Shara Bialo, MD, is the senior medical director of T1D immunology at Sanofi.

T1D Screening is Effective but Underused Among Patients With No Disease History, With Shara Bialo, MD

 screening can effectively predict the disease before the first symptoms appear; however, despite its efficacy, many patients are not offered screening and are only diagnosed after the first symptoms have appeared.

T1D is an inherited disease, and often a family history is the primary impetus for investigation and diagnosis. Relatives of patients with T1D have a roughly 15-fold greater risk of disease compared to those without a relative with T1D. However, roughly 90% of all patients who will present with new T1D do not have a positive family history.

“T1D gets a lot of attention for its metabolic consequences, but we’re starting to shift the focus a bit earlier to its true autoimmune roots, which is this underlying, silent disease evolution that doesn’t really call our attention until it’s clinically obvious,” Shara Bialo, MD, senior medical director of T1D immunology at Sanofi, told 

 in an exclusive interview. “However, it turns out that you can detect it months to years before clinical signs and symptoms emerge – and you do that through screening for T1D.”

T1D screening is typically conducted via a blood test, which is then investigated for autoantibodies created by the immune system to destroy insulin-producing cells. The presence of ≥2 diabetes-related antibodies warrants a diagnosis, although clinicians frequently corroborate this data by examining blood sugar levels.

Among the positive impacts of screening for T1D is the avoidance of diabetic ketoacidosis (DKA), a devastating and potentially life-threatening complication affecting longevity, morbidity, and quality of life. Previous trials have highlighted the efficacy of various methods of reducing the rate of DKA; among these, T1D screening and follow-up reduced the rate of DKA by 20%.

Low utilization of T1D screening is not due to limited access or high cost – most methods are free. Only a small number of patients are aware of the opportunity to predict T1D. Many clinicians have long been pushing for general population screening for T1D, which would help prevent major conditions such as DKA. However, logistical challenges, such as working with primary care physicians and optimizing cost-effectiveness, still prevent screening from being generalized to the full population.

Bialo discusses how patient awareness can be improved, suggesting that healthcare providers and clinicians emphasize the value of predicting and potentially forestalling the disease.

“Brief conversations can really make a meaningful difference for patients and their families, and it could start with simply knowing that screening exists,” Bialo said. “It’s okay for it to be a slow rollout, but over time, we should make our way to general population screening. We’ve been missing the vast majority of individuals who could be helped because we’ve kept our area of focus too narrow, but there’s definitely a chance to start somewhere.”

Editors’ Note: Bialo reports no relevant disclosures.

Sims EK, Besser REJ, Dayan C, et al. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes. 2022;71(4):610-623. 

Centers for Disease Control and Prevention. Screening for type 1 diabetes. Centers for Disease Control and Prevention. February 23, 2026. Accessed March 12, 2026. 

https://www.cdc.gov/diabetes/diabetes-testing/screening-type-1-diabetes.html#cdc_generic_section_3-how-screening-works

Videos

Bialo discusses her perspective on the importance of T1D screening and its capacity to reduce the risk of disease progression and eventual complications later in life.

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Type 1 Diabetes

Sayantani Sindher, MD, is a clinical associate professor at the Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine.

Dupilumab Improves Desensitization Outcomes in OIT, With Sayantani Sindher, MD

2026 American Academy of Allergy, Asthma & Immunology (AAAAI)

 annual meeting in Philadelphia, found that adding dupilumab to omalizumab-facilitated 

improved desensitization outcomes and reduced gastrointestinal adverse events.

However, it did not significantly increase sustained unresponsiveness. This begs the question: How should clinicians counsel patients about expectations for desensitization versus sustained responsiveness?

“I'm always trying to figure out how to apply sustained unresponsiveness data to the patient sitting in front of me,” investigator Sayantani Sindher, MD, clinical associate professor of medicine at Stanford University, told 

during the meeting. “When you have a patient in front of you as an individual, it's really hard to [figure] out, ‘Okay, are you going to be someone who will achieve sustained unresponsiveness versus not? ‘ In my outpatient care, I don't take them off of [therapy for] a long period of time. If they do miss many days or months of treatment, I will bring them back in and do observed dosing to get them right back on track. Until we have biomarkers available that can predict sustained unresponsiveness, it is not something I'm able to readily apply in my outpatient clinical care practice.”

