Using AI to Explore CPAP’s Impact on Abdominal Obesity in OSA, with Jennifer Prevot, MD

 remains a prevalent and serious disorder closely linked with 

, particularly abdominal adiposity. OSA is associated with an increased risk of 

, but the effectiveness of continuous positive airway pressure (CPAP) therapy, the standard treatment for OSA, in improving cardiovascular outcomes remains unclear.

the American Thoracic Society (ATS) International Conference 2025

 by Jennifer Prevot, MD, a pulmonary and critical care medicine fellow at Mount Sinai Hospital, addresses this gap in research by leveraging artificial intelligence to explore the relationship between OSA severity and abdominal obesity metrics, including visceral and subcutaneous adipose tissue (VAT and SAT) volumes and VAT metabolic activity, and to assess changes in these metrics following CPAP intervention using [18F]-Fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET) combined with magnetic resonance imaging (MRI).

“There is a lot of interest in obesity and obstructive sleep apnea, and CPAP has been the standard treatment for a very long time,” Prevot explained to 

. “However, it's still questionable if it actually does anything in terms of cardiovascular risk factors. One thing that we know is that obesity kind of links everything, so I thought it would be interesting to look at abdominal obesity in particular and see the relationship it has with OSA and if CPAP therapy can modulate any risk factors.”

She and a group of investigators retrospectively analyzed PET/MRI scans from 115 adults with newly diagnosed OSA, both before and after 3 months of CPAP therapy. They determined OSA severity using portable sleep testing, defined by the respiratory disturbance index (pRDI). A deep learning model, using a transfer learning approach, segmented regions of interest (ROIs) within the subcutaneous and visceral adipose tissue compartments on MRI.

“Not only was the imaging technique that we used novel, because no one else has been using PET MRIs to look at visceral adipose tissue inflammation in the body, but we also established a relationship with our biomedical engineering department to automate the process in which we segment these compartments,” Prevot explained. “Not only do we have a novel imaging tool that we're using to look at metabolic activity of the abdominal tissue, but we are also applying a novel method to do this segmentation.”

Participants had an average age of 47.0 (standard deviation [SD], 11.97) years, were predominantly male (84.0%), and had an average BMI of 31.85 kg/m² (SD, 5.08). The mean pRDI was 32.53 events/hour (SD, 19.21).

Investigators noted OSA severity was not significantly associated with baseline VAT SUVmean (0.02%, confidence interval [CI], -0.21 to 0.25; 

= .87) and CPAP therapy did not significantly alter VAT SUVmean (-2.17%, CI, -5.02 to 0.77; 

= .15), VAT volume (-0.98%; CI, -2.41 to 0.47, 

= .19), or weight (0.30%; CI, -0.83 to 1.43; 

= .61). However, they called attention to a significant reduction in the VAT/SAT volume ratio (-1.70%; CI, -3.28 to 0.09; 

Looking ahead, Prevot emphasizes the potential of exploring these fat distribution metrics in the context of GLP-1 therapies, which are gaining attention for their metabolic benefits. She also highlights the possibility of evaluating changes in tongue fat, a known anatomical contributor to OSA, as an area for future investigation.

Editors’ note: Prevot has no relevant disclosures.

Prevot J, Patel H, Fauveau V, et al. Applying Artificial Intelligence to Measure Abdominal Adipose Metrics in Obstructive Sleep Apnea Before and After CPAP Therapy [abstract]. 

https://doi.org/10.1164/ajrccm.2025.211.Abstracts.A4759

Videos

Prevot describes her research exploring the relationship between OSA severity and abdominal obesity metrics as well as changes in both metrics following CPAP.

Actinic keratosis represents one of modern healthcare's most overlooked and dangerous skin conditions. With global prevalence estimates of 14% and higher rates observed in older populations and those with significant UV exposure, the precancerous condition poses a significant risk to long-term health when left untreated or undiagnosed.

“It's really important that not just dermatologists, but that general physicians, internal medicine doctors are familiar with this diagnoses, because they do have potential to transform into non melanoma skin cancers, and they also are a marker of a risk factor that you may develop, even melanoma,” said Elizabeth Hale, MD, clinical associate professor of Dermatology at NYU Langone Medical Center and senior vice president of the Skin Cancer Foundation, in an interview with HCPLive Dermatology. “So, it's important that people are familiar with these very common skin lesions, because we see them every single day, and treating them and educating patients early and really help minimize the risk of future skin cancers."

Underscoring Hale’s remarks, a longitudinal cohort study published in JAMA found that patients with actinic keratosis had a 17.1% cumulative incidence of squamous cell carcinoma within 10 years compared to 5.7% in matched controls. A 2023 survey of more than 2500 adults aged 35 or older from the US and Europe conducted by Almirall suggested 85% of people were unaware of the condition. The same survey found 57.73% do not get skin checks by professionals.

In 2022, Almirall launched the Global Actinic Keratosis Awareness Day to raise awareness of the importance of monitoring the appearance and evolution of the skin lesions of actinic keratosis. Recognized annually on May 24, the day continues to mark an important awareness initiative, evidenced by the 2025 partnership between Almirall and Biofrontera to promote the “Hats On Challenge”, which is a social media initiative that encourages participants to wear a hat, post a video, and use the hashtags to spread awareness about skin protection.

