Yuichi Tamura, MD, PhD, is an associate professor of cardiology at the International University of Health and Welfare School of Medicine.

Yuichi Tamura, MD, PhD | Image Credit: LinkedIn

Satralizumab, an investigational anti-interleukin-6 (IL-6) receptor antibody, improved pulmonary vascular resistance in patients with 

 at 24 weeks during the SATISFY-JP trial.

American Heart Association’s Scientific Sessions 2025

 in New Orleans, Louisiana, by Yuichi Tamura, MD, PhD, associate professor of cardiology at the International University of Health and Welfare School of Medicine, these trial results highlight the validity of this novel precision medicine strategy in addressing another specific subset of patients with PAH.

SATISFY-JP was a multicenter, single-arm, open-label phase 2 study including patients with a confirmed diagnosis of Group 1 PAH classified as WHO Functional Class I, II, or III, an immune-responsive phenotype, treatment with 1-3 PAH drugs on a stable dose for ≥90 days before enrollment, and hemodynamic parameters with mean pulmonary arterial pressure ≥25 mmHg and a PVR >5 Wood units at rest in the 30 days prior to inclusion.

A total of 20 patients with high-sensitivity IL-6 were included in the study, with a baseline age of 59.3 years and a distribution by WHO class of 5 patients in class II and 15 in class III. Patients were administered satralizumab 120 mg subcutaneously at weeks 0, 2, 4, and every 4 weeks thereafter. The primary endpoint of percent change in PVR was measured in 17 patients, showing a 17.4% reduction in PVR from baseline to week 24.

For further insight into these data, the editorial team at 

 sat down for a discussion with Tamura in the following Q&A:

: During the trial, a 17.4% reduction in PVR was observed. In the context of PAH, how clinically meaningful is this magnitude of change—particularly compared with what we typically see with established vasodilator therapies?

: Yeah, all the patients had already received vasodilator therapy, at least one pill, but most of the patients, around the 80% of the patients has already double or triple combination therapy, and this is a top-up therapy for normal therapies. So this is an additional therapy for the classical vasodilator therapy, and we obtained more improvement from these therapies.

: Given that most PAH patients are already on multiple vasodilators, how do you envision anti-IL-6 therapy being integrated—additively, sequentially, or in a maintenance phase?

: For patients in this trial, prior therapy for the immunomodulation failed because some patients are responders and some aren’t. So, before the clinical trial, we tested the registry data, including serum cytokine levels, and we identified immunomodulation responsive cohorts with an AI based classification. In our study, our innovative point is that we only focused on patients with a higher IL-6 level.

: IL-6 is just one cytokine implicated in PAH. Does this trial open the door for targeting other immune mediators in specific phenotypes?

: That’s a very good point. Because PAH patients are very heterogeneous, some patients have very high levels of IL-6 and IL-6 neighborhood cytokines. However. there are another kinds of cytokines which have already been identified, like an iron beta or other kind of cytokines. So the phenotype is already defined in each case. Some patients might derive benefit from an IL-6 blockage, and another patient may benefit with another immunomodulation or another cytokine based therapy.

:IL-6 blockade carries potential immunologic risks. What safety signals should clinicians be most attentive to if this therapy becomes more widely available for PAH?

:As for our studies, we identified around 40% of the PAH patient have a higher IL-6 level, which is associated with concomitant cytokines. It is very good point to make regarding previous therapy like in our trials. It's very important to identify, prior to a clinical trial, what kinds of cytokines or chemokines may appear.

Tamura Y, Takumi I, Kohtaro A, et al. SATISFY-JP Trial: Satralizumab, an Anti-Interleukin-6 Receptor Antibody, for Pulmonary Arterial Hypertension with an Activated Immune-Responsive Phenotype: Primary Results from the Phase II Trial. Presented at the American Heart Association’s Scientific Sessions 2025. New Orleans, Louisiana. November 8-10, 2025.

