving cardiometabolic parameters, and we look forward to also looking at that as well in the pediatric population. We know that the psoriatic population is burdened with these metabolic changes. So, that will be another area of interest that we have certainly asked about. It's a known positive quality to Otezla in the adult population and we look forward to interrogating that in the pediatric population as well.

 How do you envision apremilast impacting the overall treatment of psoriasis?

 I think what was nice and comforting was the parallels that we could draw between the adult population and the pediatric population. Two things, first, seeing that continuous safety in the patient population is a boon for adults that are hesitant to begin systemic therapy. There could be a positive vote of confidence for adults that may have been on the fence when they think about starting systemic therapy, that could help their disease trajectory as well. And second, when you think about cumulative life course impairment for psoriatic patients and the earlier that an intervention can be made, we feel very encouraged that we would be able to help this population earlier and ameliorate all of the problems that can go along with having a chronic, systemic inflammatory disease. We look forward to the earlier intervention, really bringing about a change in disease trajectory and quality of life impairment.We also have trials underway in pediatric psoriatic arthritis. We have that indication for adults. We now have it in psoriasis. And we are hopeful that we will expand into an indication there as well.We really want to make sure that we're helping as many pediatric patients with this new body of research as possible. For all the reasons that we've mentioned before.

[Transcript has been edited for clarity.]

The trial showcased the continued efficacy of apremilast, with 2-year data on the forefront. 

Tareen Dermatology recently announced a partnership with pharmaceutical company CLINUVEL

. The partnership is intended to advance vitiligo research through the undertaking of advanced-stage clinical trials.

One such clinical trial is the phase 3 CUV 105 trial assessing the efficacy and safety of afamelanotide (Scenesse) in combination with phototherapy for treating vitiligo, which is actively recruiting participants at multiple study sites across the US.

Afamelanotide, a synthetic analog of alpha-melanocyte-stimulating hormone (α-MSH), functions as a melanocortin-1 receptor (MC1R) agonist. By stimulating MC1R, it promotes the production of eumelanin, the pigment responsible for skin coloration.

Afamelanotide was first approved for use in erythropoietic protoporphyria in the United States in 2019. Its previous clinical application has been limited to specialized porphyria clinics, but the drug has demonstrated a robust safety profile with over 12,000 uses and no reported life-threatening events directly attributable to the medication.

The CUV 105 clinical trial is a phase 3, multicentric, randomized, controlled study designed to evaluate the efficacy and safety of afmelanotide in combination with narrowband ultraviolet B (NB-UVB) phototherapy for treating vitiligo. Its primary objective is to assess whether the combination therapy results in superior repigmentation compared to NB-UVB monotherapy.

The study targets patients with Fitzpatrick skin types IV to VI. This inclusion criterion is based on prior research indicating more significant repigmentation in darker skin types.

Participants will be randomized into 2 treatment groups: a combination therapy and monotherapy group. The combination therapy group will receive NB-UVB phototherapy alongside afamelanotide administered as a subcutaneous implant (16 mg) every 3 weeks for a total of 5 months. This regimen includes 7 implants. The monotherapy group will receive only NB-UVB phototherapy over the same period.

The study will utilize the Vitiligo Area Scoring Index (VASI) to measure repigmentation.

A previous phase 2 study compared afamelanotide combined with NB-UVB phototherapy against phototherapy alone.

The combination therapy group demonstrated a higher percentage of patients with significant repigmentation on the face and upper extremities compared to the phototherapy-only group. Repigmentation occurred more rapidly in the combination therapy group.

Both VASI and VETF scores indicated significantly better outcomes for patients receiving afamelanotide plus phototherapy versus those receiving phototherapy alone. Notably, patients with Fitzpatrick skin types IV to VI showed improved results compared to those with type III.

Common adverse effects included erythema (68% in combination therapy vs. 82% in monotherapy) and diffuse hyperpigmentation. The latter was a universal effect due to melanocyte stimulation. Other reported effects included nausea (18% of patients) and pruritus.

Current Study Updates and Future Directions

The CUV 105 trial is expanding upon previous research by increasing the afamelanotide dosage and extending the observation period. 

The ongoing study features an increased dosage, with afamelanotide administered at a higher dose (16 mg) compared to previous trials. An additional 6-month follow-up period post-treatment aims to assess the durability of repigmentation and monitor for any potential relapse or adverse effects.

Patients must have Fitzpatrick types IV to VI and extensive vitiligo affecting both the face and body. Exclusion criteria includes recent phototherapy, history of skin cancer, and severe liver disease.

While the study holds promise, several challenges remain. 

Identifying patients with the requisite severity of vitiligo poses a challenge. Strict inclusion and exclusion criteria can limit participant eligibility.

The potential for diffuse hyperpigmentation as an adverse effect may be culturally sensitive in some populations. Awareness and education about the side effects are crucial in managing patient expectations and ensuring informed consent.

The durability of repigmentation beyond the treatment period remains a key area of interest. Ongoing monitoring will be critical to determine the long-term benefits and any need for additional treatments.

As Tareen Dermatology and CLINUVEL are still actively recruiting participants for the trial, clinicians interested in becoming involved or referring eligible patients are encouraged to visit 

 or contact director of research and clinical research coordinator, 

Tareen Dermatology partners with CLINUVEL for clinical trials on groundbreaking vitiligo treatment. News release. PR Newswire. August 23, 2024. Accessed September 5, 2024. 

https://www.prnewswire.com/news-releases/tareen-dermatology-partners-with-clinuvel-for-clinical-trials-on-groundbreaking-vitiligo-treatment-302229529.html

ClinicalTrials.gov. A study to compare the efficacy and safety of SCENESSE and narrow-band ultraviolet (NB-UVB) light versus NB-UVB light alone in patients with vitilig. Identifier NCT06109649. Accessed September 5, 2024. 

https://clinicaltrials.gov/study/NCT06109649?cond=scenesse&aggFilters=status:rec&rank=2

Polańska A, Wegner J, Nutbohm P, et al. Afamelanotide in protoporphyria and other skin diseases: a review. 

. 2024;41(2):149-154. doi:10.5114/ada.2024.138818

FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder. News release. US FDA. October 8, 2019. Accessed September 5, 2024. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-increase-pain-free-light-exposure-patients-rare-disorder

A study to assess the changes in pigmentation and safety of afamelanotide in patients with vitiligo. CTV. Accessed September 5, 2024. 

https://ctv.veeva.com/study/a-study-to-assess-the-changes-in-pigmentation-and-safety-of-afamelanotide-in-patients-with-vitiligo

The study is actively recruiting participants at multiple sites across the US.

Adam Raff, M.D., Ph.D.

Articles

Latest Updated Articles