For more on recent developments in actinic keratosis and the role of non-dermatology health care providers in the diagnosis of actinic keratosis, check out our interview with Hale.

Recognizing Actinic Keratosis, Cancer Risk, with Elizabeth Hale, MD

Hale has no relevant disclosures to report. 

George CD, Lee T, Hollestein LM, Asgari MM, Nijsten T. Global epidemiology of actinic keratosis in the general population: a systematic review and meta-analysis. 

Madani S, Marwaha S, Dusendang JR, et al. Ten-Year Follow-up of Persons With Sun-Damaged Skin Associated With Subsequent Development of Cutaneous Squamous Cell Carcinoma. 

Almirall. 85% of people unaware of actinic keratosis, the most common pre-cancerous skin condition. Almirall.com. Published May 24, 2023. Accessed May 24, 2025. 

https://www.almirall.com/newsroom/news/85-of-people-unaware-of-actinic-keratosis-the-most-common-pre-cancerous-skin-condition

Almirall. Almirall launches the Actinic Keratosis (AK) Global Day during the Skin Cancer Awareness Month. Almirall.com. Published May 22, 2025. Accessed May 24, 2025. 

https://www.almirall.com/newsroom/news/almirall-launches-the-actinic-keratosis-ak-global-day-during-the-skin-cancer-awareness-month-1

Almirall. Almirall and Biofrontera Launch the “Hats On” Challenge to Raise Awareness and Support for Actinic Keratosis. Almirall.com. Published 2025. Accessed May 24, 2025. 

https://www.almirall.com/newsroom/news/almirall-and-biofrontera-launch-the-hats-on-challenge-to-raise-awareness-and-support-for-actinic-keratosis

Elizabeth Hale, MD, discusses the need to improve awareness and diagnosis of actinic keratosis. 

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 promising Phase 2 results for Ruxoprubart in paroxysmal nocturnal hemoglobinuria (PNH), a major triglyceride-lowering breakthrough, new 

 warnings on itching related to antihistamine use, approvals for sustained delivery in diabetic retinopathy, and expanded use of roflumilast foam for scalp and body psoriasis

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 May 18, 2025—let’s jump in!

FDA Approves Once-Daily Roflumilast (ZORYVE) Foam 0.3% for Scalp and Body Psoriasis

The FDA approved Arcutis Biotherapeutics, Inc.’s roflumilast (Zoryve) foam 0.3% as a once-daily topical treatment for the treatment of plaque psoriasis of the scalp and body in adults and adolescents aged 12 years and older. This approval marked the second for this specific formulation of roflumilast foam and the fifth indication for roflumilast, with roflumilast cream boasting a trio of approvals in psoriasis as well as atopic dermatitis.

FDA Warns About Rare, Severe Itching After Stopping Cetirizine or Levocetirizine

The FDA announced it will add a warning about pruritus risk after stopping long-term use of common anti-histamines, cetirizine or levocetirizine, to the prescribing information. The label will note that pruritus symptoms may improve with restarting the medications, and regulators are requesting manufacturers add a warning to the label of over-the-counter cetirizine and levocetirizine.

FDA Approves Susvimo for Treatment of Diabetic Retinopathy

The FDA approved Genentech’s Susvimo 100 mg/mL, a ranibizumab injection administered via the Port Delivery System (PDS), to treat diabetic retinopathy. Susvimo became the first approved continuous delivery treatment capable of maintaining vision in people with diabetic retinopathy through one refill every 9 months, after similar approvals for wet age-related macular degeneration and diabetic macular edema (DME).

Olezarsen Cuts Triglyceride Levels at 6 Months in Essence Study

Olezarsen significantly cut mean triglyceride levels, compared with placebo, for people with moderate hypertriglyceridemia at risk for atherosclerotic cardiovascular disease (ASCVD). Topline results from the Essence study showed monthly doses of 80 mg and 50 mg led to a significant ~60% reduction in triglycerides at six months, with most patients returning to normal levels (<150 mg/dL).

Ruxoprubart Shows Efficacy for PNH in Interim Phase 2 Trial Results

Interim results from the Phase 2 trial of Ruxoprubart, a novel complement-targeting immunotherapy, were positive for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). At 12 weeks, NovelMed’s ruxoprubart achieved all primary efficacy endpoints, including transfusion avoidance, increased hemoglobin levels, reduced lactate dehydrogenase (LDH), and increased PNH clone size.

Articles

The latest healthcare updates include significant advancements and regulatory changes. Ruxoprubart shows promising Phase 2 results for paroxysmal nocturnal hemoglobinuria, achieving key efficacy endpoints. A breakthrough in triglyceride reduction is reported with Olezarsen, showing a ~60% decrease in levels. The FDA approves Susvimo for diabetic retinopathy, offering continuous delivery treatment. New warnings are issued for severe itching after stopping cetirizine or levocetirizine. Additionally, roflumilast foam receives FDA approval for treating scalp and body psoriasis, expanding its therapeutic indications.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and innovative treatments, in this week's essential news roundup for professionals.

