Tezepelumab Slashes Surgery Risk in Severe Nasal Polyposis
Chronic rhinosinusitis with NP is a chronic inflammatory disorder characterized by persistent inflammation of the nasal mucosa and the presence of benign growths (NP). These polyps can obstruct nasal airflow and lead to symptoms such as nasal congestion, loss of smell, rhinorrhea, facial pressure or pain, sleep disturbances, and a substantial reduction in quality of life. Standard therapies include intranasal or systemic corticosteroids, surgical resection, and more recently, biologic agents.
Adults With Severe Nasal Polyposis
Tezepelumab, developed by AstraZeneca in collaboration with Amgen, is a first-in-class human monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), an upstream epithelial cytokine known to initiate and amplify various inflammatory pathways, including those involved in allergic and eosinophilic airway diseases. Preclinical and clinical data suggest that inhibiting TSLP could be an effective strategy for modulating inflammation in both upper and lower airway diseases.
The WAYPOINT study was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial designed to assess the efficacy and safety of subcutaneous tezepelumab in adults with severe CRSwNP. Participants received either tezepelumab or placebo for a 52-week treatment period, followed by a posttreatment follow-up phase lasting 12-24 weeks.
Reduction in Polyp Severity
Treatment with tezepelumab resulted in a significant reduction in NP severity, as demonstrated by the co-primary endpoints in the phase 3 WAYPOINT trial. The NP score improved by −2.065 ( P < .0001), and use of systemic corticosteroids was reduced by 88% ( P < .0001) compared with placebo. Improvements in NP score were observed as early as week 4, while improvements in nasal congestion score were noted by week 2, the first posttreatment assessment. These effects were sustained through week 52.
Significant and clinically meaningful improvements were also observed across all key secondary endpoints in the overall trial population. Tezepelumab was associated with a 98% reduction in the need for NP surgery ( P < .0001) and again an 88% reduction in systemic corticosteroid use ( P < .0001) compared with placebo.
'The WAYPOINT study confirms the efficacy of tezepelumab in reducing the need for further surgery, systemic corticosteroid use, improving SNOT-22 scores, and restoring olfactory function,' said Geoffrey Mortuaire, MD, PhD, head of the Department of ENT and Head and Neck Surgery at Lille University Hospital, Lille, France. 'The rapid and consistent treatment response observed in patients supports the potential for making tezepelumab more broadly available. We hope to see its approval for this indication in France soon.'
Favorable Safety Profile
Tezepelumab was generally well tolerated in patients with severe nasal polyposis and demonstrated a safety profile consistent with its current indication for severe asthma. The most frequently reported adverse events in the WAYPOINT study were COVID-19, nasopharyngitis, and upper respiratory tract infections. There were no clinically meaningful differences in safety outcomes between the tezepelumab and placebo groups.
Tezepelumab is currently approved as add-on maintenance therapy for severe asthma in adults and adolescents aged 12 years or older who remain uncontrolled despite high-dose inhaled corticosteroids and additional maintenance therapy. It is approved in the United States, Europe, Japan, and nearly 60 countries worldwide. Regulatory applications for tezepelumab in severe nasal polyposis are currently under review by health authorities in several regions, according to AstraZeneca.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Fox News
3 days ago
- Fox News
Tennis champion Monica Seles reveals incurable disease as doctor shares what to know
Tennis champion Monica Seles is speaking publicly for the first time about her battle with a rare, incurable muscle-weakening disease. Myasthenia gravis (MG) is a chronic neuromuscular disease that causes weakness in "voluntary muscles," according to the National Institute of Neurological Disorders and Strokes. Voluntary muscles are the ones that connect to the bones, face, throat and diaphragm. They contract to move the arms and legs and are essential for breathing, swallowing and facial movements. "My MG journey over the past five years has not been an easy one," Seles said in a press release announcing her collaboration with the immunology company argenx. "I felt isolated and defeated, as many of the activities I enjoyed were no longer physically possible for me." Seles' partnership with argenx aims to raise awareness and understanding of MG, and to connect those affected with available tools and resources. Myasthenia gravis is classified as an autoimmune disease, according to Dr. Earnest Lee Murray, a board-certified neurologist at Jackson-Madison County General Hospital in Jackson, Tennessee. This means the body's own defense system attacks the connection between the nerves and muscles. "I felt isolated and defeated, as many of the activities I enjoyed were no longer physically possible for me." "Myasthenia gravis is different from other neuromuscular diseases in that oftentimes, patients' symptoms fluctuate throughout the day," Murray told Fox News Digital. Overall symptoms range from very mild double vision and droopiness of the eyelids to difficulty walking, breathing and swallowing. "Some patients who start with only mild eye