Tamura Y, Takeyasu R, Takata T, et al. SATISFY-JP, a phase II multicenter open-label study on Satralizumab, an anti-IL-6 receptor antibody, use for the treatment of pulmonary arterial hypertension in patients with an immune-responsive-phenotype: Study protocol. Pulm Circ. 2023;13(2):e12251. Published 2023 Jun 19. 

Articles

Satralizumab, an investigational anti-IL-6 receptor antibody, demonstrated a 17.4% reduction in pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH) during the SATISFY-JP trial. This phase 2 study involved patients with an immune-responsive phenotype already on stable PAH therapy. The trial suggests that targeting IL-6 could be a viable adjunctive treatment strategy for PAH, especially in patients with elevated IL-6 levels. However, clinicians should be cautious of potential immunologic risks associated with IL-6 blockade in this patient population.

Tamura discusses the positive results of the phase 2 trial and its implications for the treatment of a specific subset of patients with high-sensitivity IL-6 PAH.

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SATISFY-JP: Satralizumab Improves PVR in Patients With PAH, With Yuichi Tamura, MD, PhD

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

 using nemolizumab 30 mg every 4 weeks (Q4W) along with a background of topical corticosteroids (TCS) of low/medium potency with/without topical calcineurin inhibitors (TCI) improves key signs and symptoms, recent data suggest.

These data were highlighted in a poster titled ‘Long-term efficacy and safety of nemolizumab in adolescents with moderate-to-severe atopic dermatitis: Post hoc analyses from ARCADIA LTE 1-year cut-off' (NCT03989206). This poster, presented during the 

2025 Fall Clinical Dermatology Conference

 in Las Vegas, was authored by such investigators as Adam Reich, MD, PhD, a full-time professor at the Department of Dermatology, University of Rzeszów, Poland.

Nemolizumab is an antibody designed to block the interleukin (IL)-31 receptor α pathway in patients with inflammatory skin disease, and the drug has emerged in recent years as a targeted option for the management of the intense pruritus and inflammatory burdens connected with moderate-to-severe atopic dermatitis.

In previous phase 3 research highlighting nemolizumab's impact on adolescent patients, investigators identified meaningful benefits through the 16-week mark, some of which included skin lesion reductions, reductions in itch, and markedly improved sleep quality. However, Reich et al determined, given the chronic and relapsing nature of this skin disease, an extended follow-up assessment would be necessary to determine whether these gains persist and to further examine long-term safety signals.

In their present analysis, Reich and colleagues summarized the outcomes of nemolizumab use among adolescent participants on the medication for up to 56 weeks during the long-term extension program. A variety of adolescent groups were recruited for this ongoing, open-label, multicenter extension study:

Subjects previously treated with nemolizumab in ARCADIA 1 or 2 or other development programs (nemolizumab-previously experienced, NPE);

Patients without prior exposure to the drug (nemolizumab-naïve, NN);

A cohort of 37 newly-recruited adolescents.

Those involved in Reich and coauthors' analysis were 12–17 years old and treated with nemolizumab 30 mg via subcutaneous injection on an every-4-week basis. Background therapy via low- or medium-potency topical corticosteroids was permitted, with optional use of topical calcineurin inhibitors as clinically appropriate.

Assessments by the investigators included the proportion of adolescent subjects attaining an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear). Additionally, Reich and colleagues looked at the percentage of these individuals attaining ≥75% or ≥90% improvement from the point of baseline on their Eczema Area and Severity Index scores (EASI-75 and EASI-90).

Patient-reported symptoms were tracked by the investigative team via the SCORAD visual analogue scales (VAS) for itch and loss of sleep. The team focused on ≥4-point improvement thresholds and the proportion of individuals attaining VAS scores <2. They also used the Dermatology Life Quality Index (DLQI) to assess any broader quality-of-life shifts among patients. All of the investigators' results were presented via observed cases without imputation.

