Abigail Brooks is an assistant managing editor for 

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.

November brought a wave of notable updates across gastroenterology, marked by regulatory milestones, evolving clinical guidance, and new research shaping patient care. The month opened with the US Food and Drug Administration’s first-ever approval of a treatment for 

irritable bowel syndrome with constipation (IBS-C)

 in children ≥ 7 years of age, followed quickly by 52-week safety findings presented at the 

2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN)

 Annual Meeting. Meanwhile, the American Gastroenterological Association released its updated living guideline for moderate-to-severely active Crohn’s disease, reflecting the rapid expansion of high-efficacy therapeutic options and emphasizing early intervention to optimize long-term outcomes.

Beyond treatment advances, new analyses highlighted areas where access to care and clinical tools still fall short, including geographic disparities in gastroenterology specialist availability and the subpar performance of large language models in providing dietary guidance for IBS.

Check out this November 2025 gastroenterology month in review for a recap of 

’s coverage of the top GI news and research from the past few weeks:

FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C

On November 5, 2025, the FDA approved Ironwood Pharmaceuticals' linaclotide (Linzess) capsules for pediatric patients ≥ 7 years of age with IBS-C, making it the first treatment approved for IBS-C in this patient population. The decision was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7-17 years of age who met modified Rome III criteria for child/adolescent IBS-C.

Julie Khlevner, MD, AGAF, Reacts to the FDA Approval of Linaclotide for Pediatric IBS-C

AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies

On November 20, 2025, the AGA released a living clinical practice guideline on the pharmacologic management of moderate-to-severely active Crohn’s disease, intended to support a comprehensive, patient-centered, evidence-based approach to managing this patient population. The document includes 16 recommendations emphasizing early use of high-efficacy therapies including infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, and upadacitinib over step-up treatment to improve patient outcomes.

NASPGHAN 2025: Newly-Approved Linaclotide's Long-Term Safety Data

At the 2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, 52-week data on linaclotide reaffirmed its safety and tolerability in pediatric patients aged 7 to 17 years with IBS-C following its FDA approval for this indication.

Geographic Disparities in GI Specialist Availability Suggest Limited Access to Care

New research sheds light on state- and local-level geographic disparities in the availability of gastroenterologist care, highlighting limited access to care in rural areas and areas with low household incomes relative to urban areas. Study findings point to substantial disparities in the availability of specialist care, particularly in the Midwest and Southwest regions and rural and impoverished areas, all of which had fewer gastroenterologists than patients with inflammatory bowel disease needing care.

AI Tools Fall Short for Dietary Recommendations for Managing IBS

Findings from a recent study suggest large language models (LLMs) like ChatGPT and Gemini are not sufficient tools for providing dietary recommendations for patients with IBS. In the study, while ChatGPT provided mostly compliant responses with current dietary guidelines for IBS, investigators emphasize the need for further model improvements before relying solely on LLMs in clinical nutrition practice, highlighting the importance of dietitians' recommendations and the collaboration between AI models and healthcare teams.

Brooks A. FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C. HCPLive. November 5, 2025. Accessed December 1, 2025.

https://www.hcplive.com/view/fda-approves-linaclotide-linzess-capsules-for-pediatric-ibs-c

Brooks A. AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies. HCPLive. November 20, 2025. Accessed December 1, 2025. 

https://www.hcplive.com/view/aga-releases-updated-clinical-crohn-disease-guideline-reflecting-new-therapies

Fitch J. NASPGHAN 2025: Newly-Approved Linaclotide's Long-Term Safety Data. HCPLive. November 6, 2025. Accessed December 1, 2025. 

https://www.hcplive.com/view/naspghan-2025-newly-approved-linaclotide-s-long-term-safety-data

Brooks A. Geographic Disparities in GI Specialist Availability Suggest Limited Access to Care. HCPLive. November 28, 2025. Accessed December 1, 2025. 

