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Anti-endothelin A receptor (ETAR) and anti-C-X-C motif chemokine receptor 3 (CXCR3) antibodies may play an important role in predicting the disease course of 

, according to findings from a recent study.

Results suggest the potential prognostic value of the non-human leukocyte antigens for IgAN and lupus nephritis, additionally highlighting anti-ETAR antibodies’ apparent connection with membranous nephropathy prognosis and anti-CXCR3 antibodies’ association with focal segmental glomerulosclerosis (FSGS) disease course.

“Glomerular diseases are autoimmunological disorders that involve many autoantibodies, and predicting the disease course is challenging,” Maciej Szymczak, MD, PhD, a nephrologist and internal medicine specialist at Wroclaw Medical University in Poland, and colleagues wrote.

 “Furthermore, appropriate glomerular disease progression markers are still lacking.”

A prominent cause of renal impairment, glomerulonephritis leads to 10%-15% of end-stage renal disease cases in the United States and is the third most common cause behind diabetes mellitus and hypertension. Often, the disease becomes progressive without timely intervention and eventually leads to morbidity, underscoring the need for reliable prognostic markers.

To assess the influence of anti-ETAR and anti-CXCR3 antibodies on the disease course of specific glomerulonephritis types, investigators conducted a prospective observational study of patients with histopathologically confirmed membranous nephropathy (n = 18); FSGS (n = 25); systemic lupus erythematosus (n = 17); IgAN (n = 14), mesangiocapillary glomerulonephritis (n = 6); anti-neutrophil cytoplasmic antibodies (c-ANCA) vasculitis (n = 40); and perinuclear anti-neutrophil cytoplasmic antibodies (p-ANCA) vasculitis (n = 16). Patients were compared with a control group of healthy Caucasian individuals without proteinuria; with a creatinine level no higher than 1.3 mg/dL; and without a history of kidney or autoimmunological diseases (n = 22).

Participants’ blood samples were collected simultaneously with blood collection for standard laboratory evaluation. Investigators assessed the serum concentrations of ETAR and CXCR3 antibodies with commercially available enzyme-linked immunosorbent assay (ELISA) kits. Clinical parameters including creatinine, total protein, and albumin serum levels were examined for 2 years after the initial basic evaluation to assess the correlation between clinical course markers and basic receptor antibody levels.

Investigators observed lower anti-ETAR antibody levels among patients with FSGS and IgAN than in the control group (

 = .04, respectively). Additionally, they noted anti-ETAR antibody levels among patients with lupus nephritis were higher than those of the membranous nephropathy (

In contrast, the basic anti-CXCR3 antibodies did not differ between the control group and specific glomerular diseases.

Further analysis revealed basic anti-ETAR levels in patients with membranous nephropathy and IgAN correlated positively with creatinine levels after 2 years of observation (both 

 = .03). Additionally, investigators noted basic anti-CXCR3 antibodies correlated with creatinine levels after 2 years in the IgA nephropathy group (

In the systemic lupus erythematosus group, a negative association was observed between basic anti-ETAR antibodies and total protein levels after 3 months (

 = .03) and with the albumin level after 3 (

 = .03) of observation. Similarly, anti-CXCR3 antibody levels were found to be negatively correlated with total protein levels after 2 years of observation (

 = .03) and with the basic albumin level (

 = .02) and albumin level after 1 month of observation (

Results also showed anti-ETAR antibody levels correlated with anti-CXCR3 antibody levels in patients with lupus nephritis (

“This prospective observation showed that anti-ETAR and anti-CXCR 3 antibody levels are connected with the course of IgA nephropathy and lupus nephritis,” investigators concluded.

 “An influence of ETAR antibodies on the course of membranous nephropathy, and CXCR3 antibodies on the course of FSGS, is also probable.”

Szymczak M, Heidecke H, Żabińska M, et al. The Influence of Anti-ETAR and Anti-CXCR3 Antibody Levels on the Course of Specific Glomerulonephritis Types. 

