SWEDISH MEDICAL CENTER

Medtronic's Hugo Robotic Surgery System Meets Primary Endpoints in Landmark Urologic Trial

a month ago

• Medtronic's Expand URO clinical trial, the largest multi-center prospective IDE study for robotic-assisted urologic surgery in the U.S., successfully met both primary safety and effectiveness endpoints with 137 patients. • The Hugo RAS system demonstrated impressive safety outcomes with complication rates significantly below performance goals across all procedure types, and achieved a 98.5% surgical success rate, well above the 85% performance goal (p<0.0001). • Medtronic has submitted the Hugo RAS system to the FDA for urologic indications in Q1 2025, marking a significant step toward entering the U.S. market while continuing to expand its global presence across 25 countries.

Redefining Value Metrics in Cancer Care: Swedish Cancer Institute Director Calls for Reform

5 months ago

• Dr. Sara Grethlein emphasizes quality-adjusted life years (QALYs) as a crucial patient-centric metric for measuring value in cancer care, focusing on meaningful survival benefits. • The accessibility of advanced cancer treatments like CAR T-cell therapy faces significant challenges, particularly in rural areas where infrastructure limitations prevent delivery of complex treatments. • Future policy reforms should prioritize the development of "off-the-shelf" variants of personalized therapies to improve accessibility and reduce costs across geographical and socioeconomic barriers.

FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara

6 months ago

• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions. • Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications. • These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.

New Clinical Studies and Classification Criteria Advance Understanding of Axial PsA Treatment

9 months ago

• Leading research reveals that axial inflammation affects up to 40% of psoriatic arthritis patients, prompting efforts to establish clearer diagnostic criteria based on clinical features, imaging findings, and genetic markers. • Phase 2 ARGO study of sonelokimab and phase 4 STAR study of guselkumab are among key upcoming trials investigating new treatment options for axial psoriatic arthritis. • Collaborative efforts between major rheumatology research groups are developing new classification criteria for axial PsA to improve disease understanding and treatment approaches.

Acelyrin's Izokibep Shows Positive Phase 2b/3 Results in Psoriatic Arthritis

a year ago

• Acelyrin's izokibep demonstrated positive results in a Phase 2b/3 trial for psoriatic arthritis (PsA), showing efficacy and safety over 16 weeks. • The trial evaluated izokibep at different subcutaneous doses (160 mg QW, 160 mg Q2W, and 80 mg Q4W) against placebo in 351 adult patients with active PsA. • Izokibep, a small protein therapeutic, inhibits IL-17A and is being assessed in multiple late-stage trials for immune-mediated diseases, including hidradenitis suppurativa and uveitis. • Detailed findings will be presented at the European Alliance of Associations for Rheumatology (EULAR) Congress on June 15, 2024, by Dr. Philip Mease.

Acelyrin's Izokibep Meets Primary Endpoint in Phase 2b/3 Psoriatic Arthritis Trial

a year ago

• Acelyrin's izokibep demonstrated high statistical significance in meeting the primary endpoint of ACR50 at week 16 versus placebo in a Phase 2b/3 trial for psoriatic arthritis. • The study showed robust clinical responses in ACR70 and PASI100, with a favorable safety profile consistent with the IL-17A class, and a low study discontinuation rate. • Izokibep achieved clinically meaningful resolution in patients with a high burden of enthesitis, an effect not previously reported by other agents. • The results support izokibep's potential as a differentiated treatment, with the 160 mg Q2W dose showing higher clinical responses than approved IL-17A agents.

Therapeutic Trials for Long COVID-19: A Call to Action

2 years ago

The article discusses the ongoing challenges and research efforts in understanding and treating Long COVID, also known as Post-Acute Sequelae of SARS-CoV-2 infection (PASC). It highlights the need for therapeutic trials to address the persistent symptoms affecting a significant number of individuals post-acute SARS-CoV-2 infection. The National Institutes of Health's RECOVER initiative is mentioned as a key effort in this area, focusing on understanding the biological mechanisms behind Long COVID and exploring potential treatments.