https://www.hcplive.com/view/geographic-disparities-gi-specialist-availability-suggest-limited-access-to-care

Brooks A. AI Tools Fall Short for Dietary Recommendations for Managing IBS. HCPLive. November 25, 2025. Accessed December 1, 2025. 

https://www.hcplive.com/view/ai-tools-fall-short-for-dietary-recommendations-for-managing-ibs

Articles

November saw significant developments in gastroenterology, including the FDA's approval of linaclotide for pediatric IBS-C, marking a first for this age group. The AGA updated its guidelines for Crohn's disease, advocating early use of high-efficacy therapies. Long-term safety data for linaclotide was presented at NASPGHAN, confirming its tolerability. Research highlighted geographic disparities in gastroenterologist availability, affecting access to care. Additionally, large language models like ChatGPT were found inadequate for dietary guidance in IBS, underscoring the need for dietitian involvement and AI model improvements.

Catch up on GI FDA news, new American Gastroenterological Association Crohn’s disease guidelines, and more gastroenterology updates from November.

News

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Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Irritable Bowel Syndrome

On the HCPLive irritable bowel syndrome page, resources on the topics of medical news and expert insight into IBS can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBS, IBD, and more.

5 Gastroenterology Headlines You Missed in November 2025

Paul Sorajja, MD, is the associate director of the Banner – University Medicine Heart Institute and professor of medicine at the University of Arizona. 

SUMMIT-MAC: Tendyne System Improves Mortality in MAC, With Paul Sorajja, MD

Patients with severe mitral annular calcification (MAC) who underwent transcatheter mitral valve replacement with Abbott’s Tendyne implant exhibited substantially reduced all-cause mortality and 

 hospitalization, based on the SUMMIT-MAC interventional trial.

The Tendyne system includes multiple sizes to accommodate for a range of patient anatomies. The valve is self-expanding, delivered through an incision in the chest and advanced into the heart to replace the mitral valve. Tendyne is also totally repositionable and retrievable during implantation.

 spoke with Paul Sorajja, MD, associate director of the Banner – University Medicine Heart Institute and professor of medicine at the University of Arizona, to discuss the results of SUMMIT-MAC and how the Tendyne system may revolutionize this otherwise difficult-to-treat disease.

“As the first of its kind, Tendyne is quite novel, because up until now we had no knowledge of what a dedicated TMVR device would look like in terms of outcomes for these patients,” Sorajja told 

. “The results exceeded expectations; we had excellent technical success.”

SUMMIT-MAC is the first prospective clinical trial designed to assess Tendyne’s efficacy in patients with severe MAC. All included patients had severe MAC with significant mitral valve dysfunction and were at high surgical risk. An echocardiography laboratory performed independent assessments of mitral disease, and adverse events were judged by an independent clinical events committee. The study’s primary endpoint was freedom from all-cause mortality and heart failure hospitalization at 12 months post-procedure.

A total of 103 patients were ultimately included, with a mean age of 78 +/- 6.5 years. All patients underwent treatment with Tendyne, as either mitral regurgitation or stenosis was present in nearly every patient at baseline. Technical success from the implant was achieved in 94.2%. Investigators noted a 30-day mortality of 6.8%.

The primary endpoint of freedom from all-cause mortality and heart failure hospitalization was met, which reached 60.4% at 12 months (performance goal: 43%; 

 = .0002). Heart failure symptoms (NYHA Class I/II, 30.6% vs 87.5%, paired baseline vs 12 months; 

 <.0001) and quality of life (mean paired increase in the Kansas City Cardiomyopathy Questionnaire overall summary, 18.7 +/- 24.4 points; 

Ultimately, this trial was a core component in the 

 approval of Tendyne, announced by Abbott in May 2025.

“The key next steps are to ensure that the commercial outcomes match what we observed in the clinical trial, which means greater attention to even more operator education, patient selection, and being very meticulous about how the procedure is done,” Sorajja said. “I think as long as we keep an eye on those things, I think this will have a really strong role in our patients with severe MAC.”