The randomized COMBINE trial enrolled 108 individuals with multiple food allergies (peanut plus 1 or 2 additional allergens) and investigated whether dupilumab could improve outcomes during omalizumab-assisted OIT. Participants first received omalizumab for 8 weeks, after which they received OIT with either dupilumab or placebo from weeks 8 through 32. All therapies were discontinued at week 32, and sustained unresponsiveness was evaluated at week 44 using double-blind, placebo-controlled food challenges.

Although the trial’s primary endpoint, sustained unresponsiveness to ≥1043 mg of peanut protein, was not statistically different between groups, results suggested potential benefits with dupilumab. Sustained unresponsiveness was achieved in 39% of patients receiving omalizumab plus OIT and 55% of those receiving dupilumab plus OIT (

Secondary findings showed improvements in desensitization and tolerability with the addition of dupilumab. By week 32, 92% of patients receiving dupilumab tolerated the highest tested allergen dose (4043 mg) during food challenge compared with 63% of those receiving OIT without dupilumab (adjusted 

 =.013). Investigators also reported fewer gastrointestinal symptoms and treatment withdrawals in the dupilumab group.

Despite encouraging signals, Sindher emphasized that translating combination biologic strategies into routine practice requires consideration of real-world factors such as insurance coverage and drug costs.

“In clinical trials, we have funding to obtain the drugs. In the outpatient world, it all goes through insurance, and access is a big deal,” Sindher said. “The cost of it is… something we have to think through before… we start using it.”

Future analyses of the COMBINE trial are exploring immune mechanisms underlying treatment responses, including assessments of B cells, T cells, and basophil activation. Sindher said these efforts may help identify patient subgroups most likely to benefit from combination biologic approaches and inform more personalized strategies for managing food allergy.

“What we need is a much better understanding of why it works,” Sindher said. “Who is the population it works best for, and also who is the population it doesn't work for? Once we have better predictive biomarkers or algorithms that help us phenotypically cluster these patients, it'll be really hard to know when to use these biologics…Many of our food allergic kids and adults also have many other atopic conditions [such as asthma, eczema, seasonal allergies, eosinophilic esophagitis] …Having different biologics approved for some of these indications that may also help for food allergy would really help us address multiple atopic conditions with just one drug.”

A relevant disclosure for Sindher includes Genentech USA.

Sindher S, Long A, Garcia-llorett M, et al. The addition of dupilumab enhances desensitization and reduces gastrointestinal symptoms in omalizumab-facilitated multi-allergen oral immunotherapy in the COMBINE trial. 

Journal of Allergy and Clinical Immunology

doi:https://doi.org/10.1016/j.jaci.2025.12.917

Sindher S. Dupilumab Reduces GI Symptoms During Multi-Allergen OIT, With Sayantani Sindher, MD. HCPLive. Accessed on March 12, 2026. Published on March 5, 2026. 

https://www.hcplive.com/view/dupilumab-reduces-gi-symptoms-multi-allergen-oit-sayantani-sindher-md

Data presented at AAAAI 2026 showed that adding dupilumab to omalizumab-facilitated oral immunotherapy improved desensitization and reduced gastrointestinal adverse events.

Conference

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Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Food Allergy

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.

 remains one of the most common yet underrecognized chronic conditions in the United States. Affecting an estimated 35–36 million individuals, the disease often progresses silently, leaving many patients unaware of their condition until significant kidney damage has occurred.

At a recent clinical forum examining challenges in CKD identification and management, Muthiah Vaduganathan, MD, MPH, codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, and clinicians across nephrology and cardiovascular medicine discussed the persistent gap between disease prevalence and clinical awareness.

The conversation focused on improving early detection, refining risk stratification, and integrating newer therapies into practice while navigating workforce constraints and evolving care models. Experts emphasized that recent therapeutic advances can only influence outcomes if CKD is identified earlier in its course.

A central theme of the discussion was the striking lack of patient awareness surrounding CKD. Despite affecting tens of millions of Americans, only a small fraction of patients know they have the disease. Because CKD often produces few symptoms in its early stages and screening practices remain inconsistent, many patients are first identified after kidney function has already declined significantly. Disparities in diagnosis and awareness also persist, particularly among younger individuals, women, and certain racial and ethnic populations.