At the 56-week interim cut-off point, Reich et al included 248 adolescent patients in the analysis (141 NPE and 107 NN). These participants had a mean age of 15 years. After 56 weeks of continuous nemolizumab treatment, the investigative team noted substantial clinical improvements documented in both cohorts. However, responses were generally shown to be higher among participants previously exposed to nemolizumab.

IGA scores of 0/1 were shown by the team to have been attained in 72% of participants in the NPE group and 53% of those in the NN group. Additionally, the investigators noted rates of EASI-75 were high in both cohorts, with 86% in NPE and 80% in NN, and EASI-90 responses were attained by 72% and 57%, respectively.

In terms of outcomes related to itch, similarly robust gains were observed. A ≥4-point drop in SCORAD VAS pruritus was reported among 79% of NPE and 59% of NN participants. Reich and coauthors also found achievement of VAS itch <2 was reached by 64% and 38% of these groups, respectively. Sleep loss improvements were found to have paralleled reductions in patients' levels of itch, with clinically meaningful responses in 85% of the NPE arm and 41% of the NN arm.

Reich and colleagues found improvements in patients' DLQI scores in more than 87% of the adolescents treated with nemolizumab over the treatment period, suggesting broad benefits on daily functioning as well as well-being. In their evaluation of the most common adverse events (≥5% incidence), the investigative team identified disease exacerbations, COVID-19 infections, and nasopharyngitis. They also identified most treatment-emergent events as mild to moderate, highlighting the minimal likelihood of serious events.

Overall, Reich and colleagues found nemolizumab 30 mg Q4W with TCS/TCI improved patients' key signs and symptoms of atopic dermatitis, including pruritus, skin lesions, and sleep disturbance, by the Week 56 follow-up.

For any additional information highlighting related topics in dermatology, view our 

Reich A, Tauber M, Piketty C, et al. Long-term efficacy and safety of nemolizumab in adolescents with moderate-to-severe atopic dermatitis: Post hoc analyses from ARCADIA LTE 1-year cut-off. Poster presented at the 2025 Fall Clinical Dermatology Conference, Las Vegas, Nevada, Oct 23-26, 2025.

Augustin M, Tauber M, Piketty C, et al. Safety and efficacy of nemolizumab for atopic dermatitis up to 2 years in open-label extension study. J Eur Acad Dermatol Venereol. 2025 Oct 13. doi: 10.1111/jdv.70080. Epub ahead of print. PMID: 41081535.

Nemolizumab, an IL-31 receptor α pathway blocker, shows promise in treating adolescents with moderate-to-severe atopic dermatitis when combined with topical corticosteroids and calcineurin inhibitors. A study involving 248 adolescents demonstrated significant improvements in skin lesions, pruritus, and sleep quality over 56 weeks. The study highlighted higher response rates in those previously exposed to nemolizumab. Improvements in quality of life were noted, with most adverse events being mild to moderate. These findings suggest nemolizumab's potential as a long-term treatment option for atopic dermatitis in adolescents.

This post-hoc analysis highlights nemolizumab’s long-term efficacy and safety in adolescents with moderate-to-severe atopic dermatitis.

Atopic Dermatitis

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ARCADIA LTE: Long-term Nemolizumab Effective in Adolescents with Atopic Dermatitis

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

At a moment when nephrology is experiencing one of its most rapid periods of therapeutic evolution, 

American Society of Nephrology (ASN) Kidney Week 2025 

arrived in Houston, Texas as both an opportunity for reflection of extraordinary progress and a preview of what may soon redefine care further. The past year alone has seen long-awaited FDA approvals in 

, alongside expanding evidence for upstream immune-targeted strategies that are reshaping expectations for disease modification. With an anticipated regulatory decision in FSGS on the horizon in early 2026, the field is entering a new era marked by unprecedented mechanistic diversity and clinical ambition.