Sorajja, P, Thourani, V, Rogers, J. et al. Transcatheter Mitral Valve Replacement for Severe Mitral Annular Calcification: Primary Outcomes from the SUMMIT-MAC Study. JACC. null2025, 0 (0). 

https://doi.org/10.1016/j.jacc.2025.10.025

Kong C. Abbott Receives FDA Approval for Tendyne, First-Of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery. Abbott. May 27, 2025. Accessed December 1, 2025. 

https://abbott.mediaroom.com/2025-05-27-Abbott-Receives-FDA-Approval-for-Tendyne-TM-,-First-of-Its-Kind-Device-to-Replace-the-Mitral-Valve-Without-Open-Heart-Surgery

Videos

Sorajja discusses the results of this groundbreaking trial investigating a new implant for patients with severe mitral annular calcification.

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

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Firsekibart was a more effective prophylaxis against 

 compared with colchicine in patients initiating urate-lowering therapy (ULT), with a favorable tolerability profile in a new study published in 

“Given that colchicine, NSAIDs, and glucocorticoids are all associated with a range of side effects, there remains an unmet clinical need for alternative effective and well-tolerated treatments as prophylaxis against acute gout flares in patients with gouty arthritis initiating ULT,” study investigator Yiyun Yu, Department of Rheumatology and Immunology, Huashan Hospital, Fudan University, Shanghai, China, and colleagues wrote.

These data are from a randomized, multicenter, open-label, active-controlled, phase 2 trial that randomized 162 participants (1:1:1) to receive a single subcutaneous injection of firsekibart 100 mg (n = 55) or 200 mg (n = 52) or oral colchicine 0.5 mg/day (n = 55) for 12 weeks. Participants initiated ULT at baseline or within 1 week before screening.

Investigators found that the adjusted mean number of acute gout flares per participant was 0.02 with firsekibart 100 mg and 0.34 with colchicine, with a rate ratio of 0.05 (95% CI, 0.01–0.43; 

.0060). Both treatment groups receiving firsekibart had a lower proportion of patients with at least 1 acute gout flare than the colchicine group. There were no treatment-emergent adverse events (AEs) leading to treatment discontinuation/study withdrawal with firsekibart-treated participants, no treatment-related serious AEs, and no deaths, supporting its favorable safety profile.

“Gout is a highly prevalent disease with a rising global burden and is often associated with significant comorbidities. The findings in this study suggest that firsekibart may serve as a novel strategy for preventing acute gout flares in patients initiating ULT, potentially transforming the management paradigm for gout,” Yu and colleagues concluded.

Study investigator Yu Xue, MD, also from Huashan Hospital, recently presented data on firsekibart from a multicenter, randomized, double-blind, double-dummy, active-controlled, phase 3 trial conducted across 51 centers in China at the 

American College of Rheumatology (ACR) Convergence 2025

, held October 24–29 in Chicago, Illinois.

This trial included 311 patients, with 156 receiving firsekibart and 155 receiving compound betamethasone (CB). Xue and colleagues found that firsekibart significantly delayed median time to first new flare (Not estimable vs. 45 days) and reduced the risk of new flare by 90% (HR, 0.10; 95% CI, 0.06-0.17; 

<.0001) over 12 weeks and by 87% (HR, 0.13; 95% CI, 0.08-0.21; 

Pain intensity and the median time to reduce ≥50% pain was similar, but firsekibart showed better pain relief in patients from 48 hours to 7 days. Furthermore, significantly fewer patients treated with firsekibart experienced ≥ 1 new flare over 12 weeks (10.9% vs. 65.2%) and 24 weeks (14.7% vs. 66.5%; both 

<.0001), and the mean number of new flares per patient was lower in firsekibart group over 12 weeks (0.2 [standard deviation (SD), 0.52] vs. 1.2 [SD, 1.27]) and 24 weeks (0.2 [SD, 0.79] vs. 1.6 [SD, 1.79]). A smaller proportion of patients receiving firsekibart required rescue therapy (10.9%) compared to those receiving CB (48.4%) and a lower mean dosage of rescue medicine was used in the firsekibart group (corticosteroid use, 69.33 mg vs 202.03 mg). Safety profiles were similar between groups.

