Anna Nowak-Wegrzyn, MD, PhD, of NYU Grossman School of Medicine.

 Best Practices for Managing FPIES Reactions, With Anna Nowak-Wegrzyn, MD, PhD

 Food Protein–Induced Enterocolitis Syndrome (FPIES)

 highlights evolving strategies for both acute treatment and long-term dietary management in infants and young children. At the 

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

 annual meeting in Philadelphia, Anna Nowak-Wegrzyn, MD, PhD, from NYU Grossman School of Medicine, discussed best practices for clinicians navigating this complex non-immunoglobulin E–mediated food allergy.

FPIES most commonly begins in infancy and typically presents with delayed gastrointestinal symptoms after ingestion of a trigger food. Unlike classic allergic reactions, symptoms usually occur 1 to 4 hours after ingestion and are characterized by repetitive, often forceful vomiting, pallor, lethargy, and occasionally diarrhea. Because skin or respiratory symptoms are typically absent, the condition can initially be mistaken for viral gastroenteritis.

“It may start on the first known feeding of the food,” Nowak-Wegrzyn said. “Maybe [the] third or fourth time the baby tolerated a small amount, [but] then they are fed a larger amount, and now 2 hours later, between 1 and 4 hours after eating, they develop vomiting. Sometimes…if it's witnessed by the parent, it's described as projectile.”

Acute management strategies have evolved as clinicians better understand the underlying inflammatory pathways involved in FPIES. Nowak-Wegrzyn noted that increasing evidence supports the use of ondansetron, a serotonin antagonist commonly used to treat chemotherapy-related nausea and vomiting. During FPIES reactions, serotonin release appears to contribute to the vomiting response, making ondansetron an effective option for symptom control.

For milder reactions, management can often occur at home. Caregivers may administer oral ondansetron and begin careful oral rehydration using small, frequent amounts of fluids such as oral rehydration solutions or breast milk. However, more severe reactions require emergency evaluation.

“FPIES is considered an allergic emergency because a subset of patients may have more severe manifestations with hypotension, with really distributive hypovolemic shock, and this will not resolve unless you can provide fluid resuscitation,” Nowak-Wegrzyn said.

These patients need intravenous fluids and, in some cases, corticosteroids to reduce the inflammatory response.

Beyond acute treatment, one of the most challenging aspects of FPIES management is determining how and when to introduce new foods after a reaction. To reduce the risk of additional reactions, clinicians typically recommend introducing foods from entirely different food groups rather than closely related foods that may carry a higher risk of cross-reactivity. For example, if an infant reacts to oat, the next food introduced might be a fruit or vegetable rather than another grain.

Initial introductions are often done gradually, starting with very small amounts and slowly increasing to a typical serving size. As infants successfully tolerate more foods, the pace of dietary expansion can usually increase.

Because diagnostic tests are typically negative in FPIES, decisions about food reintroduction often rely on clinical judgment.

“We don't attempt to reintroduce the food sooner than 6 months after the reaction, but after that, we may wait longer if the child is avoiding multiple foods and hasn't introduced all of [the] other foods,” Nowak-Wegrzyn said. “We would like to avoid a situation [where] they will get turned off and unwilling to try other foods.”

Anna Nowak-Wegrzyn has no relevant disclosures.

Nowak-Wegrzyn, A. Update on Diagnosis and Management of FPIES in Early Life. Session presented at AAAAI 2026 in Philadelphia on February 27, 2026.

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At AAAAI 2026, Anna Nowak-Wegrzyn, MD, discussed the use of ondansetron, home management strategies, and guidance on the gradual reintroduction of foods in FPIES.

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Best Practices for Managing FPIES Reactions, With Anna Nowak-Wegrzyn, MD, PhD

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include positive data from a pre-specified week 36 interim analysis of the ongoing phase 3 RAINIER trial of povetacicept in IgA nephropathy (IgAN), the US Food and Drug Administration (FDA) acceptance of a New Drug Application (NDA) for lorundrostat in hypertension, new data on weight regain after GLP-1 RA discontinuation, the FDA approval of GSK’s leucovorin calcium (Wellcovorin) tablets as the first treatment for cerebral folate deficiency, and data from the phase 3 INTEGUMENT-OLE study of once-daily roflumilast (Zoryve) cream 0.05% in children 2 to 5 years of age with mild-to-moderate atopic dermatitis.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of March 08, 2026—let’s jump in!

