Latest news with #tezepelumab
Medscape
4 days ago
- Business
- Medscape
Tezepelumab Curbs Oral Corticosteroid Use in Severe Asthma
The addition of tezepelumab to standard treatment allowed half the adults with severe asthma to discontinue their use of oral corticosteroids (OCS) after 1 year, according to new data from nearly 300 individuals. Tezepelumab, a human monoclonal antibody, has been associated with reduction in the use of OCS in patients with OCS-dependent asthma, David J. Jackson, MD, professor and clinical director, Guy's Severe Asthma Centre at Guy's Hospital King's College London, London, England, and colleagues wrote in an abstract presented at American Thoracic Society (ATS) 2025 International Conference. Many patients with severe asthma take OCS, but previous research has shown associations between extended OCS use and increased risk for a range of side effects including osteoporosis and fractures, hypertension, and infections, and more strategies are needed to help these patients reduce OCS use, the researchers noted. 'We know prolonged oral corticosteroid use leads to adverse effects, including bone, cardiovascular, metabolic, gastrointestinal and psychiatric disorders, and adrenal insufficiency,' Jackson said in an interview. 'The WAYFINDER trial is a multicenter, open-label, single-arm trial evaluating the efficacy and safety of tezepelumab compared to placebo in severe asthma patients who require maintenance use of OCS alongside their standard treatment,' he said. A previous phase 3 OCS-sparing study known as SOURCE did not meet its primary endpoint, but patients with baseline blood eosinophil counts ≥ 150 cels/μL who received tezepelumab achieved a reduction in daily maintenance OCS (mOCS) dose compared with placebo patients, the researchers wrote in their abstract. 'The WAYFINDER trial was designed to accelerate data collection and specifically address the complexities in the SOURCE trial design that may have contributed to the result of the primary endpoint,' Jackson told Medscape Medical News . The WAYFINDER trial enrolled 298 adults with severe asthma who had received OCS for at least 3 months before starting the study. All participants received 210 mg of subcutaneous tezepelumab every 4 weeks for up to 52 weeks after a 4-week induction period. The co-primary endpoints were the proportion of patients who reduced their daily mOCS to 5 mg/d or less or discontinued OCS without loss of asthma control. A total of 273 patients completed the study; the mean baseline mOCS was 10.8 mg/d, and patients were assessed at 28 weeks and 52 weeks. Overall, 88.9% and 89.9% of patients reduced their mOCS to 5 mg/d or less by week 28 and week 52, respectively, while 32.2% and 50.3% discontinued OCS at these time periods, respectively. In a post hoc analysis, 82.2% of patients whose reason for systemic corticosteroids was related to adrenal insufficiency achieved an mOCS dose of 5 mg/d or less without loss of asthma control at week 52. The study was limited by the open-label design, but the safety profile was consistent with previous studies of tezepelumab, researchers said. A 2023 meta-analysis of safety data on tezepelumab for uncontrolled asthma showed that the most common adverse events were nasopharyngitis, headache, and bronchitis, and most AEs occurred within a month of starting tezepelumab. Rates of serious adverse events were lower in patients receiving tezepelumab than those receiving placebo in a pooled analysis. The standout findings from the study are the clinically meaningful reductions in maintenance OCS use or complete discontinuation achieved with tezepelumab among a broad severe asthma patient population, Jackson told Medscape Medical News . In addition, two thirds of participants remained exacerbation-free despite OCS dose reductions, and the OCS-sparing effect of tezepelumab was observed across pre-specified patient subgroups, including those defined by baseline blood eosinophil counts (BEC), fractional exhaled nitric oxide (FeNO) level and allergy status, Jackson said. 'These findings reinforce tezepelumab's efficacy in severe asthma as the first and only biologic targeting thymic stromal lymphopoietin (TSLP) with demonstrated efficacy for severe asthma patients across phenotypes and irrespective of biomarker levels including BEC, allergic status, and FeNO,' he said. Improving Short-Term Health and Long-Term Wellness 'For people living with severe asthma, achieving stable control and reducing or eliminating reliance on oral corticosteroids is a critical goal, not only for respiratory health but also for long-term well-being,' Jackson told Medscape Medical News . 'By showing the benefit of targeting TSLP at the top of the inflammatory cascade and controlling asthma effectively with tezepelumab, we may be able to reduce these risks from OCS and significantly improve control for patients living with severe asthma,' Jackson said. 