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Insulet Presents Real-World Evidence of Omnipod 5 Benefits in Type 2 Diabetes at ADA 2025

Real World EvidenceFDA Approval
  • Insulet shared real-world glycemic outcomes data from over 23,000 people with type 2 diabetes using the Omnipod 5 automated insulin delivery system in the United States.
  • New analysis from the SECURE-T2D pivotal trial demonstrated that Omnipod 5 significantly reduced diabetes distress in adults with type 2 diabetes over 13 weeks.
  • More than 30% of new patient starts in Q1 2025 were people with type 2 diabetes, reflecting growing adoption since FDA expanded indication in August 2024.
  • The company is advancing development of next-generation hybrid closed-loop and fully closed-loop systems, with plans to begin second EVOLUTION studies for type 2 diabetes in the second half of 2025.

Adalimumab Biosimilars Show High Acceptance and Long-Term Durability in IBD Patients Across Age Groups

Monoclonal AntibodyReal World Evidence
  • A French observational study found 92% of adult IBD patients accepted switching from adalimumab reference product to biosimilars, with 71% remaining on biosimilar therapy at 12 months.
  • Real-world data from European pediatric IBD centers demonstrated high durability rates for adalimumab biosimilars, with 67% of patients continuing treatment after median 26-month follow-up.
  • Both studies confirm cost-effectiveness of adalimumab biosimilars, with pediatric study estimating savings of 5,030 Euro per patient per year compared to reference product.
  • Clinical remission rates remained stable or improved in both populations, with 85% of adult switchers and 72% of pediatric patients achieving remission at 12 months.

Large Real-World Study Finds No Increased Cancer or Cardiovascular Risk with JAK Inhibitors in Rheumatoid Arthritis

Real World Evidence
  • A comprehensive analysis of 53,169 treatment initiations across 13 international registries found no significantly higher cancer risk in rheumatoid arthritis patients treated with JAK inhibitors compared to biologic DMARDs.
  • Separate cardiovascular safety data from 51,233 patients showed JAK inhibitors did not increase major adverse cardiovascular events compared to TNF inhibitors, with rates of 6.97 versus 7.57 per 1,000 person-years respectively.
  • The findings provide reassuring real-world evidence addressing previous safety concerns raised by the ORAL Surveillance trial, though increased keratinocyte cancer risk remains a consideration for JAK inhibitor therapy.
  • GLP-1 receptor agonists showed potential cardioprotective effects in RA patients on JAK inhibitors, with significantly lower rates of acute coronary syndromes and deep venous thrombosis.

Cytovale's IntelliSep Diagnostic Reduces Sepsis Mortality by 39% in Large Real-World Study

Real World Evidence
  • Cytovale's FDA-cleared IntelliSep diagnostic achieved a 39% relative reduction in sepsis mortality in a real-world study of over 12,000 patients at Our Lady of the Lake Regional Medical Center.
  • The rapid diagnostic test delivers results in eight minutes from a routine blood draw and reduced average hospital length of stay by 0.76 days for sepsis patients.
  • The study demonstrated improved resource allocation with a 40% decrease in blood culture usage for low-risk patients and an 8% increase for high-risk cases.
  • Following successful validation, the health system has expanded IntelliSep implementation across four additional sites within Franciscan Missionaries of Our Lady Health System.

T1D Exchange to Present 13 Real-World Data Studies at ADA 2025 Scientific Sessions

Real World Evidence
  • T1D Exchange will present 13 real-world data studies at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025.
  • The studies focus on advances in diabetes screening, mental health, health equity, and early intervention, with particular emphasis on continuous glucose monitoring adoption in type 2 diabetes patients using GLP-1 therapy.
  • The research draws from T1D Exchange's Quality Improvement Collaborative network of over 60 endocrinology clinics treating more than 150,000 patients and their Registry of over 20,000 type 1 diabetes participants.
  • The organization has contributed to more than 100 publications in leading medical journals since 2020, strengthening its leadership in diabetes research and care improvement.