This year’s meeting spotlighted this momentum, highlighting advances across glomerular disease, transplant immunology, inherited kidney disorders, and cardiorenal medicine. From deeper biologic insights to maturing late-stage pipelines, Kidney Week 2025 showcased a discipline moving beyond supportive care frameworks and toward targeted interventions capable of altering long-term kidney trajectories. In this recap, we highlight 8 trial updates to know from the meeting.

Kidney Week 2025 Recap: 8 Trial Updates to Know in Nephrology

ORIGIN 3 Sets the Stage for Atacicept in IgA Nephropathy

Interim 36-week data from the phase 3 ORIGIN 3 trial show atacicept, a dual BAFF/APRIL inhibitor, reduced UPCR by 45.7% from baseline, yielding a 41.8-point placebo-adjusted advantage in adults with IgAN.

Secondary outcomes demonstrated strong biologic and clinical effects, including a 68.3% drop in Gd-IgA1, 81.0% hematuria resolution, and a 47.3% reduction in UACR by week 36. Safety data revealed greater rates of injection-site reactions but fewer serious adverse events than placebo (0.5% vs 5.1%) and no deaths.

Kidney Compass: Atacicept and ORIGIN 3 at Kidney Week 2025, with Richard Lafayette, MD

Kidney Compass Clip of Richard Lafayette, MD, discussing Atacicept Results at Kidney Week 2025

Kidney Compass: Atacicept Results Clip

FINE-ONE: Finerenone Proves Benefit in Type 1 Diabetes and CKD

Finerenone produced a 25% relative reduction in UACR over 6 months versus placebo in adults with type 1 diabetes and chronic kidney disease, meeting the primary endpoint of the FINE-ONE trial (LSGM ratio 0.75; 95% CI, 0.65 to 0.87; 

Of note, 68.1% of finerenone-treated patients achieved a ≥30% UACR reduction compared with 46.6% on placebo, aligning with ADA thresholds linked to slower kidney disease progression. The safety profile, including hyperkalemia incidence, was consistent with prior finerenone programs, with no new safety signals identified across 242 participants.

Diabetes Dialogue: FINE-ONE and Finerenone in Type 1 Diabetes at Kidney Week 2025

Diabetes Dialogue FINE-ONE Recap Clip

PISCES: Fish Oil Slashes Cardiovascular Event Risk in Maintenance Dialysis

In the phase 3 PISCES trial, 4 grams of n−3 polyunsaturated fatty acids (n-3 PUFA) (1.6 grams EPA, 0.8 grams DHA) daily in adults on maintenance hemodialysis reduced the rate of serious cardiovascular events to 0.31 vs 0.61 per 1000 patient-days compared with placebo (Hazard Ratio [HR], 0.57, 95% CI 0.47–0.70; P < .001). Benefits were consistent across cardiac death (HR, 0.55), MI (HR, 0.56), stroke (HR, 0.37), peripheral vascular disease requiring amputation (HR, 0.57), and first CV event or all-cause death (HR, 0.73), with similar adverse-event rates between groups. Effects were observed in both patients with and without prior cardiovascular events, and no major safety signals emerged in the 1228-person cohort.

Setanaxib Clears Hurdle in Phase 2 Alport Syndrome Trial

In this 24-week phase 2a trial of 20 patients with genetically confirmed Alport syndrome, setanaxib was safe and well tolerated, with adverse-event rates similar to placebo and a single unrelated serious adverse event. Setanaxib produced a 15% mean reduction in UPCR versus placebo, with 15.4% of patients achieving ≥25% reduction and 38.5% achieving ≥10% reduction despite already optimized RAASi and SGLT2 inhibitor therapy. Notably, a 27% mean UPCR reduction persisted 4 weeks after treatment discontinuation, suggesting sustained pharmacodynamic activity.

