Segment 2

The notion of “gradient reduction therapy,” originally articulated by James Udelson,MD, is presented as a logical next step in the management of oHCM.

In this video, Matthew Martinez, MD, raises the question of whether it is acceptable to leave patients with high resting or provocable LVOT gradients (eg, ≥130 mm Hg) if they appear asymptomatic and have preserved exercise capacity. Both he and Mariko Harper, MD, argue that although definitive outcomes data are not yet available, it is physiologically plausible that sustained severe obstruction promotes adverse remodeling, including progressive left ventricular hypertrophy, left atrial enlargement, mitral regurgitation, and myocardial fibrosis, all of which may increase long-term cardiovascular risk.

Harper emphasizes that emerging long-term data from mavacamten—the first FDA-approved cardiac myosin inhibitor—demonstrate favorable cardiac remodeling, with reductions in left ventricular mass, left atrial size, and systolic anterior motion of the mitral valve, as well as sustained biomarker improvement over several years. This experience suggests that earlier gradient elimination may have disease-modifying potential, though conclusive data on atrial fibrillation, heart failure events, and other hard outcomes are still pending. In parallel, both clinicians note the similarity to the evolution of aortic stenosis care, where earlier intervention has been associated with improved long-term outcomes as procedural risk declined.

Traditional agents, including β-blockers, non-dihydropyridine calcium channel blockers, and disopyramide, remain part of background therapy but no longer dominate the treatment algorithm in expert practice. Martinez explains that he still initiates these agents given their low upfront risk, but he no longer escalates to high doses or complex combinations before switching to a myosin inhibitor. Instead, he introduces a cardiac myosin inhibitor relatively early and, once gradient and symptoms improve, often de-escalates or discontinues background drugs. In this segment, Martinez and Harper present a nuanced, forward-looking view of gradient reduction as a primary therapeutic goal and outline how cardiac myosin inhibitors are displacing escalating polypharmacy with traditional negative inotropes.

Videos

Experts explore the concept of “gradient reduction therapy,” the remodeling effects of cardiac myosin inhibitors, and the evolving role of traditional agents in oHCM.

Clinical

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Video Series

Understanding Gradient Reduction Therapy and Cardiac Myosin Inhibitors in oHCM Care

Bernard Kadosh, MD, is the medical director of the ventricular assist device and cardiogenic shock programs at NYU Langone Health.

Eiran Gorodeski, MD, MPH, is a professor of medicine and section head of the section of advanced heart failure at Case Western Reserve University School of Medicine, as well as the director of the advanced heart failure and transplant center at University Hospitals.

Improving Heart Failure Awareness and GDMT Prescription, With Bernard Kadosh, MD, and Eiran Gorodeski, MD, MPH

Recent studies have highlighted shortcomings in both patient awareness and guideline-directed medical therapy (GDMT) prescription in 

HF is a condition with an enormous patient population, affecting >6 million adults in the US and 64 million worldwide. However, research has long since shown that patients with HF have a substantial lack of understanding about the disease, including its development, definition, and trajectory. This is naturally associated with poorer outcomes, as patients are far less likely to make proper lifestyle changes if they are unaware of how it could affect them.

“Other conditions and diseases may be more linear. People get sick and they either improve or they don’t improve,” Bernard Kadosh, MD, medical director of the ventricular assist device and cardiogenic shock programs at NYU Langone Health, told 

 in an exclusive interview. “With heart failure, it’s quite different. There are points in the disease where the risk of bad outcomes accelerates, and there are points where the risk of bad outcomes decelerates. And I think that teaching patients about that aspect of the disease is very important.”

A 2023 study from the American Heart Association (AHA), conducted via a survey of sociobehavioral measures across study participants with HF, highlighted the significant percentage of patients who are unaware of their diagnosis. This questionnaire, consisting of 1 question asking if patients had or had experienced 

Of the survey recipients, 1114 completed the survey; of those who responded, 71% had validated HF (n = 787). These patients were included in the analysis, which ultimately proved that 37% were aware of their diagnosis (n = 293). After adjustment, the study found that being a woman (OR, 1.56; 95% CI, 1.1-2.22), having HFrEF (OR, 1.58; 95% CI, 1.13-2.22) or coronary artery disease (OR, 1.65; 95% CI, 1.16-2.37), and attending the HF clinic (OR, 4.07; 95% CI, 2.25-7.36) were associated with increased diagnosis awareness.

