Barriers to Using PCSK9-Targeting Therapies

The panelists address the real-world barriers that continue to limit the use of PCSK9-targeting therapies in ASCVD care. Despite strong evidence supporting their efficacy and safety, the experts note that cost, insurance restrictions, and prior authorization delays remain the most significant obstacles to access. Many patients who qualify under current guidelines face long approval processes or denials, leading to treatment gaps and frustration for both patients and clinicians. The panel also highlights the burden on healthcare teams, who spend substantial time navigating paperwork and appeals. Even when access is granted, lack of awareness or familiarity among some clinicians can delay therapy initiation. The experts emphasize that broader education, simplified approval pathways, and improved affordability are essential to expanding use. They conclude that overcoming these administrative and systemic hurdles is critical to ensuring more patients benefit from potent LDL-C–lowering therapies proven to reduce recurrent ASCVD events.

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Explore the barriers to PCSK9 inhibitors, their underuse, and how addressing misconceptions can enhance patient outcomes in cholesterol management.

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Rethinking Prevention in ASCVD Through Cumulative LDL Exposure

The panelists revisit the concept of cumulative LDL-C exposure as a central driver of atherosclerotic risk, emphasizing that prevention must begin earlier and continue consistently throughout life. The experts explain that ASCVD develops over decades, with long-term exposure to elevated LDL-C creating a continuous burden on the vascular system. They discuss emerging data showing that earlier LDL-C lowering yields greater benefit than later intervention, even when the same LDL targets are eventually reached. This reinforces the principle that both the magnitude and duration of LDL-C reduction determine clinical outcomes. The panelists suggest that prevention frameworks should expand beyond “high-risk” patients to include younger adults with elevated LDL-C or familial predisposition, aiming to limit lifetime cholesterol exposure. They conclude that achieving and maintaining low LDL-C levels over time—rather than short-term correction—represents a paradigm shift in ASCVD prevention strategy and population health management.

Experts discuss evolving strategies in atherosclerosis prevention, emphasizing early intervention and the importance of cholesterol monitoring for better patient outcomes.

Sayna Norouzi, MD, is an assistant professor of medicine, clinical nephrologist, and founder and director of the glomerular disease and polycystic kidney disease clinics at Loma Linda University Medical Center.

Chee Kay Cheung MBChB PhD, is a consultant nephrologist and honorary senior lecturer at the University of Leicester.

Positioning Emerging B-Cell Modulators in Future IgAN Treatment Algorithms

In this segment, the panel discusses how monitoring strategies will need to adapt as B-cell–targeted therapies such as atacicept, sibeprenlimab, and povetacicept move into broader clinical use. They emphasize the importance of establishing a baseline immune profile, including serum IgG levels, vaccination history, and infection risk. During treatment, clinicians should monitor immunoglobulin levels periodically, watching for declines that may increase susceptibility to infection. The panel also notes that patients receiving B-cell modulators may require updated vaccination timing, ideally before therapy starts, since vaccine responses may be blunted once treatment begins. Routine kidney disease monitoring remains essential—tracking proteinuria, eGFR trends, and urine microscopy to evaluate therapeutic response. The group highlights the need for patient education, particularly around infection precaution behaviors and when to seek care. Overall, they stress that monitoring must be proactive and individualized, ensuring both safety and sustained disease control as these therapies enter practice.

In this segment, the panel discusses how monitoring strategies will need to adapt as B-cell–targeted therapies such as atacicept, sibeprenlimab, and povetacicept move into broader clinical use.

