Acne 

Actinic Keratosis 

Aesthetics

Alopecia

Biologic Treatments for Moderate to Severe Atopic Dermatitis 

Atopic Dermatitis 

Buy-and-Bill

COVID-19

Case-Based Roundtable

Chronic Hand Eczema

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

Publication

Dermatology Times

CME/CE

Resources

DermIQ

Interactive Tools

Job Board

Partner Perspectives

Perspectives in Dermatology

Polls

Editorial Advisory Board

Partners

Subscribe

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.

Articles

Microbiome engineering offers strategies to modulate the skin microbiome, including non-targeted approaches like probiotics and targeted approaches like phage therapy.

Challenges and Future Directions in Microbiome Engineering

Marie Bosslett is the assistant editor of 

 and joined the MJH Life Sciences team in October 2024. She attended Loyola University Maryland in Baltimore and earned a Bachelor of Arts in Communication with minors in marketing and writing. When she’s not writing, Marie enjoys going to concerts, reading on the beach, and spending time with friends and family.

Nearly all patients saw improvements in small, medium, and large depressions on the cheeks and temples with just a singular treatment session.

High-Intensity Ultrasound Device Is Suitable for Facial Acne Scars in Asian Patients

The significance of patient education and setting realistic expectations for the often-slow process of repigmentation in vitiligo treatment was a key focus of the discussion.

Optimizing Vitiligo Care: Key Expert Takeaways

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.

Dermatology Times has compiled a list of dermatological meetings taking place during the month of April.

Dermatology Conferences and Meetings Calendar: April 2025

About

Advertise

Contact Us

Do Not Sell My Information

Terms and Conditions

Privacy Policy

Dermatology Times and Multimedia Medical, LLC

Facebook

Linkedin

Topics

Acne

Pigmentary Disorders

Practice Management

Psoriasis

Psoriatic Arthritis

Rosacea

1rem

clinical

Clinical

A randomized, placebo-controlled trial of the selective transient receptor potential melastatin 8 agonist explored its efficacy and safety in PN.

Cryosim-1 Safe, Effective in Patients With Prurigo Nodularis

Targeting type 2 cytokines with monoclonal antibodies has revolutionized treatment for inflammatory skin diseases, reducing symptoms and improving quality of life.

Unraveling Type 2 Inflammation in Skin Diseases

Brian S. Kim, MD, FAAD, shares itch research updates at the AAD Annual Meeting.

Breakthrough Therapies in Itch Management: Insights From Brian S. Kim, MD, FAAD

85% of Chinese PN patients saw a PP-NRS improvement of ≥ 4 points after 12 weeks of treatment.

Real-World Data Supports Dupilumab for Prurigo Nodularis Treatment in China

As 2024 comes to a close, Dermatology Times is taking a look back at the studies, therapies, and advances in prurigo nodularis this year.

Dermatology Times 2024 In Review: Prurigo Nodularis

Increased awareness for prurigo nodularis may help to usher in a new era of timelier and more targeted treatment.

The Burden of Prurigo Nodularis

“This is the first study ever conducted for a topical agent for the treatment of prurigo nodularis. So really opening up avenues for the development and treatment. We're very excited about this for our patients,” said Shawn Kwatra, MD, FAAD, in an interview at the 

2025 American Academy of Dermatology (AAD) Annual Meeting

Kwatra, a board-certified dermatologist, professor and chair of dermatology at the University of Maryland School of Medicine, chief of service dermatology at the University of Maryland Medical Center, and a 

 Editorial Advisory Board member, presented late-breaking data at AAD from the TRuE-PN1 and TRuE-PN2 studies on ruxolitinib cream 1.5% (Opzelura; Incyte) for the treatment of patients with prurigo nodularis.

Shawn Kwatra, MD, FAAD, reviews his late-breaking data presentation at AAD on the first original studies of a topical cream for prurigo nodularis. 

Late-Breaking Data: Phase 3 Updates on Ruxolitinib Cream for Prurigo Nodularis 

The pivotal phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluated twice-daily ruxolitinib cream in patients aged 18 years and older.

In TRuE-PN1, results at week 12 showed that over 44% of patients achieved a ≥4-point reduction in itch (Worst-Itch Numeric Rating Scale), compared to approximately 20% in the placebo group. Additionally, all secondary end points demonstrated statistical significance, including improvements in skin lesions, quality-of-life scores, and pruritus relief as early as day 4. Significantly more patients who applied ruxolitinib cream vs vehicle control achieved an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success at week 12 (15.8% vs 3.9%).

