Director, Center for Lung Analytics and Imaging Research (CLAIR), Endowed Professor of Airways Disease at the University of Alabama at Birmingham School of Medicine

Credit: University of Alabama at Birmingham

 (COPD) with chronic bronchitis and type 2 inflammation, defined by blood eosinophil counts of 300 cells/µL or higher, in patients remaining uncontrolled on triple therapy. GOLD 2026, published just ahead of 

European Respiratory Society (ERS) International Congress, held in Barcelona from September 5-9

, added mepolizumab alongside dupilumab as a second biologic option for this same eosinophilic, exacerbation-prone phenotype.

A post hoc analysis of pooled BOREAS and NOTUS data assessed dupilumab versus placebo across all 4 seasons by exacerbation start date, since winter exacerbations are disproportionately infection-driven while type 2 inflammatory exacerbations are not. Dupilumab reduced exacerbation rates by 25.9% in winter, 33.4% in spring, 33.1% in summer, and 27.1% in fall (all P≤.005).

 Events requiring both systemic corticosteroids and antibiotics, the most resource-intensive category, were numerically lower with dupilumab in every season.

A separate pooled analysis stratified by smoking status found dupilumab reduced exacerbation rates by 32% in both current and former smokers, with a non-significant treatment-by-subgroup interaction (

 Current smokers are often excluded from or underrepresented in COPD biologic trials, and dupilumab carries no smoking cessation prerequisite for initiation.

Across the METREX, METREO, and MATINEE trials, mepolizumab reduced exacerbations by 18% to 21% without significant gains in lung function or quality of life, while dupilumab improved both alongside exacerbation reduction of 30% to 34% in its pivotal trials.

 Both analyses discussed here are post hoc rather than prespecified, so clinicians should weigh them as supportive context within approved labeling rather than as new indications.

Surya Bhatt, MD, MSPH, professor of medicine in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama at Birmingham, discussed these findings with 

 at the ERS Congress 2026 in Barcelona. In the following interview, Bhatt addresses what the seasonal and smoking status data add to choosing between dupilumab and mepolizumab in COPD.

HCPLive: What was the hypothesis behind this seasonal analysis, and what does the consistent exacerbation reduction across seasons suggest about dupilumab's mechanism?

The goal of this analysis was to understand how dupilumab performs across seasons regardless of the presence of specific exacerbation triggers within a particular season. Given type 2 inflammation doesn't drive exacerbations only in response to specific triggers, we expected dupilumab to work similarly across seasons. Therefore, the results are consistent with our expectations, demonstrating that, regardless of season, dupilumab consistently and significantly reduced exacerbations.

HCPLive: Why is the reduction in exacerbations requiring both steroids and antibiotics particularly meaningful for frequent exacerbators?

 The decision to treat a particular patient with steroids alone, antibiotics alone, or with both is a clinical decision often made by clinicians based on clinical gestalt and prior response to these medications. Although individual events were not phenotyped for etiology, the broad efficacy of dupilumab for all types of events raises confidence that the efficacy is not confined to steroid-responsive type 2 inflammation-related exacerbations only.

HCPLive: Should smoking cessation remain a prerequisite before initiating dupilumab in a patient who meets the eosinophil threshold?

Dupilumab is already approved for eligible patients with COPD, including both current and former smokers, so smoking cessation is not a requirement to initiate dupilumab. This analysis confirms that dupilumab not only significantly reduces exacerbations in current or former smokers, but also led to improvements in other key outcomes in both populations, including improvements in lung function, health-related quality of life, and reduction in symptom burden compared to placebo.

HCPLive: How should clinicians weigh post hoc subgroup findings when making treatment decisions for dupilumab in COPD?

Clinicians should continue to prescribe dupilumab in accordance with local regulatory guidelines in alignment with approved labeling. However, post hoc analyses like these provide additional information on the potential outcomes across patient populations or other specific variables when prescribing dupilumab. These two post hoc analyses, for example, can provide clinicians more confidence in administering dupilumab regardless of smoking status and across seasons.