Improving outcomes therefore begins with more consistent detection. Panelists highlighted the underuse of urine albumin-to-creatinine ratio (UACR) testing as a key contributor to missed diagnoses. While estimated glomerular filtration rate (eGFR) is commonly included in routine laboratory panels, albuminuria testing is obtained far less consistently. Yet albuminuria is a critical biomarker of kidney damage and a strong predictor of both CKD progression and cardiovascular risk.

Several experts described efforts to reframe albuminuria testing as an early warning signal for kidney disease. When paired with eGFR, UACR can help clinicians identify patients earlier and better assess their risk of progression. Expanding the routine use of these tests was widely viewed as one of the most practical steps toward improving early CKD detection.

The forum also examined evolving referral patterns to nephrology. Some clinicians reported increased referrals from primary care, particularly from advanced practice providers, though referrals remain inconsistent. In many cases, patients are referred late in the disease course—sometimes only when kidney failure is imminent or dialysis planning is required—limiting opportunities to slow progression.

At the same time, experts acknowledged a practical reality: the nephrology workforce cannot manage every patient with early-stage CKD. With diabetes, hypertension, and cardiovascular disease continuing to rise, the population at risk for kidney disease is expanding rapidly. As a result, more effective triage and risk stratification are needed to ensure nephrology resources are directed toward patients most likely to benefit from specialist care.

Rather than relying solely on eGFR thresholds, panelists emphasized a more nuanced approach to referral decisions. Factors such as albuminuria levels, rate of kidney function decline, structural abnormalities, and underlying disease etiology can help determine which patients require specialist involvement. Many individuals with stable kidney function and minimal albuminuria may be appropriately managed in primary care with careful monitoring and risk factor control.

Strengthening collaboration between primary care clinicians and nephrologists will be essential for making these models work. Education around CKD biomarkers and referral criteria can help clinicians better identify which patients require specialist care and which can be safely managed in the community.

Recent advances in CKD therapeutics have added urgency to improving early detection. Over the past several years, therapies such as sodium-glucose cotransporter 2 inhibitors and nonsteroidal mineralocorticoid receptor antagonists have demonstrated the ability to slow CKD progression while reducing cardiovascular risk. Dapagliflozin and empagliflozin, as assessed in the DAPA-CKD and EMPA-KIDNEY trials, respectively, represent a major shift in CKD care, moving the field closer to disease modification rather than simply managing complications.

However, the benefits of these therapies depend heavily on early identification. If CKD remains undetected until advanced stages, opportunities to meaningfully alter disease trajectory may already be lost.

For clinicians, the message from the forum was clear: the tools to change CKD outcomes now exist, but realizing their full potential will require earlier recognition and a healthcare system capable of moving kidney care further upstream.

US Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2023. May 15, 2024. Accessed March 12, 2026. 

https://www.cdc.gov/kidney-disease/php/data-research/index.html

American Kidney Fund. Risk factors for kidney disease. Accessed March 12, 2026. 

https://www.kidneyfund.org/all-about-kidneys/risk-factors

Campbell P. Dapagliflozin (Farxiga) Receives Historic FDA Approval for Chronic Kidney Disease. HCPLive. April 30, 2021. Accessed March 12, 2026. 

https://www.hcplive.com/view/dapagliflozin-farxiga-receives-historic-fda-approval-for-chronic-kidney-disease

Campbell P. Empagliflozin (Jardiance) Receives CKD Approval from US FDA. HCPLive. September 22, 2023. Accessed March 12, 2026. 

https://www.hcplive.com/view/empagliflozin-jardiance-receives-ckd-approval-from-us-fda

Articles

Chronic kidney disease affects 35–36 million Americans yet frequently goes unrecognized until late, reflecting limited patient awareness and inconsistent screening. Underuse of urine albumin-to-creatinine ratio testing, despite routine eGFR reporting, drives missed early diagnosis and inadequate risk stratification. Referral to nephrology often occurs near kidney failure, while workforce limitations necessitate better triage models that incorporate albuminuria, trajectory of decline, etiology, and structural findings. Therapeutic advances—particularly SGLT2 inhibitors and nonsteroidal MRAs—heighten urgency to shift kidney care upstream.

