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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.

Articles

Experts discussed the challenges of managing GPP and highlight a pivotal study on the subcutaneous formulation of spesolimab, demonstrating its potential to prevent GPP flares and improve patient outcomes despite some limitations.

Fighting the Flare of GPP: Expert Insights on Spesolimab

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.

In a meta-analysis of over 61 million participants, it was found that AD patients have a 37% risk of developing IBD and similar conditions.

Patients with Atopic Dermatitis Are More Susceptible to Developing Inflammatory Bowel Disease

The latest publication from OJM Group provides 7 core strategies for dermatologists looking to meet their financial goals.

Wealth Strategies for Today’s Physician: David Mandell, JD, MBA, Shares Insights from New Playbook

Jackson discusses EVO756, a promising MRGPRX2 antagonist targeting mast cells to treat chronic inflammatory diseases like spontaneous urticaria.

Exploring EVO756 in Chronic Inflammatory Disease Treatment: Q&A with Evommune's Mark Jackson, MD

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, is a dermatologist at Elias Dermatology in Fort Lauderdale, Florida and a member of American Osteopathic College of Dermatology, American Academy of Dermatology, American Society for Dermatology Surgery, American Society of Mohs Surgery, Florida Society of Dermatology and Dermatological Surgery, and National Alopecia Areata Foundation.

There are many innovative and exciting developments coming to the dermatology space, both energy-based devices and injectables. 

New Tech for Skin

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

Prurigo nodularis (PN) is a chronic skin disorder characterized by multiple firm nodular lesions, often symmetrically distributed on areas of the skin that are accessible to scratching.

 A history of scratching, picking, or rubbing has been identified as one of the core symptoms of PN and can have a notable impact on patient quality of life.

PN can be mistaken for various disorders, including Kyrle disease, bullous pemphigoid, neurotic excoriations, hypertrophic lichen planus, and atopic dermatitis with lichen simplex chronicus.

 When assessing skin biopsy results, histopathologic features such as pseudoepitheliomatous hyperplasia, hypergranulosis in the epidermis, focal parakeratosis, and thick compact orthohyperkeratosis can be characteristic of PN.

The pathophysiology of PN is not fully understood but current evidence suggests that its underlying mechanism stems from the intersection of neural dysregulation and immunological dysfunction.

 Translational studies over the past 15 years have revealed new insights into the pathogenesis of the disease, leading to the identification of specific immunological pathways that play an important role in the disease.

 Specifically, Th2-associated cytokines such as IL-31 and IL-4 have been identified as therapeutics targets, leading to the FDA approval of the IL-4 and IL-13 inhibitor dupilumab (Dupixent) in 2022 and the IL-31 inhibitor nemolizumab (Nemluvio) in 2024, both indicated for the treatment of adult patients with PN.

As more therapeutic options become available for PN, a high need remains for increased awareness of the disease and its impact, which could yield earlier and/or more accurate and diagnosis and treatment. To that end, inquiries into the impact of PN have increasingly articulated its economic, comorbidity, and quality of life burden.

According to findings published in 2023, patients with PN have been found to have higher rates of comorbidities, including not only atopic dermatitis but also chronic hepatitis C, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, depression, and type 2 diabetes.

 Findings from a recent retrospective analysis presented at the 2024 Fall Clinical Dermatology Conference showed that patients were more likely to have been newly diagnosed with a comorbidity vs matched controls. Among comorbidities identified in patients with PN were other dermatologic conditions (such as atopic dermatitis), as well as attention-deficit/hyperactivity disorder, autism, autoimmune disease, metabolic disease, and sleep disorders.

 Patients with PN were also found to have significantly higher costs, likely exacerbated by the increased prevalence of comorbidities. These results echo previously published data showing that patients with PN are also more likely than the general population to have longer hospital stays and increased cost of care.

One key observation from the investigators of the recently presented data at Fall Clinical Dermatology Conference is that many patients with PN are receiving treatment for the mental health symptoms of PN, while many could benefit from treatments that address autoimmune and inflammatory aspects of the disease. They also highlighted the need for more effective measures to address these burdens in this patient population.

Given the increased knowledge regarding the pathogenesis of PN as well as the associated economic, comorbidity, and quality-of-life burden on patients, the need for greater awareness of the disease in the clinical community and among patients is clearer. As we learn more about the mechanisms of disease, patients must be educated about their disease, the importance of appropriate treatment, and the availability of systemic agents that may offer benefits.