Similarly, a 2022 study published in the 

examining GDMT prescription in patients with HF uncovered a substantial percentage of patients who are not given 1 or more of the 4 pillars of HF treatment, including ACE inhibitors/angiotensin receptor blockers (ACEi/ARBs), beta-blockers, mineralocorticoid receptor antagonists (MRAs), and SGLT2 inhibitors.

Based on an investigation of prescription history, a very small proportion (17% to 54%) are prescribed the target dose of ACEi/ARBs and beta-blockers in community settings. This has been attributed in large part to therapeutic inertia.

“Clinicians need an implementation playbook, and it needs to be protocolized in the same way as other diseases like myocardial infarction and ST elevation. These are protocol-driven therapies, and nothing is missed,” Eiran Gorodeski, MD, MPH, professor of medicine and section head of the section of advanced heart failure at Case Western Reserve University School of Medicine, as well as the director of the advanced heart failure and transplant center at University Hospitals, told 

. “We need to do a better job in creating and implementing a playbook in heart failure. Some of those playbook steps include identifying people who are admitted for compensated heart failure and then starting medications early and aggressively before discharge.”

Kadosh and Gorodeski went on to describe suggestions for clinicians in combatting these significant setbacks, educating both patients and other clinicians about this debilitating condition.

“I think it’s important to frame where the patient lies on the trajectory of the disease, and I usually do so in terms of stages,” Kadosh said. “If they come to me in Stage C, I say, ‘You have Stage C heart failure, but that doesn’t mean you necessarily will progress. There are a lot of therapies we have to help you prevent progression, to stabilize your symptoms, and to ensure that it doesn’t get worse.’ It’s our job to make sure that the patient understands the potential.”

Editors’ Note: Kadosh and Gorodeski report no relevant disclosures.

Shropshire SJ, Fabbri M, Manemann SM, et al. Patient awareness of heart failure diagnosis: A community study. 

Rastogi T, Duarte K, Huttin O, Roubille F, Girerd N. The Prescription Pattern of Heart Failure Medications in Reduced, Mildly Reduced, and Preserved Ejection Fractions. 

Kadosh and Gorodeski discuss 2 of the major challenges facing both patients and clinicians dealing with HF and how to address them.

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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.

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.

 exhibiting minimal 6-month response to ruxolitinib cream may still attain substantial repigmentation with prolonged treatment extending to 2 years, new findings suggest.

These findings resulted from an analysis assessing the long-term efficacy and safety of continuous treatment with ruxolitinib cream through 104 weeks in participants with vitiligo who had shown little or no clinical response by 24 weeks in the TRuE-V1 and TRuE-V2 trials.

 Investigators such as Albert Wolkerstorfer, MD, PhD, of Amsterdam University Medical Center authored these data.

Wolkerstorfer and coauthors described the aims of the TRuE-V1 and V2 trials as determining whether those who initially responded poorly to the medication could still see meaningful repigmentation with extended use of this therapy.

“Here, efficacy and safety of continuous ruxolitinib cream treatment over 104 weeks were evaluated among patients who had no or limited response to treatment at Week 24 in TRuE-V1/TRuE-V2,” Wolkerstorfer and colleagues wrote.

In the original studies, those involved were randomized in a 2:1 ratio to be treated either with 1.5% ruxolitinib cream twice daily or a vehicle control for the initial 24 weeks. Following this double-blind period, all trial subjects entered a 28-week open-label extension in which they used ruxolitinib twice each day. Those who had not attained a 90% improvement in their facial Vitiligo Area Scoring Index (F-VASI90) at minimum by Week 52 continued therapy with ruxolitinib cream twice daily for an additional 52 weeks.

Wolkerstorfer et al’s current analysis was aimed specifically at participants who had originally been assigned to ruxolitinib cream but demonstrated less than a 25% improvement from the point of baseline in either the facial or total Vitiligo Area Scoring Index (F-VASI or T-VASI) at the 24-week mark. To be included, patients also needed to have available VASI assessments at the 52, 80, and 104-week marks.

Investigators evaluated shifts in F-VASI and T-VASI scores among those with either no repigmentation or worsening depigmentation (defined as ≤0% improvement) as well as those with limited improvement (>0% to <25%) at Week 24. Among the 443 individuals in the efficacy-evaluable population who were initially randomized to ruxolitinib cream, the mean baseline F-VASI score was 0.92 (SD, 0.55), while the mean baseline T-VASI score was 6.64 (SD, 2.04).