symptoms can progress to more severe symptoms in the first few years of their diagnosis," the doctor added. However, some patients only experience eye issues. Heat, such as from summer weather or hot showers, can make symptoms worse, according to experts. As physical exertion can also exacerbate symptoms, Murray noted that patients must pace themselves. Certain health conditions — like COVID-19, the flu or urinary tract infections — can trigger a serious worsening of symptoms, called a "myasthenic crisis," which often leads to hospitalization for closer respiratory monitoring. It's important for patients to let their physicians know they have myasthenia gravis before starting a new medication, Murray said, as some drugs, including antibiotics, can worsen symptoms. "If there is a question, patients can always check with their neurologist," he advised. Doctors typically manage MG in two ways. First, they may prescribe a medication like pyridostigmine, which can temporarily reduce muscle weakness, according to Mayo Clinic. They may also prescribe medications that calm the immune system to stop it from attacking the nerves and muscles. In the past, this immune suppression was done with steroids like prednisone. Now, there are newer medicines that target the disease more directly. These targeted treatments can work well and may cause fewer side effects, according to Murray. While MG can be serious, the doctor stressed that it's not the end of the road. "Most patients live a fairly normal life, both personally and professionally," he said. "With close management and a neurologist familiar with MG, treatments can be tailored to optimize patients' quality of life." For more Health articles, visit Anyone who experiences occasional double vision, eyelid drooping or weakness that gets worse with fatigue should talk to their doctor about getting tested, Murray recommends. Diagnosis usually involves blood tests, nerve tests and a neurological evaluation. Symptoms like trouble breathing, swallowing or holding the head up require immediate emergency care, Murray said.
Yahoo
5 days ago
- Yahoo
Tennis Hall of Famer Monica Seles Opens Up About Myasthenia Gravis Diagnosis: 'It's a Difficult One'
The nine-time major tennis champion is raising awareness about the neuromuscular disease ahead of this month's U.S. OpenNEED TO KNOW Tennis Hall of Famer Monica Seles is opening up about her Myasthenia Gravis diagnosis Seles, a nine-time major tennis champion, said adjusting to life with the disease has been "difficult" Seles is partnering with a Dutch immunology company to raise awareness about the neuromuscular diseaseMonica Seles is opening up about a neuromuscular disease diagnosis that has impacted her daily life 'quite a lot' in recent years. The International Tennis Hall of Famer, 51, revealed to the Associated Press that she was diagnosed three years ago with myasthenia gravis, a neuromuscular autoimmune disease that causes a person's muscles to feel weak and quickly grow tired. In addition to muscle weakness, according to the Mayo Clinic, myasthenia gravis can cause a person to have double vision and drooping eyelids. It can also cause problems speaking, breathing, swallowing and chewing. There is no cure for the disease. The retired Serbian-American women's tennis star told the AP she began noticing symptoms of the disease while playing tennis with her family and began seeing multiple balls coming toward her. 'I would be playing with some kids or family members, and I would miss a ball. I was like, 'Yeah, I see two balls.' These are obviously symptoms that you can't ignore,' Seles said. 'And, for me, this is when this journey started. And it took me quite some time to really absorb it, speak openly about it, because it's a difficult one," she continued. "It affects my day-to-day life quite a lot." Seles told the outlet that routine daily tasks like doing her hair 'became very difficult' to manage. The nine-time grand slam tennis champion told the AP she had never heard of the disease before she was diagnosed, inspiring her to speak up about it now ahead of the U.S. Open, which begins next week. 'When I got diagnosed, I was like, 'What?!'' Seles recalled. 'So this is where — I can't emphasize enough — I wish I had somebody like me speak up about it.' Seles is partnering with a Dutch immunology company as a primary spokesperson for its 'Go for Greater' campaign to help those living with myasthenia gravis find resources to help them manage their life with the disease. The tennis great told the AP that her diagnosis has led her to go through yet another 'hard reset' in her life, equating the experience to some of her biggest career hurdles. Seles won eight grand slam titles as a teenager and was widely regarded to be on her way to becoming one of the most accomplished tennis stars in history when she was stabbed by a fan on the court during a match in 1993, after which she stepped away from tennis for two years. She returned to tennis in 1995 and won one more major championship, her ninth overall, before retiring for good in 2003. Never miss a story — sign up for to stay up-to-date on the best of what PEOPLE has to offer, from celebrity news to compelling human interest stories. 'I call my first hard reset when I came to the U.S. as a young 13-year-old [from Yugoslavia]. Didn't speak the language [and] left my family,' Seles told the AP. She added, 'It's a very tough time. Then, obviously, becoming a great player, it's a reset, too, because the fame, money, the attention, changes [everything], and it's hard as a 16-year-old to deal with all that. Then obviously my stabbing — I had to do a huge reset.''And then, really, being diagnosed with myasthenia gravis: another reset," she said. "But one thing, as I tell kids that I mentor: 'You've got to always adjust. That ball is bouncing, and you've just got to adjust.' And that's what I'm doing now.' Read the original article on People