Kidney Compass: Setanaxib, Alport Syndrome, and RaDaR Updates at Kidney Week 2025

Kidney Compass clip of Prof. Danny Gale discussing phase 2 data on setanaxib in Alport Syndrome

Kidney Compass Phase 2 Alport Syndrome Clip

MIL62 Increased Remission and Reduced Relapse in Membranous Nephropathy

MIL62, a glycoengineered type II anti-CD20 antibody, achieved greater complete remission rates than cyclosporine A in a 153-patient, 2-year randomized phase 3 trial of biopsy-proven primary membranous nephropathy (MN), with 49.4% vs 3.9% remission at week 76 (

 < .0001). MIL62 also produced faster and deeper disease control, including 87.5% vs 10.5% immunologic remission and a median time to complete remission of 14.1 months, which was never reached in the cyclosporine arm.

Risks of treatment failure and relapse were significantly reduced (HR, 0.04 and 0.07, respectively), alongside improvements in eGFR and quality-of-life measures. Safety was comparable between groups with no new signals, supporting MIL62 as a strong therapeutic option for primary MN.

Povetacicept Data Validate APRIL/BAFF Inhibition in IgAN and pMN

In the phase 1/2 RUBY-3 trial, povetacicept, a dual BAFF/APRIL inhibitor, produced substantial 48-week proteinuria reductions in both IgAN and primary MN, including a 64% mean UPCR reduction in IgAN (with 65% achieving <0.5 g/g and 77% declines in Gd-IgA1) and an 82% UPCR reduction with 100% immunologic remission in pMN.

Hematuria resolved in 90% of IgAN patients, over half achieved clinical remission, and kidney function remained stable across cohorts. Reductions in pathogenic biomarkers (Gd-IgA1 and anti-PLA2R) were early, deep, and sustained, supporting a potential disease-modifying effect through upstream interruption of B-cell biology. Safety data suggested povetacicept was generally well tolerated, with monitored IgG reductions but no serious infections or evidence of clinically meaningful immunosuppression.

BESTOW: Tegoprubart Showcases Safer Prevention of Kidney Transplant Rejection Over Tacrolimus

In the phase 2 BESTOW trial of 126 kidney transplant recipients, tegoprubart achieved eGFR comparable to tacrolimus at 12 months (69 vs 66 mL/min/1.73 m²), with several subgroups, including living-related and high-KDPI donor recipients, showing numerically greater eGFR on tegoprubart.

The composite efficacy failure rate (death, graft loss, BPAR) was 22% with tegoprubart vs 17% with tacrolimus, supporting noninferiority. Tegoprubart demonstrated a more favorable safety profile, with markedly lower rates of new-onset diabetes (1 in 47 vs 1 in 6), tremor (1.6% vs 25%), delayed graft function (14.3% vs 25.0%), and fewer severe infections such as sepsis/bacteremia (4.8% vs 17.2%).

Innovation in Transplant Immunosuppression With Tegoprubart, With John Gill, MD

John Gill, MD, discusses tegoprubart results in kidney transplantation from Kidney Week 2025

John Gill, MD, on tegoprubart results in kidney transplantation

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

In a 39-week randomized, double-blind trial, telitacicept, a BLyS/APRIL-targeting fusion protein, reduced 24-hour UPCR by 58.9% versus 8.8% with placebo (

 <.0001), with sustained 55% reductions at week 39. Clinically meaningful proteinuria thresholds were achieved far more frequently with telitacicept, including UPCR <0.8 g/g in 61% vs 19.5%, <0.5 g/g in 42.1% vs 7.5%, and <0.3 g/g in 24.5% vs 0.6% of patients. Kidney function remained stable, with mean eGFR essentially unchanged (−0.010 vs −0.77 mL/min/1.73 m²) and a lower risk of ≥30% eGFR decline in the telitacicept arm.