HCPLive: With 2 biologics now in the GOLD algorithm, how should clinicians choose between dupilumab and mepolizumab for individual patients?

Dupilumab is currently the only approved biologic for COPD that has demonstrated improved outcomes across exacerbations, lung function, and health-related quality of life. Dupilumab is already approved for eligible patients regardless of smoking status and can be used in any season, but the results from these post hoc analyses provide additional data that could give healthcare providers a more holistic understanding of the outcomes their patients might see while on dupilumab.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Bhatt’s disclosures include Sanofi, Regeneron, Apreo, Boehringer Ingelheim, GSK, Genentech, Merck, and others.

Criner G, Wilkinson T, Sciurba F, et al. Dupilumab reduces exacerbations regardless of season in patients with chronic obstructive pulmonary disease. Presented at: ERS Congress 2026; September 5-9, 2026; Barcelona, Spain.

Bhatt S, et al. Dupilumab is efficacious in chronic obstructive pulmonary disease with type 2 inflammation regardless of smoking status. Presented at: ERS Congress 2026; September 5-9, 2026; Barcelona, Spain. Abstract PA2555.

Cazzola M, Bajpai J, Calzetta L, Matera MG, Rogliani P. GOLD 2026: transforming COPD management with early intervention, multi-dimensional assessment, and personalized care. Drugs. 2026;86(5):581-597. doi:10.1007/s40265-026-02303-3

Articles

Dupilumab is approved for exacerbation-prone COPD with chronic bronchitis and type 2 inflammation (blood eosinophils ≥300/µL) despite triple therapy, and GOLD 2026 now lists mepolizumab as an additional biologic option. Post hoc pooled BOREAS/NOTUS analyses showed dupilumab significantly reduced exacerbations across all seasons, including winter, and numerically lowered events requiring both systemic corticosteroids and antibiotics. Another pooled analysis demonstrated comparable exacerbation reduction in current and former smokers with no interaction signal. These findings support use within labeling, acknowledging post hoc limitations.

Bhatt also discusses how these findings inform the choice between dupilumab and mepolizumab under GOLD 2026.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

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 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Dupilumab Cuts COPD Exacerbations Across Seasons, Smoking Status: Surya Bhatt, MD

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Precision medicine has become an increasingly popular topic of discussion in medicine, with some viewing it as the way of the future and others as a pipe dream.

, precision medicine has become increasingly mentioned during sessions held at major yearly meetings. It is also referred to sometimes as “personalized medicine,” though the use of “precision medicine” as a moniker has become prevalent given its reference to tailoring therapies based on individual characteristics, rather than the creation of unique drugs for each patient.

As the topic has become more commonplace at dermatology conferences, more and more have become aware that precision medicine refers to the “ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology and/or prognosis of those diseases they may develop, or in their response to a specific treatment.”

Dermatologists have highlighted the wide array of targeted immunomodulatory drugs in existence today, shaping the chronic inflammatory skin disease landscape.

 noted, selection of therapies in fields like dermatology remains primarily empirical and commonly guided by trial-and-error and mandates related to insurance versus individual patients’ underlying biology.

Personalized medicine has been touted as an answer to all of this. But the question remains: Where are we today and how far do we have to go? In this feature, there is a synthesis of recently published papers and discussions with several leading experts in dermatology, all of whom were asked about their views on what personalized medicine looks like in the modern era and whether or not it is a realistic aim for the field.

Why Dermatology Lags Behind Other Fields in Precision Medicine

“In science fiction, somebody gets a body scan and knows exactly what's wrong,” said Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, told 

 “That's really the goal: personalizing to you what would be safe and effective, the right solution to your specific problem.”

While the benefits of personalizing treatment plans for dermatology patients are widely acknowledged, precision medicine has seen greater leaps in advancement in other medical subfields. Oncology, for example, has been referred to as being at the forefront of precision medicine.

