Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Stephan Weidinger, MD, PhD
Credit: Skin Health Institute

A pair of presentations on phase 2b data from the 

European Association of Dermatology and Venereology (EADV) 2025 Congress

 offer new insight into the effects of temtokibart in adults with moderate-to-severe 

Presented as late-breaking data on September 17, 2025, results suggest temtokibart, an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit from Leo Pharma, was associated with significant improvements in several measures of disease severity and activity, with additional analysis shedding light on impact of atopic dermatitis biomarkers.

“These results are promising, as they provide further evidence of the value of targeting the IL-22 pathway in AD, via IL-22RA1 , offering a potential novel approach to the currently existing therapies used to treat atopic dermatitis” said Stephan Weidinger, MD, PhD, professor and chair for Dermatology at the Christian-Albrechts-University, director of the Department of Dermatology and Allergy at the University Hospital Schleswig-Holstein, and the International Coordinating Investigator for the Phase 2b trial.

A randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial, the phase 2b study was designed to assess the efficacy and safety of 4 different doses of subcutaneously administered temtokibart in adult patients with moderate-to-severe atopic dermatitis. The primary endpoint is percent change in EASI from baseline to week 16 and the key secondary endpoint was number of treatment-emergent adverse events at week 16.

Weidinger’s presentation at EADV 2025 Congress included 262 adult patients.

Results indicated use of temtokibart was associated with significant improvement in the primary endpoint of percentage change in EASI from baseline for 600 mg (−61.2%, 

<.01) treatment arms compared with placebo (−41.7%) at week 16. Additional analysis indicated significant improvements were observed in percentage change in EASI as early as week 1 with 450 mg (−22.3%; 

<.05), and as early as week 2 with 600 mg (−35.0%; 

<.05) compared with placebo, which saw improvements in EASI of −8.0% at week 1 and −22.7% at week 2.

Investigators also pointed out these improvements were maintained up to week 32 in the 600 mg (−59.1%; 

<.05) arms, despite no treatment use following week 14.

“Patients with moderate-to-severe atopic dermatitis still face numerous unmet needs, so we welcome any new options that could improve their disease while limiting burdensome side effects,” Weidinger added.

Following the presentation by Weidinger, a subsequent presentation highlighted data from a biomarker analysis of the phase 2b study. This study included data from 22 patients randomized to temtokibart at baseline and 14 temtokibart-treated with data out to 16 weeks.

Results of this analysis suggested a 97% improvement in immune gene expression by week 16 and expression of epidermal barrier-related genes were significantly restored by week 16. Guttman-Yassky pointed out Correlation analysis revealed reductions in EASI and SCORAD were significantly associated with reductions in Th2 and Th17/22 markers (

≤ .05). Additionally, the analysis suggested DLQI and POEM correlated with reductions of key T-cell, Th2, Th17/Th22 markers (

“Atopic dermatitis is a complex and heterogenous disease, and there remains a significant need for further understanding the effect of targeting different pathways. By investigating biomarkers in the clinical programs we are increasing our understanding of the disease, moving us closer to a more tailored approach of treating AD via different mechanisms of action,” said Emma Guttman-Yassky, MD, PhD, the Waldman Professor of Dermatology and Immunology and the Health System Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai.

These results provide further evidence that the IL-22 pathway is a key driver of disease activity in AD and that there is a strong correlation between clinical effects and dampening of several immune pathways of importance in AD, when targeting the IL-22RA1 subunit.”

Leo Pharma. LEO Pharma presents two late-breaking abstracts for temtokibart reporting positive Phase 2b efficacy, safety and biomarker results in moderate-to-severe atopic dermatitis at the 2025 EADV Annual Meeting in Paris. Leo-pharma.com. Published September 17, 2025. Accessed September 18, 2025. 

https://www.leo-pharma.com/media-center/news/2025-temtokibart-late-breaker-press-release

 IL-22RA1 antagonism with temtokibart provides significant early and sustained improvements in atopic dermatitis: results from a phase 2b dose-finding trial

. Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

 Temtokibart, an IL-22RA1 Monoclonal Antibody broadly dampens gene expression markers of activated immune pathways in Atopic Dermatitis: Results from a Phase 2b Trial Subgroup Analysis. 

Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

Articles

Phase 2b data from the EADV 2025 Congress reveal promising results for temtokibart, an investigational monoclonal antibody targeting IL-22RA1, in treating moderate-to-severe atopic dermatitis. The study demonstrated significant improvements in disease severity, with notable reductions in EASI scores across various dosages. Improvements were sustained up to week 32, even after treatment cessation. Biomarker analysis indicated a 97% improvement in immune gene expression and restoration of epidermal barrier-related genes. These findings underscore the potential of targeting the IL-22 pathway for more tailored atopic dermatitis treatments.

New phase 2b data reveals temtokibart significantly improves atopic dermatitis symptoms in adult patients.

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Atopic Dermatitis

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Temtokibart Shows Benefit, Effect on Biomarkers in Phase 2b Atopic Dermatitis Trial

2025 European Academy of Dermatology and Venereology (EADV) Congress

 in Paris, Eingun James Song, MD, of Frontier Dermatology, touched on the topic of treatment sequencing, in light of his recent phase 4 data on risankizumab for those with moderate to severe scalp and genital 

Song’s team recently authored the UnlIMMited study, a multicenter, randomized, double-blind, placebo-controlled trial evaluating risankizumab. The team designed the study to address a historically underrepresented patient population in clinical research: patients with limited body surface area (BSA) involvement but with psoriasis affecting high-impact regions of the body such as the scalp and genitals.

Risankizumab and Treatment Sequencing in Scalp and Genital Psoriasis, With Eingun James Song, MD

“In the risankizumab studies, there were some patients who were on a prior systemic agent before,” Song explained. “So for the genital cohort, over 10% of these patients were on ixekizumab, an IL-17a inhibitor, with actually really good data for the genital scan, and then for the scalp group, we saw over 10% of these patients were either on adalimumab, a TNF alpha inhibitor, or apremilast, an oral PDE4 inhibitor. While we don't necessarily know how those patients responded to those prior therapies, what we can say is that people who've been exposed to those other biologics or DMARDs in the past, even if they didn't necessarily achieve a certain level of response, we are still seeing very high levels of response with risankizumab.”

Song noted that a caveat to his comments is that the numbers in this research are smaller and the data on these prior therapies are not known.

“My feelings on this, just based on my anecdotal experience, are that patients who don't do well with one particular agent, if they have very little response, we generally will switch out of the class,” Song said. “So if a patient was on an IL-17 or a TNF inhibitor before, and they had very little movement in their skin clearance, then we probably would move to an IL-23 inhibitor.”

In his discussion of treatment sequencing, Song highlighted the necessity of balancing risks and benefits.

“Purely from that standpoint, it is really hard to argue against the fact that an IL-23 inhibitor makes a very compelling case to be a first-line agent for patients if they've never been on anything before,” Song said. “Even for patients who've been on a systemic and maybe didn't get the result that they wanted…If there's maybe one thing I want you to take away from this study, it's that even in patients who have lower body surface areas, if they have a higher impact area that affects their quality of life [in a way that is] comparable to patients with much more extensive body surface area. So please don't under-treat these patients with just topicals. If they're not responding, at least consider escalating these patients to a systemic agent.”

Song has been a consultant, speaker or investigator for the following companies: AbbVie, Janssen, Amgen, Lilly, SUN, UCB, Incyte, Novartis, Sanofi & Regeneron, Castle Biosciences, and Pfizer.

Song J, et al. Safety and Efficacy of Risankizumab in Genital and Scalp Psoriasis in the UnlIMMited Phase 4 Randomized Clinical Trial at Week 16. Presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, Sept 17-20, 2025.

Song J. Spotlighting New Data on Risankizumab for Scalp and Genital Psoriasis, With Eingun James Song, MD. HCPLive. September 17, 2025. 

https://www.hcplive.com/view/spotlighting-new-data-risankizumab-scalp-genital-psoriasis-eingun-james-song-md

Videos

This interview segment highlights Song’s risankizumab data covered during the 2025 EADV Congress in Paris.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

 with brivekimig has resulted in clinically meaningful HS improvements among biologic-naïve patients compared to placebo at Week 16, according to recent findings.

European Academy of Dermatology and Venereology (EADV) 2025 Congress

 in Paris, resulted from the HS-OBTAIN phase 2a study (NCT05849922) assessing brivekimig in patients with HS.

 HS is a chronic and debilitating inflammatory skin condition that commonly features painful cutaneous nodules, abscesses, and draining tunnels.

“Despite the debilitating impact of HS, treatment options are unfortunately limited,” Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School, said in a statement.

