Rapid Progression of CKD Can Be Detected Early Using Simple Markers in Primary Care
The 3-year risk of rapid progression from CKD stage G3 was 15% in a large Danish population. Study authors identified accessible key risk factors to aid early detection.
Resmetirom for NASH: MASESTRO-NASH Phase 3 Data in NEJM Precede PDUFA Date of 3-14-2024
Resmetirom vs placebo led to significantly greater proportion of adults reaching NASH resolution without increased fibrosis and with fibrosis improvement by ≥1 stage.
Global Obesity Rates Top One Billion, Quadrupling Among Youth from 1999-2022
Obesity rates in the US over the 3 decades rose from 11.5% to 21.7% among boys and from 11.6% to 19.4% among girls. US men ranked 10th highest for obesity in 2022.
Abrysvo Efficacy Sustained in Older Adults Through Second RSV Season
The bivalent vaccine demonstrated "durable efficacy" of more than 80% over 2 RSV seasons, according to Pfizer's report of topline findings from the RENOIR trial.
Plasma Immunoassay for Alzheimer Disease Found Highly Accurate and is Commercially Available
The accuracy of the test in detecting Aβ and tau pathology underscores its potential to become an accessible and cost effective tool for Alzheimer diagnosis.
ACIP Recommends Monovalent COVID-19 Booster for Older Adults this Spring
COVID-19 hospitalizations have never fall below 6000/week, according to the ACIP; those aged 65+ have the highest inpatient rate, those aged 75+ have the highest mortality.
Semaglutide Shows Potential for Significant CVD Prevention in Analysis of Real-World Data
Analysis of heart registry data for SELECT trial-eligible adults (obesity, first MI, no diabetes) found an NNT of 49 and 5-year MACE incidence of 10.7%.
Viking Therapeutics Dual GIP/GLP-1 Mimetic Drives Weight Loss of Up to 14.7% in Phase 2 Findings
Viking's VENTURE trial met primary and all secondary endpoints, with GI-related TAEAs reported as mild/moderate and diminishing over the course of the 13-week study.
Atogepant Safe and Effective in Treatment-Resistant Episodic Migraine: ELEVATE Phase 3b Trial
Atogepant once daily reduced mean monthly headache days in adults for whom up to 4 classes of oral migraine preventives were ineffective.
Needle-free Epinephrine Delivery: Perceptions of Physicians, Patients, and Caregivers
AAAAI 2024. Needle phobia is just one of the barriers to not just using an epinephrine autoinjector but to carrying one at all, according to 2 sets of surveys findings.
Survodutide, Dual Glucagon/GLP-1 Mimetic, Improves MASH in 83% of Phase 2 Trial Participants
The statistically significant improvements in MASH with survodutide were seen without worsening fibrosis and included a relative reduction of steatosis of 30%.
First-Ever Long COVID Tissue Bank Launched at University of California San Francisco
"Viral reservoirs" in human tissue may preserve the SARS-CoV-2 virus, provoking an immune response that could drive long COVID-associated symptoms.
Neffy Generates Favorable PK/PD Data Under Nasal Allergen Challenge in Repeat Dosing Study Requested by FDA
neffy (epinephrine nasal spray) delivered a PK and PD profile greater than or similar to that of IM epinephrine after extreme nasal challenge, reports ARS Pharmaceuticals.
SCIT May Augment Treatment for EoE with Comorbid Allergic Rhinitis: New Observations
The largest study of the differential impact of subcutaneous immunotherapy on people with EoE and allergic rhinitis found no worsening of EoE and that it could be "helpful."
EoE in Children Treated with Dupilumab More Severe at Diagnosis, Study Finds
AAAAI 2024. Dupilumab-treated eosinophilic esophagitis in children was also more often associated with comorbid asthma, according to researchers.
FDA Accepts Dupilumab sBLA for Priority Review for Treatment of COPD with Type 2 Inflammation
A PDUFA date of June 27, 2024 has been set for approval of a 6th dupilimab indication - as add-on therapy for individuals with COPD and eosinophilic inflammation.
New neffy Data on Clinical Efficacy Presented at 2024 AAAAI Annual Meeting
AAAAI 2024. New data on neffy (epinephrine nasal spray) include the first report of efficacy after oral food challenge in a pediatric population at risk for anaphylaxis.
Dupilumab Effective Up to 5 Years in Adults with Moderate-to-Severe Atopic Dermatitis in Open-Label Extension Study
AAAAI 2024. Reduction of AD signs and symptoms was significant among approximately half of study participants at 4 weeks and continuously rose through week 260, investigators report.
First Study of Oral Mucosal Immunotherapy for Peanut Allergy Elicits Robust Immunologic Response in Adults
AAAAI 2024. Oral mucosal immunotherapy delivered via metered-dose toothpaste produced a statistically significant increase in IgG4 and a decrease in IgE/IgG4 ratio.
Tezepelumab Demonstrates Sustained Post-Treatment Reductions in CSU Disease Activity, Inflammatory Markers
AAAAI 2024. The effects, seen 18 to 20 weeks after discontinuation of tezepelumab, suggest a persistent effect of thymic stromal lymphopoietin (TSLP) blockade in CSU.
Women with IBD at Risk for Reduced Fertility Even During Clinical Disease Remission, Study Suggests
Histologic inflammation was associated with reduced fertility whether IBD disease was active or quiescent in a nationwide study of Swedish women aged 15 to 44 years.
Omalizumab Granted First FDA Indication for Children and Adults with Multiple Food Allergies
The OUtMATCH trial showed that individuals as young as age 1 year could tolerate small amounts of peanut and other allergens without an allergic reaction.
Atlantic Health System Tests Novel CAR-T Cell Therapy for Lupus in First US Patient
In the open-label, phase 1 study, participants' own T cells will be extracted and engineered to target and eliminate autoreactive B cells and to potentially reset the immune system.
T2D Remission After Gastric Bypass Persists, Despite Weight Regain
People with T2D and obesity who had gastric bypass surgery maintained significant levels of disease remission, despite up to 100% weight regain, study finds.
Tighter Glycemic Control in Type 2 Diabetes May Reduce Risk for All-Cause Dementia: New Findings
Comprehensive management of T2D in primary care settings reduced risk of all-cause dementia by 28%, with lower HbA1c linked to lower, but still elevated risk.
Women with Poor Sleep During Midlife at Significantly Elevated Risk for Future CVD
Women aged 40 to 65 years who had persistent insomnia and poor sleep duration were at a 75% greater risk for incident CVD over 2 decades of follow up.
Reducing Out-of-Pocket Rx Costs May Help Improve Diabetes Outcomes, Particularly for those with Lower Incomes
Acute, preventable diabetes complications days fell by 8.4% among participants enrolled in a preventive drug list benefit and by even more among low-income subscribers.
Takeda Announces Approval of First Oral Therapy for Eosinophilic Esophagitis
Budesonide oral suspension is the first oral therapy for EoE and represents a needed option in the category, offering flexibility for both patients and clinicians.
Apixaban and Aspirin Appear Equal Against Recurrent Stroke in Individuals with Cardiopathy
Anticoagulation and antiplatelet therapy appeared equally effective in reducing risk of recurrent stroke following cryptogenic stroke in persons with evidence of atrial cardiopathy.
GSK RSV Vaccine Arexvy Under FDA Priority Review for Prevention of RSV in High-Risk Adults Aged 50 to 59 Years
Approval of the application would extend the current Arexvy indication for prevention of RSV in adults aged 60 years and older; a June 2024 PDUFA date is set.