Monitoring Considerations with Emerging B-Cell Modulators in IgAN

Additional Emerging BAFF and APRIL Inhibitors in IgAN

In this segment, the panel reviews the emerging clinical data for two additional BAFF/APRIL–pathway inhibitors: sibeprenlimab and povetacicept. They first discuss sibeprenlimab, noting that phase 2 data demonstrated dose-dependent reductions in proteinuria along with sustained suppression of serum galactose-deficient IgA1 levels, supporting the mechanism of targeting upstream production of pathogenic IgA. The panel highlights that these effects were observed without broad immunosuppression, which may offer a favorable safety profile compared with systemic corticosteroids. The discussion then moves to povetacicept, which also targets BAFF and APRIL but with a slightly different binding and receptor engagement profile. Early trial data similarly show meaningful proteinuria reductions, and the panel emphasizes interest in how response durability and tolerability compare across molecules in this therapeutic class. They note that ongoing phase 3 and extension studies for both agents will be crucial for determining optimal patient selection, sequencing, and real-world adoption.

In this segment, the panel reviews the emerging clinical data for two additional BAFF/APRIL–pathway inhibitors: sibeprenlimab and povetacicept. 

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.

Higher ambient fine particulate matter (PM2.5) exposure during the year following NICU discharge was linked to an increased risk of 

by 5 years old in children with bronchopulmonary dysplasia, a new study revealed.

“Importantly, our results build upon evidence that links ambient PM2.5 to wheeze, respiratory deficits, and asthma in infants born preterm, and demonstrate that, among children with compromised lung function, air pollution may influence asthma susceptibility later on in childhood,” wrote study investigator Lizbeth F. Gomez, PhD, MPH, from the division of pulmonary, allergy, and critical care of medicine at the University of Pennsylvania, Philadelphia, and colleagues.

 “Specifically, our findings add to the small but growing literature suggesting that post‑discharge PM2.5 exposure may influence long-term respiratory outcomes among infants with [bronchopulmonary dysplasia].”

Earlier research has found that children born preterm had lower FEV1 than healthy controls and that prenatal exposure to air pollutants, such as PM2.5, PM10, and NO2, can further impact postnatal lung function.

 These findings suggest that infants may have a reduced capacity to handle oxidative stress, making them more susceptible to respiratory inflammation and long-term impairment from pollution.

However, most prior studies used prenatal air pollution exposure as a proxy for postnatal exposure, and few have specifically examined postnatal ambient pollutants. In this retrospective cohort study, investigators evaluated whether higher mean ambient PM2.5 exposure in the first 12 months after hospital discharge was associated with asthma by age 5 in children with bronchopulmonary dysplasia, hypothesizing that greater postnatal exposure would increase the risk of developing asthma.

The study included 337 infants with bronchopulmonary dysplasia, born between 2010 and 2019, who were discharged from and followed up at the Children’s Hospital of Philadelphia Care Network until age 5. The sample was 59% male, 61% born after 2014, 62% with public insurance, and 52% identified as non-Hispanic Black. The mean gestational age at birth was 27 weeks (range, 25 – 28), the median birth weight was 771 grams, and infants had a mean age of 156 days after NICU discharge.

Although most infants were discharged without inhaled respiratory medications, 17% received albuterol, and 11% were prescribed albuterol and inhaled corticosteroid. About one-fourth required respiratory support at discharge, either oxygen (12%) or tracheostomy (14%).

Investigators estimated daily residential census block group PM2.5 exposures using a spatiotemporal machine-learning model. Estimates were averaged over the first year following the NICU discharge. The study reported that the mean annual PM2.5 exposure was 8.8 µg/m

Half of the infants received an asthma diagnosis by 5 years old. In an analysis adjusted for neonatal clinical factors, insurance, neighborhood deprivation, and race/ethnicity, every µg/m3 increment of PM2.5 was associated with a greater asthma risk (adjusted rate ratio [aRR], 1.19, 95% CI: 1.03–1.37). Infants with the most exposure were more likely to be male, born in 2014 or after, receive public insurance, be diagnosed with grade 1 bronchopulmonary dysplasia, and not require supplemental respiratory support at the time of NICU discharge.

Asthma incidence tended to rise with increasing PM2.5 exposure. Relative to the lowest tertile (mean 7.6 µg/m³), tertile 2 (mean 8.7 µg/m³) had an aRR of 1.31 (95% CI: 0.98–1.74), and tertile 3 (mean 10.0 µg/m³) had an aRR of 1.68 (95% CI: 1.17–2.4).