“In other fields of medicine, particularly oncology, we've seen the biggest leaps in precision medicine, being able to understand tumor characteristics and say, you have this mutation, so this pathway is exactly what you need... oncology is setting the tone for everybody else, but I don't think we're anywhere close to that yet with inflammatory conditions.”

Of course the mutation-driven nature of cancer is, in part, to blame for its supremacy in this area. Cancer is fundamentally a genomic disease, with tumors often maintaining a small number of driver mutations which can be targeted in a more direct manner.

Meanwhile, skin disease is considered messier. Most chronic skin diseases, such as psoriasis, chronic urticaria, and atopic dermatitis, are known to be driven by overlapping networks of cytokines such as interleukin TNF-alpha, (IL)-17, and others, as opposed to a single mutation.

There is a limited specificity of common proinflammatory markers across these different conditions, a review of dermatology biomarkers suggested.

 The review concluded that the same biomarker often cannot cleanly divide 1 disease or treatment-response subgroup from another.

Nevertheless, precision dermatology is still seeing some advancement in an oncology-related area, as gene expression profiling (GEP) for cutaneous tumors and artificial intelligence (AI) use for lesion diagnosis have seen some key insights helping to expand dermatology’s precision medicine potential.

Trial-and-Error Treatment Selection in Inflammatory Skin Disease

While common skin diseases, or dermatoses, are typically seen as non-life-threatening when compared to cancer, their effects on patients’ physical and mental health outcomes, as well as quality of life and economic productivity, are substantial.

Recent research in the field of dermatology has demonstrated the multidimensional nature of skin disease burden, especially for those living with diseases such as psoriasis and atopic dermatitis.

 The detrimental impacts of inflammation dermatoses also have disproportionate impacts on women, as 1 study demonstrated, with such diseases leading to significant increases in absenteeism, impairment at work, and activity impairment.

Given both their pervasiveness and the complexity of their diagnoses and therapeutic decision-making pathways, psoriasis and atopic dermatitis have particularly singled out as warranting an increased precision medicine approach. This is especially the case because despite the growing armamentarium of biologics and Janus kinase (JAK) inhibitors, these approvals have not solved a core problem in dermatology: knowing which therapy to initiate first.

Insurance “step therapy” is a system often which often locks this issue in place, leading to a requirement for those with psoriasis to fail an older TNF-alpha inhibitor such as adalimumab prior to payers approving an IL-17 or 23 inhibitor.

These are exactly the types of gaps precision medicine could potentially close.

 Rather than a process of cycling patients through biologics by trial and error, biomarker testing and disease endotyping could help to identify, before therapy use begins, which pathway is actually driving a given patient's disease.

Where Are We Now? The Emerging Toolkit in Precision Dermatology

"I think we're finally beginning to see enough choices to start having precision medicine discussions,” Peter Lio, MD, expressed when asked about precision dermatology today.

Despite the lag behind fields such as oncology, dermatology has seen limited progress in the precision medicine arena. There have been several notable efforts to illustrate what precision medicine could look like in dermatology, including a genetic test of a patient's skin to predict which medication class could work and a diagnostic patch doing the same thing for psoriasis.

Preliminary data on the genetic test, designed by Castle Biosciences, have been described as promising.

 According to 1 review, Castle is is “running a multi-site longitudinal clinical study to determine the utility of skin scrapings in inflammatory dermatoses, with the hypothesis that a multi-algorithmic gene expression profile…can be identified to guide systemic therapy selection in patients with psoriasis, [atopic dermatitis], and related conditions.”

At the same time, Mindera Health is a company which has worked on the development of the ‘Mind.Px’ dermal patch testing method, with the aim being to identify psoriasis treatment response genes. They too have yielded positive findings. While both companies’ approaches differ, they both have been singled out as minimally invasive tools designed to analyze genetic biomarkers in dermatology.

, Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine, appeared to concur with these types of findings, describing advances in transcriptomics and cellular immunology as areas that could play a significant role in the future of dermatologic therapy prediction.

Precision Dermatology's Path from Research to Clinical Practice

Despite advances in testing and leaps forward such as the Castle Biosciences and Mindera Health methods, doubts remain regarding precision medicine as a fully realized idea in the dermatology space.

