The FDA approved tildrakizumab-asmn for adults with active psoriatic arthritis, expanding its use beyond moderate-to-severe plaque psoriasis.
The approval was supported by INSPIRE-1 and INSPIRE-2, phase 3 trials of tildrakizumab 100 mg in adults with active psoriatic arthritis.
In a pooled analysis of 806 participants, week 24 ACR20 responses occurred in 38.8% of patients receiving tildrakizumab and 24.4% receiving placebo.
Among participants with psoriasis affecting at least 3% of body surface area, 41.0% receiving tildrakizumab and 10.9% receiving placebo achieved at least 75% PASI improvement.
The most common adverse reactions, each reported in at least 3% of patients with psoriatic arthritis, were upper respiratory tract infections and COVID-19.
The FDA revised boxed warnings for Minivelle, Vivelle, and Vivelle-Dot, removing statements about cardiovascular disease, breast cancer, and probable dementia.
Information about cardiovascular and breast cancer risks remains elsewhere in the prescribing information, and the boxed warning for endometrial cancer with unopposed systemic estrogen remains.
The revised Vivelle-Dot label retains contraindications for current or prior breast cancer, deep vein thrombosis, pulmonary embolism, and arterial thromboembolic disease.
The label advises considering therapy initiation in women younger than 60 years or within 10 years of menopause and notes uncertainty about applying WHI findings to other estrogen products or routes.
The FDA reported that estradiol patch output doubled over 12 months and that no nationwide shortage was imminent, although localized supply difficulties persisted.
Objective: Evaluate the feasibility of monthly 5-day fasting-mimicking diet (FMD) cycles for people with type 2 diabetes (T2D) in primary care. Approach: Design
In a 1-year trial of 100 patients with type 2 diabetes, researchers compared monthly 5-day fasting-mimicking diet cycles plus usual care with usual care alone.
Among participants assigned to the fasting-mimicking diet, 61% completed the program, while 31% discontinued because of diet-related issues and 8% for other reasons.
Serum ketone levels were higher in the fasting-mimicking diet group than in the usual-care group, while treatment satisfaction did not differ between groups.
Focus groups identified convenience, short cycles, motivation, perceived health improvements, and social support as adherence facilitators; taste, portion size, frequency, and environmental temptation
The study assessed feasibility, not long-term clinical effectiveness, and its small sample and inclusion of patients taking metformin or no glucose-lowering medication limit applicability.
Objective: The article examines the objective, findings, and clinical context described in Top 10 evidence-based essentials in ObGyn. Approach: Cervical screeni
This retrospective, single-center study included 176 surgically treated patients with Bethesda II benign thyroid cytology and postoperative histopathology.
Postoperative malignancy was identified in 20 patients (11%), while 156 patients (89%) had benign findings.
Malignancy was found in 32% of patients with TIRADS classifications of 4 or greater, compared with 7% of those with lower classifications.
TIRADS classifications of 4 or greater were associated with about 5.7 times the adjusted odds of malignancy, and each additional year of age with about 8% lower odds.
The authors cautioned that the 11% malignancy rate reflects a selected surgical population and should not be generalized to all patients with Bethesda II nodules.
In this retrospective study, 31 patients with malignant distal femoral tumors underwent freezing tank–assisted pedicle freezing and were followed for a mean of 52.3 months.
Limb preservation was achieved in 90% of patients, and local recurrence occurred in 10%; all recurrences involved surrounding soft tissue, not frozen bone.
Estimated overall survival was 93% at 2 years and 82% at 5 years, while mean Musculoskeletal Tumor Society functional score was 87.7%.
No nonunions were reported, but 9 patients had nononcologic complications and 9 underwent reoperation.
The authors noted that the small, retrospective study lacked a comparison group and called for comparative studies against established reconstruction methods.
Objective: The article presents Erik Vaessen’s perspective on manufacturing challenges for cell and gene therapies, including scale-up, process development, and
High costs, complex workflows, specialized labor, and biological variability make consistent, large-scale cell and gene therapy manufacturing difficult.
Developers increasingly prioritize scalability, manufacturability, supply chain robustness, and commercial viability earlier in development.
Technology transfer, reproducibility, operator training, raw material variability, documentation, and GMP execution complicate the move to commercial manufacturing.
Advances in cell culture media and process development can improve cell growth, productivity, and consistency across production scales.
Automation, reliable supplies, and emerging in vivo approaches such as CAR-T and self-amplifying RNA may shape future manufacturing strategies.
Objective: The article examines the objective, findings, and clinical context described in The Unanswered Questions About Vitamins. Approach: Research trajector
Michael Rychlik’s research has focused on food analysis using mass spectrometry and stable isotopes, spanning flavor, toxins, and vitamins.
Rychlik says improved analytical methods revealed the complexity of vitamins, but limited sensitivity still prevents measuring them in their natural state.