The HCPFive: Top News for Healthcare Providers from the Week of 05/18

A recent retrospective analysis examining the effects of combining anti-vascular endothelial growth factor (anti-VEGF) treatments with panretinal photocoagulation (PRP) has indicated a reduced risk of 

PRP has become a mainstay in the treatment of retinal ischemic disease, particularly proliferative diabetic retinopathy (PDR). Despite its effectiveness, there have been concerns regarding the adverse effects of PRP treatment. The most common side effects include choroidal effusions, exudative retinal detachments, visual field deficits, night vision defects, and macular edema.

Anti-VEGF also exhibits positive effects on treating PDR and reducing leakage in DME. Anti-VEGF therapies have also been proposed as a treatment for PDR; compared to those receiving PRP alone, anti-VEGF monotherapy recipients had lower rates of DME and less visual field loss.

“This design emphasizes the potential for varying treatment responses but does not reflect real-world scenarios where patients might receive diverse treatment modalities and continue clinical follow-up regardless of complications,” wrote Hsuan-Chieh Lin, MD, National Taiwan University, and colleagues. “Therefore, it is important to evaluate the efficacy of combining anti-VEGF agents and PRP alone for patients with PDR on the risk of DME or vitreous hemorrhage (VH) and relevant clinical ocular outcomes using real-world data, which may provide valuable evidence for managing patients with PDR in clinical practice.”

The team collected data from patients treated with PRP alone or in combination with intravitreal anti-VEGF at the National Taiwan University Hospital or its Hsin-Chu Branch between 2019-2021. Inclusion criteria were patients with type 1 or 2 diabetes, age ≥20 years, treatment-naïve PDR confirmed by color fundus photography and fluorescein angiography, a best-corrected visual acuity (BCVA) ≥20/400, and a follow-up period of ≥12 months.

A total of 95 eyes from 69 patients were collected, with 37 eyes from 25 patients in the PRP/anti-VEGF combination group and 58 eyes from 44 patients in the PRP group. Mean age was 54.4 years (range: 27-76 years) and neither group showed significant differences at baseline between age, sex, laterality, best-corrected visual acuity (BCVA), central retinal thickness (CRT), or PDR severity.

The PRP group received retinal photocoagulation, the completion of which was defined as 1200-1600 scattered laser burns. These were applied in three sessions between months 0 and 2, with each session 2 weeks apart. The combined group received ranibizumab at months 0, 1, and 2, along with complete PRP treatment.

In the PRP group, 20 eyes developed the first DME between 3 and 52 weeks after initial PRP treatment, while 3 developed DME between 22 and 36 weeks in the combined group. Combination treatment substantially reduced DME risk (cumulative incidence, 8.1% vs 31% at 12 months; 

 = .004). In the PRP group, 20 eyes exhibited first VH between 6 and 140 weeks after initial PRP treatment, and 10 eyes exhibited it between 17 and 136 weeks in the combined cohort. There was no significant difference in risk between the two groups (cumulative incidence, 19% vs 19.2% at 12 months; 

Univariate analysis displayed a significant reduction in risk after initial combination treatment (cause-specific hazard ratio [csHR], 0.211; 95% CI, .060-.743, 

 = .015). In multivariate analysis, combined treatment lowered the DME-specific risk by almost 80% compared with PRP treatment (csHR, 0.211; 95% CI, .064-.700, 

Multivariate analysis also indicated VH hazard decreased with age (csHR, 0.966; 95% CI, .933-.999, 

 = .045). The combined group exhibited superior BCVA at month 3 and 12; additionally, the combination group was less likely to need additional treatment within 1 year (adjusted OR, 0.254; 95% CI, .088-.739, 

Lin and colleagues indicated that these results demonstrated the superiority of combination therapy in reducing the risk of DME. However, it was also noted that patients with poorly controlled blood glucose levels or a thicker baseline CRT have a higher risk of DME development.

“Approximately one-fifth of patients may experience VH within one year despite complete PRP or combined treatment,” Lin and colleagues wrote. “Therefore, regular follow-ups are essential to maintain treatment efficacy in patients with PDR.”

Lin H-C, Huang Y-C, Hsieh Y-T, Chang S-H. Treatment effects of panretinal photocoagulation or combined anti-vascular endothelial growth factor therapy for proliferative diabetic retinopathy on the risks of diabetic macular edema and vitreous hemorrhage. 

Reddy SV, Husain D. Panretinal photocoagulation: A review of complications. 

Combining anti-VEGF treatments with panretinal photocoagulation (PRP) significantly reduces the risk of diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR). A retrospective analysis of 95 eyes from 69 patients showed that the combination therapy group had a lower cumulative incidence of DME compared to the PRP-only group. The study also found that combination therapy resulted in better best-corrected visual acuity (BCVA) and reduced the need for additional treatments. However, the risk of vitreous hemorrhage (VH) remained similar between the two groups.

Panretinal photocoagulation and anti-VEGF therapy combined also results in better BCVA and were less likely to require additional treatment within 1 year.