One organization that is raising awareness about PN is the Prurigo Nodularis League, which was founded in 2014 and serves as a mutual platform for clinicians and patients to raise global awareness and provide news relating to PN. League members are regularly informed about the results of current studies and news about diagnostics and treatment. Visit 

The next article in this series on prurigo nodularis will explore the data for available and emerging systemic agents.

Elmariah S, Kim B, Berger T, et al. Practical approaches for the diagnosis and management of prurigo nodularis: United States expert panel consensus. 

. 2021;84(3): 747-760. doi:10.1016/j.jaad.2020.07.025

Müller S, Zeidler C, Ständer S. Chronic prurigo including prurigo nodularis: new insights and treatments. 

. 2024;25(1):15-33. doi:10.1007/s40257-023-00818-z

Labib A, Ju T, Vander Does A, Yosipovitch G. Immunotargets and therapy for prurigo nodularis. 

Joel MZ, Hydol-Smith J, Kambala A, Cornman H, Kwatra SG. Prevalence and comorbidity burden of prurigo nodularis in United States adults enrolled in All of Us research program. 

. 2023;89(5): 1056-1058. doi:10.1016/j.jaad.2023.06.045

Elmariah SB, Princic N, Richards M, et al. Economic and comorbidity burden of prurigo nodularis and drivers of higher healthcare costs in the US: a retrospective analysis of claims data of patients diagnosed between 2017 and 2022. Poster presented at: 44th Annual Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV

Whang KA, Kang S, Kwatra SG. Inpatient burden of prurigo nodularis in the United States. 

. 2019;6(3): 88. doi:10.3390/medicines6030088

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

The Burden of Prurigo Nodularis

Galderma announced Friday that the US Food and Drug Administration (FDA) has approved nemolizumab (Nemluvio) for the treatment of moderate to severe atopic dermatitis (AD) in patients aged 12 years and older with a history of inadequate response to topical therapies.

 Nemolizumab is now indicated for combined use with topical corticosteroids and/or calcineurin inhibitors for this patient population.

This approval follows nemolizumab's prior FDA approval in August 2024 for prurigo nodularis.

The approval was based on posiitve results from the phase III ARCADIA clinical program. This double-blind, placebo-controlled trial included 1,728 patients aged 12 years and older with moderate to severe AD. Patients received subcutaneous nemolizumab every 4 weeks alongside background topical corticosteroids, with or without topical calcineurin inhibitors, and were evaluated against placebo groups.

Researchers observed statistically significant improvement in achieving "clear" (0) or "almost clear" (1) skin at week 16, as well as a 75% reduction in eczema severity.

Significant reductions in itch were reported as early as week 1, and patients experienced meaningful reductions in sleep disturbance. Nemolizumab was well-tolerated, with a safety profile consistent with placebo.

Nemolizumab is the first monoclonal antibody targeting interleukin (IL)-31 receptor alpha, a pathway critical to itch and inflammation in AD. By inhibiting IL-31 signaling, nemolizumab provides a targeted approach to alleviate these symptoms and improve skin health.

Flemming Ørnskov, MD, MPH, CEO of Galderma, emphasized the innovation behind this approval.

"As just one example of our innovative, science-based pipeline, Nemluvio is an important and effective new treatment option for patients with atopic dermatitis, where unmet needs remain," Ørnskov said in a news release.

 "Another key milestone on Galderma’s journey, this FDA approval will accelerate the ongoing growth of our US organization and our Therapeutic Dermatology Business, and underscores our commitment to delivering innovative first-in-class solutions to patients across the full spectrum of the fast-growing dermatology market."

Professor Jonathan Silverberg, MD, PhD, MPH, lead investigator and dermatology expert at George Washington University, highlighted the trial’s outcomes.

"Despite currently available treatment options, atopic dermatitis continues to have a massive impact worldwide, with patients not only burdened by intense itch and recurrent skin lesions, but also potentially several associated symptoms including sleep issues, pain, anxiety, and depression. I look forward to being able to offer this option to atopic dermatitis patients in my practice who are seeking relief from burdensome itch and lesions," he said.

Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate-to-severe atopic dermatitis. News release. Galderma. December 14, 2024. Accessed December 16, 2024. 

https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic

Galderma receives US FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis. News release. Galderma. August 13, 2024. Accessed December 16, 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

Nemolizumab is intended for use in combination with topical corticosteroids and/or calcineurin inhibitors in this indication.