Experts discuss gaps in CKD detection, the role of albuminuria testing, and the need for earlier, risk-based care to improve outcomes.

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

Improving Early Detection of CKD in an Evolving Cardio-Kidney-Metabolic Era

Mary K Roberts, PhD is a Post Doctoral Researcher at the Leverhulme Centre for Demographic Science at the University of Oxford.

Adrian Brown, PhD, NIHR Advanced Fellow and Associate Professor in Nutrition and Dietetics at University College London and programme co-lead of the MSc Dietetics (Pre-registration) course

Salvatore Viscomi, MD, is the chief executive officer of Carna Health.

Shahinian is a Dr. Robert H and Eva M Moyad Research Professor of UrologyCo-Chief of Dow Division of Health Services ResearchProfessor of Internal Medicine, and Professor of Urology at the University of Michigan Medical School. 

Holly Kramer, MD, is a nephrologist at Loyola University Medical Center and the editor in chief of 

Maya Clark Cutaia, PhD, RN, is the inaugural Evelyn Lauder Associate Dean for Nurse Practitioner Programs and Professor at the Hunter-Bellevue School of Nursing at Hunter College.

Crisis Point: The Cause and Calamity, Neighborhood Disadvantage and Kidney Disease

Data from the US Census Bureau identify 24 million Americans living in disadvantaged neighborhoods, defined as communities where at least 1 in 5 residents falls below the federal poverty line.

The inequities embedded within these communities create profound barriers to healthcare access, barriers that are especially consequential for silent diseases like 

, where delayed diagnosis and limited resources can mean irreversible disease progression before a patient ever receives care.

Neighborhood disadvantage is not an abstract concept. As Maya Clark-Cutaia, PhD, RN, describes it, it is a place-based measure reflecting the structural and material conditions of a community, poverty, housing instability, limited educational opportunities, unemployment, and restricted access to basic resources. For patients with kidney disease, it manifests as higher exposure to environmental stressors: pollution, extreme heat, the absence of safe spaces to exercise, unreliable access to healthy food, and a cascade of logistical barriers that make even reaching a primary care provider an overwhelming undertaking.

"There may not be a lab value I can assign to it, but the modifier risk and the impact it could have on outcomes is unparalleled," said Cutaia.

These stressors do not simply correlate with poor health; they have been found to actively drive it. Acute environmental exposures like heat stress and dehydration can trigger acute kidney injury, and repeated episodes of acute kidney injury accelerate the progression of CKD. Furthermore, chronic exposures, such as air pollution, contribute more gradually but no less devastatingly to disease incidence and decline over months and years. 

The Silence of CKD and the Cost of Invisibility

In the US, > 90% of people with kidney disease are unaware they have it. This is not a failure of individual attention, however, but a structural failure. CKD is largely asymptomatic in its early stages, and for patients in disadvantaged communities, screening is inconsistent at best and nonexistent at worst.

The answer, too often, is the latter. Patients in disadvantaged neighborhoods present far later than clinicians would like, after years of silent disease and silent decline, after the early asymptomatic phase has passed without a single screening, after missed opportunities have accumulated downstream into irreversible harm. This is not inevitable. It is a system failing its most vulnerable patients.

Individuals residing in disadvantaged communities face a significantly elevated risk of obesity. Low-income individuals often rely on cheaper, calorie-dense, and nutrient-poor foods, driven not by poor choices but by economic reality, in many communities, processed foods are simply more affordable and accessible than fresh vegetables and fruit. The result is nutrient deficiency alongside increased body weight, a paradox of deprivation.

Obesity is a common comorbidity in kidney disease that, similar to living in a disadvantaged neighborhood, can create a feedback loop of inflammation and kidney injury. But its consequences extend beyond biology: obesity creates significant transplant barriers by increasing surgical risks, reducing organ survival rates, and triggering strict BMI-based eligibility limits. It drives increased rates of wound infections, delayed graft function, and cardiovascular complications. Morbidly obese patients face a 22-23% higher chance of being bypassed for an organ entirely.

When considered together, obesity and neighborhood disadvantage reinforce one another. Socioeconomic deprivation fosters conditions that drive obesity, while obesity then becomes a clinical gatekeeping mechanism that disproportionately excludes already-marginalized patients from transplantation. These are not two separate problems, but are mutually reinforcing forces targeting the same population.