Of these individuals, 127 had shown either no facial repigmentation or only minimal improvement by the 24-week mark. Continued use of ruxolitinib cream was linked with progressively increased facial repigmentation rates over time.

 At the 52-week mark, 71.7% of these patients (n = 113) had achieved some level of improvement in F-VASI. This proportion was shown by the investigators to have risen to 87.5% at Week 80 (n = 80) and attained 90.1% by the 104-week mark (n = 71).

When stratified by Week-24 response status, improvement by the 104-week mark was seen in 97.1% of those who had no repigmentation at Week 24 and in 83.3% of subjects with limited early improvement.

 The investigators also found the proportion of patients attaining at least a 75% reduction in F-VASI from baseline rose steadily during follow-up. Specifically, F-VASI75 was reached by 13.3% of patients at 52 weeks, 38.8% at 80 weeks, and 54.9% by 104 weeks.

A similar pattern was observed for total body repigmentation outcomes. Among 193 patients who had demonstrated no or minimal improvement in T-VASI at Week 24, the percentage showing subsequent improvement increased over time.

 By Week 52, 68.8% (n = 173) had experienced some degree of improvement in T-VASI. This rose to 81.4% at Week 80 (n = 118) and 84.9% at Week 104 (n = 106).

In their subgroup analyses, Wolkerstorfer and coauthors found improvement at Week 104 took place in 93.3% of individuals who initially had no total body repigmentation and in 81.6% of those showing a limited level of improvement at Week 24.

 T-VASI50 attainment, defined as at least a 50% reduction in T-VASI from baseline, also rose throughout the study period. The investigators noted the proportion of patients reaching this endpoint was 23.1% at Week 52, 42.4% at Week 80, and 50.0% at Week 104.

“In conclusion, >80% of patients with no or limited repigmentation at 6 months who continued to apply ruxolitinib cream over an additional 18 months achieved F-VASI or T-VASI improvements,” the investigative team concluded.

 “Half of the patients achieved clinically meaningful F-VASI75 or T-VASI50 at 2 years.”

Wolkerstorfer A, Gooderham M, Sebastian M, Harris JE, et al. Prolonged ruxolitinib cream treatment for vitiligo among patients with no or limited response in the first 6 months. J Eur Acad Dermatol Venereol. 

Rosmarin D, Passeron T, Ezzedine K et al. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828. PMID: 36260792.

Articles

Prolonged twice-daily ruxolitinib 1.5% cream can yield meaningful repigmentation in vitiligo despite minimal response at 24 weeks. In a 104-week evaluation of TRuE-V1/V2 participants with <25% early improvement in F-VASI or T-VASI, repigmentation rates increased progressively through Weeks 52, 80, and 104. By 2 years, most patients demonstrated facial and/or total-body VASI improvement, and approximately half reached clinically meaningful thresholds (F-VASI75 or T-VASI50), supporting extended treatment beyond 6 months in initial poor responders.

New data suggest those who exhibit minimal early response to ruxolitinib cream may still achieve repigmentation with prolonged use extending to 2 years.


Vitiligo

Vitiligo condition center page is a comprehensive resource for clinical news and insights on the dermatologic condition. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for the affected skin of vitiligo patients.

Dermatology

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Prolonged Ruxolitinib Cream Effective for Vitiligo in Early Non-Responders

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

OFC Updates for FPIES in Infants, With Anna Nowak-Wegrzyn, MD, PhD

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

annual meeting in Philadelphia, Anna Nowak-Wegrzyn, MD, PhD, of NYU Grossman School of Medicine, presented updates on the diagnosis and management of 

food protein–induced enterocolitis syndrome (FPIES)

 in infants. Updates included efforts to refine oral food challenge (OFC) protocols and improve recognition of the condition in early life.

 spoke with Nowak‑Wegrzyn during the meeting to discuss key takeaways from her session. She emphasized that despite growing clinical awareness, the condition remains fundamentally a clinical diagnosis.

“We didn't have any kind of diagnostic breakthroughs,” Nowak‑Wegrzyn said. “It’s still a clinical diagnosis, so the clinician has to be familiar with the manifestations, with the symptoms to make a diagnosis, because there's no blood test, there’s no skin test that can confirm it.”

FPIES is a non–immunoglobulin E–mediated food allergy that typically presents in infancy with delayed gastrointestinal symptoms following ingestion of a trigger food. Unlike classic immunoglobulin E–mediated food allergies, which can often be identified through skin prick testing or serum immunoglobulin E measurement, most patients with FPIES have negative results on standard allergy testing. However, a subset of patients may develop positive immunoglobulin E tests to the triggering food, a presentation sometimes described as atypical disease.