RAINIER: Povetacicept Reduces Proteinuria By 52.0%

On March 9, Vertex Pharmaceuticals announced positive data from a pre-specified week 36 interim analysis of the ongoing phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF and APRIL cytokines, in IgAN. Results showed patients treated with povetacicept achieved a 52% reduction from baseline in proteinuria as measured by 24-hour urine protein to creatinine ratio (UPCR) and achieved a statistically significant and clinically meaningful 49.8% reduction in UPCR versus placebo (

Lorundrostat Secures FDA NDA Acceptance for Hypertension, Falls Short in Phase 2 OSA Trial

On March 9, 2026, the FDA accepted Mineralys Therapeutics’ NDA for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The NDA was based on positive data from the phase 3 Launch-HTN and phase 2 Advance-HTN trials demonstrating favorable safety and blood pressure reduction in adults with hypertension. With the acceptance, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.

Discontinuing GLP-1 Treatment Associated With Up to 60% Weight Regain, With Brajan Budini

Findings from a recent study suggest GLP-1RA cessation is associated with a predictable and decelerating pattern of weight regain, reaching 60% at 1 year, that plateaus below pre-treatment levels, suggesting that partial weight-loss benefit may persist long-term but is substantially attenuated.

FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

On March 10, 2026, the FDA approved GSK’s leucovorin calcium (Wellcovorin) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1), making it the first treatment for the rare genetic condition of cerebral folate deficiency. The approval was based on a systematic review of the published literature on the topic, including published case reports with patient-level information, as well as mechanistic data.

New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children

On March 10, 2026, Arcutis Biotherapeutics announced that 

 published data from the phase 3 open-label extension (INTEGUMENT-OLE) study evaluating once-daily roflumilast (Zoryve) cream 0.05% in children 2 to 5 years of age with mild-to-moderate atopic dermatitis. Data from the INTEGUMENT-OLE trial, which supported the FDA approval of roflumilast cream 0.05% in October 2025, demonstrated that roflumilast cream 0.05% is safe and well-tolerated, and efficacy was not only maintained but continued to improve with up to 56 weeks of treatment.

Articles

Vertex reported week-36 interim phase 3 RAINIER data showing povetacicept (dual BAFF/APRIL inhibitor) reduced 24-hour UPCR 52% from baseline and 49.8% versus placebo (P<.0001) in IgA nephropathy. Mineralys’ lorundrostat NDA for adjunctive hypertension therapy was accepted, with a Dec 22, 2026 PDUFA date, supported by Launch-HTN and Advance-HTN results. GLP-1RA discontinuation was linked to decelerating weight regain approaching 60% at one year. FDA approved GSK’s Wellcovorin for CFD-FOLR1. Long-term INTEGUMENT-OLE data supported sustained/improving pediatric AD control with roflumilast cream to 56 weeks.

Stay updated with the latest healthcare breakthroughs, including FDA actions and new trial data, in this week’s essential news roundup.

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The HCPFive: Top News for Healthcare Providers from the Week of 03/08

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. 

PCP's Role in Reducing ER Use Among ESKD Patients on Dialysis

Having a primary care physician (PCP) along with a nephrologist for patients with 

 receiving dialysis may help reduce emergency department (ED) utilization, a major driver of healthcare costs in this patient population.

"We kind of hypothesize that having a primary care physician, separate from the nephrologist, might help reduce health care utilization,” said Vahakn Shahinian, MD, MS, Co-Chief of Dow Division of Health Services Research, Professor of Internal Medicine and Urology at the Medical School at the University of Michigan, in an interview with 

. “They might be more available after hours on an urgent basis to see patients and head off issues, and overall just kind of help the management of a lot of the underlying chronic conditions that accompany most patients on dialysis."

The > half a million patients receiving dialysis for ESKD in the US represent 4 times the national mean rate for all Medicare beneficiaries. Furthermore, approximately 98% of patients with ESKD have ≥1 comorbidity, with 83 to 90% living with hypertension and up to 69% living with diabetes. While a majority of these patients see a nephrologist to manage their dialysis, study investigators wondered whether having a PCP would impact ED visits.