The TRuE-PN2 study yielded similar findings, with approximately 40% of patients achieving a 4-point itch reduction, despite a slightly higher placebo response. According to the announcement, although the primary end point was in favor of ruxolitinib cream vs vehicle, it did not reach statistical significance due to high placebo response. The overall safety profile of ruxolitinib in the TRuE-PN clinical trial program was consistent with previous data and no new safety signals were found.

According to Kwatra, these phase 3 trials mark the first-ever study of a topical therapy for prurigo nodularis. Given the significant early and sustained improvements observed, ruxolitinib cream represents a promising non-systemic option for patients with prurigo nodularis, addressing both pruritus and lesion resolution.

Kwatra S. Efficacy and safety of ruxolitinib cream in patients with prurigo nodularis: results from a phase 3, randomized, vehicle-controlled study (TRuE-PN1). Poster presented at: 2025 American Academy of Dermatology Annual Meeting. March 8, 2024; Orlando, FL.

Incyte announces results of phase 3 clinical trials evaluating ruxolitinib cream 1.5% (Opzelura) in patients with prurigo nodularis (PN) at 2025 American Academy of Dermatology Annual Meeting. News release. Incyte. March 8, 2025. Accessed March 8, 2025. 

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-results-phase-3-clinical-trials-evaluating

Videos

Ruxolitinib cream 1.5% has shown promise as a topical treatment for prurigo nodularis, according to phase 3 TRuE-PN1 and TRuE-PN2 studies. These trials, presented at the 2025 AAD Annual Meeting, demonstrated significant improvements in itch reduction and skin lesions, with over 44% of patients in TRuE-PN1 achieving a ≥4-point reduction in itch. Although TRuE-PN2 showed a high placebo response, the overall safety profile was consistent with previous data. Ruxolitinib cream offers a promising non-systemic option for managing prurigo nodularis symptoms.

Late-Breaking Data: Phase 3 Updates on Ruxolitinib Cream for Prurigo Nodularis

Christophe Piketty, MD, PHD, provides a deeper look at the promise of nemolizumab in addressing unmet needs faced by patients with atopic dermatitis and prurigo nodularis.

Christophe Piketty, MD, PhD: The Role of Nemolizumab in Addressing Unmet Needs of Patients With AD and PN

 recently spoke with Christophe Piketty, MD, PhD, a dermatologist and the global program head at Galderma R&D, to discuss the recent regional approvals for nemolizumab (Nemluvio), including approvals in the European Union, UK, and Switzerland.

Piketty shared insights into the unmet needs of patients with atopic dermatitis (AD) and prurigo nodularis (PN) and delved into the significance of these approvals in supporting this underserved patient population.

The Burden of Atopic Dermatitis and Prurigo Nodularis

Patients with AD and PN often experience debilitating symptoms that go far beyond visible skin lesions. 

"Even if there are already some drugs approved for both atopic dermatitis and prurigo nodularis, we know that a lot of patients are still not disease controlled or inadequately responding to those conditions," Piketty said. 

These patients frequently struggle with high symptom burdens such as itch, sleep disturbance, and poor quality of life associated with these symptoms, making effective treatment options essential.

Currently, several treatments are available for AD and PN, including biologics and JAK inhibitors. While these treatments can be effective, Piketty noted he remains unconvinced that switching between biologics targeting the same pathway will offer significant improvements for patients who are not responding adequately.

With the introduction of nemolizumab, Piketty believes there could be a significant shift in treatment paradigms. Based on the encouraging results of the phase 3 clinical trials, which demonstrate efficacy on both skin lesions and symptoms such as itch and sleep disturbances, nemolizumab may be positioned as a first-line treatment for both AD and PN. 

"In patients with high burden of symptoms, I would say probably Nemluviowill be a very good choice as a first line for the treatment of AD and PN," he noted.

While the efficacy of biologics and JAK inhibitors in treating AD is well-documented, safety concerns—especially in long-term use—remain a critical issue. This is especially relevant for patients with PN, who are often older (50 years and above). Piketty noted that JAK inhibitors, in particular, are associated with risks such as MACEs, thrombosis, and embolism, making them a less favorable option for elderly patients.

In contrast, nemolizumab’s safety profile, alongside its efficacy, makes it a promising option for patients in need of long-term management. 

"For AD, there is clearly still room for new drugs, and coming with a new target is definitely a good therapeutic option for patients with AD," he said.

Piketty highlighted that PN represents a major unmet medical need in dermatology. Since 2022, the FDA has approved dupilumab for PN, but the need for further therapeutic options is undeniable. The expert emphasized that nemolizumab could be a game-changer for patients with PN, citing its robust clinical development plan, which includes a phase 3 program with more than 500 patients—a program that is now the largest of its kind.