ICYMI: FDA Approves Galderma's Nemolizumab for Moderate to Severe Atopic Dermatitis in Patients 12 and Older

The US Food and Drug Administration (FDA) announced today that it has approved tapinarof cream, 1% (Vtama; Organon) for patients aged 2 years and older with atopic dermatitis (AD).

The approval is supported by positive data stemming from the phase 3 ADORING 1 and 2 studies, a pharmacokinetics trial in children, and interim results from the ongoing ADORING 3 trial.

“With the FDA’s approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected,” said Kevin Ali, Organon’s Chief Executive Officer, in a statement. “Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.”

In the ADORING studies, patients saw an improved Validated Investigator Global Assessment for AD score of clear (0) or almost clear (1) from baseline at week 8. In ADORING 1, 45.4% of patients achieved this while 46.4% reached this outcome in ADORING 2, versus 18% of patients on vehicle (p < 0.0001). Participants who received tapinarof cream compared to those who received vehicle saw at least a 75% improvement in Eczema Area and Severity Index score and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale. Itch relief was rapid, with patients and caregivers reporting improvement as early as 24 hours after the first application.

The aryl hydrocarbon receptor agonist was well-tolerated with ≥1% incidence of adverse events. The most commonly reported adverse effects were upper and lower respiratory tract infection, folliculitis, headache, asthma, vomiting, ear infection, pain in extremities, and abdominal pain.

The approval also was supported by data from ADORING 3, a 48-week open-label, long-term extension study. This trial included 728 eligible participants from ADORING 1, ADORING 2, a 4-week pharmacokinetics trial, and direct enrollees who were naive to tapinarof. 378 patients achieved complete disease clearance and discontinued treatment, with a mean duration of the first treatment-free interval of about 80 consecutive days. Patients whose AD returned were retreated until clearance was achieved. The long-term safety profile was consistent with the safety profile observed at week 8, even on affected sensitive skin areas.

In a press release, Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program, said, “VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease. Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream."

Dermavant Sciences announced its supplemental New Drug Application (sNDA) submission for this drug and indication in April.

 However, in November, the FDA announced it had extended the target action date for the sNDA for tapinarof cream, 1% by 3 months, shifting the Prescription Drug User Fee Act date to March 12, 2025.

 The extension stemmed from the FDA’s request for additional long-term study data but did not reflect concerns about the drug’s safety or efficacy.


1. FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. News release.BusinessWire. December 16, 2024. Accessed December 16, 2024. 

https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/

2. Dermavant announces FDA acceptance of supplemental new drug application (sNDA) for Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. Dermavant Sciences. April 29, 2024. Accessed December 13, 2024. 

https://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/

3. Update on FDA review of Vtama (tapinarof) cream 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. BusinessWire. November 5, 2024. Accessed December 13, 2024. 

https://www.businesswire.com/news/home/20241105332994/en/Update-on-FDA-Review-of-VTAMA%C2%AE-tapinarof-Cream-1-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-2-Years-of-Age-and-Older

The approval is based on positive data stemming from the ADORING clinical trial program.

FDA Approves Tapinarof Cream, 1% for Atopic Dermatitis in Patients 2 Years and Older

It was announced today that Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for roflumilast cream 0.05% (Zoryve).

 This new indication is targeted for patients between the ages of 2 and 5 for the treatment of mild to moderate atopic dermatitis (AD). Pediatric patients saw a rapid reduction in itch and a meaningful overall clearance of disease.

“When choosing a therapy for very young children living with AD, healthcare providers and caregivers have to account for unique considerations for pediatric patients, including sensitive skin, and select a medication that is appropriate for long-term use by a child with a chronic skin condition. Data from the pivotal trial demonstrated that roflumilast cream 0.05% provided consistent and rapid relief, and was well-tolerated,” Rocco Serrao, MD, FAAD, of DOCS Dermatology and INTEGUMENT-PED and INTEGUMENT-OLE investigator, said in a statement. “If approved, roflumilast cream 0.05% would offer a new topical option with the potential to advance the standard of care for these young patients, offering fast relief to the children and their families from the onerous symptoms of AD.”