To address this gap in the benefit of PCPs in this patient population, Shaninian and colleagues conducted a national, retrospective, cross-sectional study of 181,520 patients receiving maintenance hemodialysis to assess the association between primary care involvement and ED utilization and hospitalization in this population.

Upon analysis, In the instrumental variable model comparing patients estimated to have a 100% probability of having a PCP with those estimated to have a 0% probability of having a PCP, there was not a significant difference in the estimated risk of any hospitalization (51.0%; 95% Confidence Interval [CI], 49.6%-52.4% vs 48.7%; 95% CI, 45.9%-51.4%), but there was a difference in estimated risk of any ED visit (69.4%; 95% CI, 68.1%-70.7% vs 75.0%; 95% CI, 72.5%-77.6%; 

 = .003), particularly in estimated risk of any ED visit not resulting in hospitalization (51.2%; 95% CI, 49.7%-52.7% vs 72.1%; 95% CI, 69.2%-74.9%; 

"What we saw was that having a primary care physician really didn't make a difference with respect to being hospitalized. Where it made its biggest difference was ER visits that didn't result in hospitalization... to me, the story that our paper seems to suggest is that's where primary care can potentially help, in perhaps heading off issues early on before they become very serious or just less serious issues."

Editor’s Note: Shahinian reports no relevant disclosures. 

Bailoor K, Hirth RA, Guro P, Oerline MK, Hollingsworth JM, Shahinian VB. Primary Care Involvement and Health Care Utilization Among Patients With End-Stage Kidney Disease. 

https://doi.org/10.1001/jamanetworkopen.2026.080

MacRae C, Mercer SW, Guthrie B, Henderson D. Comorbidity in chronic kidney disease: a large cross-sectional study of prevalence in Scottish primary care. 

Chronic Kidney Disease

Douglas P. Mack, a pediatric allergist and assistant clinical professor at McMaster University

Epinephrine Nasal Spray Shows Strong Patient Preference, With Douglas Mack, MD

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

 a pediatric allergist and assistant clinical professor at McMaster University, on how clinicians can integrate 

into shared decision-making conversations with patients and families. He emphasized that patient preference and real-world usability will likely play a critical role in the success of these therapies.

“We have to, as clinicians, have no preconceptions about what a patient wants,” Mack said. “Some families, we think they're going to want one thing, and they want something separate. Whenever I go into these discussions, I always want to show both options for the families, show how they work, [and] even let them try them. In the end, I know the science. I know what's going to work to some degree, but in the end, if they don't buy into this, it doesn't matter what I give them if they're not going to use it; that dose is never getting into that patient. Shared decision making is absolutely critical in this scenario and having an open mind to what a patient wants.”

New data presented at the meeting found that among 90 participants in a randomized crossover study, 88% reported preferring the intranasal device over injectable epinephrine. Investigators found the preference was consistent regardless of whether participants had prior experience using auto-injectors. Reasons for favoring the nasal spray included the absence of a needle, ease of use, portability, and the perception that it would be easier for bystanders to administer in an emergency.

Among survey responses addressing barriers to carrying epinephrine, 98–100% of participants rated factors such as device size, weight, and temperature flexibility more favorably for the intranasal product. In addition, 93% of participants reported they could bring the nasal spray with them in daily situations, compared with 43% for auto-injectors.

“We already have preliminary data on real-world use of [epinephrine nasal spray], and it… appears to have very similar outcomes to what we see with injectables,” Mack said. “I think once we get more comfortable with that, we [will] see that more patients are using this. What I do wonder is: are we going to see earlier use of this? In the real world, are people actually using this earlier… or more frequently, simply because of the fact that it's needle-free? I think if we do see…less hesitation in the real-world…that's going to be absolutely golden data.”

New data reveals 9 in 10 people prefer EURneffy, a needle-free nasal adrenaline spray, over auto-injectors. BioSpace. Published March 4, 2026. Accessed March 5, 2026. 

https://www.biospace.com/press-releases/new-data-reveals-9-in-10-people-prefer-eurneffy-a-needle-free-nasal-adrenaline-spray-over-auto-injectors

Research presented at AAAAI 2026 found that 88% of participants preferred intranasal epinephrine over injectables.

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. 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.

 has approved secukinumab for the treatment of moderate to severe 

 in pediatric patients aged 12 and older, positioning it as the only interleukin (IL)-17A inhibitor currently indicated for this population.

