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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.

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In case you missed it, this week we had news about phase 2 initiation of EVO756 for chronic inducible urticaria, IBI363's Fast Track Designation for advanced melanoma, Arcutis' enrollment of the last patient in ARQ-255 trial for alopecia areata, and more.

The Weekly Roundup: September 2-6

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.

A recent study investigated the acceptability, barriers, and facilitators associated with digital health tools.

Exploring the Perception of Digital Health Tools in Dermatology

The JAK1 inhibitor provided significant relief for 2 patients with refractory PN.

Abrocitinib Shows Promise for Prurigo Nodularis

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.

Researchers conducted a web-based survey to gain insights into current clinical practice for PN in Japan. 

Approximately 65% of Dermatologists in Japan Report Dissatisfaction With Treatment Options for Severe Prurigo Nodularis

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Patients’ ability to choose can affect your practice.

 Considering consumerism in health care

"Atopic dermatitis (AD) remains a challenging condition to manage effectively, and despite advances in treatment, there is a persistent issue of therapeutic inertia in the field. This inertia, characterized by the failure to escalate treatment when patients do not meet their therapeutic targets, continues to undermine patient outcomes. The 

 has highlighted this issue in the real-world, showing that many patients with moderate-to-severe AD remain undertreated, leading to inadequate disease control and reduced quality of life," wrote Christopher Bunick, MD, PhD, associate professor of dermatology and translational biomedicine at Yale University School of Medicine in New Haven, Connecticut, and 

recent review of new atopic dermatitis treatment targets.

The chronic physical symptoms of AD such as itchy and painful skin are often associated with affecting patients’ quality of sleep, sexual and social interactions, and work productivity. Due to the mental and physical effects of AD combined with dissatisfaction with current treatment regimens, more effective therapies are needed. 

Answer the poll below to learn more about recently published atopic dermatitis treatment recommendations.

The TARGET-DERM registry longitudinal study highlighted the continued trend of the failure to escalate atopic dermatitis treatments when patients do not meet their therapeutic targets.

News 

clinical

POLL: When Do You Escalate AD Treatment if Treatment Targets are Not Achieved?

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?

, symptoms of psoriasis often start between the ages of 15 and 25.

 However, symptoms of psoriasis can start at any age and stage of life.

The majority of patients with psoriasis will experience their first flare when they are between the ages of 15 and 35. Despite this, nearly 1 in 3 patients are under the age of 20 at the disease's first onset.

"While it can begin at any age, psoriasis has 2 peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years," according to April Armstrong, MD, MPH.

 "It affects men and women equally but is more common in non-Hispanic whites. Some patients are more prone to developing psoriasis, especially if there is a family member with psoriasis."

Psoriasis: Causes, triggers and treatments. The National Psoriasis Foundation: National Psoriasis Foundation. Accessed August 4, 2023. 

https://www.psoriasis.org/about-psoriasis/

This Psoriasis Awareness Month, test your knowledge of the condition. Click here to answer this week's poll.

POLL: At What Age Do Symptoms of Psoriasis Often Start?

that the US Food and Drug Administration (FDA) approved nemolizumab (Nemluvio) as a pre-filled pen for subcutaneous injection for the treatment of adult patients with prurigo nodularis.

“Because this patient population has suffered for a long time, anytime there's a hope of new therapeutics, it's very exciting for doctors and for patients; nemolizumab has the potential to be a very significant addition to our armamentarium against treating itch,” said Shawn Kwatra, MD, in a 

associate professor of dermatology at Johns Hopkins University School of Medicine and director of the Johns Hopkins Itch Center, in Baltimore, Maryland, and an OLYMPIA investigator, discussed the latest phase 3 OLYMPIA 2 data of nemolizumab for prurigo nodularis published in the 

Prurigo nodularis is associated with chronic itch, skin nodules covering large body areas, and poor sleep quality. Based on the need for a specific therapeutic to address the symptoms of prurigo nodularis, nemolizumab inhibits IL-31 cytokine signaling to target itch, inflammation, altered epidermal differentiation, and fibrosis.