The phase 3 trials have demonstrated "quick onset of action on itch" and a "very high level of efficacy on lesions," which could significantly improve the lives of those suffering from PN. Furthermore, the long-term extension (LTE) studies show that nemolizumab's efficacy continues to improve over time. 

"At the end of the first year of LTE, we have reached a high proportion of patients responding to Nemluvio on both signs and symptoms," Piketty shared.

Given the strong data from the clinical trials, Piketty is confident in the potential of nemolizumab to serve as a key therapeutic option for both AD and PN.

Galderma’s Nemluvio (nemolizumab) approved in the European Union for moderate-to-severe atopic dermatitis and prurigo nodularis. News release. February 14, 2025. Accessed February 25, 2025. 

https://www.galderma.com/news/galdermas-nemluvior-nemolizumab-approved-european-union-moderate-severe-atopic-dermatitis-and

Galderma’s Nemluvio (nemolizumab) granted marketing authorization in the United Kingdom and Switzerland for moderate-to-severe atopic dermatitis and prurigo nodularis. News release. February 18, 2025. Accessed February 25, 2025. 

https://www.galderma.com/news/galdermas-nemluvior-nemolizumab-granted-marketing-authorization-united-kingdom-and-0

Christophe Piketty, MD, PHD, discusses the promising efficacy, novel mechanisms, and patient benefits of nemolizumab in targeting IL-31 for atopic dermatitis and psoriasis.

Christophe Piketty, MD, PhD: Nemolizumab's Unique Mechanism of Action and Next Steps Globally

Galderma’s nemolizumab (Nemluvio) recently received approval

 from the European Commission for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 years and older, as well as moderate to severe prurigo nodularis (PN) in adults.

 The therapy has also been authorized for the same indications 

 spoke with Christophe Piketty, MD, PhD, a dermatologist and the global program head at Galderma R&D, to discuss the unique mechanism of action of nemolizumab and the next steps for global approval.

Nemluvio and IL-31: A Novel Mechanism of Action

Piketty began by highlighting the significance of Nemluvio's unique mechanism of action. While other biologics typically target IL-13 or IL-4 for conditions like AD, nemolizumab targets the IL-31 pathway, a cytokine pathway that plays a central role in these diseases.

The importance of this distinction lies in the significant therapeutic potential that targeting IL-31 offers, as it directly affects skin inflammation, bio disruption, and even fibrosis.

"We know that IL-31, of course, is the main driver for itch,” Piketty remarked, underscoring how this cytokine influences the pathological processes that lead to itching in AD and PN. "Nemluvio is markedly improving itch."

Addressing Skin Inflammation and Fibrosis

Piketty continued by elaborating on how nemolizumab's impact extends beyond just alleviating itch. He highlighted recent data demonstrating how IL-31 targeting also addresses skin inflammation in both AD and PN. For instance, in AD, the biologic helps to improve biodisruption, a key feature of the disease's pathophysiology.

"Targeting IL-31 could improve the biodisruption, which is a key feature of the pathophysiology of atopic dermatitis," Piketty explained.

Additionally, PN, which is associated with significant tissue remodeling and fibrosis, has shown significant improvements with nemolizumab treatment. 

"We know that there is a lot of data now demonstrating that targeting IL-31 could improve also fibrosis," Piketty said. This antifibrotic effect explains the quick improvement of thick lesions observed in patients treated with nemolizumab 

The approvals in the European Union, UK, and Switzerland follow nemolizumab's approval in the US last year.

"The submission process is ongoing at the moment. We have received the approval in the US last year for both AD and PN," Piketty said. "We have received a formal approval in Europe for both indications."

The drug is awaiting approval in Australia, Singapore, and several other countries. Additionally, ongoing submissions are happening in South Korea and Brazil, with more submissions planned for the coming months.

"It’s moving fast, I think, and soon we will have a lot of countries where the review will be approved," Piketty said. He expressed confidence that this rapid expansion will make a significant difference for patients suffering from AD and PN globally.

Treatment Regimen: Convenience for Patients

One of the standout features of nemolizumab is its convenient treatment regimen. According to Piketty, the biologic allows for injections every 4 weeks, which is notably less frequent than other biologics on the market.

For patients who respond well to treatment, the regimen becomes even more convenient. After reaching specific response markers such as EASI75 or IGA response at week 16, patients can switch to an even less frequent injection schedule. 