Kazi AM, Hashmi MF. Glomerulonephritis. StatPearls [Internet]. June 26, 2023. Accessed January 20, 2025. https://www.ncbi.nlm.nih.gov/books/NBK560644/

Articles

Anti-endothelin A receptor (ETAR) and anti-CXCR3 antibodies may serve as prognostic markers for IgA nephropathy (IgAN) and lupus nephritis. A study found lower anti-ETAR levels in FSGS and IgAN patients compared to controls, while lupus nephritis patients had higher levels. Anti-ETAR levels correlated with creatinine in membranous nephropathy and IgAN, and anti-CXCR3 levels correlated with creatinine in IgAN. Negative associations were observed between these antibodies and protein levels in systemic lupus erythematosus. The study suggests potential roles for these antibodies in predicting glomerular disease progression.

Study findings point to the prognostic value of anti-ETAR and anti-CXCR3 antibodies in IgA nephropathy and lupus nephritis.

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Anti-ETAR, Anti-CXCR3 Antibodies Linked to IgA Nephropathy, Lupus Nephritis Prognosis

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JAK inhibitor (JAKi) therapy was not associated with an increased risk of cardiovascular disease, venous thromboembolism (VTE), or some cancers in people with psoriatic arthritis (PsA) and spondyloarthritis (SpA) compared to TNF inhibitors (TNFi) or 

“Compared to TNFi, tofacitinib was shown to increase risk of CVD and cancer among people with rheumatoid arthritis (RA) with risk of CVD. Although JAKi are widely used in SpA, their safety profile remains unclear. Risk profiles may differ among SpA patients who are typically younger and have lower systemic inflammatory burden,” lead investigator Sizheng Steven Zhao, MBChB, PhD, Clinical Lecturer at the Centre for Musculoskeletal Research, University of Manchester, United Kingdom, and colleagues wrote.

Zhao and colleagues analyzed data from a large population of patients in the TriNetX Global Collaborative Network, a large electronic health record network including over 100 million patients mostly in the United States. The study included adults with SpA, including axial SpA and PsA, and excluding those with RA or juvenile idiopathic arthritis, who initiated JAKis such as tofacitinib or upadacitinib, and TNFi, or IL-17is such as secukinumab or ixekizumab. They looked at rates of CVD,including acute myocardial infarction or cerebral infarction; VTE, including pulmonary embolism or deep vein thrombosis; and cancers including breast, colorectal, lung, or prostate. They also included herpes zoster as a positive control outcome. On statistical analyses, investigators corrected for age, gender, ethnicity (white vs non-white), BMI (<25, 25-30, >30kg/m2, missing), C-reactive protein (<5, 5-10, >10 mg/dL, missing), axSpA/PsA, hypertension, tobacco use, Chronic obstructive pulmonary disease (as proxy for smoking), overweight/obesity, type 2 diabetes mellitus, dyslipidaemia, and extra-musculoskeletal manifestations (uveitis, psoriasis, Crohn disease, ulcerative colitis). Intention to treat analyses were performed at 1, 3 and 5 years, as the stop date of each drug was not reliably available.

Zhao and colleagues analyzed data from 2849 patients with SpA starting JAKi (mean age, 51 years [standard deviation (SD), 13]; 35% male; 80% white) and 32,694 patients with SpA starting TNFi (mean age, 48 years [SD, 14]; 49% male; 75% white). After propensity-score matching, 2844 remained in each group. Compared to TNFi, initiation of JAKi was not associated with risk of CVD (hazard rate [HR], 0.779 [95% CI, 0.547-1.108]), VTE (HR, 0.827 [95% CI, 0.480-1.425]) or cancer (HR, 0.820 [95% CI, 0.546-1.231) at 1 year, but was associated with a higher risk of herpes zoster (HR, 1.855 [95% CI, 1.151-2.991).