Rychlik is interested in vitamin bioavailability and says some vitamins may not be adequately supplied by a general diet.
Rychlik says identifying and structurally assigning unknown compounds remains tedious and is interested in how AI could help.
Rychlik describes RAFA as a forum for new methods, emerging food-analysis topics, and discussion with colleagues.
Objective: To assess whether selectively enriching brain-derived tau improves the ability of blood tests to distinguish Alzheimer’s disease from amyotrophic lat
Direct serum testing found elevated brain-derived tau and p-tau217 in patients with Alzheimer’s disease and amyotrophic lateral sclerosis compared with disease controls.
Researchers used antibody-coated magnetic beads to enrich brain-derived tau before measuring tau and p-tau217 in a subgroup of the multicenter cohort.
After enrichment, brain-derived tau and brain-derived p-tau217 were elevated in Alzheimer’s disease but not in amyotrophic lateral sclerosis.
For distinguishing Alzheimer’s disease from amyotrophic lateral sclerosis, p-tau217’s area under the curve rose from 0.729 with direct testing to 0.900 after enrichment.
Mass spectrometry found brain-derived tau predominated in frontal cortex and big tau in skeletal muscle, supporting muscle-derived tau as a potential source of blood-test confounding.
Kenya has approximately 1 to 3 pathologists per million people, many concentrated in major cities, while shortages of histology laboratories and transport impede timely diagnosis.
The modular network separates slide preparation, courier logistics, and remote pathologist review, allowing a small number of laboratories and pathologists to serve multiple sites.
A centralized software platform coordinates hospitals, laboratories, and pathologists; the pilot reportedly reduced diagnostic turnaround times by 70% to 90%.
Standardized protocols, reporting templates, peer review, and consensus reporting support consistency across the network, which has served 79 facilities.
Local workforce training, locally generated diagnostic data, and African governance of health data are central to sustainable expansion and representative AI development.
Objective: Develop a filtration-based diagnostic platform to detect low concentrations of bacteria and assess antibiotic susceptibility rapidly. Approach: Platf
Researchers developed a filtration-based SERS platform that captures bacteria on a gold-coated glass microfiber filter and amplifies their molecular signals with additional gold particles.
In tests using Escherichia coli, the platform captured more than 99.9% of bacteria at the concentrations tested and detected levels as low as 1,000 CFU/mL.
A 1-hour culture step improved the platform’s detection sensitivity to 10 CFU/mL.
The platform distinguished Escherichia coli, Staphylococcus aureus, and Klebsiella pneumoniae by their molecular fingerprints.
In Escherichia coli tests, antibiotic responses to amikacin and ampicillin were distinguishable within 2 hours, but validation with patient blood samples and more pathogens remains necessary.
Objective: The article summarizes KFF projections of 2027 Medicare Part D premiums and cost-sharing requirements, including projected costs for enrollees who re
KFF projects that the average monthly premium for stand-alone Medicare Part D plans will rise 50%, from $34 in 2026 to $51 in 2027.
The projected 2027 average monthly premium is $9 for Medicare Advantage plans with Part D coverage, compared with $51 for stand-alone plans.
No stand-alone Part D plans will have zero premiums in 2027, affecting more than 4 million current enrollees who pay no premium.
Projected 2027 monthly premiums among the 8 national stand-alone plans range from $6.50 for Wellcare Value Script Rx to $204.50 for AARP Medicare Rx Preferred.
In 2027, the average deductible is projected to be $643 for stand-alone plan enrollees and $489 for Medicare Advantage Part D enrollees.
Objective: Correct a misspelling in the author and corresponding-author name for an Original Investigation on trauma-care resources and timely access for patien
Objective: The article describes HHS’s final rule specifying that gender dysphoria not resulting from a physical impairment falls within the statutory exclusion
Objective: Report an author-identified error in the study’s Funding section. Approach: Correction: The Funding section was revised. The correction notice does n
Objective: The article examines the objective, findings, and clinical context described in Applying Evidence-Based Care to Low-Risk Thyroid Cancer. Approach: Cl
Guidelines increasingly endorse thyroid lobectomy for selected patients with low-risk differentiated thyroid cancer, with tumors smaller than 4 cm and no nodal metastases or other high-risk features.
Total thyroidectomy remains the treatment for approximately 60% to 80% of patients with low-risk thyroid cancer despite evidence supporting lobectomy.
In interviews and observations across 7 practices, surgeons most often favored performance feedback, but no single intervention was identified as optimal.
Surgeons often viewed practice-changing interventions as more applicable to colleagues than to themselves, while professional identity and individualized decision-making shaped views of change.
Future research should test stakeholder-informed interventions across diverse settings and support individualized care, including less-intensive treatment for appropriate patients.
Objective: To describe an atypical, asymptomatic tattoo-associated cutaneous nontuberculous mycobacterial infection and its diagnostic and management considerat