"By targeting and blocking this neuroimmune cytokine signaling, which drives key symptoms of prurigo nodularis, nemolizumab has the potential to rapidly and effectively address the most burdensome symptom for people with prurigo nodularis – itch, as well as the appearance of skin nodules,” said Baldo Scassellati Sforzolini, MD, PhD, MBA, the global head of research and development at Galderma, in a 

The approval of nemolizumab is based on positive data from the phase 3 OLYMPIA clinical trials which were the largest clinical trial program for prurigo nodularis conducted to date. OLYMPIA 1 (

) evaluated the safety and efficacy of nemolizumab administered subcutaneously every 4 weeks in more than 500 patients with prurigo nodularis.

Key data from the primary and secondary end points included:

56% and 49% of patients treated with nemolizumab in OLYMPIA 1 and 2 respectively, achieved at least a 4-point reduction in itch intensity at week 16, as measured by the Peak-Pruritus Numerical Rating Scale, compared to 16% in both placebo groups (p<0.001) (primary end point)

41% of patients treated with nemolizumab in OLYMPIA 1 and 2 achieved at least a 4-point reduction in itch intensity at week 4, as measured by the peak-pruritus numerical rating scale, compared to 6% and 7% in the placebo group (p<0.001) (key secondary endpoint)

26% and 38% of patients treated with nemolizumab in OLYMPIA 1 and 2 respectively, reached clearance (Investigator’s Global Assessment [IGA] 0) or almost-clearance (IGA 1) of skin nodules at week 16, when assessed using the IGA score (range: 0-4), compared to 7% and 11% in the placebo group (p<0.001) (primary end point)

50% and 52% of patients treated with nemolizumab in OLYMPIA 1 and 2 respectively, achieved at least a 4-point reduction in sleep disturbance at week 16, as measured by the Sleep Disturbance Numerical Rating Scale, compared to 12% and 21% in the placebo group (p<0.001) (key secondary end point)

"The US FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology. We’re confident in the impact this first-in-class therapy will have for patients with prurigo nodularis who urgently need more treatment options and look forward to potentially bringing Nemluvio to patients with other itch-related skin diseases in the near future,” said Flemming Ørnskov, MD, MPH, chief executive officer of Galderma, in the news release.

Additionally, the FDA has also accepted for review Galderma’s Biologics License Application for nemolizumab for the treatment of moderate to severe atopic dermatitis. A decision from the FDA is expected at the end of 2024.

Galderma receives U.S. FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis. News release. Galderma. August 13, 2024. Accessed August 13, 2024. 

https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo#:~:text=Zug%2C%20Switzerland%20%E2%80%93%20August%2013%2C,of%20adults%20with%20prurigo%20nodularis

Galderma investigational therapy nemolizumab granted FDA Breakthrough Therapy Designation for the treatment of patients suffering from prurigo nodularis. News release. Galderma. December 9, 2019. Accessed August 13, 2024. 

https://www.galderma.com/news/galderma-investigational-therapy-nemolizumab-granted-fda-breakthrough-therapy-designation

Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. News release. Galderma. February 14, 2024. Accessed August 13, 2024. 

https://www.galderma.com/news/galderma-announces-regulatory-filing-acceptance-nemolizumab-prurigo-nodularis-and-atopic

Galderma’s nemolizumab is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31.

FDA Approves Nemolizumab for the Treatment of Prurigo Nodularis 

Earlier this month, Galderma announced that it received filing acceptances

 for nemolizumab for the treatment of prurigo nodularis and moderate to severe atopic dermatitis in 4 additional countries, including Australia, Singapore, Switzerland, and the United Kingdom. The regulatory authorities of Australia, Singapore, Switzerland, and the United Kingdom are members of the Access Consortium and an approval decision from the consortium is expected in 2025.

The US Food and Drug Administration (FDA) and the European Medicines Agency accepted filing submissions for nemolizumab in 

. The FDA’s US decision is expected in 2024. Additionally, the FDA granted nemolizumab Priority Review for prurigo nodularis.

The regulatory submissions of nemolizumab in prurigo nodularis are based on data from the phase 3 OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks in patients with prurigo nodularis. In the OLYMPIA program, patients treated with nemolizumab monotherapy showed clinically and statistically significant improvements in both primary end points compared to placebo after 16 weeks of treatment.

To further discuss the significance of additional regulatory filing acceptances of nemolizumab for prurigo nodularis, 

 spoke to Baldo Scassellati Sforzolini, MD, PhD, MBA, the global head of research and development at Galderma.

Q&A With Baldo Scassellati Sforzolini, MD, PhD, MBA

: Nemolizumab has the potential to become a first-line treatment for much-needed relief of prurigo nodularis. What makes nemolizumab’s mechanism of action unique?