'We look forward to sharing a manuscript in the future for the phase 3b WAYFINDER study,' he added. Support for Steroid-Sparing The current study highlights an important population: Patients with asthma who are dependent on OCS, said Sucharita Kher, MD, pulmonologist and vice chair of clinical operations and quality for the Department of Medicine at Tufts Medical Center, in an interview. The endpoint tapering OCS without loss of asthma control is clinically meaningful because of the known side effects of OCS, said Kher, who was not involved in the study. The results were not unexpected, but more details on whether patients with eosinophils below 150 cells/µL also benefitted from tezepelumab would be helpful, Kher noted. The data are exciting because they suggest another option for patients with OCS dependent asthma, said Kher. 'The data also guide clinicians to adopt a strategy to wean patients off OCS when on tezepelumab with the goal of reducing OCS exposure and hence, side effects of prolonged OCS use,' she said. 'We know that OCS have side effects and negative consequences on factors including bone health, blood pressure, and blood sugar control and infection risk,' she added. Potential barriers to expanding the use of tezepelumab for reducing OCS in asthma patients exist at the patient and healthcare systems levels, Kher told Medscape Medical News . Patient-level barriers include cost sharing, worry/hesitancy about injections, lack of specialty access, and patient health literacy, she said. In addition, healthcare system barriers include a lack of knowledge on the part of primary care providers, and even some specialty physicians, of the benefits of biologics for severe asthma, said Kher. Other potential challenges include limited infrastructure in clinician offices, such as trained personnel and staff to navigate prior auth/insurance mandates, pre-authorization barriers, and denials based on tiers by insurance companies, she noted. 'Overcoming the barriers requires a multipronged approach, improving awareness and education for healthcare professionals, improve access to specialty care for patients, and advocacy to reduce the processes for insurance approvals,' Kher said.
Yahoo
15-05-2025
- Health
- Yahoo
Eosinophilic Esophagitis Market Set to Surge as New Research Unveils Breakthrough Treatments
The dynamics of the eosinophilic esophagitis market are anticipated to change in the coming years owing to the expected launch of emerging therapies such as APT-1011 (Ellodi Pharmaceuticals), tezepelumab (AstraZeneca,) and ESO-101 (EsoCap) during the forecast period (2024–2034). LAS VEGAS, May 15, 2025 /PRNewswire/ -- Eosinophilic esophagitis (EoE) is a multifaceted disease marked by diverse clinical features, including variations in age of onset, symptoms, disease progression, comorbid conditions, and treatment responses. Although diagnosing and managing EoE remains challenging, both clinical and experimental studies consistently support that the disease is primarily driven by a CD4+ T helper type 2 (Th2) allergic inflammatory reaction to food allergens in the esophageal lining. In 2023, around 800,000 prevalent cases of EoE were diagnosed across the 7MM, with this number projected to grow at a moderate CAGR through 2034. Current eosinophilic esophagitis treatment guidelines include dietary modifications, medications, and endoscopic procedures. Among pharmacological options, proton pump inhibitors (PPIs) and corticosteroids are commonly used, though they are frequently associated with high relapse rates. The market holds limited approved eosinophilic esophagitis medications such as DUPIXENT (dupilumab) and JORVEZA (budesonide). Learn more about the treatment options for eosinophilic esophagitis @ Medications for Eosinophilic Esophagitis Treatment DUPIXENT (dupilumab) is a human IgG4 monoclonal antibody that blocks IL-4 and IL-13 signaling by targeting the IL-4Rα subunit, which is common to both IL-4 and IL-13 receptor complexes. In May 2022, the U.S. FDA approved DUPIXENT for the treatment of eosinophilic esophagitis in adults and adolescents aged 12 and older who weigh at least 40 kilograms (88 pounds). More recently, in January 2024, the FDA expanded its indication to include children as young as 1 year old with EoE. DUPIXENT eosinophilic esophagitis received Breakthrough Therapy Designation (BTD) from the FDA in September 2020 for treating EoE in patients aged 12 and older. DUPIXENT eosinophilic esophagitis was developed using Regeneron's VelocImmune technology and has been co-developed with Sanofi since 2007. JORVEZA (budesonide), developed by Dr. Falk Pharma GmbH, is a non-halogenated glucocorticoid that exerts its primary anti-inflammatory effect through activation of the glucocorticoid receptor. In January 2018, JORVEZA received