Combination Therapy for Diabetic Retinopathy Reduces DME Risk

The FDA has granted interchangeability designation to 

-aaty, or Yuflyma (Celltrion) including its prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations, for all the same indications as reference adalimumab (Humira), including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (PsO), hidradenitis suppurativa (HS), and uveitis (UV) in adult patients; Crohn's disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older.

"This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape," Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, said in a statement.

 "YUFLYMA – a high-concentration, citrate-free adalimumab biosimilar now fully interchangeable with Humira – reflects our long-standing commitment to delivering high-quality, accessible treatment options. Going forward, Celltrion will continue to put patients first by keeping drug costs affordable and remaining at the forefront of the U.S. biosimilar market, bringing competitive pricing and high-quality, accessible treatment options."

The interchangeable designation was based off of the Phase III interchangeability study, which demonstrated similar pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque PsO who received reference adalimumab continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Weeks 25-27. The full data from the interchangeability study were presented at the European Academy of Dermatology & Venereology (EADV) in the Netherlands in September 2024.

Adalimumab-aaty first entered the United States market in July 2023 and is currently available as a 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg in autoinjectors. The biosimilar is available in both branded and unbranded versions at 2 pricing options.

Other recent research supported adalimumab biosimilar interchangeability and the practice of non-medical switches between such biosimilars for patients with psoriasis, with the most commonly registered treatment discontinuation reason being a loss of effect.

Among all of the study cohorts, it was reported that therapy discontinuation took place within 6 months after the switch ranged from 0% - 8.2%. The highest rate of discontinuiation that the investigative team observed took place following the initial switch from the originator to GP2017.

They added that the lowest rate had been seen following the third switch in the originator cohort, specifically from ABP 501 to GP2017. Among the reasons given for cessation, the loss of therapeutic effect was the most commonly reported one. The investigators highlighted that 2 subjects stopped treatment as a result of adverse events, though subsequent remission was attained upon resuming the originator biologic.

Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths. News release. Celltrion. May 23, 2025. 

https://www.prnewswire.com/news-releases/celltrions-yuflyma-adalimumab-aaty-receives-fda-interchangeability-designation-for-all-its-approved-dosage-forms-and-strengths-302464475.html

Krogh-Jensen O, Schwarz CW, Kaur-Knudsen D, et al (2025). Real-world experience of multiple switches between adalimumab biosimilars in patients with psoriasis. 

Celltrion's Yuflyma gains FDA interchangeability, offering a cost-effective biosimilar option for various conditions, including rheumatoid arthritis and psoriasis.

Adalimumab-aaty Receives Interchangeability Designation

In a recent case series presented at the 

American Thoracic Society (ATS) 2025 International Conference

 in San Francisco, dupilumab (Dupixent) treatment has been shown to be safe and generally well-tolerated in patients with chronic obstructive pulmonary disease (COPD) and elevated eosinophil counts.

The data indicate that dupilumab’s utilization was linked to fewer exacerbations and improvement in patients COPD symptoms, as suggested by patient-reported outcomes. This analysis, presented in a poster session at ATS, was titled ‘Real-World Experience of Dupilumab Treatment for Patients With COPD’ and authored by such investigators as Ophir Freund, MD, of Tel Aviv Sourasky Medical Center.

Prior to this research, dupilumab was noted as having recently demonstrated efficacy in individuals with COPD characterized by type 2 inflammation. However, Freund and colleagues noted that routine clinical practice data had been scarce prior to this analysis, and therefore their study was conducted sought to examine real-world outcomes in COPD with dupilumab treatment.

Individuals with COPD who were consecutively treated with dupilumab were invited to take part in this analysis, with a structured interview being utlized by the investigative team first. Criteria for eligibility in the study included a baseline blood eosinophil count of ≥300 cells/μL. Additionally, those being considered for eligibility would have to have at least a single exacerbation of their COPD noted from the prior year despite ongoing triple-inhaler therapy use.

There were a total of 14 individuals that were evaluated by Freund and coauthors throughout the analysis, with these subjects reporting a median duration of dupilumab therapy of 187 days (interquartile range [IQR] 173–195). The severity of their disease, based on GOLD classification, was GOLD 3E in 43% and GOLD 4E in 21% of those involved in the study.

Overall, the investigative team concluded that the participants’ median number of COPD exacerbations showed a reduction from 2 (IQR 2–2) in the period prior to dupilumab treatment to 1 (IQR 0–1) during the course of treatment period. In addition, the team highlighted a decline in the study subjects’ median COPD Assessment Test (CAT) scores from 17 to 14, which they noted would indicate symptomatic improvement.

A lack of change was also noted by Freund et al in forced expiratory volume in a single second (FEV₁). Additionally, the investigators acknowledged that a single trial participant reported a having dermatologic adverse event.

Freund and colleagues determined that patient-reported outcomes had been generally positive among those taking part in the study, with 69% of the participants highlighting their own satisfaction with the use of dupilumab. They also pointed to indications by 62% of those in the study that they would recommend the medication to others individuals living with COPD.