“Millions of people with gout struggle with inadequate treatment options, especially those living with kidney disease or uncontrolled disease despite standard therapy,” an ACR spokesperson said in a statement about recent gout data presented at the conference, including Xue’s study.

 “The results presented at ACR Convergence this year highlight encouraging new approaches that could transform care for some of the most difficult-to-treat patients.”

Yu Y, Xue Y, Hu J, et al. Firsekibart as a Prophylactic Treatment for Acute Gout Flare in Participants Initiating Urate‐Lowering Therapy: A Phase 2, Randomized, Open‐Label, Multicenter, Active‐Controlled Trial. 

Xue Y, Chu T, Hu J, et al. Efficacy and Safety of Firsekibart in Acute Gouty Arthritis Patients with Limited Treatment Options: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase III Trial. Presented at: ACR Convergence 2025; October 24-29; Chicago, Illinois. Abstract #2013

New Gout Therapies Show Promise in Phase III Trials at ACR Convergence 2025. News release. ACR. October 25, 2025. https://rheumatology.org/press-releases/new-gout-therapies-show-promise-in-phase-iii-trials-at-acr-convergence-2025

Firsekibart has demonstrated superior efficacy and tolerability compared to colchicine in preventing acute gout flares in patients initiating urate-lowering therapy (ULT). A phase 2 trial showed significantly fewer flares with firsekibart, and no serious adverse events were reported. A subsequent phase 3 trial confirmed firsekibart's effectiveness, showing a 90% reduction in flare risk over 12 weeks and 87% over 24 weeks. Firsekibart also required less rescue therapy and had a comparable safety profile to compound betamethasone, suggesting it could transform gout management, especially for difficult-to-treat patients.

New data support firsekibart's efficacy over colchicine for preventing acute gout flares.

Gout

On the HCPLive gout page, resources on the topics of medical news and expert insight into gouty arthritis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on gout, and more.

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Firsekibart Beats Colchicine as Gout Flare Prophylaxis When Initiating ULT

Gerard Criner, MD, is chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center.

Linda Rogers, MD: Professor of pulmonary medicine at Mount Sinai.

Pulmonary and Critical Care Fellow at the Temple Lung Center

This Year in Medicine 2025 Asthma and COPD

 has been undergoing a profound transformation. What was once a field dominated by incremental adjustments to inhaled bronchodilators and corticosteroids is now moving toward a more individualized, precision-medicine model.

Despite previous setbacks in the field such as with benralizumab (Fasenra), that shift has accelerated in 2025, driven not only by expanding biomarker research but also by the long-awaited arrival of biologic therapies for 

chronic obstructive pulmonary disease (COPD)

 approvals of dupilumab (Dupixent) for eosinophilic COPD in 2024 and mepolizumab in 2025, clinicians finally have targeted options and an expanded toolbox that reflect an increasingly nuanced understanding of disease endotypes beyond traditional silos of “

“At least in certain patients, there are mechanisms across the traditional disease categories, which, which may be flawed. It may be that our traditional names for these diseases are even fundamentally flawed. You know, there are some experts in the field who are discussing that more and more… There’s definitely food for thought in what they say,” Linda Rogers, MD, associate professor in the Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Mount Sinai, told 

 series, HCPLive spoke with Rogers along with Gerard Criner, MD, and Andrew (Troung-An) Ho, MD, from Temple University, to explore how biologics, biomarker-guided decision making, and new conceptual frameworks for airway disease are reshaping care today—and where the next decade of precision pulmonology may be headed.