Clinically, the syndrome is characterized by delayed onset vomiting, typically occurring 1–4 hours after ingestion of the offending food. Infants may also appear pale or lethargic and can develop decreased muscle tone during episodes, symptoms that can initially resemble other serious conditions.

Because of this presentation, physicians must often consider infectious etiologies during the initial evaluation. Sepsis and viral gastroenteritis are common conditions included in the differential diagnosis.

The overlap in clinical presentation can also extend to laboratory findings. Infants experiencing a reaction may demonstrate elevated white blood cell counts with a predominance of neutrophils, a pattern that can mimic infection and complicate early diagnosis. However, symptom resolution patterns can help distinguish FPIES from infectious illnesses.

“Unlike with sepsis or viral gastroenteritis, infants have symptoms that resolve quite quickly,” Nowak-Wegrzyn said. “If they are not being fed the food, then within several hours, they…start going back to baseline. “Obviously, you have to do all of the workup right…you have to rule out infections, and only after the fact, when you know there's resolution of symptoms, there's negative tests for infectious causes, then you can conclude that this was likely food protein-induced enterocolitis syndrome reaction.”

Diagnosis becomes clearer if a child later experiences a similar reaction after re-exposure to the same food. Typically, infants remain healthy between episodes and demonstrate normal growth and development, with symptoms appearing only when the trigger food is ingested.

Beyond diagnosis, Nowak-Wegrzyn highlighted evolving recommendations regarding OFCs.

“We are changing the protocol to involve only a partial surveying of the food,” Nowak-Wegrzyn said. “We're simplifying that approach [of] the food challenge, providing guidance [on] what is the age-appropriate serving size of the most common foods like milk, egg, oat, wheat, rice, peanut… just to make it to facilitate introduction of foods.”

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

At AAAAI 2026, Nowak-Wegrzyn presented FPIES diagnosis in infants, emphasizing clinical recognition and updated oral food challenge protocols.

Conference

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Allergy

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.

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 the US Food and Drug Administration acceptance of a New Drug Application for rusfertide in polycythemia vera, topline data from the phase 3 AFFIRM study of risankizumab (Skyrizi) subcutaneous induction in Crohn’s disease, phase 3 data for ralinepag in pulmonary arterial hypertension, phase 2 SUMMIT trial data on bezuclastinib in nonadvanced systemic mastocytosis, and ACTIVATE trial data on vaginal seeding in cesarean-delivered infants.

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 01, 2026—let’s jump in!

FDA Accepts New Drug Application for Rusfertide, Grants Priority Review In Polycythemia Vera

On March 2, 2026, the FDA accepted and granted Priority Review to an NDA for rusfertide for polycythemia vera based on results from the phase 3 VERIFY, phase 2 REVIEW, and long-term extension THRIVE study. Announced by Takeda and Protagonist, the Prescription Drug User Fee Act (PDUFA) target action date is set for the third quarter of this calendar year.

AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease

On March 2, 2026, AbbVie announced positive topline results from the phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (Skyrizi) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease. Findings showed significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index clinical remission and endoscopic response at week 12 compared to placebo.

ADVANCE OUTCOMES: Ralinepag Outperforms Placebo in Slowing Disease Progression in PAH

On March 2, 2026, United Therapeutics Corporation announced that its investigative prostacyclin receptor agonist ralinepag met its primary endpoint of reducing worsening clinical events in patients with pulmonary arterial hypertension in the phase 3 ADVANCE OUTCOMES study. The study additionally met several important secondary endpoints, including increasing odds of clinical improvement by 47%, in predominantly pre-treated patients with pulmonary arterial hypertension.

