Latest news with #AmericanAcademyofAllergy
Medscape
15-05-2025
- Health
- Medscape
Tezepelumab Slashes Surgery Risk in Severe Nasal Polyposis
Tezepelumab (Tezspire) has shown significant clinical benefits in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), including marked reductions in nasal congestion and polyp size and a near elimination of the need for surgical intervention. Findings from the phase 3 WAYPOINT trial were published in The New England Journal of Medicine and presented as a late-breaking oral presentation at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization annual meeting. 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.
Vox
31-03-2025
- Health
- Vox
Get ahead of allergy season this year
is a senior reporter at Vox covering mental health, relationships, wellness, money, home life, and work through the lens of meaningful self-improvement. That sneezy, itchy, watery-eyed time of year has yet again returned: it's allergy season. Seasonal allergies are the body's response to pollen from trees and grass; the immune system releases chemicals, like histamines, leukotrienes, and prostaglandins, which cause all those uncomfortable, familiar symptoms. The best way to combat the unpleasant barrage is to get ahead of them, says Russell Leftwich, a fellow at the American Academy of Allergy, Asthma, and Immunology and an adjunct assistant professor of biomedical informatics at Vanderbilt University School of Medicine. Since allergy season arrives at roughly the same time every year, Leftwich recommends starting your allergy relief of choice for a few days before pollen levels get too high. (The Weather Channel, AccuWeather, and IQAir provide local pollen monitoring.) If the dizzying variety of drugs at the pharmacy has you confused, here are a few things to know about the most effective types of over-the-counter allergy medications as well as non-pharmaceutical ways to keep your allergies in check. Today, Explained Understand the world with a daily explainer plus the most compelling stories of the day, compiled by news editor Sean Collins. Email (required) Sign Up By submitting your email, you agree to our Terms and Privacy Notice . This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Before heading to the drugstore One of the best ways to alleviate allergy symptoms is to prevent pollen from getting into your body in the first place. This means keeping windows closed and wearing a mask while doing yard work, Leftwich says. If you've been outdoors for a while, change your clothes and wash your face when you get home, says Rita Kachru, the chief of allergy and immunology in the department of medicine at UCLA. Related 4 tips for dealing with a ferocious allergy season Another prevention method includes rinsing your nose with a saline solution: a mixture of baking soda, salt, and distilled or boiled water, Kachru says. The American Academy of Allergy, Asthma, and Immunology recommends mixing three tablespoons of iodide-free salt with one teaspoon of baking soda in a small container. Then add one teaspoon of the salt/baking soda mixture to eight ounces of lukewarm distilled or boiled water. You can also buy nasal saline sprays at the drugstore. When to take antihistamines When avoidance strategies aren't totally effective, you can treat your symptoms with over-the-counter allergy medications. One of the major categories of these treatments are antihistamines, which are available in pill, tablet, eye drop, or nasal spray forms. Antihistamines help reduce itchiness and sneezing and are your first line of defense, Kachru says. 'The reason I always start with an antihistamine is because you may just have a day of a high pollen count,' she says, 'and you just need a one-time antihistamine because you're sneezing and you're itchy and you're a little congested.' Kachru and Leftwich suggest opting for long-acting antihistamines — like loratadine (Claritin), cetirizine (Zyrtec), or fexofenadine (Allegra) — over short-acting ones. People can develop a resistance to short-acting antihistamines, like diphenhydramine (Benadryl), very quickly. Plus, Benadryl often makes people sleepy. Both short- and long-acting antihistamines provide relief within 15 to 30 minutes, Kachru says. Take them at the start of the day before you are exposed to pollen. For mild nose itchiness and sneezing, an antihistamine nasal spray, like azelastine (Astepro), might work for you. A common side effect is a metallic taste in the back of the throat, Kachru says. When to try nasal steroid sprays If you're reaching for an antihistamine three to four times a week, Kachru suggests adding a nasal steroid into the mix. Not only do nasal steroids reduce sneezing and itchiness, but they'll help with congestion, too. These include fluticasone (Flonase), budesonide (Benacort), triamcinolone (Nasacort), and mometasone (Nasonex). Nasal steroids do take a few days until you feel the full effects, Kachru says, so don't give up if you don't feel better right away. To properly administer nasal sprays, insert the tip in your nostril and point it toward your ear. A common mistake when using a nasal spray is pointing it straight up your nose. 'It goes up their nose, down their throat and does nothing for them,' Kachru says. 'Or they stick it inwards into their nose, and then they get nosebleeds. … So you want to always make sure that when you put it in, you point it out towards your ear, spray, sniff in, and then do the alternate nostril.' While not a nasal steroid, Kachru advises against using oxymetazoline (Afrin), a nasal spray decongestant. 'Patients who use Afrin regularly end up having really, really severe rebound nasal congestion,' she says. Leftwich advises against decongestants more broadly, as the over-the-counter decongestant medications are not very effective. After a few weeks of daily nasal spray use, you may consider stopping an antihistamine, if you're taking both. 'That's usually what I tell people to do,' Kachru says. 'Eventually just use that antihistamine as needed' because the nasal spray is more effective.
