Muthiah Vaduganathan, MD, MPH, is a cardiologist specializing in cardiorenal metabolism at Brigham and Women's Hospital in Boston, MA. Vaduganathan is a member of Practical Cardiology's advisory board and co-host of Don't Miss a Beat, a podcast presented by Inside Cardiology.

Stephen Greene, MD, is an associate professor of medicine at Duke University School of Medicine and cardiologist at the Duke Clinical Research Institute in Durham, NC. Greene is a member of HCPLive's advisory board and co-host of Don't Miss a Beat, a podcast presented by Inside Cardiology.

Expert-led podcast episode examining MRA updates at ACC 2026 Scientific Sessions

Don't Miss a Beat: MRA Updates at ACC 2026 Scientific Sessions

Few subspecialties in cardiovascular medicine have welcomed the same abundance of new data and clinical trials as heart failure specialists, particularly as it relates to 

 with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF).

Against that backdrop, the mineralocorticoid receptor antagonist (MRA) class has emerged as a focal point of ongoing debate. Current US heart failure guidelines assign MRAs a Class IIb recommendation in HFpEF, which is a designation reflecting uncertainty shaped in large part by the contested TOPCAT trial, where a post-hoc analysis of the Americas subpopulation suggested benefit, even as the full trial failed its primary endpoint.

American College of Cardiology's Annual Scientific Session (ACC.26)

, now adds a prospective null result to that record, while finerenone continues accumulating phase 3 evidence across diabetic and non-diabetic chronic kidney disease populations — most recently through the FINE-ONE and FIND-CKD trials announced ahead of ACC.26.

hosts Muthiah Vaduganathan, MD, MPH, a cardiologist and codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, and Stephen Greene, MD, an advanced heart failure specialist at Duke University School of Medicine, break down the latest updates and news related to mineralocorticoid receptor agonists, including a deep dive into SPIRIT-HF and topline announcements from finerenone’s phase 3 clinical trial program.

On March 29, 2026, investigators presented results from the SPIRIT-HF trial at ACC.26 showing spironolactone did not significantly reduce the composite of heart failure hospitalization and cardiovascular death compared with placebo in patients with HFpEF or HFmrEF. 

Based on the randomized, placebo-controlled trial of 730 patients across 56 European centers, event rates at 24 months were 12.7 versus 10.8 per 100 patient-years in the spironolactone and placebo groups, respectively, with no significant difference observed across prespecified subgroups.

Secondary endpoints revealed significantly greater rates of total hospitalizations, hypotension, renal events, and hyperkalemia in the spironolactone arm, and more than half of participants assigned to the drug discontinued treatment before trial completion, largely attributable to COVID-19 pandemic disruptions. 

A pooled meta-analysis incorporating TOPCAT Americas data similarly showed no significant benefit, leaving the role of aldosterone blockade in HFpEF and HFmrEF unresolved pending additional registry data.

On November 6, 2025, Bayer announced positive phase 3 results from the FINE-ONE trial evaluating finerenone in adults with type 1 diabetes and chronic kidney disease. Based on the randomized, double-blind, placebo-controlled trial in 242 participants, finerenone added to standard of care demonstrated a 25% relative reduction in urine albumin-to-creatinine ratio from baseline over 6 months compared with placebo (95% CI, 0.65–0.87; 

On March 16, 2026, Bayer announced positive phase 3 results from the FIND-CKD trial evaluating finerenone versus placebo added to standard of care in adults with non-diabetic chronic kidney disease. Based on the randomized phase 3 trial, finerenone demonstrated a statistically significant improvement in eGFR slope, the mean annual rate of eGFR change from baseline to month 32, a validated surrogate endpoint for kidney failure risk.

Finerenone has now shown kidney-protective benefits across 5 completed phase 3 studies spanning diabetic and non-diabetic CKD populations. In their March 16 announcement, Bayer disclosed plans to submit the FIND-CKD data to health authorities to pursue a label extension to non-diabetic CKD.

Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others. Relevant disclosures for Greene include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others.