: Nemolizumab specifically inhibits interleukin-31 (IL-31) cytokine signaling by targeting the IL-31 receptor alpha. By targeting and blocking this neuroimmune cytokine signaling, which drives key symptoms of prurigo nodularis, nemolizumab has the potential to rapidly and effectively address the most burdensome symptom for people with prurigo nodularis – itch, as well as the appearance of skin nodules.

: In your opinion, what is the significance of nemolizumab for PN recently receiving filing acceptances in 4 additional countries outside of the US within months of the US acceptance?

: Despite the significant burden of prurigo nodularis, there is only one approved treatment option for people diagnosed with this condition. The filing acceptances in these additional countries are a step towards bringing nemolizumab to patients in these countries, who are in need of alternative therapeutic options that act on itch and skin nodules to treat prurigo nodularis. The fact that this milestone came within months of the US Food and Drug Administration and European Medicines Agency also accepting filing submissions in both prurigo nodularis and atopic dermatitis shows how Galderma is committed to ensuring rapid access to nemolizumab in many countries around the world.

: What key data points are most important for dermatology clinicians to keep in mind regarding the phase 3 OLYMPIA trials that the regulatory submissions are based on?

: Over 50% of nemolizumab-treated patients achieved a significant reduction in itch intensity and sleep disturbance at week 16, with over 40% seeing an improvement in itch within 4 weeks. Additionally, more than three times as many patients treated with nemolizumab reached clearance or almost-clearance of skin lesions, compared to placebo at week 16.

58% and 56% of nemolizumab-treated patients in OLYMPIA 1 and 2, respectively, achieved an at least 4-point reduction in itch intensity at week 16, as measured by the peak-pruritus numerical rating scale, compared to 17% and 21% in the placebo group (p<0.001).

41% of nemolizumab-treated patients in OLYMPIA 1 and 2, achieved an at least 4-point reduction in itch intensity at week 4, as measured by the peak-pruritus numerical rating scale, compared to 6% and 7% in the placebo group (p<0.001).

26% and 38% of nemolizumab-treated patients in OLYMPIA 1 and 2, respectively, reached clearance (investigator’s global assessment (IGA) 0) or almost-clearance (IGA 1) of skin lesions at week 16, when assessed using the IGA score (range: 0-4), compared to 7% and 11% in the placebo group (p<0.001).

50% and 52% of nemolizumab-treated patients in OLYMPIA 1 and 2, respectively, achieved an at least four-point reduction in sleep disturbance at week 16, as measured by the sleep disturbance numerical rating scale, compared to 12% and 21% in the placebo group (p<0.001).

: In your opinion, how will nemolizumab change the way dermatology clinicians are able to address the physical and mental burden of PN in their patients?

: Itch is the most burdensome symptom for people with prurigo nodularis. The relentless itch can make it difficult to concentrate and sleep, which can have a significant impact on quality of life. Patients also report that having firm skin nodules on visible body areas really impacts their confidence and means they don’t feel comfortable in social settings. We’ve seen in the OLYMPIA trials that nemolizumab can significantly improve these three key areas that contribute to the physical and mental burden of the disease – itch, sleep disturbance, and skin lesions.

: In addition to these 4 countries, nemolizumab is also under review for the treatment of prurigo nodularis and moderate to severe atopic dermatitis by the US Food and Drug Administration and European Medicines Agency. With the first regulatory decisions expected later this year, we hope to bring this treatment option to patients with prurigo nodularis, as well as atopic dermatitis, who equally suffer from impaired quality of life from their disease, as soon as possible to help alleviate the significant burden they face.

Baldo Scassellati Sforzolini, MD, PhD, MBA

, is the global head of research & development at Galderma. He holds an MD from the University of Bologna, a PhD in neurosensory science and ophthalmology residency from the Marche Polytechnic University, a diploma of Pharmaceutical Medicine from Cardiff University, and an MBA from Cranfield School of Management.

Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries. News release. Galderma. May 7, 2024. Accessed May 17, 2024. 

https://www.galderma.com/news/galderma-receives-filing-acceptances-nemolizumab-prurigo-nodularis-and-atopic-dermatitis-four

Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. News release. Galderma. February 14, 2024. Accessed May 17, 2024. 