When comparing patients initiating JAKi to 13,390 initiating IL17i (mean age, 50 years [SD, 13]; 42% male; 75% white), 2,792 in each group remained after propensity score-matching. Compared to IL17i initiation, JAKi initiation was not associated with risk of CVD (HR, 1.083 [95% CI, 0.732-1.603), VTE (HR, 0.900 [95% CI, 0.504-1.607) or cancer (HR, 0.890 [95% CI, 0.588-1.348) at 1 year. Findings on all analyses were directionally concordant for years 3 and 5.

Other recent research on an IL-17i, secukinumab, found that intravenous (IV) secukinumab for the rapid improvement of disease signs and symptoms in patients with active PsA. Investigators found that all primary and secondary efficacy endpoints for secukinumab achieved statistical significance (all adjusted 

 <.05) versus placebo. A significantly greater proportion of patients receiving IV secukinumab achieved the primary endpoint of ACR50 response rates at Week 16 compared with placebo (31.4% vs. 6.3%; adjusted 

Zhao SS, Riley D, Austin P, Alam U. Comparative Safety of Jak Inhibitors Versus TNF or Il-17 Inhibitors for Cardiovascular Disease, Venous Thromboembolism and Cancer in Psoriatic Arthritis and Axial Spondyloarthritis. 

Kivitz A, Sedova L, Churchill M, et al. Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: Results From the Randomized, Placebo-Controlled Phase III INVIGORATE-2 Study. 

. Published online September 19, 2024. doi:10.1002/art.42997

JAK inhibitors (JAKi) in patients with psoriatic arthritis (PsA) and spondyloarthritis (SpA) do not increase the risk of cardiovascular disease (CVD), venous thromboembolism (VTE), or certain cancers compared to TNF inhibitors (TNFi) or IL-17 inhibitors (IL-17i). The study analyzed data from a large electronic health record network, adjusting for various factors. JAKi was associated with a higher risk of herpes zoster. Additionally, intravenous secukinumab showed significant efficacy in improving symptoms in PsA patients, achieving primary and secondary endpoints compared to placebo.

Cancer risk was examined for breast, colorectal, lung, and prostate cancer. 

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JAKi Treatment for Psoriatic Arthritis Not Associated With Increased CVD, VTE, Cancer Risk 

Connor Iapoce is the assistant managing editor for 

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Elevated levels of oxidized high-density lipoprotein (HDL) were associated with 

heart failure with preserved ejection fraction (HFpEF)

 in a new analysis, suggesting the presence of reduced HDL antioxidant function in this population.

This cross-sectional observational study assessed the antioxidant function of HDL in more than 350 patients with suspected heart failure, with HFpEF assessment conducted according to the current Heart Failure Society of America (HFSA) clinical guidelines.

“Our results consistently show that increased HDLox levels are associated with HFpEF in both univariate and multivariate analyses,” wrote the investigative team, led by Benjamin Sasko, department of cardiology, Medical School Theodor Fontane, University Medical Center Brandenburg an Der Have. “Therefore, our main finding is that reduced antioxidant HDL function is present in HFpEF.”

Guidelines designate HFpEF by clinical signs of HF, irrespective of a normal left ventricular ejection fraction (LVEF) of ≥50%. More than half of all HF cases are considered HFpEF, driven by an abnormal ventricular filling from impaired relaxation due to increased myocardial stiffness. Ventricular-arterial uncoupling stemming from this increased myocardial stiffness results in increased LV filling pressure.

HDL-cholesterol (HDL-C) has not previously been considered in guidelines as a contributor to HF rates, with very low and high levels of high-density HDL-C traditionally a lower indicator of cardiovascular disease (CVD). Sasko and colleagues suggested HDL function, rather than absolute HDL-C levels, could be a more accurate predictor of CVD risk, with prior research tying HDL function to an inverse association with CVD.