The submission to the FDA is supported by positive results from the pivotal phase 3, vehicle-controlled, INTEGUMENT-PED trial, as well as a long-term extension study and a phase 1 pharmacokinetic study. The INTEGUMENT-PED research included 652 children aged 2 to 5 with a mean AD body surface area of 22% and a range between 3% and 82%. Compared to the 10.7% of children treated with vehicle, 25.4% of patients saw a 2-grade improvement from baseline and achieved a score of “clear” or “almost clear” at week 4, according to the validated Investigator Global Assessment – Atopic Dermatitis scale (

 < 0.0001). Some significant improvements were seen as early as week 1, with all secondary endpoints being met. Additionally, 35.3% of participants with a baseline Worst Itch Numeric Score of ≥ 4 achieved a 4-point reduction in the 4th week, compared to 18.0% of vehicle-treated children (nominal 

Overall, the once-daily, phosphodiesterase 4 (PDE4) inhibitor was well-tolerated, with a safety profile that was consistent in adult and older pediatric patients treated with roflumilast cream 0.15% with mild to moderate AD. The most frequent adverse effects were upper respiratory tract infection, diarrhea, and vomiting.

The submission is also supported by data from the open-label, INTEGUMENT-OLE extension study, in which 562 pediatric patients were treated for up to 52 weeks. Roflumilast cream 0.15% is currently approved by the FDA for the treatment of mild to moderate AD in patients 6 years of age and older. The 0.3% cream version is also FDA-approved for plaque psoriasis treatment.

Frank Watanabe, president and CEO of Arcutis, said in a press release, “Parents, caregivers, and healthcare professionals need to feel confident in their treatment plan. Our clinical development program for ZORYVE reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream, which was designed to deliver the drug without disrupting the skin barrier or using sensitizing excipients and irritants. This lower concentration of roflumilast cream was intentionally formulated for the needs of younger children with AD and demonstrates our commitment to serving this vulnerable patient population. We look forward to the opportunity to offer ZORYVE cream 0.05%, if approved, as a new topical therapy for the 1.8 million children between the ages of 2 to 5 with AD and their families.”

1. Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis. News release. Arcutis Biotherapeutics, Inc. December 16, 2024. Accessed December 16, 2024. 

https://www.globenewswire.com/news-release/2024/12/16/2997469/0/en/Arcutis-Submits-ZORYVE-roflumilast-Cream-0-05-Supplemental-New-Drug-Application-to-the-FDA-for-the-Treatment-of-Children-Aged-2-to-5-with-Mild-to-Moderate-Atopic-Dermatitis.html

The supplemental New Drug Application is supported by positive results from the INTEGUMENT-PED and INTEGUMENT-OLE trials.

Arcutis Submits sNDA for Roflumilast Cream 0.05% to FDA for Patients Ages 2 to 5 with Atopic Dermatitis 

As 2024 ends, it is important to step back and reflect on the strides dermatology has made in managing atopic dermatitis (AD) and psoriasis, as these are 2 of the most common inflammatory disorders we manage. At the heart of dermatology is the patient, and integrating patient-reported outcomes (PROs) with clinical assessments is essential to providing truly patient-centered care. Aiming for optimal treatment targets is key to achieving minimal disease activity (MDA) for individuals with these conditions. The notion that “the patient is good enough” is fading along with the final days of 2024. As we look ahead to 2025, patients deserve more than “good enough.” Over the past year, dermatology has embraced MDA as a transformative standard, poised to elevate the quality of life for those with chronic inflammatory skin disorders. 

To elevate the standard of care in AD, the Aiming High in Eczema/Atopic Dermatitis (AHEAD) guidelines

 recommend setting optimal treatment targets for both skin clearance and itch relief. Achieving both targets simultaneously defines MDA. Why is this recommendation so crucial? Data indicate that patients with AD and itch numerical rating scores (NRS) of 2 and 10, even those with high levels of skin clearance (Eczema Area and Severity Index [EASI] 90 or Investigator’s Global Assessment [IGA] 0/1), may experience a 40% to 60% reduction in quality of life.

 Meeting both EASI 90 and itch NRS 0/1 thresholds leads to improved outcomes and quality of life, ultimately fulfilling the goal of MDA. This emphasis on dual outcomes is why the recent LEVEL-UP trial, comparing upadacitinib (Rinvoq; AbbVie) with dupilumab (Dupixent; Regeneron and Sanofi), used the composite end point EASI 90+ itch NRS 0/1 as a primary measure, marking it as the most stringent end point in an AD trial to date.