According to the Global Evaluation of Treatment Effectiveness (GETE), 38% of the participants reported marked clinical improvement. The team noted that the most commonly cited treatment barriers were determined to be cost, among 50%, and the frequent injection requirement, among 29%. Expression of interest in new and safe therapeutic alternatives was further noted among those involved in this analysis.

In all, the investigators’ case series would suggest that dupilumab may be considered a safe and generally well-tolerated treatment for COPD among patients who report having elevated eosinophil counts. The use of this therapeutic option was linked to fewer disease exacerbations and symptom improvement, as suggested by patient-reported outcomes.

For any additional information on new data presented at ATS, view updates in the 

Freund O, Meoded O, Bar-Shai A et al. (Poster Board # P899) Real-World Experience of Dupilumab Treatment for Patients With COPD. Abstract presented at the American Thoracic Society (ATS) International Conference 2025 in San Francisco, CA, from May 18 - May 21, 2025.

Dupilumab has been shown to be safe and well-tolerated in COPD patients with elevated eosinophil counts, according to a case series presented at the ATS 2025 International Conference. The study, involving 14 patients, demonstrated a reduction in COPD exacerbations and improvement in symptoms, as indicated by patient-reported outcomes. Despite no change in FEV₁, 69% of participants expressed satisfaction with dupilumab, and 62% would recommend it. Cost and frequent injections were noted as barriers. The findings suggest dupilumab as a viable treatment option for this patient population.

These data from ATS 2025 highlight patients’ real-world outcomes related to treatment of their chronic obstructive pulmonary disease (COPD) with dupilumab.

Study Highlights Real-World Dupilumab Experiences for Individuals with COPD

 approved treprostinil inhalation powder (YUTREPIA), a prostacyclin analog targeted to improve exercise capability for adults with 

pulmonary hypertension associated with interstitial lung disease (PH-ILD)

Announced by Liquidia Corporation on May 23, 2025, regulatory approval was awarded based on positive data from the Phase 3 INSPIRE trial, in which treprostinil was shown to be safe and well-tolerated regardless of a patient’s previous exposure.

“I am so pleased that patients with PAH and PH-ILD now have this newly introduced option for inhaled treprostinil. Having treated patients for more than six years in Liquidia’s INSPIRE and extension studies, I am confident in the safety, tolerability and dosing that [treprostinil] offers,” said Nicholas Hill, chief of the pulmonary, critical care and sleep division and professor of medicine at Tufts University School of Medicine, and principal investigator on the Phase 3 INSPIRE study. “The low-effort inhalation device used to deliver [treprostinil] may make it easier to start and maintain patients on treatment, especially those with limited inspiratory flows or lung capacity.”

An estimated 45,000 patients with PAH have been diagnosed in the US. Current estimates suggest the PH-ILD prevalence in the United States is greater than 60,000 patients, although many ILD diseases are unknown due to underdiagnosis. Inhaled treprostinil solution (Tyvaso) was first approved by the FDA for PH-ILD in March 2021.

With this approval, Treprostinil marked the first prostacyclin dry-powder formulation using Liquidia’s patented PRINT technology, designed to enhance deep-lung delivery with uniform, free-flowing particles in a low-effort device requiring lower inspiratory effort.

“PAH and PH-ILD impact more than 105,000 patients in the U.S. alone. These patient communities and the physicians who serve them need therapies that can lead to the improvement of quality of life,” said Matt Granato, president and chief executive officer of the Pulmonary Hypertension Association. “We are always glad to see industry research leading to the development of drugs that expand options for the patient community.”

The Phase 3, open-label, multicenter INSPIRE trial enrolled adults with PAH who transitioned to treprostinil inhalation powder from nebulized treprostinil or added treprostinil inhalation powder to prostacyclin-naive patients on ≤2 nonprostacyclin oral therapies. The primary safety outcomes were the incidence of adverse events (AEs) and serious AEs, followed by exploratory efficacy measures.

With 121 patients enrolled in the trial, 29 discontinued due to AEs. Approximately 80% of the transition group and 96% of the prostacyclin naïve group were titrated to a dose ≥79.5 mcg four times daily at Day 360, respectively, with a single patient achieving a dose of 212 mcg. The most common AEs reported in the trial were cough, headache, upper respiratory tract infection, dyspnea, dizziness, throat irritation, diarrhea, chest discomfort, fatigue, and nasopharyngitis.

Although most events were considered treatment-related, investigators noted they were mild to moderate in severity and anticipated for prostacyclin therapy administered by inhalation. Exploratory efficacy analysis indicated patients remained stable or improved across the 1 year of treprostinil treatment.

Administration of treprostinil inhalation powder could offer clinicians and patients a preferred inhaled PAH therapy, with the opportunity for added convenience and a favorable safety profile. With the approval, Liquidia indicated its intent to launch treprostinil inhalation powder and inform physicians and patients of the potential unique benefits in the coming weeks.

“Today, we celebrate for the patients and physicians who will now have access to a potential best-in-class dry-powder form of treprostinil with exceptional portability, tolerability, titratability and durability,” said Roger Jeffs, chief executive officer of Liquidia. “Thank you to the clinical investigation team, our steering committee, and the members of the pulmonary hypertension patient communities who helped make this day a reality.”