Across this cross-sectional study, Sasko and colleagues evaluated HDL’s antioxidant function in a population with confirmed HFpEF, hypothesizing a reduced antioxidant function linked to the presence of HFpEF. A population of 366 consecutive patients presenting with symptoms of HF, including dyspnea, orthopnea, and fatigue, at a single center in Germany underwent assessment between 2019 and 2021.

Two cohorts were built based on the assessment: patients with HFpEF determined by LVEF ≥50%, echographic evidence of cardiac functional and structural alterations, and increased NT-proBNP levels (n = 88) and patients without HF, defined by LVEF ≥50% with normal range NT-proBNP levels (n = 180). Individuals with an LVEF < 50% (n = 98) were excluded from the study.

The study used a validated cell-free biochemical assay to determine reduced HDL antioxidant function as determined by increased HDL-lipid peroxide content (HDLox), normalized by HDLC levels, and the mean value of a pooled serum control from healthy participants (nHDLox).

Patients with HF were older than patients without HF (

 <.001), with a higher proportion of females (

 = .002) and more frequently dealing with diabetes (

 <.001). Investigators identified no differences in LV function between patients with HFpEF and those without HF.

Upon analysis, those with HFpEF had 15% higher mean relative levels of nHDLox than those patients without HF. A multivariate model analysis, adjusted for age, sex, and estimated glomerular filtration rate (eGFR), found nHDLox remained a significant risk factor for HFpEF (odds ratio [OR], 2.03; 95% CI, 1.19–3.45; 

Further multivariate analysis, adjusted for diabetes, hypertension, atrial fibrillation (AF), low-density lipoprotein cholesterol (LDL-C), high-sensitivity C-reactive protein (hsCRP), and coronary artery disease (CAD), revealed nHDLox remained an independent predictor for HFpEF (

 <.05). An increase in 1-SD in nHDLox was linked to a 67% elevated risk for HFpEF, compared with patients without heart failure (OR, 1.67; 95% CI, 1.07–2.6; 

Based on these data, Sasko and colleagues called for further studies to focus on the mechanistic impact of HDLox on the cardiomyocyte and endothelial function.

“It is plausible to hypothesize that the oxidation of HDL significantly contributes to the development of HFpEF and improving HDL function is a promising target for early heart failure treatment,” Sasko and colleagues added.

 “However, further studies are needed, focusing on the mechanistic impact of HDL-lipid peroxide content on the cardiomyocyte and endothelial function.”

Sasko, B., Kelesidis, T., Kostin, S. et al. Reduced antioxidant high-density lipoprotein function in heart failure with preserved ejection fraction. Clin Res Cardiol (2025). https://doi.org/10.1007/s00392-024-02583-3

Bozkurt B, Coats AJ, Tsutsui H, et al. Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure. J Card Fail. Published online March 1, 2021. doi:10.1016/j.cardfail.2021.01.022

Mody P, Joshi PH, Khera A, Ayers CR, Rohatgi A. Beyond Coronary Calcification, Family History, and C-Reactive Protein: Cholesterol Efflux Capacity and Cardiovascular Risk Prediction. J Am Coll Cardiol. 2016;67(21):2480-2487. doi:10.1016/j.jacc.2016.03.538

Elevated oxidized HDL levels are linked to heart failure with preserved ejection fraction (HFpEF), indicating reduced HDL antioxidant function in these patients. A study involving over 350 patients assessed HDL's antioxidant function, revealing that increased HDLox levels are associated with HFpEF. The study suggests that HDL function, rather than HDL-C levels, may better predict cardiovascular disease risk. Multivariate analyses confirmed nHDLox as an independent risk factor for HFpEF. Further research is needed to explore HDLox's mechanistic impact on cardiomyocyte and endothelial function.

Increases in oxidized HDL levels were linked to HFpEF in new analyses, suggesting reduced antioxidant HDL function is present in this patient population.

Cardiology

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Dyslipidemia

Heart Failure

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HDL Antioxidant Function Diminished in Patients with HFpEF, Study Finds 

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 

 led to clinically relevant improvements within a 16-week timeframe, according to a recent study from Spain, and the drug’s safety and efficacy continued over 52 weeks.