Yahoo
03-03-2025
- Health
- Yahoo
Injectable asthma drug resolves dangerous food allergies in one-third of children
More than a third of food-allergic kids were able to eat full servings of their trigger foods after treatment with an injectable asthma drug, new clinical trial findings report. In all, 36% of children treated with omalizumab (Xolair) for a year successfully ate full servings of allergy-triggering foods, according to phase 2 trial results presented Sunday at a meeting of the American Academy of Allergy, Asthma & Immunology in San Diego. By comparison, only 19% of children could do the same when given a shorter round of omalizumab followed by months of oral immunotherapy, a treatment through which patients build tolerance by eating gradually increasing amounts of food allergens. Further, early stage 3 results from the clinical trial found that children retained some resistance to food allergies even after they stopped taking omalizumab, researchers reported. "This is the first time we've been able to directly compare these two treatments for multiple food allergies, and our study shows omalizumab was superior to oral immunotherapy," principal investigator Dr. Robert Wood, director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children's Center, said in a news release. Food allergies are common, affecting 8% of U.S. children and 10% of adults, researchers said in background notes. Omalizumab works by binding to the antibodies that promote allergic reactions, rendering them inactive, researchers said in background notes. The drug has been on the market since 2003, first approved by the U.S. Food and Drug Administration as a preventive treatment for allergic asthma, according to And based on early results from this clinical trial, the FDA approved omalizumab as a treatment for food allergies in adults and children as young as 1 year old, researchers said in background notes. The stage 2 clinical trial involved 117 children with an average age of 7 who were allergic to peanuts and at least two other common food allergens -- milk, egg, cashew, wheat, walnut or hazelnut. At week 44, the children were fed all three of their food allergens in amounts equivalent to about 20 peanuts or a half-cup of milk. The lower results for children on oral immunotherapy were driven by the fact that more of these kids had to drop out of the study due to adverse reactions, researchers said. About 88% of children treated with omalizumab finished the stage 2 trial, compared with 51% of those receiving oral immunotherapy, results show. No children taking omalizumab experienced serious adverse reactions, compared with more than 30% of those treated with oral immunotherapy. "We have demonstrated that there are multiple paths to living a safe life with food allergies," senior researcher Dr. Sharon Chinthrajah, acting director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford Medicine, said in a news release. "This study is very encouraging because it shows that we have treatment choices for our patients that are safe and not too burdensome," she added. Researchers at the AAAAI meeting also presented preliminary results from stage 3 of the clinical trial, which focused on the first 60 children in the study. Stage 3 focused on different pathways that children with food allergies might take in real-world settings, after they've gained tolerance to trigger foods through omalizumab therapy. Each of the children was assigned one of three strategies for each of their food allergens -- start eating the food, continue with oral immunotherapy or avoid the food. These strategies were assigned based on how the kids responded to a food challenge following omalizumab treatment. More than 80% of the plans began with the kids eating the foods to which they'd been allergic, results show. The kids were then tracked for a year to see how they fared. Preliminary results show that consumption of milk, egg and wheat had a greater success rate (61% to 70%) than peanuts and tree nuts (38% to 56%). In most cases, kids ate declining amounts of their allergens during the follow-up period. Some adverse events occurred, including food reactions severe enough to require an epinephrine shot. Stage 3 is ongoing, with completion expected this summer, researchers said. "While the results of Stage 3 are still preliminary, the majority of the first 60 participants were able to successfully introduce allergenic foods into their diet after stopping omalizumab," lead researcher Dr. Jennifer Dantzer, a pediatric allergist at Johns Hopkins Children's Center, said in a news release. "Omalizumab is currently approved in the U.S. for the reduction of allergic reactions that may occur with accidental exposures," Dantzer said. "These results indicate that omalizumab may have additional uses that may be valuable for patients, but the potential risks should be recognized." Funding for the clinical trial came from Genentech and Novartis, the makers of omalizumab. Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal. More information The American Academy of Allergy, Asthma & Immunology has more about food allergies. Copyright © 2025 HealthDay. All rights reserved.