"When using Nemluvio in combination with topical corticosteroids or topical calcineurin inhibitors, we have demonstrated that for patients responding, those patients could move to an even more convenient regimen," he explained.

Patients who achieve these milestones could reduce their injection frequency to once every 2 months, offering a substantial improvement in treatment convenience. 

"I spent a lot of time on the development of this drug, from the beginning actually, in 2016," Piketty shared. "It’s quite a long journey, but now I’m pretty happy to see that the product is available for patients."

Christophe Piketty, MD, PHD, discusses the promising efficacy, novel mechanisms, and patient benefits of nemolizumab in targeting IL-31 for atopic dermatitis and prurigo nodularis.

Professor Diamant Thaçi, MD, PhD, discusses findings from the ARCADIA and OLYMPIA clinical trial programs, highlighting nemolizumab’s rapid efficacy in treating atopic dermatitis and prurigo nodularis.

Diamant Thaçi, MD, PhD: Understanding the Impact of Nemolizumab Efficacy Post Approvals in EU, UK, and Switzerland

The European Commission recently approved Galderma’s nemolizumab

 (Nemluvio) for the treatment of moderate to severe atopic dermatitis (AD) in patients aged 12 and older and moderate to severe prurigo nodularis (PN) in adults.

Additionally, nemolizumab was also approved for the same indications 

Approval was based on strong phase 3 ARCADIA and OLYMPIA trial results, demonstrating rapid and sustained efficacy. With its first-in-class mechanism and 4-week dosing interval, nemolizumab offers a promising new option for dermatologists and patients in these regions.

 spoke with one of the researchers involved in the studies, Diamant Thaçi, MD, PhD, a university professor at University of Lübeck in Germany, to discuss the data supporting the approval and what the action means for patients with AD and PN.

These conditions, often characterized by severe and persistent itch, pose significant treatment challenges, making the results of these trials particularly relevant to clinical practice.

"In both clinical trials, in the ARCADIA and OLYMPIA programs, this has been a very comprehensive program investigating efficacy and safety of nemolizumab in 2 very important indications," Thaçi said.

Clinical Outcomes: Rapid and Significant Itch Relief

A key takeaway from the trials was the rapidity of symptom relief observed with nemolizumab. Thaçi emphasized the importance of treatments that deliver fast results, particularly for patients suffering from severe itching.

"It is very important that the treatment options that we have nowadays, that they are not only effective, let's say after 2 or 3 months, but that they have a rapid response," he noted. "This is especially [true for] diseases which are compared with itch, and we are talking about a bothering itch, a very severe itch... improvement of the itch within hours and days."

This rapid onset of action differentiates nemolizumab from other available treatments and provides a critical benefit for patients whose quality of life is significantly impacted by persistent pruritus, he added.

Efficacy Across Different Patient Profiles

Thaçi also highlighted the drug’s effectiveness across various patient populations. While it was initially believed that patients with more severe itch might respond better, the trials demonstrated efficacy across the spectrum.

"We do see that patients who are prone to be more itchy, who have a more severe itch, that [their] perception [is that] they do respond better. However, in the clinical trials, it has been shown that in the vast majority of the patients, there was no big difference between the patient who has a severe or less severe itch," he said.

This finding suggests that nemolizumab can be a viable option for a broad range of patients, not just those experiencing extreme symptoms.

Unlike existing therapies, nemolizumab targets interleukin-31 (IL-31), a cytokine known to play a central role in itch signaling.

"Also in this population, we had a very nice response showing that nemolizumab, with the inhibition of IL-31, offers a little bit more from the treatment options which are already on the market," Thaçi said.

By blocking IL-31, nemolizumab effectively disrupts the itch-scratch cycle, providing relief and potentially improving skin healing over time.

Safety Considerations and Clinical Implications

While efficacy remains paramount, Thaçi underscored the significance of safety in managing chronic dermatological conditions.

"In my personal opinion, efficacy is very important, but in diseases like atopic dermatitis and prurigo nodularis, safety plays a very important role," he said.

Phase 3 trial results indicated a favorable safety profile, further supporting nemolizumab's potential as a long-term treatment option.

Key Takeaways for Prurigo Nodularis Treatment

Video content above is prompted by the following:

Do you have any tips for your colleagues when it comes to educating patients and raising awareness about prurigo nodularis and the role of systemic treatments in care?

TJ Chao, MPAS, PA-C, discusses tips for educating patients and raising awareness about prurigo nodularis, focusing on the importance of informing patients about the role of systemic treatments and empowering them to make informed decisions about their care.

Prurigo Nodularis

Latest News

More News