American College of Cardiology. Study Finds No Significant Benefit of Spironolactone in HFpEF or HFmrEF - American College of Cardiology. American College of Cardiology. Published March 29, 2026. Accessed March 31, 2026. 

https://www.acc.org/About-ACC/Press-Releases/2026/03/29/14/57/Study-Finds-No-Significant-Benefit-of-Spironolactone-in-HFpEF-or-HFmrEF

Bayer. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. Bayer. Published November 6, 2025. Accessed November 6, 2025. 

https://www.bayer.com/media/en-us/finerenone-showed-statistically-significant-reduction-of-uacr-in-adults-with-chronic-kidney-disease-associated-with-type-1-diabetes/

Bayer. KERENDIA® (finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease. Bayer.com. Published March 16, 2026. Accessed March 31, 2026. 

https://www.bayer.com/en/us/news-stories/kerendiar-meets-primary-endpoint

Podcasts

Hosts break down the latest updates in mineralocorticoid receptor agonists, including the SPIRIT-HF trial and announcements from the finerenone program.

News

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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.

Chronic Kidney Disease

Type 2 Diabetes

Type 1 Diabetes

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.

Don’t Miss a Beat

The Don't Miss a Beat Podcast is a regular news roundup of the latest evidence and clinical trial insights across cardiovascular, renal, and metabolic diseases. Don’t Miss a Beat as Steve Greene, MD, and Muthu Vaduganathan, MD, MPH, critically examine recent advances in clinical care and research with perspectives from global experts in the field.

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...

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Professor and Chair of the Department of Dermatology and Professor of Internal Medicine in the Division of Rheumatic Diseases and in the Peter O'Donnell Jr. School of Public Health at UT Southwestern Medical Center in Dallas

Evolving Research Landscape Drives Progress in CLE at AAD 2026

Cutaneous lupus erythematosus (CLE) is a disease whose therapeutic stagnation has stood in stark contrast to the scientific progress made in understanding its underlying biology. Over the past two decades, advances in immunology have illuminated the central role of plasmacytoid dendritic cells, type I interferon signaling, and innate immune dysregulation in driving the skin inflammation, tissue injury, and scarring that define the disease.¹ That growing mechanistic clarity has not only reframed how clinicians think about CLE pathophysiology but has begun to translate into a new generation of rationally designed therapeutic candidates targeting the specific immunological pathways responsible for disease activity.

Litifilimab is perhaps the clearest example of that translation. Its development as a BDCA2-targeting monoclonal antibody was predicated on the understanding that pDC-driven type I interferon production is a proximal driver of lupus pathogenesis, and its two positive Phase 2 trials in CLE represent the most advanced clinical validation of that mechanistic hypothesis to date.² The progress made in CLE is also inseparable from broader advances in lupus research, where a deepening understanding of immune dysregulation across the spectrum of disease has created shared scientific infrastructure that benefits both systemic and cutaneous manifestations.

For patients who have lived with inadequate treatment options for generations, the convergence of scientific understanding and clinical evidence now underway represents a genuine inflection point. In this final segment, Joseph Merola, MD, MMSc, and Victoria Werth, MD, reflect on how the field's evolving understanding of CLE pathophysiology has shaped the current moment in drug development, and what the trajectory of innovation suggests for the future of care in this long-underserved disease.

Furie R, Werth VP, Merola JF, et al. Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus. 

 2019;129(3):1359-1371. doi:10.1172/JCI124466

Biogen Inc. Biogen announces second positive Phase 2 litifilimab trial in cutaneous lupus erythematosus at 2026 American Academy of Dermatology Annual Meeting, showing a significant reduction in skin disease activity. Published March 28, 2026. 

https://investors.biogen.com/news-releases/news-release-details/biogen-announces-second-positive-phase-2-litifilimab-trial

Videos

Experts reflect on how advances in understanding CLE have fueled drug development and what the trajectory of innovation holds for the field.

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.

AMETHYST Phase 3 and Remaining Questions Surrounding Litifilimab in CLE

Cutaneous lupus erythematosus (CLE) remains one of dermatology's most consequential unmet needs. Despite its prevalence, chronicity, and capacity for permanent disfigurement, no targeted therapy has ever been approved for the disease, and the clinical trial landscape has historically been sparse. That context makes the emerging litifilimab program not only scientifically significant but unusually anticipated — 2 positive Phase 2 trials in a condition where positive Phase 2 data alone represent a meaningful advance.

With consistent efficacy signals established across the LILAC and AMETHYST Part A studies, attention now turns to AMETHYST Part B, the phase 3 portion of the phase 2/3 trial, which is currently ongoing with results remaining blinded. Part B will be critical in several respects. 