Criner, Ho, and Rogers concur that clinicians have been moving away from rigid disease categories and lean instead into a “treatable traits” philosophy that prioritizes inflammatory patterns, biomarker profiles, exacerbation behavior, patient history, and longitudinal outcome tracking. This evolution is still in its early phases, and the field continues to grapple with operational challenges such as incomplete data sharing, fragmented care, and the wide variability in patient expectations for what optimized control looks like. But the shift is undeniable, and for many specialists, it represents the most exciting era in respiratory medicine in decades.

For much of modern respiratory medicine, asthma and COPD have been treated as distinct, siloed conditions defined primarily by symptoms, spirometry thresholds, and smoking history. Yet clinicians increasingly recognize these categorical labels often oversimplify a highly heterogeneous set of airway diseases. This is particularly true in COPD, where the past decade has revealed substantial variation in inflammatory profiles, exacerbation patterns, airway remodeling, and longitudinal progression.

All 3 experts emphasized that Type 2 (T2) inflammation—long associated with asthma—has a meaningful footprint in COPD as well. Its presence has diagnostic, prognostic, and therapeutic implications, especially now that multiple biologics are proving active across both disease spaces. The idea that a COPD patient can meaningfully respond to therapies historically approved for severe asthma has forced the field to re-examine earlier assumptions about what defines each disorder.

“This is what a clinician is going to have to decide when they see a patient, you know, is this asthma? Is this COPD? Is a COPD with overlap? And I guess the question is, does it really matter if they've they're phenotypically behaving more like COPD,” Ho, a Pulmonary and Critical Care Fellow at the Temple Lung Center, said.

Clinicians have moved away from the concept of “asthma-COPD overlap” which implies 2 fixed diseases coexisting in the same patient, in favor of viewing airway disease as a spectrum. In that model, features such as eosinophilia, fixed airflow limitation, hyperreactivity, and exacerbation susceptibility can present in various combinations, independent of which diagnostic label a patient initially receives. 

This spectrum-based framing aligns with the emerging “treatable traits” strategy clinicians have adopted: identifying which traits drive morbidity in their patients, including T2 inflammation, chronic bronchitis, emphysema distribution, exacerbation frequency, and treating them directly.

“We used to kind of think about these as 2 really separate baskets. And the more we learn, the less separate they are. There are definitely gray areas in between… The therapies that are effective in patients with asthma with eosinophils and type 2 inflammation seem to also be effective in COPD with that type of inflammation. And so, the therapies are crossing boundaries, and that is going to add a lot of value for high-risk COPD patients. We're pretty excited about that,” Rogers said.

As both asthma and COPD shift toward biological phenotyping, blood eosinophil counts have become indispensable to patient selection, risk stratification, and monitoring, especially in patients without clear separating features between asthma and COPD.

Eosinophil counts have long been considered more traditionally associated with asthma, but in practice they have become one of the most clinically actionable measures for COPD as well. However, they do not provide a full picture alone, and they can be influenced by infection, steroids, and comorbidities. Additionally, not all patients with elevated eosinophils respond to biologics, and some patients with lower counts can still exhibit T2-driven disease.

The diagnostic boundary between asthma and COPD has always been porous, but biological insights and therapeutic advances are prompting clinicians to question whether traditional labels remain fit for purpose, especially when they may fail to predict response to key therapies.

Yet moving beyond categorical diagnoses is not trivial. It impacts trial design, regulatory structures, payer policies, and the logistics of real-world practice. Even so, 2025 appears to be a tipping point: a year when novel biologic options for COPD have enabled trait-based thinking to align with therapeutic reality. 

“The lines between the 2 diagnoses are getting blurrier as more data comes out. I think there may be changes in these diagnostic boxes. It's a complicated issue because it impacts sort of how the criteria for designing clinical trials and drug approval. So, it's not an easy issue to really shift on, but there's definitely movement in those spaces,” Rogers said.