Scassellati Sforzolini discusses the significance of Galderma’s nemolizumab receiving 4 additional filing acceptances for prurigo nodularis and atopic dermatitis. 

Baldo Scassellati Sforzolini, MD, PhD, MBA: Expanding Nemolizumab’s Access

Incyte recently announced its new collaboration

 and license agreement with China Medical System Holdings Limited (CMS) for the research, development, and commercialization of povorcitinib in Mainland China, Hong Kong, Macao, Taiwan Region, and 11 Southeast Asian countries, as well as a non-exclusive license to manufacture povorcitinib in CMS’ territory.

Povorcitinib is a selective oral JAK1 inhibitor currently being evaluated for the treatment of non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis, asthma, and chronic spontaneous urticaria.

Based on their agreement, CMS will make an upfront payment to Incyte, and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of povorcitinib in CMS’ territory.

“We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options. There remains a significant need for new, innovative treatment for vitiligo and other immune-mediated dermatologic conditions, and we look forward to working together with the CMS team to bringing these products to market in China,” said Hervé Hoppenot, the Chief Executive Officer of Incyte, in the news release.

CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib. The transaction and agreement are effective immediately for both companies.

“We expect that this collaboration will enhance CMS Skinhealth's portfolio of potential treatments for vitiligo that, if approved, will provide differentiated treatment options for vitiligo patients in China. Upon approval, povorcitinib is poised to synergize with the innovative drugs in the commercialization stage of our pipeline Ilumetri (tildrakizumab injection), original/drugs including Hirudoid (mucopolysaccharide polysulfate cream) and Aethoxysklerol (polidocanol injection) in terms of our network and market resources, which will help the Product to realize its clinical and commercial value,” said Huang Anjun, the general manager of CMS Skinhealth, in the news release.

phase 2 safety and efficacy data of oral povorcitinib for prurigo nodularis

 was presented last month at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.

In the phase 2 study of oral povorcitinib (

), a small molecule JAK1-selective inhibitor, 126 adult patients with ≥20 pruriginous lesions, an Investigator’s Global Assessment (IGA) score of ≥3, prurigo nodularis for ≥3 months, and an average itch Numerical Rating Scale (NRS) score of ≥5 were randomized to receive once-daily povorcitinib (15, 45, or 75 mg) or placebo for 16 weeks.

The primary end point of the phase 2 study was a ≥4-point improvement in itch NRS score (NRS4) at week 16, which was achieved by significantly more patients who received povorcitinib(15mg: 36.1% [P=0.0066],45mg: 44.4% [P=0.0006], 75mg: 54.1% [P<0.0001]) vs placebo (8.1%).

Median times to NRS4 were 58.0 days for 15mg, 35.0 days for 45mg, and 17.0 days for 75mg povorcitinib vs not estimable for placebo. IGA Treatment Success (IGA score of 0 or 1 with a ≥2-grade improvement from baseline) at week 16 was achieved by 13.9%, 30.6%, and 48.6% of patients receiving povorcitinib (15, 45, and 75 mg, respectively) vs 5.4% for placebo.

First author Shawn Kwatra, MD, associate professor of dermatology at Johns Hopkins University School of Medicine and director of the Johns Hopkins Itch Center, in Baltimore, Maryland, spoke to 

 at AAD 2024 about the significance of this phase 2 study and its results.

"I'm very thankful and have a lot of gratitude that I had the opportunity to have my hands all over the design of this trial. It was actually based on a lot of our laboratory's data, where we performed the first immunophenotyping studies from the skin and blood of prurigo nodularis patients. And in these patients, we looked at the different compartments and found high IL-22, from CD4+ CD8+ T-cells, high IL-4 and IL-13 in subsets, IL-31, and also IL-6," said Kwatra in his 

Incyte and CMS announce collaboration and license agreement for povorcitinib, an oral JAK1 inhibitor, in Mainland China, Hong Kong, Macau, Taiwan and Southeast Asia. News release. Incyte. April 1, 2024. Accessed April 1, 2024. 

https://investor.incyte.com/news-releases/news-release-details/incyte-and-cms-announce-collaboration-and-license-agreement-0

Martin M. Efficacy and safety of oral povorcitinib in patients with prurigo nodularis: results from a randomized, double-blind, placebo-controlled phase 2 study. Presented at: 2024 American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA.

Povorcitinib is being evaluated for non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis, asthma, and chronic spontaneous urticaria. 

Jim Keller, MD

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