"I think the precision medicine journey is something that will probably never hit an end point,” Peter Lio, MD, explained.

 “It's going to be a continuous journey of refinement and improvement, much like the virtuous cycle of drug development: we get a new medicine, it teaches us more about the underlying disease state, and that in turn allows us to refine and get better medicines. It's a building process. Rarely do we have a breakthrough that solves the whole thing; most of what I'm involved in never works that way, it's a slow process of iteration.”

Other dermatologists, such as Eingun James Song, MD, associate chief medical officer and the director of clinical research at Frontier Dermatology, have echoed these sentiments regarding the potential for personalized care for dermatology patients.

“I think personalized medicine is going to be the best way to improve patient treatment outcomes, because hopefully we can predict what type of patients are going to respond the best,” Song noted to 

. “But also [we need to ensure] the least amount of side effects to a certain drug based on their patient profile.”

While views expressed by clinicians such as Lio and Song highlight the cautiousness expressed by many in the field, others have nonetheless stressed the importance of finding an alternative to the trial-and-error method chaining dermatologists to the step therapy system required by health insurance companies. Jason Hawkes, MD, professor of dermatology at the University of California, Davis, described his own frustration with this system to 

“We need some metrics or measures or testing that can help us better select therapies at the outset that have a higher likelihood of working because we just want to get those patients better,” Hawkes expressed, noting clinicians’ inability to look at a patient’s whole needs when restricted in this manner. “We're in a try-and-fail system, and we don't always know they can look like they're going to respond and not respond.”

Although the dermatology field will not jump directly ahead to the oncology model of matching a single mutation to a single treatment in 1 day, advancements continue to appear in precision dermatology. Between tests already arriving in dermatology clinics, medications built around newly mapped immune pathways, and literature pushing further into proteomics and cellular immunology, the field of skin health slowly but surely evolving toward a more personalized future for patients.

Editor’s note: The clinicians quoted had no relevant financial disclosures of note

National Research Council (US) Committee on A Framework for Developing a New Taxonomy of Disease. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease. Washington (DC): National Academies Press (US); 2011. Appendix E, Glossary. 

https://www.ncbi.nlm.nih.gov/books/NBK92148/

Yuan M, Lee J, Cheng JB, et al. Advancing Precision Medicine in Inflammatory Skin Disease. Am J Clin Dermatol. 2025 Nov;26(6):853-861. doi: 10.1007/s40257-025-00963-7. Epub 2025 Aug 17. PMID: 40819342; PMCID: PMC12615522.

Lio P. Q&A: Precision Medicine's Next Steps in Atopic Dermatitis, With Peter Lio, MD. HCPLive. September 10, 2026. Accessed September 15, 2026. 

https://www.hcplive.com/view/q-a-precision-medicine-next-steps-atopic-dermatitis-peter-lio-md

Zakria D, Brownstone N, Lebwohl M. Integrating Precision Medicine into Medical Dermatology Clinical Practice: An Expert Consensus Panel. J Drugs Dermatol. 2023 Jun 1;22(6):588-593. doi: 10.36849/JDD.7432. PMID: 37276166.

Lio P. The Present and Future of Precision Medicine in Dermatology, With Peter Lio, MD. HCPLive. September 1, 2026. Accessed September 15, 2026. 

https://www.hcplive.com/view/present-future-precision-medicine-dermatology-peter-lio-md

Tan IJ, Podwojniak A, Cohen BA, et al. Precision Dermatology: A Review of Molecular Biomarkers and Personalized Therapies. Curr Issues Mol Biol. 2024 Mar 30;46(4):2975-2990. doi: 10.3390/cimb46040186. PMID: 38666916; PMCID: PMC11049353.

Mehrmal S, Tan MG, Tolkachjov SN, et al. Gene Expression Profiling (GEP) in Dermatology, Part 1: Introduction, Development, Benefits, Limitations, and Future Directions of GEP. J Am Acad Dermatol. 2025 Oct 27:S0190-9622(25)03081-6. doi: 10.1016/j.jaad.2025.10.084. Epub ahead of print. PMID: 41161602.