It will need to confirm the efficacy signal observed in Part A in a larger, more powered population, establish the durability of response beyond the 24-week controlled period examined in Phase 2, and provide the robust safety dataset that will ultimately inform regulatory review. Importantly, AMETHYST was designed with a globally representative enrollment strategy, with 74% women and 33% non-white participants in Part A, reflecting the demographic realities of CLE. Whether that representation is maintained and whether the efficacy signal holds across subgroups defined by disease subtype, severity, and background therapy will be among the most closely watched questions as Phase 3 data mature.¹

For clinicians who have long managed CLE with tools borrowed from adjacent indications, the prospect of a purpose-built, mechanism-driven therapy with a Phase 3 program underway is a substantive shift in the trajectory of the field. The Breakthrough Therapy Designation granted to litifilimab by the FDA adds further momentum, signaling regulatory recognition of both the unmet need and the strength of the existing evidence base.

In this segment, Joseph Merola, MD, MMSc, and Victoria Werth, MD, share what they are most anticipating from the AMETHYST Phase 3 program, which data points will be most informative for clinical practice, and what approval of a first targeted therapy for CLE would mean for patients who have been waiting decades for a better option.

Experts share what they anticipate most from the ongoing AMETHYST Phase 3 program and what approval of a first targeted therapy would mean for patients.

Potential of Targeting BDCA2 in Cutaneous Lupus Erythematosus Management

Cutaneous lupus erythematosus (CLE) is driven by a complex interplay of innate and adaptive immune dysregulation, with plasmacytoid dendritic cells (pDCs) occupying a central role in disease pathogenesis. Activated pDCs produce substantial quantities of type I interferon and other pro-inflammatory cytokines and chemokines that perpetuate skin inflammation, drive keratinocyte injury, and contribute to the irreversible tissue damage that defines the most severe presentations of the disease. For a patient population that has long been managed with broadly immunosuppressive agents carrying significant toxicity profiles, a therapy designed to interrupt this pathway at its source represents a meaningful mechanistic departure from the standard of care.

Litifilimab targets BDCA2, a receptor selectively expressed on pDCs. Binding of litifilimab to BDCA2 suppresses pDC activation and downstream production of type I interferon and associated inflammatory mediators, offering a targeted approach to interrupting the immunological cascade thought to underlie CLE pathology. The specificity of this mechanism is clinically relevant: by acting on pDCs rather than broadly suppressing immune function, litifilimab has the potential to attenuate disease-driving inflammation while preserving broader immune competence.

That mechanistic rationale is now supported by a pair of positive Phase 2 trials. In the phase 2 portion of the AMETHYST study, litifilimab demonstrated a statistically significant 11.8% higher rate of clear or almost clear skin versus placebo at Week 16 (14.7% vs 2.9%; 95% CI: 1.39, 22.27; P < .05), with separation from placebo observed as early as Week 4. At Week 24, 40.8% of litifilimab-treated participants achieved a CLASI-50 response compared with 21% receiving placebo, and 1 in 6 participants in the litifilimab group achieved a CLASI score of 0 to 3, indicating no or minimal disease activity, compared with none in the placebo group. These results are consistent with the earlier LILAC Phase 2 study and collectively represent the only investigational program with positive efficacy data across multiple CLE trials to date.¹

In this segment, Joseph Merola, MD, MMSc, and Victoria Werth, MD, examine how the mechanism of action of litifilimab maps onto the immunopathology of CLE, what the AMETHYST results reveal about the durability and depth of response, and what these findings may mean for patients who have exhausted current treatment options.

Drenkard C, Barbour KE, Greenlund KJ, Lim SS. The burden of living with cutaneous lupus erythematosus. 

 2022;9:897987. doi:10.3389/fmed.2022.897987

Experts explore how litifilimab's BDCA2-targeting mechanism maps onto CLE pathophysiology.

Navigating Multidisciplinary Care for CLE in an Evolving Landscape

Cutaneous lupus erythematosus (CLE) does not exist in a clinical vacuum. While skin disease is the defining feature, CLE frequently intersects with systemic manifestations, comorbid autoimmune conditions, and the ever-present risk of progression to systemic lupus erythematosus. Managing this complexity has historically required coordination across specialties, with dermatologists, rheumatologists, and primary care clinicians each playing a role in the care of a patient population whose needs often exceed what any single specialty can address alone. Yet in the absence of approved targeted therapies, that collaboration has had limited tools to work with, and management decisions have largely defaulted to the same narrow, off-label options regardless of disease severity or phenotype.