Addressing obesity in this context requires a holistic approach. Evidence-based care must account for the realities of kidney failure, acknowledge the barriers patients face around hunger and fatigue, and consider options including bariatric surgery and incretin-based therapies where clinically justified, alongside diet and physical activity. Critically, it must also address the upstream drivers: food insecurity, lack of access to whole foods, and the absence of robust social support systems.

Transplant Access: Where Every Barrier Converges

Neighborhood disadvantage significantly restricts access to organ transplantation. Patients from high-deprivation areas experience lower rates of waitlisting, fewer living donor transplants, and reduced preemptive transplant rates compared to those from low-disadvantage areas — even after researchers attempt to adjust for confounding factors.

The barriers compound at every pressure point along the transplant continuum. Do you live within a feasible distance of a transplant center? Can you demonstrate the transportation and social support that listing requires? Is your social support network legible to the medical system evaluating it, or does it look different from what clinicians in resource-rich settings expect? As Clark-Cutaia observes, for some patients, that network is not a partner and a parent. It is a church group. The question clinicians must ask themselves is whether they are flexible enough to recognize that as sufficient.

"We know that transplant is the gold standard. It's definitely not likely that this is something our patients are going to see," she explained.

Financial strain, transportation barriers, time off work, childcare, health literacy, trust, or the profound lack of it, all impede forward progress. These burdens are not evenly distributed. Financial concerns are disproportionately reported among Black and Hispanic individuals, reflecting broader structural inequalities. Black and African American patients spend significantly more time on dialysis compared to White patients and receive far fewer transplants, a disparity that cannot be explained by biology alone.

The Primary Care Gap: A System That Expects Too Much

While data consistently demonstrate that individuals in disadvantaged communities experience poorer health outcomes, these same communities face significant barriers to primary care and routine wellness visits — including limited time, financial constraints, and lack of access to providers. The cruel irony is that the very resources needed to address the burden of disease are precisely what these communities lack.

It is not that patients do not want care, but that the healthcare system has been designed around assumptions of availability, available transportation, available time off, available money for copays, and available proximity to a specialist. In some parts of the country, obtaining basic blood and urine testing for kidney disease requires a 5-hour round trip. 

The Charge: Clinicians Must Meet Patients Where They Are

Truly meeting patients where they are begins with treating social context not as a footnote, but as a fundamental component of the care plan. The weight of poverty, systemic inequity, and limited access does not disappear at the clinic door, patients carry it with them. As clinicians, understanding the structural and social factors that place certain patients at a systemic disadvantage is not peripheral to patient care. It is central to it.

Clark-Cutaia regularly shares an image with her students: a painting by New Orleans artist Terrence Osborne called Evacuation Plan. It depicts a Volkswagen bus with an entire home stacked on top, furniture, instruments, fishing gear, a life, everything someone would carry out of the city ahead of Hurricane Katrina. Her message to clinicians is simple and urgent, 

"Treat people like they're that Volkswagen bus. We all walk in every day with those things on our backs. You may not see it, but we walk in with our history, our culture, our trauma.”

In practice, this means acting sooner, making that referral earlier, and connecting patients with resources before a crisis rather than after. It means bringing screening and monitoring into communities through mobile units, pharmacies, places of worship, and workplaces so that patients do not have to choose between their health and their livelihood to access care. It means recognizing that peritoneal dialysis and home dialysis, while clinically preferable, are not realistic options for patients without the space, the privacy, or the support to make them work.

Addressing these disparities requires meeting patients where they are, bringing preventive care and wellness resources directly into disadvantaged communities rather than expecting residents to overcome systemic barriers to reach them. If disadvantaged communities cannot come to the healthcare system, the healthcare system must come to them.

 is the inaugural Evelyn Lauder Associate Dean for Nurse Practitioner Programs and Professor at the Hunter-Bellevue School of Nursing at Hunter College.

 is a NIHR Advanced Fellow and Associate Professor (Principal Research Fellow) in Nutrition and Dietetics in the Centre of Obesity Research at University College London (UCL) and programme co-lead of the MSc Dietetics (Pre-registration) course at UCL.

 is the Chief Medical Officer at Evergreen Nephrology.

 is the Chief Executive Officer and Founder of Carna Health.

 is a nephrologist and Professor of Public Health Sciences and Medicine, Division of Nephrology and Hypertension at Loyola University Chicago, and the Editor in Chief of 

 is a postdoctoral researcher at the Leverhulme Centre for Demographic Science at the University of Oxford.

 is the Dr. Robert H and Eva M Moyad Research Professor of Urology, Co-Chief of Dow Division of Health Services Research, Professor of Internal Medicine, and Professor of Urology at the Medical School at the University of Michigan.