Padovan M, Benincasa BB, Foddis R, et al. Assessing the burden of dermatological diseases on work life from a gender perspective. Sci Rep. 2025 Jul 5;15(1):24014. doi: 10.1038/s41598-025-07804-x. PMID: 40617854; PMCID: PMC12228698.

Haran K, Kranyak A, Liao W, et al. Commercial Diagnostics and Emerging Precision Medicine Technologies in Psoriasis and Atopic Dermatitis. Psoriasis (Auckl). 2024 Aug 5;14:87-92. doi: 10.2147/PTT.S478377. PMID: 39132449; PMCID: PMC11314430.

Bunick C. What Will Precision Dermatology Look Like in Atopic Dermatitis? HCPLive. June 25, 2026. Accessed September 15, 2026. 

https://www.hcplive.com/view/what-will-precision-dermatology-look-like-atopic-dermatitis-

Smith T. Eingun James Song, MD: Upcoming Treatments for Psoriasis. HCPLive. January 16, 2024. Accessed September 15, 2026. 

https://www.hcplive.com/view/eingun-james-song-md-upcoming-treatments-for-psoriasis

Hawkes J. Q&A: How Is Precision Medicine Changing Atopic Dermatitis Care? With Jason Hawkes, MD. HCPLive. July 24, 2026. Accessed September 15, 2026. 

https://www.hcplive.com/view/q-a-how-precision-medicine-changing-atopic-dermatitis-care-jason-hawkes-md

Precision dermatology is gaining traction but remains less mature than oncology due to polygenic, cytokine-network–driven inflammatory dermatoses and non-specific biomarkers that poorly stratify endotypes or predict treatment response. Therapeutic choice for psoriasis and atopic dermatitis is still largely empirical, compounded by payer-mandated step therapy. Emerging minimally invasive tools—including skin-sampling gene expression approaches and transcriptomic dermal patches—aim to forecast biologic or JAK inhibitor responsiveness. Clinicians anticipate iterative progress via transcriptomics, proteomics, and cellular immunology, prioritizing earlier efficacy and fewer adverse effects.

In this feature, several leaders in the dermatology space were asked how far we have come and where the field is headed in precision medicine.

Dermatology

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

Atopic Dermatitis

Atopic Dermatitis 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 dermatitis research, treatment, and drug development.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Where is Precision Medicine Today in Dermatology?

Abigail Brooks is a strategic content lead overseeing 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Boehringer Ingelheim has discontinued the phase 3 EASi-KIDNEY trial evaluating vicadrostat (BI 690517) in combination with empagliflozin (Jardiance) for chronic kidney disease (CKD), following a recommendation from an independent Data Monitoring Committee (DMC).¹

The Company reported accumulating trial data did not support a meaningful expectation of clinical benefit on the primary composite endpoint versus empagliflozin alone.¹ EASi-KIDNEY was conducted in partnership with the University of Oxford as 1 of 4 phase 3 studies within the broader EASi program.¹

“While this outcome is disappointing, it does not diminish the significant unmet medical need faced by these patients,“ Will Herrington, Chief Investigator EASi-KIDNEY at the University of Oxford, said in a statement. “We sincerely thank the patients, investigators and study teams who participated in and supported this trial.”

The discontinuation applies solely to EASi-KIDNEY. Separate DMCs reviewing the remaining phase 3 studies in the EASi program independently recommended those trials continue unchanged.¹ Empagliflozin's established benefit-risk profile, supported by extensive clinical study data and years of real-world use, is not affected by the EASi-KIDNEY findings.¹

Vicadrostat and Empagliflozin in EASi-KIDNEY Trial Design

EASi-KIDNEY evaluated vicadrostat, an investigational aldosterone synthase inhibitor (ASi), added to empagliflozin, an SGLT2 inhibitor marketed since 2014, against empagliflozin alone in adults with CKD.¹ The trial was designed to determine whether the combination could slow kidney disease progression and reduce cardiovascular risk beyond what empagliflozin provides on its own.¹