U.S. FDA approves Liquidia’s YUTREPIATM (treprostinil) inhalation powder for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Liquidia Corporation. May 23, 2025. Accessed May 23, 2025. 

https://www.liquidia.com/news-releases/news-release-details/us-fda-approves-liquidias-yutrepiatm-treprostinil-inhalation

Kunzmann K. Treprostinil (Tyvaso) receives FDA approval for pulmonary hypertension linked to interstitial lung disease. HCP Live. April 17, 2023. Accessed May 23, 2025. 

https://www.hcplive.com/view/treprostinil-tyvaso-fda-approval-pulmonary-hypertension-linked-to-interstitial-lung-disease

Hill NS, Feldman JP, Sahay S, et al. INSPIRE: Safety and tolerability of inhaled Yutrepia (treprostinil) in pulmonary arterial hypertension (PAH). Pulm Circ. 2022;12(3):e12119. Published 2022 Jul 1. doi:10.1002/pul2.12119

The FDA has approved treprostinil inhalation powder (YUTREPIA) for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). This approval is based on the Phase 3 INSPIRE trial, which demonstrated the drug's safety and tolerability. Treprostinil offers a new inhaled treatment option with a low-effort delivery device, potentially improving patient adherence. The trial showed that most adverse events were mild to moderate. The drug's approval marks the first prostacyclin dry-powder formulation using Liquidia's PRINT technology, enhancing deep-lung delivery.

The FDA approves treprostinil inhalation powder, enhancing treatment options for patients with pulmonary arterial hypertension and interstitial lung disease.

FDA Approves Treprostinil Inhalation Powder for PAH, PH-ILD

This Peanut Allergy Prediction Web Tool can speed allergy management, calculating the probability of an individual’s allergic reaction based on skin prick test, Ara h 2-sIgE, or basophil activation test results. Oral food challenges can be time-consuming, taking about 3 – 4 hours to complete, and this online tool could be a way for allergists to diagnose peanut allergies without all that waiting.

“Currently, the suboptimal accuracy of routinely used tests leads to long waiting lists and often unnecessary allergen avoidance, that can increase the risk of peanut allergy,” wrote investigators, led by Alexandra F. Santos, MD, PhD, from Evelina London Children’s Hospital and St. Thomas’ Hospital in London.

Santos and colleagues conducted this study to validate the diagnostic performance of the Peanut Allergy Prediction web tool in 173 children and to assess its ability to distinguish peanut-allergic vs peanut-sensitized tolerant cases. The team had previously developed the tool

The team collected data on demographics, clinical history, and results for skin prick test, Ara h 2-sIgE, basophil activation test, and oral food challenges. The study included 129 children with a confirmed peanut allergy and 44 with peanut sensitization, making it a 3:1 ratio of peanut-allergic to peanut-sensitized cases.

Investigators found the tool was excellent at distinguishing between peanut-allergic and peanut-sensitized patients. The basophil activation test results were the superior single test performer, with an area under the curve of 0.945. Ara h 2-sIgE was the second best (AUC, 0.879). The skin prick test, at last, had an AUC of 0.861.

Despite the basophil activation test being superior on its own, the 2-test combination of Ara h 2-sIgE and basophil activation test (AUC, 0.959) was the best at discriminating between allergy and sensitization cases and diagnostic accuracy. The 3-test combination, computing skin prick test, Ara h 2-sIgE, and basophil activation test results, was the third best diagnostic performance (AUC, 0.949).

The ROC analysis included cases with all 3 test results (n = 140) and showed consistent findings, with the skin prick test performing the least optimally (AUC, 0.853). The best combinations included the basophil activation test, specifically the combination of the basophil activation test and the Ara h 2-sIgE.

The sensitivity analysis demonstrated the high sensitivity (92.16%) but low specificity (63.16%) of the skin prick test, suggesting that only using this for the tool’s calculations could result in patients with peanut sensitizations receiving a peanut allergy diagnosis.

The basophil activation test results performed the best in sensitivity, specificity, and positive predictive value. Investigators wrote that its high positive predictive value indicates a high likelihood of detecting the presence of peanut allergy in the database.

The team noted several limitations, including an uneven number of peanut-allergic vs peanut-sensitized patients, missing test data reduced the number of cases in the analysis, and the low number of patients with severe reactions prevented the assessment of the tool’s ability to predict reaction severity. They wrote that further research with more cases is needed to expand the tool’s diagnostic accuracy.

“This study validates the online tool and supports its use with single, double, or triple test results to calculate reaction probabilities as an aid to diagnosis due to their effectiveness in accurately classifying allergic and sensitized tolerant cases,” investigators wrote. “The successful validation of the online prediction tool so far instills confidence in its ability to detect peanut allergy and discriminate between allergy and clinically irrelevant sensitization. Given this initial validation of the model’s performance, there is optimism for its clinical use in diagnosing peanut allergy in children.”