 “The phase 2a results presented at EADV indicate targeting TNF and OX40L pathways together with brivekimig may offer a promising strategy to reduce underlying inflammation, leading to improvement in HS symptoms.”

Brivekimig was designed as a dual-target Nanobody block both tumor necrosis factor (TNF) and OX40-ligand. These are both known to be important immune mediators. The medication is currently under investigation for its application in several immune-mediated and inflammatory conditions.

During the HS-OBTAIN trial, a phase 2a randomized, double-blind, placebo-controlled proof-of-concept study design was used. The research team evaluated the safety and efficacy of brivekimig in adults patients with moderate-to-severe HS. Those taking part as subjects were assigned in a 2:1 ratio to receive either subcutaneous brivekimig 150 mg or placebo every 2 weeks for a total of 16 weeks.

This was followed by a 12-week open-label extension and an additional 8-week safety follow-up. The investigative team's main endpoint was the proportion of biologic-naïve individuals attaining a Hidradenitis Suppurativa Clinical Response (HiSCR50) at the 16-week mark, evaluated through the use of a Bayesian logistic regression model adjusted for Hurley stage.

In their assessment of secondary endpoints, the team included reports of HiSCR75, HiSCR90, and shifts in draining tunnel count. These secondary endpoints were each assessed at Week 16 with adjusted estimates and nominal p-values.

Outcomes related to efficacy at the 16-week mark included:

HiSCR50 (≥50% reduction in abscesses and inflammatory nodules without worsening of abscess or fistula counts): attained by 67% of individuals involved as participants treated with brivekimig (n=48) compared with 37% in the placebo arm (n=23). The Bayesian primary analysis indicated an estimated difference of 29% (90% credible interval [CrI]: 10%–47%), with a 99.28% probability of superiority.

HiSCR75: 54% of brivekimig-treated subjects attained this outcome compared with 22% of placebo-treated individuals (estimated difference 29%; 90% CI: 11%–48%; 

HiSCR90: 31% of those in the brivekimig cohort attained this threshold compared with 9% in the placebo cohort (estimated difference 20%; 90% CI: 5%–34%; 

Draining tunnel count: mean percent change from baseline was –56.0% for those on brivekimig versus +10.9% given a placebo, representing an estimated difference of –67.0% (90% CI: –105.2% to –28.8%; 

In assessing safety findings, HS-OBTAIN investigators found the most common treatment-emergent adverse events (taking place in more than 10% of subjects and at higher frequency with brivekimig than placebo) were nasopharyngitis and headache.

Brivekimig remains an investigational agent for HS and has not yet undergone regulatory review or approval.

Press Release: EADV: Sanofi’s brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study. Sanofi. September 17, 2025. 

https://www.sanofi.com/en/media-room/press-releases/2025/2025-09-17-05-00-00-3151353

Brivekimig, a dual-target Nanobody, has shown significant efficacy in treating hidradenitis suppurativa (HS) in biologic-naïve patients, as demonstrated in the HS-OBTAIN phase 2a study. The study, presented at the EADV 2025 Congress, revealed that brivekimig significantly improved HS symptoms by targeting TNF and OX40L pathways. At Week 16, 67% of patients treated with brivekimig achieved a HiSCR50 response compared to 37% in the placebo group. The study also reported notable improvements in HiSCR75, HiSCR90, and draining tunnel count, with nasopharyngitis and headache as common adverse events.

These HS-OBTAIN phase 2a trial data highlight the impacts of treatment with brivekimig on patients naïve to biologics with moderate-to-severe HS.

Hidradenitis Suppurativa

Hidradenitis Suppurativa condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatology research, treatment, and drug development.

HS-OBTAIN: Brivekimig Achieves Positive Results in Hidradenitis Suppurativa

Josephine Harrington, MD, is an advanced heart failure and transplant fellow at Duke University.

Bumetanide Nasal Spray and the Future of Edema With Josephine Harrington, MD, and Nihar Desai, MD

 approved bumetanide nasal spray for the treatment of edema associated with congestive 

, liver disease, and kidney disease. Under the name ENBUMYST, the spray is the first and only intranasal loop diuretic approved in the US offering a self-administered alternative between oral and intravenous diuretics.