Boehringer Ingelheim based its decision on a comprehensive benefit-risk assessment of accumulating data reviewed by the independent DMC.¹ The Company concluded the available data did not support a meaningful expectation of clinical benefit for the EASi-KIDNEY CKD population on the primary composite endpoint.¹ Analyses of the trial data remain ongoing, and the Company said its conclusion reflects the totality of information available to date.¹

EASi-KIDNEY Discontinuation and Status of the EASi Program

Boehringer Ingelheim characterized the discontinuation as driven by a lack of expected clinical benefit rather than a new safety signal.¹ Health authorities, investigators, and study sites are being informed, and trial participants are being contacted by their investigators and given guidance on their study treatment and the trial's closure.¹

EASi-KIDNEY was 1 of 4 phase 3 trials in the broader EASi program, which also includes EASi-HF Reduced and EASi-HF Preserved in heart failure and EASi-PROTKT in type 2 diabetes with hypertension and established cardiovascular disease.² Their respective DMCs recommended these trials continue without modification following separate reviews of currently available data.¹

Vicadrostat remains investigational and has not received marketing authorization in any country, and the EASi-KIDNEY results do not change empagliflozin's approved indications.¹

“Millions of people worldwide live with interconnected cardiovascular, renal, and metabolic conditions, and the need for better treatment options remains urgent”, said Lykke Hinsch Gylvin, Chief Medical Officer and Head of Global Medicine at Boehringer Ingelheim. “Our commitment to advancing science in this area remains unchanged and we will continue to pursue new approaches with the same scientific rigor, transparency, and focus on patient safety that guided this decision.”

Boehringer Ingelheim did not name specific data from the primary composite endpoint in its announcement. The Company said further analyses of EASi-KIDNEY are ongoing, and the discontinuation reflects the totality of information available at this stage of the trial.¹

Boehringer Ingelheim. Boehringer provides update on EASi-KIDNEY trial. Published September 15, 2026. Accessed September 15, 2026. 

https://www.boehringer-ingelheim.com/human-health/boehringer-provides-update-easi-kidney-trial

ClinicalTrials.gov. A study to test vicadrostat (BI 690517) taken together with empagliflozin in people with symptomatic chronic heart failure (EASi-HF Reduced). Identifier: NCT06935370. Accessed September 15, 2026. 

https://clinicaltrials.gov/study/NCT06935370

ClinicalTrials.gov. The studies of heart & kidney protection with BI 690517 in combination with empagliflozin (EASi-KIDNEY). Identifier: NCT06531824. Accessed September 15, 2026. 

https://clinicaltrials.gov/study/NCT06531824

Boehringer Ingelheim discontinued the phase 3 EASi-KIDNEY study after an independent DMC advised that accumulating data did not support a meaningful expectation of added clinical benefit for vicadrostat plus empagliflozin versus empagliflozin alone on the primary composite endpoint. The stop was attributed to insufficient efficacy rather than an emergent safety signal, with trial closure communications underway for sites and participants. Other phase 3 EASi program trials in heart failure and cardiometabolic disease were separately reviewed and recommended to continue unchanged.

Boehringer Ingelheim halted EASi-KIDNEY after a DMC found data did not support a meaningful clinical benefit on the trial's primary endpoint.

Nephrology

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

Chronic Kidney Disease

Vicadrostat EASi-KIDNEY Trial Discontinued for Lack of Benefit in CKD

Professor and Pneumologist, University Hospitals Leuven 

Interim data from FIBRONEER-ON, the open-label extension of the phase 3 FIBRONEER-IPF and FIBRONEER-ILD trials, show that nerandomilast's favorable safety profile held up with longer-term use, according to Wim A. Wuyts, MD, PhD, professor at KU Leuven and head of the Unit for Interstitial Lung Diseases at University Hospitals Leuven. 

