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Sanofi Launches Long-term Safety Study for TZIELD in Stage 2 Type 1 Diabetes Patients

Real World Evidence
  • Sanofi has initiated an observational study to evaluate the long-term safety and efficacy of TZIELD (teplizumab-mzwv) in patients with Stage 2 Type 1 Diabetes.
  • The study compares patients treated with TZIELD against a control group to assess real-world outcomes of the approved drug that delays progression to Stage 3 Type 1 Diabetes.
  • The prospective cohort study began recruiting on September 27, 2024, and represents Sanofi's commitment to advancing early-stage diabetes management strategies.

Integra LifeSciences Launches Pediatric Registry for AERA Eustachian Tube Balloon Dilation System

Real World Evidence
  • Integra LifeSciences has enrolled the first patient in the Acclarent AERA Pediatric Registry, a prospective multi-center observational study evaluating real-world use of the AERA Eustachian Tube Balloon Dilation System in children.
  • The registry aims to capture safety and efficacy outcomes for up to 300 pediatric patients with obstructive Eustachian tube dysfunction across up to 20 U.S. sites.
  • Primary endpoint focuses on failure-free status following balloon dilation, with failure defined as need for revision surgery including additional procedures or tube placement.
  • The study will generate real-world evidence to support broader clinical adoption and improve reimbursement pathways for pediatric Eustachian tube balloon dilation procedures.

ADHD Medication Benefits Diminish as Prescription Rates Rise, Swedish Study Reveals

Real World Evidence
  • A Swedish population study of 247,420 individuals found that ADHD medications consistently reduced risks of self-harm, unintentional injury, traffic crashes, and crime across all age groups and sexes.
  • The protective effects of ADHD medications weakened over time as prescription rates increased from 0.6% to 2.8% between 2006 and 2020, particularly for unintentional injury, traffic crashes, and crime.
  • Changes in patient demographics did not fully explain the diminishing benefits, highlighting the need for ongoing evaluation of medication use and patient selection as prescribing expands.
  • The findings suggest that while ADHD medications remain beneficial, the real-world outcomes may be affected by shifts in the patient population receiving treatment.

Real-World Study Reveals Only 8% of Patients Continue GLP-1 Obesity Treatment After Three Years

Real World Evidence
  • Prime Therapeutics' three-year analysis of 5,780 commercially insured adults found only 8.1% remained on GLP-1 obesity medications throughout the study period.
  • High-potency obesity-approved drugs like semaglutide (Wegovy) showed better persistence at 14.3% compared to daily liraglutide at 2.5% over three years.
  • One-year persistence rates improved dramatically from 33.2% in 2021 to 62.7% in 2024, largely attributed to resolved drug shortages and better clinical management.
  • The study highlights the critical need for comprehensive care management programs and behavioral interventions to support long-term obesity treatment success.

Updated COVID-19 Vaccines Show Strong Protection Against Severe Illness in Comprehensive CDC Study

Real World Evidence
  • A comprehensive CDC VISION Network study spanning over 345,000 emergency department encounters and 111,000 hospitalizations found that 2023-2024 COVID-19 vaccines reduced critical illness risk by 48% during the first seven to 299 days after vaccination.
  • The vaccines demonstrated maximum protection during the first two months after vaccination, with up to 68% reduction in severe cases against critical illness, though effectiveness waned over time particularly beyond six months.
  • The study reinforces the importance of updated COVID-19 vaccination for vulnerable populations, especially adults 65 and older, as vaccines continued to provide strong defense against hospitalization and death throughout the study period.
  • Updated vaccines reduced emergency department visits by 24% and hospitalizations by 29%, offering significant protection above and beyond previous infection or vaccination during XBB and JN.1 Omicron subvariant waves.

Duvelisib-Romidepsin Combination Shows 61% Response Rate in Relapsed T-Cell Lymphomas

Real World Evidence
  • A real-world study by Mass General Brigham's PETAL Consortium demonstrated that the combination of duvelisib and romidepsin achieved a 61% overall response rate in 38 patients with relapsed/refractory T-cell lymphomas.
  • The treatment enabled 11 patients to proceed to stem cell transplantation, with 47% achieving complete response and no detectable cancer.
  • Patients with nodal T-follicular helper cell subtype showed particularly strong results with an 82% response rate to the combination therapy.
  • Despite manageable side effects and the need for dose modifications, the study provides evidence for this novel therapeutic strategy in aggressive blood cancers that resist standard treatment.

Theranica's Nerivio REN Wearable Shows Sustained Migraine Efficacy Over Three Years in Real-World Studies

Real World Evidence
  • Theranica presented three real-world evidence studies at the 2025 American Headache Society meeting demonstrating the sustained efficacy of its FDA-cleared Nerivio REN wearable for migraine treatment.
  • A long-term study showed the REN wearable maintains consistent efficacy over three years without signs of tachyphylaxis or treatment fatigue, providing ongoing pain relief and functional recovery.
  • Analysis of nearly 32,000 patients revealed comparable treatment outcomes between migraine with aura and without aura subtypes, reinforcing the device's reliable performance across different migraine types.
  • The studies support REN as a non-drug alternative for patients seeking sustainable migraine management without the risks of systemic side effects or drug interactions.

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.

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.
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