This research was authored by a team led by Eulalia Baselga Torres, from the dermatology unit at Hospital Sant Joan de Déu in Barcelona. Torres et al. highlighted dupilumab’s use as a human monoclonal antibody that can impact interleukin (IL)-4 and IL-13 signalling, adding that it has been licensed in various countries for treatment of atopic dermatitis in patients beginning at 6 months of age.

The research team highlighted the value of this study’s real-world data in routine clinical settings in Spain, noting atopic dermatitis’s burden on patients and caregivers.

“The present study aimed to describe the management, effectiveness and safety data of dupilumab in Spain in adolescents (12–17 years of age) with moderate to severe [atopic dermatitis], and in children (6–11 years of age) with severe [atopic dermatitis], in the context of real clinical practice,” Torres and colleagues wrote.

The study was titled READAP, with the design being retrospective, multicenter, and observational. The investigators looked at patients who had been given dupilumab treatment for atopic dermatitis over a minimum of 3 months, collecting data from medical records in the timeframe between March - September 2023.

Specifically, the investigators included adolescents in the age range of 12–17 who had moderate to severe atopic dermatitis. They defined a diagnosis of this skin condition by an Eczema Area and Severity Index (EASI) score ≥16. The researchers determined that children ages 6–11 years with severe disease would be defined by an EASI score of ≥21 at the time of dupilumab initiation.

The participants of the analysis were required by the team to have completed at least 3 months of dupilumab treatment, additionally noting that subjects could not be part of any clinical research during this period.

Overall, the study’s primary aim had been to describe the patient population in terms of clinical course of disease, demographics, comorbid conditions, scores in terms of life quality (QoL) with tools such as the Dermatology Life Quality Index (DLQI) and Peak Pruritus Numerical Rating Scale (PP-NRS), and disease severity as determined by EASI and Investigator's Global Assessment (IGA) scores.

Additionally, the investigators assessed any previous and concurrent medications utilized for treating atopic dermatitis. The team also assessed dupilumab responses among subjects by looking into severity changes and life quality rankings at the 16, 24, and 52-week marks relative to baseline, as well as assessing the safety of the medication.

By the study’s conclusion, a total of 211 individuals were included, with 69.6% of them at initiation reporting an IGA score of 4 and, consequently, severe disease. The research team found that the median DLQI and PP-NRS scores among the subjects had been 17 and 8, respectively, suggesting QoL issues and severe levels of itch.

Among 69.7% of participants, they observed comorbid atopic conditions. Additionally, the researchers noted that 97.1% of subjects had received systemic treatments prior to dupilumab, with oral corticosteroids being the most common.

The investigative team concluded that dupilumab therapy resulted in substantial improvements in participants’ disease severity. Specifically, the team found that at the 16 and 52-week marks, mean reductions in EASI scores from baseline had been −77.5% and −84.7%, respectively.

The researchers also noted that 71.8% and 82.4% of the trial’s subjects were shown to have achieved EASI scores of ≤7. The research team also reported 70.5% of subjects successfully improving by at least a 75% in their EASI scores (EASI-75) by the 16-week mark.

This EASI score increase went up to 78% by the 52-week mark. In a similar vein, it was noted that 36.5% of participants reported a 90% improvement (EASI-90) at 16 weeks and that this rose to 48.4% at 52 weeks.

Dupilumab was shown to be well-tolerated, as the investigators identified no serious adverse events. Mild side effects included treatment-related conjunctivitis among 6.2% of subjects and eosinophilia among 1.4%, neither of which resulted in treatment cessation.

Quality of life was also noted as having improved, with the research team highlighting that 70% of trial participants had at least a 4-point reduction of in their PP-NRS score and 87% showed at least a 6-point reduction on the DLQI by the 52-week mark.