Biologics Reshape the COPD Treatment Landscape

The approval of dupilumab in late 2024 as the first biologic for eosinophilic COPD marked a watershed moment in respiratory care. For more than a decade, pulmonologists had seen targeted biologics transform outcomes in severe asthma, with patients who needed chronic prednisone, or had multiple annual exacerbations, suddenly able to dramatically reduce flares, improve symptoms, and in some cases even achieve clinical remission.

COPD clinicians, dealing with a condition historically defined by slow decline and limited therapeutic innovation, lacked equivalent tools. The arrival of dupilumab—and soon after, mepolizumab—changed that calculus as the first targeted biologic option for COPD, one that offered hope to a subset of patients who had exhausted traditional inhaled regimens.

Although the experts note that biologics do not work for everyone, there is consensus that when they work, the responses can be striking. Patients long accustomed to multiple exacerbations per year, chronic systemic steroid use, or prolonged symptom burden may see substantial improvement once T2 inflammation is addressed directly.

Even more strikingly, subsets of patients have begun to achieve clinical remission using reasonable definitions of “no systemic steroids, no exacerbations, and good symptom control.” While remission terminology is not yet widely applied in COPD, the idea is beginning to permeate discussions—especially since the same medications are now approved in both diseases. Clinicians are beginning to wonder: if remission is possible in asthma, might it be achievable for a biologic-eligible COPD subset as well?

That question remains open, but the shift in mindset is meaningful. Many pulmonologists are moving from managing deterioration to aiming for measurable stability, flare prevention, and long-term maintenance.

Ho, Criner, and Rogers agreed that remission criteria will increasingly shape real-world care and clinical trials, particularly as more therapies targeting different inflammatory pathways enter evaluation. Biomarkers, trait-based diagnostics, early intervention, and better patient education will all be necessary to operationalize remission as a standard clinical goal.

“We'll still need some kind of bedside tool biomarker that everyone can use to define the patients better moving forward. So, I think it's still early days on patient selection, at least for COPD,” Ho said.

Real-World Implications for Clinical Decision-Making 

In practice, most clinicians already treat based primarily on traits rather than labels—particularly when faced with a patient who has a significant smoking history, fixed obstruction, and elevated eosinophils. Furthermore, what clinicians historically considered overlap may simply reflect flawed disease constructs. If T2 inflammation is driving exacerbations regardless of whether spirometry meets classic asthma criteria, does labeling meaningfully change management? Our experts think not.

“Whether they have asthma or COPD, if they have [T2 inflammation], then we're going to treat that patient with those agents that treat [T2 inflammation]. Similarly, if we have a patient with type 1 inflammation, we're going to identify and treat the patient with that… I think a lot of the classifications that have been used for disease categories in the past, they're going to become less important in the biologic pathway that needs to be treated that's causing the patient's symptoms. That's what's going to be treated,” Criner, chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center, said.

Other hurdles include clinical trial design, which will evolve to allow inclusion of patients with mixed or ambiguous phenotypes in the near future, and regulatory frameworks, which may need to consider approvals based on trait profiles rather than diseases. 

But for now, the practical takeaway is clear: clinicians cannot rely on historical categories to guide every therapeutic decision. Biologics and biomarkers are forcing the field to accept that asthma and COPD share more pathobiology than once thought and that patient outcomes improve when therapies target what is driving disease rather than what diagnosis the chart says.

Precision Pulmonology Is Here—But Needs System-Level Reinforcement

Despite growing enthusiasm for biologics and precision medicine, major barriers still limit optimal airway disease care. Many patients underreport or forget exacerbations—especially those treated outside pulmonology—which leaves clinicians without full visibility into disease activity. At the same time, long-standing expectations that flare-ups are inevitable prevent some patients from recognizing that zero exacerbations may now be attainable with advanced therapies. Compounding these issues, many individuals reach specialty care only after years of progressive damage, underscoring the need for earlier identification of high-risk patients through better education, improved data integration, and proactive biomarker- or risk-based screening.