Loop diuretics are the standard first-line treatment for congestion, and are used to control patients’ volume status in HF. Most patients admitted to the hospital are given intravenous loop diuretics, regardless of perfusion status or other factors. However, blunted use of loop diuretics leads to blunted diuretic response in acute decompensated HF, which is related to functional and structural tubular remodeling. Bumetanide nasal spray was developed in part to circumvent the gastrointestinal absorption issues.

In addition to revitalizing diuretic therapy for patients with HF, bumetanide has the capacity to overhaul key factors of the HF treatment landscape and open the way to address the unmet need of edema. 

 spoke with Josephine Harrington, MD, an advanced heart failure and transplant fellow at Duke University, and Nihar Desai, MD, MPH, an associate professor of medicine and vice chief of the section of cardiovascular medicine at Yale University, to discuss the implications of this groundbreaking approval.

“Too many of our patients become resistant, or traditional oral diuretics are ineffective, and so we need other ways to optimize their volume status,” Desai told 

. “I was quite excited to see the data for the intranasal bumetanide, and I think that it does have a very important role to play for some of our patients.”

Harrington expressed her curiosity on how bumetanide will fit into the overall HF treatment cascade. She highlighted the lack of intranasal medications in cardiology prior to this approval, leaving many clinicians with limited experience prescribing similar drugs. She noted this as a potential gap in knowledge, possibly limiting the clinical uptake of bumetanide nasal spray.

“I think there are some opportunities to understand how this could fit into a patient’s armamentarium for symptom relief,” Harrington said. “But candidly, I think a lot of us need a lot more experience with this. Most of us don’t prescribe intranasal drugs as cardiologists regularly.”

Edema and fluid overload are still the leading causes of hospitalization for patients with congestive HF – recent estimates suggest 6.7 million Americans live with heart failure, and fluid overload directly causes >1 million hospitalizations annually. The bumetanide nasal spray is a step towards alleviating this unmet need and could potentially provide a path towards approval for future diuretic drugs to follow.

“Getting back to the very fundamental aspects of heart failure management, diuretics have and always will play a very important role in that,” Desai told

. “Having some of these novel mechanisms and routes of administration offers a really important adjunctive part of our medical intervention for our patients.”

“Edema is a condition that bothers patients quite a great deal, and they’re always interested in ways to manage it that don’t affect their quality of life,” Harrington said. “I think having another arrow in your quiver to do that is always going to be a good thing. And exactly what the role is going to be compared to oral diuretics, I think still remains to be seen.”

Corstasis Therapeutics, Inc. Corstasis Therapeutics Announces FDA Approval of ENBUMYST (bumetanide nasal spray) for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease, and Kidney Disease. Business Wire. September 15, 2025. Accessed September 17, 2025. 

https://www.businesswire.com/news/home/20250915243998/en/Corstasis-Therapeutics-Announces-FDA-Approval-of-ENBUMYST-bumetanide-nasal-spray-for-the-Treatment-of-Edema-Associated-with-Congestive-Heart-Failure-Liver-Disease-and-Kidney-Disease

Biegus J, Ponikowska B, Canonico ME, Damman K, Palazzuoli A, Ambrosy AP. Bumetanide nasal spray: a novel approach to enhancing diuretic response and advancing ambulatory heart failure care?. Heart Fail Rev. 2025;30(5):1123-1126. 

Harrington and Desai weigh in with their thoughts on the bumetanide approval and how we can continue to battle edema in heart failure.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Heart Failure

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Chief of Pediatric Rheumatology at Hackensack University Medical Center, and Professor of Pediatrics at the Hackensack Meridian School of Medicine.

Advancing Research and Care in Juvenile Arthritis, With Yukiko Kimura, MD

Management for juvenile idiopathic arthritis (JIA), the most common rheumatologic disease in children, has undergone a dramatic shift in outcomes over the past 2 decades. Once a condition that frequently left children with visible disability, limited mobility, and lifelong complications, JIA is now often managed successfully with targeted therapies that prevent severe damage and help children live active, healthy lives. This progress is largely attributed to the advent of biologics, beginning with TNF inhibitors and now extending to a wide array of therapies with distinct mechanisms of action, including IL-6 inhibitors, T-cell co-stimulation blockers, and JAK inhibitors.

 The expansion of treatment options has not only improved quality of life but has also transformed how clinicians approach disease control in pediatric populations.

Alongside therapeutic breakthroughs, international collaboration has become a driving force in JIA research. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) in North America and the Pediatric Rheumatology European Society (PReS) have joined efforts to launch some of the first global investigator-initiated studies in this space. One such initiative, the SMART-JIA trial, seeks to address a longstanding clinical question: how to optimize treatment strategies for patients who do not respond to first-line biologics.