“Consequently, the results obtained corroborate those of previous pivotal and real-world studies,” they wrote. “This information will be important to better understand how dupilumab works in real clinical practice in children and adolescents, and to learn about the characteristics of the patients who were treated with dupilumab after its approval as the first innovative drug in both subgroups.”1

Baselga Torres E, Ivars M, Prat C, Vicente A, Feito Rodríguez M, Maseda Pedrero R, et al. Real-life retrospective multicentre study to describe the use of dupilumab in paediatric patients with atopic dermatitis in Spain: patient profile, effectiveness and safety. JEADV Clin Pract. 2024; 1–9. https://doi.org/10.1002/jvc2.565.

Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014; 371: 130–139.

Dupilumab treatment for atopic dermatitis demonstrated significant clinical improvements within 16 weeks, with sustained efficacy and safety over 52 weeks. The study, conducted in Spain, focused on adolescents and children with moderate to severe atopic dermatitis, using real-world data. The retrospective, multicenter study included 211 participants, revealing substantial reductions in EASI scores and improvements in quality of life. Dupilumab was well-tolerated, with mild side effects such as conjunctivitis and eosinophilia. The findings align with previous studies, enhancing understanding of dupilumab's role in clinical practice.

These real-life data highlight dupilumab’s efficacy at 16 weeks, with the safety and effectiveness in children with atopic dermatitis continuing to 52 weeks.

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.

Dupilumab Effective for Pediatric Patients with Atopic Dermatitis at 16 Weeks

The US Food and Drug Administration has granted Breakthrough Therapy designation to Bluejay Therapeutics’ brelovitug (BJT-778) for the treatment of 

Announced on January 21, 2025, the designation comes just 2 months after phase 2 data demonstrating 100% virologic response and up to 78% combined virologic response and alanine aminotransferase (ALT) normalization with brelovitug monotherapy were presented at The Liver Meeting 2024 of the American Association for the Study of Liver Diseases.

"Chronic hepatitis delta is the most aggressive form of viral hepatitis and the lack of approved treatments in the United States creates a major unmet need for patients," Keting Chu, MD, PhD, founder and chief executive officer of Bluejay Therapeutics, said in a press release.

"Breakthrough Therapy designation recognizes the potential of brelovitug to transform the lives of people living with CHD. We look forward to initiating a global pivotal trial as soon as possible to meet our goal of improving patients’ lives."

A high potency, fully human immunoglobulin G1 monoclonal antibody, brelovitug targets the surface antigen (anti-HBsAg) of the hepatitis B virus. It is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles, making brelovitug a potentially safe and highly efficacious treatment for CHD.

According to a release from Bluejay, brelovitug has also shown immunomodulatory functions in patients with chronic hepatitis B (CHB), which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents.

In the phase 2 study for CHD, participants with quantifiable hepatitis D virus (HDV) RNA and hepatitis B virus (HBV) suppressed on nucleos(t)ides were assigned to 1 of 3 doses of BJT-778: 300 mg weekly (n = 18); 600 mg every week for 12 weeks, then every 2 weeks (n = 11); or 900 mg every 4 weeks after a loading dose administered at week 2 (n = 18).

Key endpoints included safety and tolerability; virologic response, defined as ≥2 log10 HDV RNA IU/mL reduction from baseline or HDV RNA target not detected (TND); ALT normalization in participants with abnormal ALT at baseline; and a combined response of virologic response plus ALT normalization.

Results showed BJT-778 achieved 100% virologic response across all dose arms and up to 78% of participants reached the combined endpoint of virologic response and ALT normalization. Parallel declines in HDV viral load and ALT were observed across all doses, indicating a beneficial effect on liver inflammation as a result of viral load reduction.

Additionally, BJT-778 demonstrated a favorable safety profile, and all doses were safe and well tolerated with no ≥ grade 3 adverse events, no severe adverse events, and no treatment discontinuations due to adverse events.