marketing authorization for treating EoE in adults over 18 years old. It also holds orphan drug designation. For acute treatment, the recommended dosage is two 1 mg tablets taken twice daily. To know more about the eosinophilic esophagitis treatment, visit @ Eosinophilic Esophagitis Drug Information Despite the recent FDA and EMA approvals of two eosinophilic esophagitis medications, effective curative options remain limited. Concerns around the safety and efficacy profiles of these newly approved drugs, along with the lack of standardized dosing guidelines, often deter gastroenterologists from incorporating them into routine clinical practice. The emerging eosinophilic esophagitis treatment landscape consists of tezepelumab (AstraZeneca), APT-1011 (Ellodi Pharmaceutical), ESO-101 (EsoCap), and others. The eosinophilic esophagitis market presents a wide opportunity for these players to capitalize on the untapped eosinophilic esophagitis drugs market. Discover which therapies are expected to grab major eosinophilic esophagitis drug market share @ Eosinophilic Esophagitis Mechanism of Action APT-1011 is an innovative oral formulation of fluticasone that utilizes Adare's proprietary AdvaTab technology, enabling targeted topical delivery to the esophagus. It has been granted Orphan Drug Designation (ODD) by both the FDA and EMA, along with Fast Track Designation (FTD) from the FDA. These regulatory designations were based on clinical data demonstrating histological remission and symptom improvement following a 12-week induction phase, as well as the sustained maintenance of these benefits. Following the successful completion of the FLUTE 1 (Phase IIb) and FLUTE 2 (Phase III) studies, the company has initiated FLUTE 3, a second ongoing Phase III trial. TEZSPIRE (tezepelumab) is a potentially first-in-class human monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a key cytokine that initiates multiple inflammatory pathways. It has also received ODD from the FDA for the treatment of eosinophilic esophagitis. The drug is currently being evaluated in a Phase III clinical trial (CROSSING) to assess its efficacy and safety in EoE patients. ESO-101 is a novel, esophagus-targeted formulation of mometasone furoate, designed to enhance mucosal contact and maximize drug deposition in the esophagus. It holds promise for delivering meaningful clinical improvements in EoE patients. ESO-101 has received ODD from the FDA and has successfully completed a Phase II trial in EoE, with results already published. Discover more about eosinophilic esophagitis drugs in development @ Eosinophilic Esophagitis Clinical Trials The anticipated launch of these emerging eosinophilic esophagitis treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the eosinophilic esophagitis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for eosinophilic esophagitis in the 7MM is expected to grow from USD 1.8 billion in 2023 at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. DelveInsight's latest published market report titled Eosinophilic Esophagitis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the eosinophilic esophagitis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The eosinophilic esophagitis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Prevalence of EoE Age-specific Cases of EoE Gender-specific Cases of EoE The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM eosinophilic esophagitis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this eosinophilic esophagitis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the eosinophilic esophagitis market. Also, stay abreast of the mitigating factors to improve your market position in the eosinophilic esophagitis therapeutic space. Related Reports Eosinophilic Esophagitis Epidemiology Forecast Eosinophilic Esophagitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted eosinophilic esophagitis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Eosinophilic Esophagitis Pipeline Eosinophilic Esophagitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key eosinophilic esophagitis companies, including Sanofi, Regeneron, AstraZeneca, Bristol Myers Squibb, Ellodi Pharmaceuticals, Allakos, EsoCap AG, Arena Pharmaceuticals, GlaxoSmithKline, Landos Biopharma, Calypso Biotech, DBV Technologies, Celldex Therapeutics, NexEos Bio, Aqilion, Quorum Innovations, Serpin Pharma, RAPT Therapeutics, among others. Eosinophilic Disorder Market Eosinophilic Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key eosinophilic disorder companies including Children's Hospital Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases, among others. Eosinophilic Disorder Pipeline Eosinophilic Disorder Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key eosinophilic disorder companies, including Children's Hospital Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