 With multiple biologic and targeted options available, determining which pathway to pursue after treatment failure remains a challenge for clinicians. Another critical area of investigation focuses on when and how it may be safe to taper or discontinue therapy, an issue of great importance for patients and families navigating long-term treatment.

 spoke with Yukiko Kimura, MD, Chief of Pediatric Rheumatology at Hackensack University Medical Center, and Professor of Pediatrics at the Hackensack Meridian School of Medicine, to learn more about her experience with the evolving treatment landscape. Kimura, who is also cochair of the CARRA Registry and Research Oversight Committee (RROC), also highlighted the importance of ongoing research to address these pressing questions in JIA care.

“The kids that get diagnosed [with pediatric arthritis] can really benefit from knowledge of specialists in this area who know how to use [biologics] and can treat them the way that they should be,” Kimura said.

Shishov M, Weiss PF, Levy DM, et al. 25 Years of Biologics for the Treatment of Pediatric Rheumatic Disease: Advances in Prognosis and Ongoing Challenges. 

. 2025;77(5):573-583. doi:10.1002/acr.25482

Trial of Sequential Medications After TNF Failure (SMART) and Precision Treatment Decisions in Juvenile Idiopathic Arthritis. CARRA. 

https://carragroup.org/grant/trial-of-sequential-medications-after-tnf-failure-smart-and-precision-treatment-decisions-in-juvenile-idiopathic-arthritis/

Kimura highlighted some of her ongoing research tackling high priority questions in JIA.

Rheumatology

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Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A study suggests associations between opioids during pregnancy and neurodevelopmental disorders are mainly due to confounding factors, not causal effects.


Psychiatry

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Prenatal Opioid Pain Medications Likely Not Linked to Autism or ADHD Risk

This study highlights improvements with izokibep for HS, sustained or improved across disease measures through to Week 16.


Izokibeb Effective in 16 Weeks Among Patients with Moderate to Severe Hidradenitis Suppurativa

Allysa Saggese, NP, is a nurse practitioner at Weill Cornell.

Saggese explains the importance of effective communication in MASH management and emphasizes the need for more therapies to offer patients.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Collaboration and Innovation in MASH Management, With Allysa Saggese, NP

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

When compared to transitions of care coordinators, MIH saw no additional benefit to either health status or 30-day hospital readmissions for postacute patients with HF.

Mighty-Heart: Mobile Integrated Health Offers No Benefit in Heart Failure Readmissions

A recent study reveals diverse real-world data on abrocitinib use for atopic dermatitis.

Real-World Data Shed Light on Abrocitinib Use for Atopic Dermatitis, With Raj Chovatiya, MD, PhD

New data reveals bimekizumab offers sustained disease control for hidradenitis suppurativa, improving patient quality of life for 3 years.

BE HEARD: Bimekizumab Benefit in Hidradenitis Suppurativa Persists for 3 Years

Icotrokinra outperforms deucravacitinib in achieving skin clearance for plaque psoriasis, offering a promising new oral treatment option.

ICONIC-ADVANCE: Icotrokinra Beats Deucravacitinib for Plaque Psoriasis

These 24-week, interim data from the phase STOP-HS study highlight the impacts of povorcitinib on patients with hidradenitis suppurativa (HS).

Povorcitinib Improves Moderate to Severe Hidradenitis Suppurativa at Week 24

Eingun James Song, MD, highlights recent phase 4 data on risankizumab for patients with moderate to severe scalp and genital psoriasis.

Spotlighting New Data on Risankizumab for Scalp and Genital Psoriasis, With Eingun James Song, MD

Shawn Kwatra, MD, highlights his team’s findings presented at EADV on the efficacy of dupilumab in treating prurigo nodularis.

Latest News

Temtokibart Shows Benefit, Effect on Biomarkers in Phase 2b Atopic Dermatitis Trial

Risankizumab and Treatment Sequencing in Scalp and Genital Psoriasis, With Eingun James Song, MD

HS-OBTAIN: Brivekimig Achieves Positive Results in Hidradenitis Suppurativa

Bumetanide Nasal Spray and the Future of Edema With Josephine Harrington, MD, and Nihar Desai, MD

Advancing Research and Care in Juvenile Arthritis, With Yukiko Kimura, MD