LivaNova's CORE-VNS Study Demonstrates Sustained Seizure Reduction in Drug-Resistant Epilepsy Patients

Real World Evidence
  • LivaNova's comprehensive CORE-VNS study of over 800 patients worldwide demonstrates sustained effectiveness of VNS Therapy for drug-resistant epilepsy over 36 months.
  • The study shows 77% median reduction in generalized tonic-clonic seizures at 24 months, with 43% of participants achieving complete seizure freedom.
  • VNS Therapy proved effective across age groups, with early seizure reduction observed at three months and benefits maintained throughout the study period.
  • The real-world evidence validates VNS Therapy as an effective adjunctive treatment for patients who have failed multiple anti-seizure medications.

Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.

NCT03529045Completed
LivaNova
Posted 2/5/2018

Comprehensive Analysis of Methotrexate Safety Profile Reveals Gender and Age-Specific Adverse Event Patterns

Real World Evidence
  • A comprehensive analysis of 130,818 adverse event reports from the FDA's FAERS database spanning 2004-2024 reveals methotrexate's broad safety profile, with immune system disorders showing the strongest signal strength at ROR 2.35.
  • Female patients experienced significantly more adverse events (64.2% of reports) with longer onset times (median 227 days) compared to males (median 78 days), while males showed higher risks for severe complications like pneumonia and pancytopenia.
  • The study identified previously unreported adverse reactions not listed in prescribing information, including drug allergy, fatigue, and headache, suggesting methotrexate's side effect spectrum may be broader than currently recognized.

Real-World Data Confirms Low-Severity Safety Profile for Lisocabtagene Maraleucel Across Blood Cancer Settings

CAR-TReal World Evidence
  • Real-world data from 877 patients and clinical trial data from 702 patients demonstrate that most cytokine release syndrome and neurological events with lisocabtagene maraleucel occur within 15 days of infusion and are not severe.
  • Among patients experiencing late-onset adverse events after day 15, the vast majority were grade 1/2 events that resolved without requiring intensive care unit-level management.
  • The findings support optimized monitoring strategies that could improve patient access to CAR-T therapy while maintaining safety standards across multiple blood cancer indications.

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

NCT03483103CompletedPhase 2
Juno Therapeutics, a Subsidiary of Celgene
Posted 7/27/2018

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT03331198RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/27/2017

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

Real-World Data Shows Yescarta CAR-T Therapy Safe and Effective in Outpatient Setting

CAR-TReal World Evidence
  • Kite presented real-world data from 238 patients showing comparable safety and effectiveness outcomes for Yescarta CAR-T therapy administered in outpatient versus inpatient settings for relapsed/refractory large B-cell lymphoma.
  • The analysis found no significant differences in rates of cytokine release syndrome, neurologic events, or immune effector cell-associated neurotoxicity syndrome grade ≥3 between treatment settings.
  • Nearly 25% of outpatient-assigned patients avoided hospital admission within 30 days, and 50% avoided admission within 3 days, demonstrating potential cost-effective advantages.
  • The study supports expanding access to this potentially curative one-time treatment while reducing healthcare system burden and improving patient convenience.

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

Large-Scale Study Reveals Significant Racial Disparities in Early-Onset Colorectal Cancer Diagnosis

Real World EvidenceOncology
  • A comprehensive analysis of 105,000 colorectal cancer patients found that Black, Hispanic, Latino, and American Indian populations are disproportionately represented in early-onset cases diagnosed before age 50.
  • Early-onset patients were significantly more likely to be diagnosed at advanced stages (III and IV), with a 10 percentage point higher likelihood compared to average-onset patients.
  • Current screening guidelines starting at age 45 fail to cover over half of early-onset patients, particularly those under 44, highlighting the need for risk-based screening approaches.
  • The study revealed diagnostic delays of 4-8 months longer for younger patients, emphasizing the urgent need for reduced time from symptom onset to definitive diagnosis.
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