According to a press release from Bluejay at the time of the phase 2 data, the company expected longer-term, 48-week data across all dose arms to be shared in the second half of 2025.

Bluejay Therapeutics. Bluejay Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for Brelovitug (BJT-778) for the Treatment of Chronic Hepatitis Delta. January 21, 2025. Accessed January 21, 2025. https://bluejaytx.com/bluejay-therapeutics-receives-u-s-fda-breakthrough-therapy-designation-for-brelovitug-bjt-778-for-the-treatment-of-chronic-hepatitis-delta/

Bluejay Therapeutics. Bluejay Therapeutics Reports Best-in-Class Monoclonal Antibody BJT-778 Achieved 100% Virologic Response and Up To 78% Combined Virologic Response and ALT Normalization as Monotherapy in Participants With Chronic Hepatitis D (CHD). November 15, 2024. Accessed January 21, 2025. https://bluejaytx.com/bluejay-therapeutics-reports-best-in-class-monoclonal-antibody-bjt-778-achieved-100-virologic-response-and-up-to-78-combined-virologic-response-and-alt-normalization-as-m/

The FDA has granted Breakthrough Therapy designation to Bluejay Therapeutics' brelovitug (BJT-778) for chronic hepatitis delta (CHD) treatment. This follows phase 2 data showing 100% virologic response and up to 78% combined virologic response and ALT normalization. Brelovitug, a high potency monoclonal antibody, targets hepatitis B virus surface antigen, neutralizing hepatitis B and D virions. It demonstrated a favorable safety profile with no severe adverse events. Bluejay plans a global pivotal trial and anticipates sharing 48-week data in late 2025.

The Breakthrough Therapy designation comes just months after positive phase 2 data for brelovitug were presented at AASLD The Liver Meeting in 2024.

Hepatology

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FDA News

Brelovitug Receives FDA Breakthrough Therapy Designation for Chronic Hepatitis Delta

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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.

The FDA approved esketamine (SPRAVATO) nasal spray as the first monotherapy for adults with TRD, showing rapid efficacy at 4 weeks.

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FDA Approves Esketamine as First Monotherapy for Treatment-Resistant Depression

Videos

Panelists discuss how the standard of care in atopic dermatitis (AD) has evolved with recent advances in treatment, highlighting the use of assessment tools and scoring systems in clinical practice, and compare real-world outcomes with those seen in clinical trials for AD treatments.

Video Series

Improvement in Standard of Care in Atopic Dermatitis

A study showed that vitamins, supplements, and antipsychotics were associated with an increased dementia risk.

Geriatrics

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Antimicrobials, Vaccinations, Anti-inflammatories Linked to Lower Dementia Risk

The analysis of NHANES data revealed higher LE8 scores for cardiovascular health were linked to a decreased risk of MASLD.

MASH / MASLD

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Higher Life’s Essential 8 Score for Cardiovascular Health Linked to Reduced MASLD Risk

A post-hoc analysis evaluated pooled data from 4 trials of pegloticase.

Gout

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Pegloticase Does Not Increase Risk of CV/TE Events in People With Gout

A new study found high concentrations of pollen from 3 species classes—ragweed, deciduous trees, and grass—are linked to increased chronic respiratory mortality.

Allergy

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High Pollen Exposure Linked to Increased Chronic Respiratory Mortality

Findings show differences in the clinicopathological characteristics and prognosis of patients with IgAN and nephrotic syndrome across renal pathologies.

Study Describes Clinical Features, Prognosis of Patients with IgAN, Nephrotic Syndrome

In this summary, we highlight the latest issue of our pulmonology research quarterly newsletter powered by the American Lung Association Research Institute.

The Respiratory Report

Pulmonology

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Welcome Back to The Respiratory Report

This interview in the latest issue of The Respiratory Report features Stephen Schworer, Md, PhD, discussing the role of mucus plugging in severe asthma.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Insights Into the Role of Mucus Plugging in Asthma

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 18, 2025.

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