“Average annual PM2.5 exposure in the cohort was less than the current EPA threshold of 9 μg/m3,” investigators noted.

 “Therefore, it is important to note that the adverse health effects of fine PM exposure may remain even at relatively low concentrations.”

The study showed that small reductions in average ambient pollen exposure, even as little as 1 µg/m3, may offer meaningful long-term respiratory benefits for children with bronchopulmonary dysplasia.

“These findings suggest that creating guidance to decrease fine PM exposure during a pivotal phase of lung growth may offer an actionable pathway to mitigate long‑term respiratory morbidity among high-risk neonates with [bronchopulmonary dysplasia],” investigators concluded.

“Given that environmental exposures may be modifiable with personal exposure mitigation and environmental policy, these results have important implications for developing targeted interventions to improve long-term health outcomes in children with [bronchopulmonary dysplasia].”

Gomez LF, Szeto JJ, Radack JK, et al. Associations of Early Life Ambient PM2.5 Exposure With Asthma Risk in a Cohort of Preterm Infants With Bronchopulmonary Dysplasia. 

Decrue F, Gorlanova O, Salem Y, et al. Increased Impact of Air Pollution on Lung Function in Preterm versus Term Infants: The BILD Study. 

Articles

Exposure to higher levels of ambient fine particulate matter (PM2.5) in the year following NICU discharge is linked to an increased risk of asthma by age five in children with bronchopulmonary dysplasia. This study highlights the impact of postnatal PM2.5 exposure on long-term respiratory outcomes, emphasizing the vulnerability of infants with compromised lung function. The findings suggest that even low concentrations of PM2.5 can have adverse health effects, underscoring the need for targeted interventions and policies to reduce exposure and improve respiratory health in high-risk neonates.

A study found that higher PM2.5 exposure during the first year after NICU discharge increased asthma risk in children with bronchopulmonary dysplasia by age 5.

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Post-NICU PM2.5 Exposure Raises Asthma Risk in Children With Bronchopulmonary Dysplasia

Shervin Assassi, MD, is the director of the division of rheumatology at McGovern Medical School, UTHealth Houston.

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Nerandomilast Approval Expands Treatment Options for PPF, With Shervin Assassi, MD

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

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Diabetes Dialogue: Orforglipron, Cagrilintide, and the Libre Assist

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The approval is based on the 64-week phase 3 OASIS 4 trial showing anaverage weight loss of ~17% if all patients stayed on treatment with semaglutide and ~14% regardless of if patients stayed on treatment.

FDA Approves Semaglutide (Wegovy) Pill As First Oral GLP-1 for Weight Loss

Innovative therapies and devices are transforming food allergy management, enhancing safety and quality of life for patients and families.

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A New Era in Food Allergy Treatment: The Push Toward Multi-Allergen Immunotherapy

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Catch up on the most impactful headlines in ophthalmology from all of 2025 with our Year in Review.

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Ophthalmology in 2025: Year in Review

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.

Catch up on some of the most significant headlines in atopic dermatitis news coverage from 2025 with our Year in Review.

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Atopic Dermatitis in 2025: Year in Review

The FDA’s decision is based on positive results from the phase 3 THRIVE and THRIVE-2 clinical trials, which showed veligrotug’s efficacy and rapid onset of benefits.

FDA Accepts, Grants Priority Review to Veligrotug BLA for Thyroid Eye Disease

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A multi-state cross-sectional analysis linked chronic kidney disease with increased COVID-19 hospitalizations, indicating more severe disease outcomes


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Latest News

Barriers to Using PCSK9-Targeting Therapies

Rethinking Prevention in ASCVD Through Cumulative LDL Exposure

Monitoring Considerations with Emerging B-Cell Modulators in IgAN

Additional Emerging BAFF and APRIL Inhibitors in IgAN

Post-NICU PM2.5 Exposure Raises Asthma Risk in Children With Bronchopulmonary Dysplasia