Kidney Compass: Phase 3 Data on Telitacicept in IgA Nephropathy at ASN Kidney Week 2025

Kidney Compass clip discussing Telitacicept eGFR Data at Kidney Week 2025

Kidney Compass: Telitacicept eGFR Data at Kidney Week 2025

Novartis. Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN). Novartis United States of America. Published April 2, 2025. Accessed November 22, 2025. 

https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan

Novartis. Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G). Novartis. Published March 21, 2025. Accessed November 22, 2025. 

https://www.novartis.com/news/media-releases/novartis-receives-third-fda-approval-oral-fabhalta-iptacopan-first-and-only-treatment-approved-c3-glomerulopathy-c3g

Apellis Pharmaceuticals. FDA Approves Apellis’ EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older | Apellis Pharmaceuticals, Inc. Apellis Pharmaceuticals, Inc. Published July 28, 2025. Accessed November 22, 2025. 

https://investors.apellis.com/news-releases/news-release-details/fda-approves-apellis-empavelir-pegcetacoplan-first-c3g-and

Vera Therapeutics. Vera Therapeutics Announces Positive ORIGIN Phase 3 Data for Atacicept in IgA Nephropathy Presented at ASN Kidney Week 2025 and Published in the New England Journal of Medicine | Vera Therapeutics. Vera Therapeutics. Published November 6, 2025. Accessed November 22, 2025. 

https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-positive-origin-phase-3-data

Bayer. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. Published November 6, 2025. Accessed November 22, 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/

Lok CE, Farkouh M, Hemmelgarn BR, et al. Fish-Oil Supplementation and Cardiovascular Events in Patients Receiving Hemodialysis. 

. Published online November 7, 2025. doi:

Safety and Preliminary Efficacy Findings from a Phase 2A Randomized, Double- Blind, Placebo-Controlled Trial of Setanaxib in Patients with Alport Syndrome. 

Presented at the American Society of Nephrology (ASN) Kidney Week. Houston, Texas. November 05-09, 2025.

Cui Z, Wei M, Li P, et al. Efficacy and Safety of MIL62, a Glycoengineered Type II Anti-CD20 Antibody, in Primary Membranous Nephropathy: A Phase 3, Randomized, Controlled Trial. October 2025 - Volume 36 - Issue 10S: Journal of the American Society of Nephrology. Published online October 2025. Accessed November 18, 2025. 

https://journals.lww.com/jasn/fulltext/2025/10001/efficacy_and_safety_of_mil62

Efficacy and Safety of Povetacicept in Patients with IgAN and Primary Membranous Nephropathy (pMN) at 48 Weeks of Treatment: The RUBY-3 Study

. the American Society of Nephrology (ASN) Kidney Week. Houston, Texas. November 05-09, 2025.

Eledon Pharmaceuticals. Eledon Presents Phase 2 BESTOW Trial Results for Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting | Eledon Pharmaceuticals, Inc. Eledon Pharmaceuticals, Inc. Published November 6, 2025. Accessed November 22, 2025. 

https://ir.eledon.com/news-releases/news-release-details/eledon-presents-phase-2-bestow-trial-results-tegoprubart

Vor Bio. Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China | Vor Bio. Vor Bio. Published November 8, 2025. Accessed November 22, 2025. 

https://ir.vorbio.com/news-releases/news-release-details/telitacicept-achieved-primary-endpoint-reducing-proteinuria

Nephrology is undergoing a transformative period with significant therapeutic advancements, as highlighted at the ASN Kidney Week 2025 in Houston. Recent FDA approvals in IgA nephropathy and C3 glomerulopathy, along with emerging immune-targeted strategies, are reshaping disease management. The meeting showcased progress in glomerular disease, transplant immunology, inherited kidney disorders, and cardiorenal medicine, emphasizing a shift from supportive care to targeted interventions. Key trial updates included promising results for atacicept, finerenone, fish oil, setanaxib, MIL62, povetacicept, tegoprubart, and telitacicept, indicating a new era of mechanistic diversity and clinical ambition.

A curated recap of 8 impactful trial updates from the American Society of Nephrology Kidney Week 2025.