Wuyts discussed the late-breaking abstract, presented at the 

European Respiratory Society (ERS) Congress 2026

 in Barcelona, Spain, held September 5 to 9, in an interview with 

. Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, previously slowed decline in forced vital capacity (FVC) versus placebo in both parent trials, with a survival signal also observed in FIBRONEER-ILD, which enrolled patients with progressive pulmonary fibrosis (PPF).

FIBRONEER-ON: Nerandomilast's Durable IPF, PPF Safety, With Wim Wuyts, MD, PhD

In FIBRONEER-ON, 1102 patients who received nerandomilast in the parent trials continued the drug, and 541 patients previously on placebo initiated it, with rollover rates exceeding 95% in both groups.

 At baseline of the extension, FVC was 74.7% and 71.4% predicted in the continued and initiated groups, respectively, and 43.1% and 17.2% of patients overall were on background nintedanib or pirfenidone.

 Adverse events led to discontinuation of nerandomilast in 6.9% of patients who continued treatment and 10.2% of those newly initiating it; diarrhea was the most frequent adverse event but led to discontinuation in fewer than 1% of patients overall.

“I would be really curious to see how that holds on the longer term, and I was highly surprised to see that this was confirmed in the open-label trial,” Wuyts said of the drug's durability.

Wuyts said diarrhea was reported in about 24.8% of newly initiating patients versus 16% of those continuing treatment, and speculated this may partly reflect early-onset side effects that ease over time, alongside possible survivor bias among patients who had already tolerated the drug in the parent trials. He noted only 1.7% of patients in the open-label extension required a dose reduction from 18 mg to 9 mg twice daily, which he took as an indirect sign of the drug's tolerability. He also said investigators appeared to prioritize keeping patients on the highest nerandomilast dose, in some cases adjusting background antifibrotic therapy rather than reducing nerandomilast when side effects arose, though he cautioned this interpretation is speculative.

Looking ahead, Wuyts said he is most interested in longer-term FVC and quality-of-life data from the extension, particularly for patients who initiated nerandomilast without prior exposure in a parent trial, as well as outcomes in the subset of patients with underlying connective tissue disease who required additional immunosuppressive therapy. He said further results are expected to be presented at a future meeting, potentially the American Thoracic Society conference next year.

Wuyts’ disclosures include Roche and Boehringer Ingelheim.

Richeldi L, Azuma A, Cottin V, et al; FIBRONEER-IPF Trial Investigators. Nerandomilast in patients with idiopathic pulmonary fibrosis. 

 2025;392(22):2193-2202. doi:10.1056/NEJMoa2414108

Wuyts W, Assassi S, Azuma A, et al. Safety and tolerability of nerandomilast in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF): data from FIBRONEER-ON. Late-breaking abstract presented at: European Respiratory Society (ERS) Congress 2026; September 5-9, 2026; Barcelona, Spain.

Interim open-label extension data indicate nerandomilast maintains a favorable longer-term safety and tolerability profile in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. High rollover rates support acceptability, with low discontinuation due to adverse events and infrequent dose reductions. Diarrhea remained the most common event, more frequent in newly initiated patients, suggesting an early-onset effect and possible survivor bias among prior users. Key next steps include longer-term FVC and quality-of-life trajectories, especially in newly exposed patients and those with connective tissue disease requiring immunosuppression.

Wuyts, of University Hospitals Leuven discusses interim FIBRONEER-ON open-label extension data showing nerandomilast's favorable safety profile.

Pulmonary Fibrosis

Jonathan Piccini, MD, is the director of cardiac electrophysiology at Duke University Health System.

Catheter ablation in patients with concomitant 

heart failure with preserved ejection fraction (HFpEF)

 improves symptoms and functional status and may reverse myocardial fibrosis and reduce HF progression.

Catheter Ablation Improves, May Reverse HFpEF Symptoms in Patients With AF

European Society of Cardiology (ESC) Congress 2026

 in Munich, Germany, Jonathan Piccini, MD, director of cardiac electrophysiology at Duke University Health System, discussed the potential for catheter ablation in this patient population by citing the effects of the process on symptoms of HFpEF in prior research and ongoing trials.