In the LEVEL UP trial, upadacitinib demonstrated superiority over dupilumab at every time point in patients with moderate to severe AD. During period 1 (0 to 16 weeks), nearly twice as many patients treated with upadacitinib achieved the stringent primary MDA endpoint of EASI 90 & itch NRS 0/1 compared to those treated with dupilumab. In period 2 (16 to 32 weeks), patients who did not achieve EASI 75 on dupilumab by week 16 were allowed to switch directly to upadacitinib (15 mg daily) without a washout period. Remarkably, nearly 70% of these patients reached EASI 75 just 1 month after switching, and the majority achieved EASI 90 with clinically meaningful itch improvement by 4 months post switch. This is a practice-defining study that set a new standard for efficacy in AD. 

Adopting higher standards of care for moderate to severe AD requires clinicians to embrace the concept of MDA in real-world practice. A practical way to implement this is by ensuring patients achieve clear or almost clear skin (IGA 0/1) and little to no itch (itch NRS 0/1). If patients are not meeting these benchmarks, clinicians should confidently consider switching therapies. 

Moreover, the emergence of advanced systemic therapies for AD—including JAK inhibitors such as upadacitinib and abrocitinib (Cibinqo; Pfizer Inc), as well as biologics like dupilumab, tralokinumab (Adbry; LEO Pharma), and lebrikizumab (Ebglyss; Eli Lilly and Company)—offers effective alternatives to traditional immunosuppressive agents such as systemic corticosteroids. The American Academy of Dermatology guidelines

 for AD management support this approach, recommending against the use of systemic corticosteroids, except for short-term use as a bridge to another approved systemic therapy, as they no longer align with modern standards of care.

Innovations in psoriasis therapeutics have significantly advanced the standard of care, particularly with biologics that achieve optimal skin clearance with fewer doses per year—such as risankizumab (Skyrizi; AbbVie), requiring only 4 doses annually, guselkumab (Tremfya; Janssen) with 6 doses, and bimekizumab (Bimzelx; UCB) with 8 doses. The practice-defining IMMpulse study further elevated the standard by demonstrating the superiority of risankizumab over oral apremilast (Otezla; Amgen) in patients with moderate plaque psoriasis. These results encourage dermatologists to consider risankizumab earlier in the treatment pathway, even for patients with moderate disease, particularly for patients who desire optimal outcomes. Another ongoing, head-to-head study is BE BOLD, comparing bimekizumab , an anti–IL-17, vs risankizumab, an anti–IL-23, in patients with active psoriatic arthritis (PsA). However, a recent population-based study from the US has shown that patients receiving IL-23 inhibitors are at lower risk of developing inflammatory arthritis or psoriatic arthritis than those receiving IL-17 and tumor necrosis factor (TNF) inhibitors.

 Looking ahead to 2025, my vision for dermatology providers is to “take back ownership” of PsA by managing all aspects of psoriasis—skin and joints. Advances in systemic therapies have positioned dermatologists to embrace this holistic approach. With that in mind, let’s reflect on 3 key psoriasis narratives that defined 2024. 

First, p19-specific IL-23 biologics are the most widely prescribed class of advanced psoriasis treatments by dermatologists, yet little was previously understood about their molecular differences. A recent study

 has shown that the efficacy of these biologics correlates with their molecular structure. Specifically, a larger epitope surface area (risankizumab > guselkumab > tildrakizumab [Ilumya; Sun Pharmaceutical]) is associated with higher binding affinity and a lower dissociation rate (koff), resulting in a more stable antibody-p19/IL-23 complex. This stability translates to superior clinical outcomes, with higher skin clearance (Psoriasis Area and Severity Index [PASI] 90 and PASI 100) response rates observed over both short- and long-term treatment periods. This discovery provides a molecular explanation for the efficacy of p19-specific biologics. Looking ahead, innovation in the IL-23 space includes promising developments. Ongoing phase 3 trials are evaluating JNJ-2113 (Icotrokinra; Protagonist Therapeutics), an oral cyclic peptide that inhibits the IL-23 receptor, for psoriasis. Additionally, extended halflife technology is being applied to create an IL-23 monoclonal antibody with potentially improved dosing schedules. These advancements represent exciting opportunities to further refine IL-23-targeted therapies. 