Mears H, Sanghera SA, Bahnson HT, et al. Open access online calculator predicts peanut allergic reactions with high accuracy. 

. Published online May 14, 2025. doi:10.1016/j.jaip.2025.05.016

https://my.clevelandclinic.org/health/diagnostics/9544-food-challenge-test

A new online calculator, the Peanut Allergy Prediction Web Tool, offers a promising method for diagnosing peanut allergies with high accuracy, potentially reducing the need for time-consuming oral food challenges. The tool evaluates the probability of allergic reactions using skin prick tests, Ara h 2-sIgE, and basophil activation test results. In a study involving 173 children, the tool effectively distinguished between peanut-allergic and peanut-sensitized individuals. The combination of Ara h 2-sIgE and basophil activation test provided the highest diagnostic accuracy, though further research is needed to enhance its diagnostic capabilities.

A recent study validated an online tool’s ability to accurately predict peanut allergy; the basophil activation test was the top performer, especially when paired with Ara h 2-sIgE.

Validated Web Tool Accurately Predicts Peanut Allergy in Children

A recent observational, single-center, prospective, cross-sectional study evaluated the short-term postinjection intraocular pressure (IOP) changes after aflibercept 8 mg and faricimab, comparing them to aflibercept 2 mg.

Intravitreal injection of anti-vascular endothelial growth factors (anti-VEGFs) has emerged as a primary first-line treatment for various retinal diseases, including 

neovascular age-related macular degeneration (nAMD)

, and cystoid macular edema secondary to retinal vein occlusion. These treatments have resulted in substantial visual gains in patients exhibiting these conditions.

However, several studies have examined intravitreal injections of anti-VEGF treatments such as pegaptanib, ranibizumab, bevacizumab, and aflibercept. All four medications have been shown to increase IOP as a side effect after a short period without iridocorneal angle closure. However, these same studies have also indicated that IOP increases are often transient.

In recent months, two new intravitreal compounds have been introduced into clinical practice: faricimab, which targets both angiopoietin-2 and VEGF-A, and aflibercept 8 mg, a higher-concentration version of aflibercept 2 mg with enhanced stability. Both medications are administered in volumes of .07 mL.

“To date, the immediate effects of intravitreal faricimab and aflibercept 8 mg on IOP in real-world practice remain unclear,” wrote Arianna Paris, Institute of Clinical Neurosciences of Southern Switzerland, and colleagues. “This study aimed to investigate short-term IOP changes following IVT aflibercept 8 mg and IVT faricimab.”

Paris and colleagues enrolled all patients diagnosed with nAMD and DME requiring intravitreal treatment who had attended the Institute of Clinical Neurosciences of Southern Switzerland’s medical retina clinic between February and May 2024. Patients were then divided into three cohorts according to the agent used: aflibercept 2 mg (group 1), aflibercept 8 mg (group 2), and faricimab (group 3). Patients were excluded if they had a diagnosis of glaucoma, ocular hypertension, or prior vitrectomy surgery in the study eye.

A final total of 90 eyes from 90 patients were enrolled. Each cohort consisted of 30 patients. Investigators took IOP measurements before the injection (T0), as well as 30 seconds (T1), 5 minutes (T2), and 15 minutes (T3) after the injection. The primary outcome included absolute and relative changes at these four time points within each treatment group and between groups.

Each of the three cohorts exhibited highly significant differences in mean IOP at each time point compared with mean IOP at baseline (

 <.001). A significant difference occurred at T1 between groups 1 and 3 (

 = .002). No significant difference was observed at any time point between groups 1 and 2. At T1, mean IOP increased by 41.47 +/- 12.95 mm Hg, 43.46 +/- 8.97 mm Hg, and 32.19 +/- 11.06 mm Hg in groups 1, 2, and 3 respectively compared with baseline.

Notably, the team indicated that the IOP elevation pattern mirrored earlier studies, both in its increase shortly after injection and the gradual return below 21 mm Hg within 15 minutes. Additionally, while significant difference was found at T1, the average pressures showed no significant difference by T2 and returned within normal limits at T3. Investigators concluded the study by indicating no significant association between the type of anti-VEGF used and short-term postinjection IOP fluctuations.

“Further research involving larger sample sizes is necessary to validate the IOP fluctuations observed and to evaluate IOP changes following IVT aflibercept 8 g and faricimab in patients with glaucoma or ocular hypertension,” Paris and colleagues wrote. “Moreover, longitudinal studies are required to investigate potential long-term anatomical changes in retinal nerve fibre layer thickness after repeated IVT of these new formulations.”

Paris A, Volpe G, Perruchoud-Ader K, Casanova A, Menghini M, Grimaldi G. Short-term intraocular pressure changes after intravitreal aflibercept 2 mg, aflibercept 8 mg and faricimab: A prospective, comparative study. 

. 2024;109(5):600-605. doi:10.1136/bjo-2024-326053

El Chehab H, Agard E, Russo A, Boujnah Y, Dot C. Intraocular Pressure Spikes after Aflibercept Intravitreal Injections. 

. 2016;236(1):43-47. doi:10.1159/000446878

Knip MM, Välimäki J. Effects of pegaptanib injections on intraocular pressure with and without anterior chamber paracentesis: a prospective study. 