Yahoo
03-03-2025
- Health
- Yahoo
KalVista Pharmaceuticals Shares Latest Sebetralstat Findings at the American Academy of Allergy, Asthma & Immunology 2025 Annual Meeting
–Sebetralstat enabled prompt treatment of laryngeal HAE attacks with median time of 1 hour and 16 minutes to onset of symptom relief– –Pooled data analysis showed adolescents treated with sebetralstat in median 4 minutes compared to over 3 hours in surveys – CAMBRIDGE, Mass. & SALISBURY, England, March 03, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the presentation of novel sebetralstat data related to laryngeal hereditary angioedema (HAE) attacks and adolescents with HAE at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025. "The growing body of data from the KONFIDENT-S study consistently demonstrate that sebetralstat enabled early treatment and fast symptom relief from HAE attacks, regardless of age, attack location, or severity," said Ben Palleiko, CEO of KalVista. "This is especially critical for vulnerable populations, such as those experiencing laryngeal attacks or adolescents whose only approved options are injectable on-demand treatments. Sebetralstat, if approved, would be the first oral on-demand treatment for HAE attacks, with the potential to address some of the most significant unmet needs in HAE and become the foundational therapy for HAE management." Effectiveness of Sebetralstat for the On-demand Treatment of Laryngeal Hereditary Angioedema Attacks: Interim Analysis from KONFIDENT-S was presented by Jonathan Bernstein, MD, FAAAAI, Professor of Clinical Medicine in the Department of Internal Medicine, Division of Allergy and Immunology at the University of Cincinnati College of Medicine; Partner at Bernstein Allergy Group and Clinical Research Center. 32 laryngeal attacks were treated with sebetralstat (September 14, 2024 cutoff) Median time to treatment with sebetralstat: 11.5 minutes after attack onset Median time to beginning of symptom relief: 1.27 hours 96% of those achieving beginning of symptom relief within 12 hours did so with a single dose No reports of difficulty swallowing film-coated tablet "Laryngeal attacks are often unpredictable and can progress rapidly, potentially leading to asphyxiation," said Dr. Bernstein. "Any attack involving the larynx must be considered a medical emergency and treated as quickly as possible after onset before symptoms worsen. Despite this, recent U.S. survey data showed the mean time to treatment for laryngeal attacks with injectable on-demand therapies was 2.5 hours. Patients in the KONFIDENT-S study treated their attacks with sebetralstat, with a median time to treatment of just under 12 minutes, followed by symptom relief with a median time of 1 hour and 16 minutes. These results show that in the time it takes many patients to decide whether to treat, prepare and administer an injectable on-demand treatment, most patients in KONFIDENT-S were already experiencing symptom relief. If approved, sebetralstat could represent a therapeutic advance over injectables." On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat In Adolescents: Pooled Analysis From KONFIDENT And KONFIDENT-S was presented by Professor Danny Cohn, Head of the HAE clinic at Amsterdam University Medical Center (UMC), University of Amsterdam, Netherlands. 149 attacks were treated with sebetralstat across KONFIDENT/KONFIDENT-S (September 14, 2024 cutoff) Median time from attack onset to treatment: 4 minutes Safety and efficacy consistent with adults; no serious adverse events or adverse events leading to discontinuation "Adolescents face considerable challenges in treating their HAE attacks, with substantially longer delays to treatment than adults. This challenge is compounded in the U.S., where the only approved treatments options require either intravenous administration or subcutaneous administration by an HCP," said Dr. Cohn. "The pooled data from the KONFIDENT and KONFIDENT-S studies show that adolescents administered sebetralstat in a median of 4 minutes after attack onset, which compares favorably to a median of 3 hours and mean of 5.2 hours based on international survey data that was presented at AAAAI by Dr. Paula Busse titled, 'Burden of Injectable On-Demand Treatment for Hereditary Angioedema Attacks in Adolescents'. Importantly, the safety and effectiveness of sebetralstat were consistent with what was observed in adults. The portability and ease of administration of sebetralstat, along with the elimination of injection-site reactions and associated anxiety, has the potential to bring transformative change to this underserved patient population." Links to all posters and presentations shared at AAAAI can be found on the KalVista website under Publications. About Sebetralstat Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on Contacts Ryan BakerHead, Investor Relations(617) Molly CameronDirector, Corporate Communications(978) Sign in to access your portfolio
Yahoo
03-03-2025
- Health
- Yahoo
Some kids may successfully eat trigger foods after stopping anti-allergy med, early study suggests