Yahoo
6 days ago
- Yahoo
New Irish Healthtech Firm Phyxiom Set to Transform Asthma and COPD Management
Groundbreaking research by Professor Richard Costello leads to innovative digital health platform DUBLIN, August 12, 2025--(BUSINESS WIRE)--Phyxiom, a pioneering digital healthcare company, today announced its official launch, bringing transformative technology developed through extensive clinical research led by globally recognised respiratory specialist, Professor Richard Costello (RCSI University of Medicine and Health Sciences and Beaumont Hospital). Built upon groundbreaking studies published in Lancet Respiratory Medicine and validated by health economists, Phyxiom's platform provides clinicians with precise, real-time data to significantly enhance asthma and Chronic Obstructive Pulmonary Disease (COPD) management. Co-founded by experienced tech executive Grace O'Donnell as Chief Executive Officer and healthcare professional Elaine Mac Hale as Clinical Operations Director, along with Prof Costello, Phyxiom is a spin-out company from RCSI. Based on a strong foundational IP portfolio developed under an Enterprise Ireland (EI) Commercialisation Fund award the company has recently achieved EI High Potential Start- Up (HPSU) status. O'Donnell and Mac Hale lead Phyxiom's day-to-day operations, driving forward its mission to revolutionise respiratory healthcare through advanced digital solutions. Professor Richard Costello, Chief Medical Officer at Phyxiom and Professor of Respiratory Medicine at RCSI, explained the science behind the innovation: "Our research, spanning over a decade, has conclusively demonstrated that digitally-informed treatment significantly reduces medication use, prevents unnecessary hospitalisations, and ultimately lowers healthcare costs. By providing clinicians with objective, real-time insights into lung function and medication adherence, Phyxiom fundamentally improves diagnosis accuracy and treatment outcomes." Phyxiom's technology is already operational across 13 Health Service Executive (HSE) asthma clinics in Ireland, processing nearly 350 patients to date, with plans to expand further and engage Irish private health insurers in 2025. Grace O'Donnell, CEO, said: "Elaine and I are incredibly proud to lead this exciting RCSI spin-out company into the commercial market. We are passionate about using Richard's groundbreaking research as the foundation to deliver transformative, patient-centric healthcare solutions, significantly improving quality of life for patients suffering from uncontrolled asthma and COPD." Elaine Mac Hale, Clinical Operations Director, added: "Phyxiom seamlessly integrates into existing healthcare systems, ensuring minimal disruption to clinicians' workflows. Our evidence-based approach empowers healthcare providers with the insights needed to deliver personalised, effective, and efficient patient care." Following its successful Irish rollout, Phyxiom is expanding into the UK market in H1 2026 and plans a US launch in 2027, supported by established partnerships and integration with leading electronic health record systems. Phyxiom's launch marks a significant milestone in Ireland's healthtech landscape, highlighting Irish innovation on the global healthcare stage. Those interested in learning more about Phyxiom, can visit the website here: About RCSI University of Medicine and Health Sciences RCSI University of Medicine and Health Sciences is ranked first in the world for its contribution to UN Sustainable Development Goal 3, Good Health and Well-being, in the Times Higher Education (THE) University Impact Rankings 2025. Founded in 1784 as the Royal College of Surgeons in Ireland with responsibility for training surgeons in Ireland, today RCSI is an innovative, not-for-profit, international university exclusively focused on driving improvements in human health worldwide through education, research and engagement. RCSI is among the top 300 universities worldwide in the World University Rankings (2025) and has been awarded Athena Swan Bronze accreditation for positive gender practice in higher education. In 2026, RCSI will open a new public engagement space, dedicated to health and well-being, at 118 St Stephen's Green in Dublin city centre. The space is designed to engage the public in dialogue about living longer, healthier and happier lives through dynamic events and exhibitions. Our aim is to bridge the gap between health sciences research, professional expertise, and public understanding, empowering people to make informed decisions about their health. Visit the RCSI MyHealth Expert Directory to find the details of our experts across a range of healthcare issues and concerns. Recognising their responsibility to share their knowledge and discoveries to empower people with information that leads them to better health, these clinicians and researchers are willing to engage with the media in their area of expertise. View source version on Contacts phyxiom@ or call Lewis Oakley or Kirsty Leighton on +44 20 3637 7310 Sign in to access your portfolio