. 2012;90(3):254-258. doi:10.1111/j.1755-3768.2010.01904.x

A recent study assessed short-term intraocular pressure (IOP) changes following intravitreal injections of aflibercept 8 mg and faricimab, compared to aflibercept 2 mg. The study involved 90 patients with neovascular age-related macular degeneration and diabetic macular edema. Results showed significant IOP increases shortly after injection, which normalized within 15 minutes. Differences in IOP changes were noted between the groups at 30 seconds post-injection, but not at later time points. The study concluded no significant association between the type of anti-VEGF used and short-term IOP fluctuations.

While aflibercept 8 mg and faricimab both trigger intraocular pressure, the effects are transient and no more significant than other anti-VEGF treatments.

Intraocular Pressure Changes Transient, Consistent Among Anti-VEGF Treatments

New research has developed a Fibromyalgia Quality of Life Scale (FM-QoLS) specific to patients with 

 with high validity and reliability that can be used to address the multifaceted QoL challenges of these patients.

“Although several standardized tools have been used to evaluate symptom severity, functionality, and disease impact in fibromyalgia (i.e., the Fibromyalgia Impact Questionnaire and its revised version, there is no specific standardized questionnaire or scale that directly assesses QoL in fibromyalgia.

 Instead, in studies, QoL is evaluated by widely-used tools such as the Medical Outcomes Study Short Form (SF)-36, SF-12, Quality of Life Scale (QOLS), EuroQol (EQ-5D), and the Nottingham Health Profile (NHP). Given the lack in the literature, the current study aimed to develop a fibromyalgia-specific QoL scale,” lead investigator Ilke Coskun Benlidayi, MD, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Cukurova University, Adana, Türkiye, and colleagues wrote.

Benlidayi and colleagues developed the scale in four steps: (1) Issue collection, (2) Face validity and selection of the most relevant items, (3) Formation of the preliminary scale and pilot testing, and (4) Psychometric evaluation. For psychometric evaluation, the scale was administered to a sample of fibromyalgia patients.

The investigators used the Kaiser–Meyer–Olkin (KMO) test and Bartlett's Test of Sphericity to assess suitability for exploratory factor analysis (EFA); Cronbach's alpha, Guttman split-half test, and test–retest correlations to assess reliability; and Principal Axis Factoring to determine construct validity with exploratory factor analysis.

Benlidayi and colleagues tested the correlation of the scale with established measures of QoL, fibromyalgia impact, fatigue, sleep, and mood to assess convergent validity and examine floor and ceiling effects. They first developed an item list including 25 issues related to QoL in fibromyalgia. They removed 10 issues after assessing and rating the initial list through cognitive interviews. The investigators administered the remaining questions to 60 patients with fibromyalgia before finalizing the FM-QoLS to contain 14 items and 2 domains: symptomatology-functionality and psychosocial. (After inspection of inter-item correlations, Q15 was found highly correlated with Q12 [correlation coefficient, 0.920] and was removed from the scale.)

The scale exhibited moderate-strong correlations between most items, indicating that the scale has a homogeneous structure and measures the same construct. The FM-QoLS showed moderate-strong correlations with pain, anxiety, depression, sleep, fatigue, and established measures of QoL. Regarding the test–retest reliability of FM-QoLS items, the gamma values ranged from 0.923 to 0.995 (

“In conclusion, FM-QoLS is a 14-item QoL scale that is specific to patients with fibromyalgia. The scale has two domains: the symptomatology-functionality domain and the psychosocial domain. It allows for a comprehensive evaluation of fibromyalgia-related deterioration in QoL, with high reliability and validity. Future research could further refine the tool by exploring its use in diverse populations, as well as its role in informing treatment decisions and tracking patient progress over time. Compared to existing generic QoL measures, the FM-QoLS offers a detailed, fibromyalgia-specific perspective, which could help physicians better address the multifaceted challenges faced by patients,” Benlidayi and colleagues concluded.

Coskun Benlidayi I, Ornek C, Sariyildiz A, Sertdemir Y. Development of a fibromyalgia-specific quality of life instrument: the Fibromyalgia Quality of Life Scale (FM-QoLS). 

2025;45(6):142. Published 2025 May 16. doi:10.1007/s00296-025-05895-3

Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL (2009) The revised fibromyalgia ımpact questionnaire (FIQR): validation and psychometric properties. 

A new Fibromyalgia Quality of Life Scale (FM-QoLS) has been developed, offering a specific, reliable, and valid tool for assessing quality of life in fibromyalgia patients. Unlike existing generic tools, FM-QoLS addresses the unique challenges faced by these patients through its two domains: symptomatology-functionality and psychosocial. The scale was developed through a rigorous four-step process and demonstrated strong psychometric properties, including high reliability and validity. Future research may explore its application in diverse populations and its potential role in treatment planning and patient progress monitoring.

Researchers introduce the Fibromyalgia Quality of Life Scale (FM-QoLS), a reliable tool designed to assess the unique quality of life challenges faced by fibromyalgia patients.

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