More than half of children in early stages of an ongoing study were able to eat a food they were allergic to one year after stopping Xolair, a medication used for some kids with food allergies. Researchers say the results are encouraging but caution that not all children will respond the same, and this approach should only be done under medical supervision. In the study, 60 kids who previously received treatment with Xolair for at least 24 weeks were followed for a year after stopping the drug at hospitals across the country. According to researchers, each child was assigned three treatment plans, one per food trigger. Of these treatment plans, 82% involved kids eating a food trigger under medical guidance. After a year, 61-70% of children successfully ate milk, egg, or wheat, while 38-56% were able to eat peanut or tree nuts. These preliminary findings were presented by Jennifer Danzer, M.D., a pediatric allergist at Johns Hopkins Children's Center, on Sunday, March 2 during a late-breaking symposium at the American Academy of Allergy, Asthma & Immunology and World Allergy Organization Joint Congress in San Diego. "While the results of Stage 3 are still preliminary, the majority of the first 60 participants were able to successfully introduce allergenic foods into their diet after stopping omalizumab," Danzer said in a Johns Hopkins press release. "Omalizumab is currently approved in the U.S. for the reduction of allergic reactions that may occur with accidental exposures. These results indicate that omalizumab may have additional uses that may be valuable for patients, but the potential risks should be recognized." Treatment failure was linked to taste, food aversion, allergic reactions, and two cases of eosinophilic esophagitis, which led to stopping treatment. The study included peanut, cashew, egg, milk, walnut, hazelnut, and wheat. Success was defined as eating at least 300mg of the food trigger daily. So far, there are no clear predictors that suggest which kids will be successful or not. "What we were hypothesizing going into this stage of study is that while you still had Xolair in your system, you could be rapidly desensitized and that turned out to be the case for a majority of people, that was actually possible," Robert Wood, M.D., director of Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children's Center, who also led this study, told ABC News. Originally approved by the Food and Drug Administration for asthma, Xolair is a lab-made monoclonal antibody that works by targeting a key allergy trigger called IgE. In February 2024, it became the first drug FDA-approved to reduce allergic reactions from accidental exposure. It is not currently FDA-approved for use while intentionally consuming allergens, but this can be done under appropriate medical guidance. Introducing your baby to food allergens, according to an expert Wood explained it's believed kids who have success with this approach would need to remain "rigidly compliant with [that food] exposure that needs to be daily, or very, very close to daily, and as far as we know, needs to be maintained forever." This is also true for kids who undergo an alternative and common food allergy treatment called oral immunotherapy that can also successfully allow kids to eat some foods they are allergic to. These two treatment options were compared against each other for the first time in a study presented at the same conference that suggests Xolair may be more successful than oral immunotherapy, but doctors say both are safe treatment options. "The findings will inform patients' real-world treatments," Sharon Chinthrajah, M.D., a senior study author, associate professor of medicine and of pediatrics, and acting director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford Medicine, said in a Stanford press release. However, it was emphasized there's no therapy that's one-size-fits-all. 3 things to know as new study emphasizes need to give kids peanut butter at a young age Chinthrajah said families and individuals should consider multiple factors with their doctor when creating a treatment plan based on their goals. Some may want to eat a specific food they react to, while others may focus on avoiding severe complications from accidental exposure. The study of success eating food triggers after stopping Xolair is ongoing, so researchers are still collecting data for doctors to use making treatment plans with their patients. Parents interested in this option should talk with their child's allergy doctor to know if or when it may be possible to try. 'We and others are already using this approach for select patients with caution, recognizing that this use is not consistent with the FDA label,' Danzer told ABC News. Doctors say people who eat foods they are allergic to are still at risk for allergic reactions that can be life-threatening. Xolair is a type of medication that can cause a severe allergic reaction, and the injections can be painful. Doctors stress any changes to a food allergy treatment plan should not be done independently, only under medial guidance by an appropriately trained doctor. Jade A. Cobern, MD, MPH, is board-certified in pediatrics and general preventive medicine, and is a medical fellow of the ABC News Medical Unit. Some kids may successfully eat trigger foods after stopping anti-allergy med, early study suggests originally appeared on
