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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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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

Armstrong shared insights on the recently released NPF psoriasis health indicator report including pearls on national health data and unmet needs in public health campaigns. 

April Armstrong, MD, MPH, Shares Insights on the NPF's Psoriasis Health Indicator Report

Misleading marketing and incomplete scientific data have led to widespread misinformation about botulinum toxin products.

Unmasking Botulinum Toxin Myths

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Frequent fliers, including pilots and cabin crew, are exposed to greater levels of UV and cosmic ionizing radiation than the general population, leading to higher incidence of skin cancers.

Aircrews Face Increased Risk of Developing Skin Cancer

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. 

News 

clinical

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. 

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

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.

Exploring Afamelanotide for Vitiligo: Insights into the CUV 105 Phase 3 Clinical Trial

Quality of Life + Closing Thoughts

Mickey Bryson describes the impact of atopic dermatitis on his quality of life and family, and the session concludes with final reflections. 

Video Series

Quality of Life + Closing Thoughts 

Anthony Nuara, MD, PhD, presents the case of a 32-year-old woman with vitiligo, covering her initial diagnosis and workup findings.

Vitiligo Management Strategies: A Case-Based Discussion on Treatment Challenges and Solutions

Anthony Nuara, MD, PhD, presents the case of a 32-year-old woman with vitiligo, covering her initial diagnosis and workup findings, ending this segment with her prescribed treatments and how shared decision-making lead to these choices.

An expert on the treatment of vitiligo reviews a second patient case, a 50-year-old male patient who regularly wears medical gloves for his work.

Community Physician Voices: Exploring Management Options for a 50-Year-Old Patient with Vitiligo

An expert on the treatment of vitiligo reviews a second patient case, a 50-year-old male patient who regularly wears medical gloves for his work and whose development of well-defined white patches on his fingers and toes prompted treatment.

Elianna Goldstein

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