SUMMIT: Bezuclastinib Delivers Durable, Deepening Symptom Relief in NonAdvSM, With Cem Akin, MD

Bezuclastinib, an oral, highly selective type 1 KIT inhibitor, has demonstrated that clinically meaningful symptom improvement not only holds but continues to deepen out to 48 weeks of treatment in patients with nonadvanced systemic mastocytosis (NonAdvSM), with every assessed symptom domain showing progressive gains over the treatment course. Data from the pivotal, multicenter, randomized, double-blind, placebo-controlled phase 2 SUMMIT trial were presented at the 

American Academy of Allergy, Asthma & Immunology (AAAAI)

 2026 Annual Meeting held in Philadelphia, Pennsylvania.

Vaginal Seeding Partially Modifies Infant Microbiome in ACTIVATE, With Jose Clemente, PhD

Vaginal seeding in cesarean-delivered infants was associated with altered early gut microbiome patterns and differences in food sensitization at 12 months, according to late-breaking ACTIVATE trial data presented at the 2026 AAAAI Annual Meeting in Philadelphia. Jose Clemente, PhD, associate professor of Genetics and Genomics and Immunology at the Icahn School of Medicine at Mount Sinai, explains the biologic rationale behind the trial and what the findings may mean for clinicians.

FDA granted Priority Review for rusfertide in polycythemia vera, with an NDA supported by phase 3/2 and extension datasets and a PDUFA decision targeted for Q3. In Crohn’s disease, subcutaneous risankizumab induction met co-primary endpoints at week 12, demonstrating clinical remission and endoscopic response versus placebo. In pulmonary arterial hypertension, ralinepag reduced worsening clinical events and improved odds of clinical improvement in largely pre-treated patients. Bezuclastinib showed durable, deepening symptom benefit through 48 weeks in nonadvanced systemic mastocytosis. Vaginal seeding modestly shifted infant microbiome trajectories and food sensitization signals.

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

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.

Hematology

The HCPFive: Top News for Healthcare Providers from the Week of 03/01

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.

The FDA approval of milsaperidone and a pair of positive trials in depression signal a month of progress in psychiatry.

Psychiatry

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5 Psychiatry Headlines You Missed in February 2026

Karen Maddox, MD, MPH, is a professor of medicine and public health and co-director of the Center for Advancing Health Services, Policy & Economics Research at the Washington University School of Medicine.

Maddox discusses the AHA’s recent statement indicating that, should current trends continue, 6 in 10 US women will have cardiovascular disease by 2050.

Arrhythmia

Stroke

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6 in 10 US Women Predicted to Have Cardiovascular Disease by 2050, With Karen Maddox, MD, MPH

Barbara Gillespie, MD, is Chief Medical and Strategy Officer of the International Society of Glomerular Disease and Adjunct Professor at the University of North Carolina.

Experts outline a 2026 vision for glomerular disease care, including new endpoints, combination therapies, and gene therapy advances.

Nephrology

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IgA Nephropathy

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C3 Glomerulopathy

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Focal Segmental Glomerulosclerosis

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Strategic Alliance Partnership

Clinical Trial Summit 2026: Advanced Therapies, Equity, Global Outlook For Glomerular Diseases

The PARASOL initiative is reshaping glomerular disease trials through shared data and improved surrogate endpoints.

PARASOL, Endpoints, and Rethinking Clinical Trials in Glomerular Disease

PLA2R antibodies are advancing precision care in membranous nephropathy and informing new surrogate endpoints through PARASOL.

PLA2R, Membranous Nephropathy, and the PARASOL Membranous Project

Anti-nephrin autoantibodies are redefining minimal change disease and enabling more precise, steroid-sparing treatment strategies.

Anti-Nephrin Autoantibodies, Precision in Nephrotic Syndrome

APOL1 kidney disease highlights the need for community trust, increased screening, and stronger clinical trial participation.

APOL1 Kidney Disease: Community, Trust, and Trial Participation

Rapid advances in glomerular disease, from single-cell tech to biomarkers and phase 3 trials, are reshaping diagnosis and treatment.

ISGD and the Fastest 5 Years in Glomerular Disease

Phase 2 ALPHA-SOLAR data presented at AAAAI 2026 show navenibart provides >95% median attack reduction in HAE with favorable safety for 3- and 6-month prophylaxis.


Navenibart at 3- and 6-Month Dosing Reduces HAE Attacks, With Adil Adatia, MD

This FDA News Month in Review provides a round-up of regulatory decisions from February 2026.

FDA News

Endocrinology

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Latest News

Understanding Gradient Reduction Therapy and Cardiac Myosin Inhibitors in oHCM Care

Improving Heart Failure Awareness and GDMT Prescription, With Bernard Kadosh, MD, and Eiran Gorodeski, MD, MPH

Prolonged Ruxolitinib Cream Effective for Vitiligo in Early Non-Responders

OFC Updates for FPIES in Infants, With Anna Nowak-Wegrzyn, MD, PhD

The HCPFive: Top News for Healthcare Providers from the Week of 03/01