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Chronic Kidney Disease

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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 supplemental New Drug Application (sNDA) for roflumilast (Zoryve) cream 0.3% in children aged 2-5 years with 

 and the approval of plozasiran (Redemplo) for the reduction of triglycerides in adult patients with familial chylomicronemia syndrome (FCS), new American Gastroenterological Association (AGA) clinical practice guidelines on the pharmacologic management of moderate-to-severely active Crohn’s disease (CD), and phase 3 data on telitacicept in IgA nephropathy and tralokinumab in adults with 

 and moderate-to-severe hand involvement.

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 November 16, 2025—let’s jump in!

FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

On November 17, 2025, the FDA accepted Arcutis Biotherapeutics’ sNDA for roflumilast (Zoryve) cream 0.3% in children 2-5 years of age with psoriasis, assigning a PDUFA target action date of June 29, 2026. The sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2-5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range.

FDA Approves Plozasiran for Adults With Familial Chylomicronemia Syndrome

On November 18, 2025, the FDA approved Arrowhead Pharmaceuticals’ plozasiran (Redemplo) for the reduction of triglycerides in adult patients with FCS, making it the first and only FDA-approved siRNA medicine for people living with FCS. The decision was supported by clinical data from the phase 3 PALISADE study.

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

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

New phase 3 data show that in patients with IgAN at high risk of progression, treatment with telitacicept for 39 weeks resulted in a rapid, substantial, and statistically significant reduction in proteinuria compared with placebo, with a favorable safety profile. The investigational recombinant fusion protein enters a rapidly evolving therapeutic landscape in IgAN, where multiple B-cell–, BAFF-, and APRIL-targeted approaches are under active clinical investigation.

Tralokinumab Improves Atopic Dermatitis with Hand Involvement at 32 Weeks

On November 17, 2025, LEO Pharma A/S announced positive topline key findings on tralokinumab in adults with atopic dermatitis and moderate-to-severe hand involvement who are also candidates for systemic treatments. Findings from the 32-week analysis of the phase 3b ADHAND trial evaluating patients with atopic dermatitis and disease involvement affecting the hands build upon previous week 16 findings demonstrating statistically significant improvement compared to placebo in all primary and key secondary endpoints such as clear or almost clear skin, itch, and pain.

The FDA has accepted a supplemental New Drug Application for roflumilast cream for young children with psoriasis, with a decision expected by June 2026. Plozasiran has been approved for reducing triglycerides in adults with familial chylomicronemia syndrome, marking it as the first siRNA treatment for this condition. The AGA has updated its guidelines for Crohn’s disease, recommending early use of high-efficacy therapies. Telitacicept has shown significant efficacy in reducing proteinuria in IgA nephropathy. Tralokinumab has demonstrated improvements in atopic dermatitis with hand involvement in a phase 3b trial.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and new Crohn's disease guidelines, 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 

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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.

The HCPFive: Top News for Healthcare Providers from the Week of 11/16

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

New data presented as a late breaker at the 

2025 American College of Allergy, Asthma, & Immunology (ACAAI) Annual Scientific Meeting 

in Orlando, Florida, show that the Viaskin Peanut Patch builds 

 in more than 70% of toddlers within 3 years.

“These results show that ongoing treatment with the peanut patch continues to improve tolerance and remains safe over time,” said lead investigator Matthew Greenhawt, MD, MBA, from the Children’s Hospital Colorado, in a statement. “For parents of toddlers with peanut allergies, this kind of approach may one day offer peace of mind by reducing the risk of having an allergic reaction, including severe reactions, from accidental exposure.”

Back in April, the phase 3 EPITOPE trial published in the Annals of Allergy, Asthma, & Immunology reported that Viaskin Peanut Patch (VP250; 250 µg) was effective and safe in desensitizing peanut allergies in children aged 1 – 3 years by month 12, regardless of atopic comorbidities, such as asthma, atopic dermatitis, and concomitant food allergy.

 The Viaskin Peanut Patch, which is an epicutaneous immunotherapy, delivers small amounts of peanut protein through the skin. This new analysis, presented at the meeting, was the open-label extension of EPITOPE, examining 56 toddlers who initially received a placebo in an earlier 1-year study and then used the peanut patch for up to 3 years.