The question of who owns CLE therapeutically is one the field has not fully resolved. Dermatologists are often the first to diagnose and treat, given the primacy of skin involvement, but rheumatologists bring expertise in systemic disease monitoring and immunosuppressive management that is frequently essential. For patients with refractory or severe disease, navigating this divide can translate into fragmented care, delayed escalation, and outcomes that reflect the limitations of the system as much as the limitations of available therapies.

An approved targeted therapy for CLE would not just add a treatment option, it could reframe the clinical conversation. A therapy with a defined mechanism, a validated efficacy profile, and a manageable safety record would give both dermatologists and rheumatologists a shared reference point around which to organize care, set treatment goals, and evaluate response in a more structured and collaborative way. It could also expand access for patients who are currently undertreated because no specialist feels sufficiently equipped to escalate beyond standard of care.

In this segment, Joseph Merola, MD, MMSc, and Victoria Werth, MD, reflect on how CLE patients move through the health care system today, where the gaps in multidisciplinary coordination are most acute, and how the availability of a first approved targeted therapy could reshape not only treatment paradigms but the broader infrastructure of collaborative care for this disease.

Experts discuss how an approved targeted therapy could restructure collaboration between dermatology and rheumatology.

Experts examine why the CLASI and CLA-IGA-R reflect the true burden of CLE.

Understanding AMETHYST Design and Patient Needs in CLE

With no targeted therapies approved in more than 70 years, new phase 2 AMETHYST data for litifilimab may signal a turning point for CLE.

Understanding Unmet Need and Recent Advances in CLE at AAD 2026 

Merola discussed how new data from AAD 2026 suggest broader anti-inflammatory properties of GIP/GLP-1 RAs may offer benefits beyond weight loss.

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.

Together-PsA: Ixekizumab + Tirzepatide Deliver Superior Efficacy Over Biologic Monotherapy, With Joseph Merola, MD

Blauvelt discussed highlights from the phase 3 ONWARD1 and ONWARD2 clinical trials presented at AAD 2026.

ONWARD: Oral Envudeucitinib Demonstrates High PASI Responses in Phase 3, With Andrew Blauvelt, MD

Cheng Zhou, MD, is a professor and chair of the department of dermatology at Peking University People`s Hospital in China.

Articles

Phase 3 data on rademikibart in moderate-to-severe atopic dermatitis (AD) have been released from the AAD late-Breaking research session.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

RADIANT-AD: Rademikibart Effective Over 52 Weeks in Atopic Dermatitis, With Cheng Zhou, MD

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.

These data from REMIX-1 and 2 suggest remibrutinib, in those with chronic spontaneous urticaria (CSU), can lead to fast, early symptom control.

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.

REMIX: Early CSU Symptom Improvement Observed with Remibrutinib Therapy

Monica Kraft, MD, is Murray M. Rosenberg Professor of Medicine and System Chair for the Department of Medicine at Mount Sinai Health System and the Icahn School of Medicine at Mount Sinai.

Deep learning applied to routine ECGs identifies subtle cardiac signals linked to early COPD, potentially enabling earlier diagnosis and intervention.

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.

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.

AI-Enhanced ECGs Detect Early COPD, With Monica Kraft, MD

This interview highlights phase 3 findings on sonelokimab for individuals with hidradenitis suppurativa (HS).

Hidradenitis Suppurativa

Hidradenitis Suppurativa condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatology research, treatment, and drug development.

VELA: Phase 3 Data Suggest Sonelokimab Effective for HS, With Alexa Kimball, MD, MPH

Pranav Garimella, MBBS, MPH, is chief medical officer of the American Kidney Fund.

Garimella discusses the history, clinical impact, and rationale for removing race-based GFR from clinical decision-making.

How Rewriting Race-Based GFR Equations Changed Kidney Transplant Access, With Pranav Garimella, MBBS, MPH

Michael E. Thase, MD, of the University of Pennsylvania

Inhaled GH001 achieved 57.5% remission by day 8 in TRD with a large effect size vs placebo; Thase discusses interpretation, unblinding, and phase 3 implications.

Psychiatry

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Major Depressive Disorder

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Latest News

Don't Miss a Beat: MRA Updates at ACC 2026 Scientific Sessions

Evolving Research Landscape Drives Progress in CLE at AAD 2026

AMETHYST Phase 3 and Remaining Questions Surrounding Litifilimab in CLE

Potential of Targeting BDCA2 in Cutaneous Lupus Erythematosus Management

Navigating Multidisciplinary Care for CLE in an Evolving Landscape