“Regardless of which condition is driving which, when they are together, the outcomes are worse, and the symptoms are worse,” Piccini told 

 in an exclusive interview. “Reducing or minimizing the amount of AF that a patient with HFpEF has is important, independent of the subtype of HFpEF that they have.”

The presentation contributes to an ongoing debate regarding the effectiveness of the procedure in reducing or reversing HFpEF – in particular, an analysis published in 2024 showed no notable association between catheter ablation and HFpEF events. The investigators in this study collected 12 randomized controlled trials with a total of 2465 participants, of whom 1552 had HF with reduced ejection fraction (HFrEF) and 913 with HFpEF.

Based on this analysis, catheter ablation was associated with a reduced risk of HF events in HFrEF (risk ratio [RR], 0.59; 95% CI, 0.48-0.72) – however, there was no documented benefit in patients with HFpEF (RR, 0.93; 95% CI, 0.65-1.32). The procedure also reduced risk of cardiovascular death compared with conventional therapies in HFrEF (RR, 0.49; 95% CI, 0.34-0.7), but a differential association was not found in HFpEF (RR, 0.91; 95% CI, 0.46-1.79).

In this presentation, however, Piccini cites a 2023 study published in 

, which indicated that AF ablation successfully improves invasive exercise hemodynamic parameters, exercise capacity, and quality of life in patients with AF and HFpEF. Of the 31 included patients, 16 were randomly assigned to receive AF ablation, while 15 were assigned to medical therapy. After 6 months of treatment, ablation reduced the primary outcome of peak pulmonary capillary wedge pressure from baseline (30.4 +/- 4.2 to 25.4 +/- 4.5 mmHg; 

 <.01). Improvements were also noted in peak relative VO2 and NT-proBNP.

The 2021 CABANA-HF trial, also cited in the presentation, displayed substantial improvements in survival, freedom from AF recurrence, and quality of life following ablation compared to standard drug therapy. Of the 778 patients enrolled, 378 received ablation and 400 received medical treatment. The ablation arm ultimately exhibited a 36% relative reduction in the primary composite endpoint of death, disabling stroke, serious bleeding, or cardiac arrest, and a 43% relative reduction in all-cause mortality compared with drug therapy.

Piccini goes on to highlight ongoing trials investigating the potential connection between HFpEF with AF and atrial fibrillation, including CABA-HFpEF, STABLE-SR IV, and CASTLE HFpEF, all of which are actively recruiting. CABA-HFpEF is comparing catheter ablation with usual care, while STABLE-SR IV examines the procedure versus AAD, and CASTLE HFpEF compares it to guideline-directed medical therapy.

Ultimately, however, Piccini shares his belief that AF may be placed unduly on a pedestal as a treatment target for HFpEF. He acknowledges other variants of the condition, as well as patients with different forms of HF, are equally prevalent.

“I think AF burden sometimes gets overemphasized,” Piccini said. “It’s odd for me to say that, because I think it’s incredibly important. The way I choose to think about it is that it’s more about how much AF someone is exposed to, and the lower we can get that, the better off they will be.”

Editors’ Note: Piccini reports disclosures with Abbott, Amgen, Bayer, Medtronic, Lilly, Milestone Pharmaceuticals, and others.

Piccini J. Can catheter ablation of atrial fibrillation reverse HFpEF? Presented at the European Society of Cardiology (ESC) Congress 2026, Munich, Germany. August 28-31, 2026.

Oraii A, McIntyre WF, Parkash R, et al. Atrial fibrillation ablation in heart failure with reduced vs preserved ejection fraction. 

Chieng, D, Sugumar, H, Segan, L. et al. Atrial Fibrillation Ablation for Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial. 

https://doi.org/10.1016/j.jchf.2023.01.008

Packer DL, Piccini JP, Monahan KH, et al. Ablation versus drug therapy for atrial fibrillation in heart failure. Circulation. 2021;143(14):1377-1390. 

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Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

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