Our conversations with Criner, Ho, and Rogers reveal a specialty in transition. COPD is no longer managed solely through bronchodilation, smoking cessation, and palliative stabilization. With biologics now entering the treatment armamentarium, clinicians are beginning to treat COPD in a manner more akin to modern asthma care, in which inflammatory pathways dictate therapy, biomarkers guide decisions, and remission becomes an attainable target rather than an abstract ideal.

“The data we have in clinical trials [support] that there is a role for biologics in patients with COPD and [T2 inflammation]. I think the big kind of hurdle to cross is patient selection and how to really define these in the clinical setting, and which treatments to use for patients. I don't think we know that yet, and it's a little bit too early,” Ho cautioned.

This transformation requires more than new drugs. It demands broader adoption of trait-based diagnostic models, better integration between primary care and specialty care, and a concerted effort to define what good control looks like. The historical silos separating asthma and COPD management are becoming increasingly artificial, and collapsing those silos may be essential for maximizing the benefits of precision medicine.

As 2025 continues to unfold, pulmonology finds itself in a moment of convergence: biologics that transcend traditional categories, biomarkers that illuminate new pathways of risk, and clinicians who are rapidly evolving their definitions of success. The task now is to ensure that these scientific gains translate into practical, equitable, and forward-looking care for every patient with chronic airway disease.

Criner GJ, Celli BR, Brightling CE, et al. Benralizumab for the Prevention of COPD Exacerbations. N Eng J Med. 2019;381(11):1023-1034. doi: 10.1056/nejmoa1905248

Smith T. FDA Approves Dupilumab (Dupixent) for Treatment of COPD. Article. HCPLive. September 27, 2024. 

https://www.hcplive.com/view/fda-approves-dupilumab-dupixent-for-treatment-of-copd

Johnson V. FDA Approves Mepolizumab for Eosinophilic COPD. Article. HCPLive. May 22, 2025. 

https://www.hcplive.com/view/fda-approves-mepolizumab-for-eosinophilic-copd

Pulmonology is transitioning towards precision medicine, driven by biomarker research and biologic therapies for COPD. Recent FDA approvals of dupilumab and mepolizumab have expanded treatment options, challenging traditional asthma and COPD categorizations. Experts advocate for a "treatable traits" approach, focusing on inflammatory patterns and biomarker profiles. This shift necessitates rethinking diagnostic labels and trial designs. Despite challenges like data sharing and patient expectations, the integration of biologics and biomarkers is reshaping care, aiming for stability and remission in airway diseases.

Discover how precision medicine reshapes COPD treatment, focusing on inflammation and patient-specific traits for improved outcomes in airway diseases.

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.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Pulmonology

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.

This Year In Medicine

Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management 

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.

New research suggests adjusting the kidney failure risk equation (KFRE) to account for competing mortality risks in patients with 

 can improve 5-year kidney failure prediction outcomes, particularly for those with multimorbidity.

Findings from a 2-cohort external validation and recalibration study of the 4-variable KFRE highlight the clinical usefulness of an updated competing mortality risk model to increase individualized referral rates and improve subsequent treatment burden in patients with CKD, with and without multimorbidity.

“This is the first study that we are aware of validating KFRE in those with multiple long-term conditions, and that also considers the competing risk of mortality,” wrote study investigator Heather Walker, MBChB, a PhD candidate of cardiovascular and metabolic health at the University of Glasgow, and colleagues.

KFRE’s variables are age, sex, estimated glomerular filtration rate (eGFR), and urine albumin-to-creatinine ratio. Typically, eGFR is calculated using creatinine, which can be influenced by reduced muscle mass related to aging or multimorbidity. In contrast, as a biomarker, cystatin C is less affected by muscle mass. Prior investigation has questioned whether using a cystatin C-based eGRF can improve prediction in this patient population, but no updated KFRE models have been developed.

To address this gap, investigators developed and validated an updated model using the same KFRE variables while accounting for competing mortality risks. They also compared performance using cystatin C-based eGFR (eGFRcys) or combined creatinine-cystatin-based eGFR (eGFRcr-cys) versus creatinine-based eGFR (eGFRcr), assessing discrimination, calibration, and overall fit at 2 and 5 years in both patient populations.