“These results are consistent with outcomes observed after 36 months in VP250-treated EPITOPE participants,” Greenhawt and colleagues wrote.

After 3 years of treatment, 71.2% of toddlers could tolerate the equivalent of 3 to 4 peanut kernels (≥1000 mg), compared to only 62.7% after 1 year of treatment. Nearly half of the toddlers could tolerate even greater amounts of peanut, tolerating ≥ 2000 mg at month 12 (36.5%) and 36 (46.0%). In total, 28.4% and 42% completed the double-blind, placebo-controlled food challenges at months 12 and 36 without meeting stopping criteria.

Not only was the peanut path effective, but it was also safe. The study had no reports of treatment-emergent anaphylaxis in the third year. The most common adverse event, which was skin irritation at the patch side, became less frequent over time.

During the 3 years, children’s reactions during food challenges turned milder. Children also had fewer severe symptoms after 3 years than after 1 year. In the study, 10% had severe symptoms during food challenges at month 36, compared with 19.2% at month 12.

These findings suggest that intervening early in young children may help alter the trajectory of peanut allergy. Investigators emphasized that parents should not attempt any form of peanut desensitization at home but rather discuss treatments with a board-certified allergist.

According to FARE, 1 in 13 children have food allergies, and among them, more than 40% have experienced a severe reaction.

 Although children with peanut allergy can turn to oral immunotherapy, it is linked to adverse events of nausea, vomiting, eosinophilic esophagitis, and anaphylaxis. Omalizumab, approved for food allergies in February 2024, has demonstrated effectiveness for this indication, but limited evidence exists on this drug’s sustained duration of effect. 

 The Viaskin Peanut Patch provides another potential desensitization option for young children with peanut allergy.

Peanut Patch Treatment Continues to Help Toddlers Safely Build Tolerance Over Three Years. Acaai.org. Published 2025. Accessed November 21, 2025. 

https://annualmeeting.acaai.org/2025/peanut-patch-treatment.cfm

Derman, C. Viaskin Patch Effective in Peanut-Allergic Kids with Atopic Comorbidities. HCPLive. 

https://www.hcplive.com/view/viaskin-patch-effective-in-peanut-allergic-kids-with-atopic-comorbidities

Food Allergy Research & Education. Facts and statistics. Food Allergy Research & Education. Published 2024. 

https://www.foodallergy.org/resources/facts-and-statistics

Smith T. FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults. HCPLive. February 16, 2024. 

https://www.hcplive.com/view/fda-approves-omalozumab-first-treatment-of-1-or-more-food-allergies-for-children-adults

The Viaskin Peanut Patch has shown promising results in building peanut tolerance in over 70% of toddlers within three years, according to new data from the ACAAI Annual Scientific Meeting. The patch, an epicutaneous immunotherapy, delivers small amounts of peanut protein through the skin and has proven effective and safe, with no treatment-emergent anaphylaxis reported in the third year. The study highlights the potential of early intervention in altering the trajectory of peanut allergies, though it emphasizes the importance of consulting a board-certified allergist for treatment.

New findings reveal the Viaskin Peanut Patch effectively builds peanut tolerance in over 70% of toddlers, offering hope for allergy management.

Over 70% of Toddlers Tolerate 3 to 4 Peanut Kernels 3 Years After Peanut Patch

Podcasts

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Kidney Compass: Navigating Clinical Trials

Hosted by Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, Kidney Compass: Navigating Clinical Trials is a regular podcast exploring and breaking down the latest updates and nuances of clinical trials in nephrology. By listening to Kidney Compass, you'll get the guidance you need to navigate the changing landscape of clinical trials across the spectrum of kidney disease. 

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

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The HCPFive: Top News for Healthcare Providers from the Week of 11/16

Over 70% of Toddlers Tolerate 3 to 4 Peanut Kernels 3 Years After Peanut Patch