The approval adds a differentiated biologic option to an area where treatment choices for younger patients have historically been limited. HS is a chronic, systemic inflammatory condition known to be characterized by recurrent, painful, boil-like nodules, causing significant discomfort among individuals living with the disease.

 The nodules resulting from HS can rupture, cause open wounds, and result in permanent scarring.

“Hidradenitis suppurativa (HS) often begins in adolescence and can cause irreversible scarring and disabilities,” Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical trials in adult HS patients, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, said in a statement.

 “The approval of [secukinumab] represents an important advancement for younger HS patients who have had limited treatment options.”

HS impacts approximately 1 in 100 people globally and frequently makes its first appearance around puberty, with more than 50% of those reporting symptom onset reporting the disease at the time of adolescence. Secukinumab is a fully human monoclonal antibody designed to directly targeting interleukin-17A, a key cytokine known to drive the inflammatory pathways implicated in several immune-mediated diseases.

The drug carries adult approvals across a broad range of indications, including HS, ankylosing spondylitis, psoriasis, psoriatic arthritis (PsA), and non-radiographic axial spondyloarthritis. On the pediatric side, it is now approved for HS alongside existing indications in plaque psoriasis, enthesitis-related arthritis, and juvenile PsA.

For clinicians managing adolescent HS patients, the approval introduces weight-based dosing for those at or above 30 kg, a regimen designed to achieve drug exposure comparable to that seen in adult HS trials. The pediatric indication was supported by a combination of data. Such findings included well-controlled adult HS studies, pharmacokinetic modeling extrapolated from adult data on HS and psoriasis, and clinical trial reslts from other approved pediatric indications.

In dosing analyses, results also validated the weight-adjusted approach as a reliable replication of the systemic exposure established in adults.
The distinct mechanism of IL-17A inhibition provides prescribers with a targeted therapeutic agent designed for individualization and based on patient weight.

“Hidradenitis suppurativa (HS) affects far more than skin; it impacts confidence, emotional well-being and relationships during a formative period for many pediatric patients,” Brindley Brooks, founder and CEO of HS Connect, said in a statement.

 “For families watching their children struggle, this FDA approval brings hope for earlier intervention.”

Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. Novartis. March 13, 2026. 

https://www.novartis.com/us-en/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa

Montero-Vilchez T, Diaz-Calvillo P, Molina-Leyva A, et al. The Burden of Hidradenitis Suppurativa Signs and Symptoms in Quality of Life: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jun 22;18(13):6709. doi: 10.3390/ijerph18136709. PMID: 34206415; PMCID: PMC8293810.

FDA approval extends secukinumab to adolescents (≥12 years) with moderate-to-severe hidradenitis suppurativa, making it the only IL-17A inhibitor indicated for this pediatric population. The decision expands biologic optionality in a disease that commonly presents around puberty and can lead to chronic pain, rupturing nodules, open wounds, and irreversible scarring. Support for the pediatric indication leveraged robust adult HS efficacy data, PK modeling and extrapolation from adult HS/psoriasis datasets, and clinical evidence from other pediatric indications, enabling weight-based dosing to match adult exposure targets.

This FDA approval of secukinumab (Cosentyx) for hidradenitis suppurativa (HS) represents the fourth pediatric indication for the drug.

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FDA Approves Secukinumab for Pediatric Patients 12 Years and Older with HS

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.

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

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.

7 experts come together to address neighborhood disadvantage and its impact on kidney health in the latest Crisis Point. 

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

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

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

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

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Check back throughout the year for discussions on a variety of topics, including data privacy in health apps, euthanasia and medical assistance in dying, reproductive rights and technologies, and more!

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Clinical, Ethical Impacts of Solitary Confinement on Health

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

Experts weigh new biologics including dupilumab, tezepelumab, and depemokimab, and how eosinophils guide real-world prescribing.

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Latest News

Best Practices for Managing FPIES Reactions, With Anna Nowak-Wegrzyn, MD, PhD

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PCP's Role in Reducing ER Use Among ESKD Patients on Dialysis

Epinephrine Nasal Spray Shows Strong Patient Preference, With Douglas Mack, MD

FDA Approves Secukinumab for Pediatric Patients 12 Years and Older with HS