The observational cohort study included 24,489 individuals from the research-based UK Biobank, and 30,147 from the population-based Stockholm Creatinine Measurements project (SCREAM), identifying multimorbidity as ≥2 long-term conditions with CKD and kidney failure as long-term dialysis or kidney transplantation. In competing risk analyses, all-cause mortality was identified through linkage to national death registers.

In the UK Biobank and SCREAM cohorts, respectively, 61.2% and 70.3% of individuals had multimorbidity, the mean age was 62.8 and 70.1 years, while 54% and 66% of patients were female.

Upon analysis, investigators observed consistently strong discrimination for kidney failure across eGFRcr, eGFRcys, and eGFRcr–cys, with Area Under the Curve (AUC) and concordance index (C-index) ≥0.86 in individuals with and without multimorbidity. Adding the biomarker cystatin C did not improve discrimination or calibration. When calibration was assessed without accounting for the competing risk of mortality, investigators noted an underestimated kidney failure risk(Observed-to-expected ratio [O/E] ratio range, 1.01-2.18), and cystatin C did not enhance accuracy.

In competing risk analysis, investigators saw the 5-year cumulative incidence of kidney failure in multimorbidity cohorts was 3.0% (95% CI, 2.7-3.2) for SCREAM and 1.6% (95% CI, 1.4-1.8) for UK Biobank. In no multimorbidity cohorts, incidence was 3.6% (95% CI, 3.2-3.9) for SCREAM and 0.7% (95% CI, 0.6-0.9) for UK Biobank.

Mortality risk was higher in multimorbidity groups, with a 5-year cumulative incidence of death of 34.0% (95% CI, 33.4-34.6) in SCREAM and 7.2% (95% CI, 6.7-7.6) in UK Biobank. In comparison, no multimorbidity groups had lower mortality: SCREAM 11.1% (95% CI, 10.5-11.7) and UK Biobank 3.3% (95% CI, 3.0-3.7).

A model accounting for the competing risk of death improved performance compared to the UK-calibrated 5-year KFRE, with an O/E ratio of 0.98 at 5 years in multimorbidity groups. Calibration improvements were most notable in these groups, and overall model fit was enhanced.

Accounting for competing risk also influenced clinical decision-making. Applying a kidney failure risk threshold >5% increased total referrals in both cohorts compared to KFRE. Referred individuals had decreased multimorbidity, fewer deaths within 5 years, and were younger in SCREAM. Overall, the competing risk model captured more kidney failure events within 5 years than KFRE.

“KFRE has good discrimination accuracy to predict kidney failure in individuals with multimorbidity, but has less robust calibration and crucially does not account for the competing risk of death,

” investigators concluded. “A model accounting for competing mortality risk improves model performance, particularly calibration, in individuals with multimorbidity.

Walker H, Carrero JJ, Sullivan MK, et al. The kidney failure risk equation in people with CKD and multimorbidity: the effect of competing mortality risks. 

. Published online November 24, 2025. doi:

Benoit SW, Ciccia EA, Devarajan P. Cystatin C as a biomarker of chronic kidney disease: latest developments. 

https://doi.org/10.1080/14737159.2020.1768849

Adjusting the kidney failure risk equation (KFRE) to include competing mortality risks enhances 5-year kidney failure predictions, especially in patients with multimorbidity. A study validated an updated model using the same KFRE variables, comparing cystatin C-based eGFR with creatinine-based eGFR. The study involved 24,489 UK Biobank participants and 30,147 from the SCREAM project. Results showed strong discrimination for kidney failure across eGFR types, but cystatin C did not improve accuracy. The updated model improved calibration and clinical decision-making, capturing more kidney failure events than the original KFRE.

A competing mortality-risk model improves calibration and captures more true 5-year kidney failure events.


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