Editor’s Note: Cutaia declares no relevant disclosures. Brown reports no relevant disclosures. Pflederer reports relevant disclosures with Evergreen Nephrology. Viscomi reports relevant disclosures with Carna Health, Dama Health, QuantaBrain, and others. Shahinian reports no relevant disclosures.

Christie-Mizell CA. Neighborhood Disadvantage and Poor Health: The Consequences of Race, Gender, and Age among Young Adults. 

International Journal of Environmental Research and Public Health

Jawad K, Feygin YB, Stevenson M, et al. The association between four neighborhood disadvantage indices and child chronic health classifications. 

https://doi.org/10.1038/s41390-025-04143-5

Crawford S. Evaluating the Association Between Neighborhood Disadvantage and Mortality. Yale School of Medicine. Published December 12, 2024. 

https://medicine.yale.edu/news-article/connection-between-neighborhood-disadvantage-and-mortality/

Huang Y, Sparks PJ. Longitudinal exposure to neighborhood poverty and obesity risk in emerging adulthood. 

https://doi.org/10.1016/j.ssresearch.2022.102796

Li Y, Menon G, Kim B, et al. Residential Neighborhood Disadvantage and Access to Kidney Transplantation. 

https://doi.org/10.1001/jamanetworkopen.2025.49679

Crisis Point

Welcome to Crisis Point, a comprehensive look at the public health crises affecting the United States today, with global implications tomorrow.

Shows

video shows page features a feed of exclusive series, including Crisis Point and Rethinking Psychiatry with Dr. Steve Levine.

Remibrutinib Enables Peanut Tolerance in as Little as 1 Week, With Robert Wood, MD

Remibrutiib has demonstrated striking early efficacy data in IgE-mediated peanut allergy, with just 1 week of treatment enabling 88% of adult participants to tolerate a previously reactive dose in new phase 2 data presented at the 

American Academy of Allergy, Asthma & Immunology (AAAAI)

 2026 Annual Meeting held in Philadelphia, Pennsylvania, from February 27 to March 2.

sat down with Robert A. Wood, MD, Chief of the Eudowood Division of Pediatric Allergy and Immunology at Johns Hopkins Children's Center and Professor of Pediatrics at the Johns Hopkins University School of Medicine, who presented the data at the meeting, to learn more about the promising findings and what they may suggest about BTK inhibition’s potential for modifying food allergy. 

The phase 2 study evaluated 3 dose levels of remibrutinib, an oral, highly selective BTK inhibitor, versus placebo in 59 adults with IgE-mediated peanut allergy confirmed by double-blind, placebo-controlled oral food challenge (DBPCFC) at screening. The primary endpoint was tolerating a single dose of ≥600 mg peanut protein without dose-limiting symptoms during DBPCFC at week 4. Four weeks of treatment across the 10, 25, and 100 mg twice-daily dose arms produced estimated response rates (ERR) of 0.41, 0.52, and 0.84, respectively, all superior to placebo. Most striking was the 1-week arm — in which participants received 3 weeks of placebo run-in followed by just 1 week of remibrutinib 25 mg twice daily — which yielded an ERR of 0.88, the highest of any arm in the study. Remibrutinib was well tolerated across all arms with no serious adverse events.

Wood contextualized the mechanism and implications for a field where treatment speed has long been a limiting factor. Remibrutinib works upstream of the allergen-specific pathway, targeting mast cells directly — the final effector cell in IgE-mediated allergic reactions regardless of the triggering allergen. That mechanism carries 2 significant clinical implications: first, the drug is likely to be effective across all food allergens, not just peanut, making it potentially well-suited to the 60–80% of food-allergic patients who react to multiple foods simultaneously. Second, the 1-week onset raises the possibility of intermittent rather than continuous use — providing targeted protection around specific high-risk exposures such as travel or medical procedures, rather than requiring year-round maintenance dosing. 