Second, in 2024, bimekizumab completed its first full year of availability for psoriasis. A key advancement was the publication

 detailing the molecular basis of its dual inhibition of IL-17A and IL-17F, which underpins its clinical efficacy. Bimekizumab demonstrated the ability to elevate response thresholds, including achieving PASI-100, and showed potential for very rapid skin clearance.

 Late in 2024, bimekizumab was also approved for PsA. Clinical trial data from the BE COMPLETE and BE VITAL studies highlighted its effectiveness in patients with prior inadequate response or intolerance to TNFα inhibitors. At week 16, American College of Rheumatology response criteria (ACR) 20/50/70 responses were 67%, 43%, and 27%, respectively. These rates improved by week 52, reaching 68%, 52%, and 36%, respectively.

 Additionally, 44% of patients achieved a version of MDA at week 16, increasing to 47% by week 52. The stringent composite end point of ACR 50 + PASI 100 was achieved by 34% at week 16 and 47% at week 52, demonstrating the potential of innovative targeted therapies like bimekizumab to set new standards of care for both psoriasis and PsA. 

Third, the next-generation oral TYK2 inhibitor for psoriasis and PsA, zasocitinib (formerly TAK-279; Takeda), is in phase 3 trials. This molecule is over 1.7 million-fold more selective for the TYK2 JH2 domain over the JAK1 JH2 domain (compared with 87-fold for deucravacitinib [Sotyktu; Bristol Myers Squibb]), and its plasma concentration exceeds the TYK2 half-maximal inhibitory concentration (IC50) for a full 24 hours (compared to 3 hours for deucravacitinib) inhibiting 91% of TYK2 signaling daily (compared to 24% for deucravacitinib).

 In the phase 2b clinical trial, 30 mg zasocitinib once daily achieved 46% PASI 90 and 33% PASI 100 responses at week 12.

 For PsA, 27% of patients achieved ACR50 and approximately 30% MDA at week 12.

Lastly, dermatologists should note that oral upadacitinib is FDA-approved for PsA,

 demonstrating ACR 20/50/70 response rates at week 12 with the 15 mg daily dose ranging from 57% to 71%, 32% to 38%, and 9% to 16%, respectively. Notably, upadacitinib, in addition to AD, is FDA-approved for 7 immune-mediated disorders, and is currently being studied for alopecia areata, vitiligo, and hidradenitis suppurativa, underscoring the versatility of JAK inhibitors as anti-inflammatory agents. While the focus here has been on systemic therapies, it is important to note the significant advances in nonsteroidal topicals in psoriasis with roflumilast (Zoryve; Arcutis Biotherapeutics) and tapinarof (Vtama; Dermavant Sciences). Roflumilast, in particular, has emerged as a highly potent, effective, tolerable, and safe topical that can reduce Th1, Th2, Th22, and Th17 inflammatory cytokines, explaining roflumilast’s ability to effectively treat AD, psoriasis, and seborrheic dermatitis, along with other roflumilast-responsive dermatoses. 

The MDA principle is not only raising the standard of care in AD, psoriasis, and PsA, but is also likely to influence the management of other inflammatory skin conditions such as chronic hand eczema. As we move into 2025, one thing is clear: The true beneficiaries are the patients. With an unprecedented array of advanced and targeted therapies now available, it is incumbent upon clinicians to adapt their thinking and treatment strategies to integrate these transformative medications into everyday clinical practice, ultimately improving patient outcomes and quality of life. 

 is an associate professor of dermatology and translational biomedicine at the Yale University School of Medicine in New Haven, Connecticut. He is 


1. Silverberg JI, Gooderham M, Katoh N, et al. Combining treat-to-target principles and shared decision-making: International expert consensus-based recommendations with a novel concept for minimal disease activity criteria in atopic dermatitis. 

Reflecting on 2024, dermatology has advanced in managing atopic dermatitis (AD) and psoriasis by integrating patient-reported outcomes with clinical assessments, aiming for minimal disease activity (MDA). The LEVEL-UP trial highlighted upadacitinib's superiority over dupilumab in AD treatment. Innovations in psoriasis therapeutics, such as IL-23 and IL-17 inhibitors, have set new standards. The emergence of advanced systemic therapies, including JAK inhibitors, offers effective alternatives to traditional treatments. As 2025 approaches, dermatologists are encouraged to adopt these transformative therapies to improve patient outcomes.

Join Dermatology Times’ quarterly editor in chief Christopher Bunick, MD, PhD, as he discusses transformative advances in psoriasis care.

Matthew J. Elias, DO

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