On the regulatory pathway, Wood noted that remibrutinib is already approved for chronic spontaneous urticaria, clearing an initial safety bar for long-term use, though he flagged that the dose likely required for food allergy efficacy appears higher than the approved urticaria dose, and that dose-dependent safety characterization will be a key focus of the phase 3 trial — which is now underway in adults and adolescents down to age 12, with the question of whether it will extend to younger children dependent on the safety data that emerge from those older cohorts.

“The speed is again, pretty remarkable, and opens the possibility that this treatment might be used intermittently rather than continuously. So if a if a patient with severe food allergy didn't want to be on a long term maintenance medicine, but wanted [short-term] protection… say, for travel,” Wood said.

Wood’s disclosures include Aimmune, ALK, DBV Technologies, FARE, Genentech, NIAID, Novartis, Regeneron, Siolta, and Aravax.

Derman C. FDA Approves Remibrutinib for Chronic Spontaneous Urticaria. HCPLive. Article. September 30, 2025. 

https://www.hcplive.com/view/fda-approves-remibrutinib-chronic-spontaneous-urticaria

Wood R, Tan R, Shah R, et al. Efficacy and safety of remibrutinib, a Bruton’s tyrosine kinase inhibitor, for individuals with IgE-mediated peanut allergy. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Abstract #563

Wood discussed the potential of BTK inhibition for peanut allergy and beyond.

Tatyana Kushner, MD, is an associate professor of medicine in the division of gastroenterology and hepatology at Weill Cornell Medicine.

Kushner discusses the global burden of hepatitis D, gaps in testing, and emerging therapies reshaping the treatment landscape.

Hepatology

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

New Momentum in Hepatitis D Research and Treatment, With Tatyana Kushner, MD

Mark G. Lebwohl, MD, the dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai,

At AAAAI 2026, Lebwohl discussed REMIX trial data showing oral remibrutinib reduced CSU symptoms within 12 hours and improved disease control.

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.

Urticaria

The HCPLive urticaria page is a comprehensive resource for clinical news and insights on chronic idiopathic urticaria and chronic spontaneous urticaria. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for urticaria, and more.

Strategic Alliance Partnership

Remibrutinib Shows Rapid Symptom Relief in CSU, With Mark Lebwohl, MD

Melissa Wallach, MD, is a pediatrician at K. Hovnanian Children’s Hospital, Hackensack Meridian Jersey Shore University Medical Center.

Tozzi and Wallach discuss ways to omit artificial sweeteners and added sugars from children’s diets and minimize risk for T2D and MASLD later in life.

Type 2 Diabetes

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Sugar-Sweetened Beverages in Childhood Increases Diabetes, MASLD Risk, With Melissa Wallach, MD, and Meghan Tozzi, MD

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

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.

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.

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.

Eosinophils, Exacerbations, and Endpoints: Biologic Therapy Selection in COPD and Asthma

Experts discuss the clinical significance of the updated international CSU guidelines, which for the first time incorporate 3 step-up therapy options.

Overview of the New International CSU Guidelines and Expanded Treatment 

Nicole Negbenebor, MD, is a clinical assistant professor of dermatology and the director of the Skin of Color Clinic for the University of Iowa, as well as a Skin of Color Society (SOCS) member.

In this segment of the latest Skin of Color Savvy podcast, Nicole Negbenebor, MD, highlights her experiences as director of a Skin of Color Clinic.

Discussing Work as the Director of a Skin of Color Clinic in Dermatology

Experts discuss the goal of complete symptom control in CSU and the practical limitations of achieving complete control of disease.

Treatment Goals, Disease Control Targets, and the Role of Patient-Reported Outcome Measures 

Matthew Krantz, MD, from Vanderbilt University Medical Center

This HCPLive Five captures 5 interviews conducted on-site at AAAAI 2026.

HCPLive Five at AAAAI 2026

Lala discusses the ethical, medical, and practical concerns surrounding xenotransplantation of pig hearts – and how they should be addressed in clinical research.

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.

ISHLT Provides Updates in Xenografting in Patients with Cardiac Diseases, With Anu Lala, MD

This segment of Bhatia's interview highlights imsidolimab's reported durability of response for those with generalized pustular psoriasis (GPP).

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.

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