Latest news with #Omalizumab
Vox
15-04-2025
- Health
- Vox
We're on the verge of a universal allergy cure
covers health for Vox, guiding readers through the emerging opportunities and challenges in improving our health. He has reported on health policy for more than 10 years, writing for Governing magazine, Talking Points Memo, and STAT before joining Vox in 2017. If you're bothered by allergies every spring, you may pop a Benadryl or Claritin most mornings to make the days tolerable. Two-thirds of Americans report spring allergies, and about 4 in 10 say they take an allergy medication several times a week. But those medicines, while valuable, don't exactly fix the problem. One 2001 study in the United Kingdom found 60 percent of people who took some kind of over-the-counter medication for allergies reported they were not satisfied with how it managed their symptoms. Nasal sprays are not exactly enjoyable or easy to operate. Allergy medicines have to be taken every day if you deal with serious hay fever, and they can produce, ironically, tiredness for some people during this season of renewal. A missed dose can lead to a day of hacking and sneezing. Oh, and the more you take them, the less likely they are to work. A century ago, antihistamines were a revolution in allergy treatment. But now, we're on the cusp of another. Omalizumab, sold as Xolair, is an asthma medication that was approved more than 20 years ago, but it has proven successful in treating seasonal allergies in recent preliminary trials. So successful, in fact, that now some doctors in the US are prescribing it for certain patients during hay fever season. It is an injection, rather than a pill or a spray, that's given a couple of weeks before pollen and grass levels start to rise. One obvious benefit is you get a single shot and enjoy your spring. But even better, omalizumab can forestall allergic reactions at the source. That means an injection could stop all allergic reactions — not only seasonal allergies but food allergies (such as peanuts) and insect allergies for a prolonged period of time. This class of treatment — monoclonal antibodies, special artificial proteins that carry instructions to the body's immune system — have the potential to be a genuine all-in-one allergy wonder drug. Related The freaky part of allergy season that no one warned you about 'The biggest advantage of antibody-based therapeutics is that they offer the potential to target the underlying pathways driving allergic reactions in general,' said Sayantani Sindher, a clinical associate professor at Stanford University's Sean N. Parker Center for Allergy and Asthma Research. 'This means antibody-based therapies will simultaneously impact all of the patient's allergens.' Large clinical trials are underway in China and Japan, which could lead to omalizumab's approval in those countries for seasonal allergies. The next generation of monoclonal antibody allergy treatments is already in the works. How monoclonal antibodies could stop allergy season before it starts In the United States, the use of monoclonal antibodies started with doctors studying and prescribing preexisting treatments 'off-label' — meaning these are drugs that were actually developed for something else. Asthma and seasonal allergies often occur in tandem, which made omalizumab an obvious candidate for a new approach to allergy treatment. The drug had also separately proven effective in treating food allergies, adding to evidence that it had the right properties to stop seasonal allergies at the source. The treatment has demonstrated significantly better outcomes than antihistamines in small randomized trials, requiring only one dose two weeks before pollen and grass season. A 2022 study reported that patients who received a 300 mg injection of Xolair experienced fewer symptoms and fewer days that required a daily antihistamine or other medication; the patients also reported a better quality of life during the allergy season. Their symptoms were particularly improved during the worst pollen days when compared to the people who only took a daily medication. When pollen and other allergens emerge every year and enter your body through your eyes, ears, or nose while you're enjoying the crisp spring air, your body's immune system overreacts. Immunoglobulin, proteins that are supposed to identify and attack parasites or a virus, instead go after the otherwise harmless allergen. When the immunoglobulin attacks the allergen, your body releases histamine, a chemical critical to inflammation (which, again, is really important when you are actually exposed to a dangerous parasite or virus). That inflammation then creates all that mucus and sneezing. Monoclonal antibodies stop that process before it begins. They deliver artificial proteins that carry instructions to your immune system to block the receptors that create allergic reactions and prevent the overresponse that releases histamine in the first place. Artificially altered antibodies have been around for decades, with different iterations being developed to respond to new health threats. Monoclonal antibodies were developed for Covid-19 during the pandemic and recently provided the platform for an RSV vaccine. Dupilumab (another monoclonal antibody treatment used for skin rashes, asthma, and a lung disease that makes it difficult to breathe called COPD) targets a different receptor but has likewise shown promising results in studies so far. In a large 2018 study, asthma patients who suffer from seasonal allergies received a 300 mg injection every two weeks and showed significant improvements in their nasal blockage. A 2022 study found fewer allergy symptoms among both people with allergic asthma and people without. Monoclonal antibody injections superficially resemble allergy vaccines, which have been investigated more aggressively in recent years. Those shots as well as oral tablets that work in the same way function differently: They expose people to small amounts of the actual allergen, giving their bodies a chance to develop natural immunity to it. They can unlock more durable resistance to specific allergies — but they can only treat one allergy at a time. You may also need to go to the doctor once a week for a month or longer during the initial treatment course. Some companies are trying to make them easier to use. Going forward, the conventional kind of allergy vaccine could still have a place, particularly for patients who are at particularly high risk of developing asthma, by strengthening immune systems for the longer term; monoclonal antibodies, by contrast, do not actually modify the immune system in the same way, so they would need to be taken again periodically. But Sindher emphasized the potential to treat all allergies at once as an obvious advantage for monoclonal antibodies over immunotherapies. 'Pollen allergy and food allergy are frequently found together,' she said. 'Omalizumab has the potential to treat both.' With monoclonal antibody shots, patients also report fewer side effects. There is a subset of people for whom antihistamines don't work, including those who have built up a tolerance to those drugs after frequent usage. These new monoclonal antibodies may help them where those old treatments are now failing. Specially tailored allergy-specific products are now in the works, ushering in this new era of allergy treatment. In early April, the final stage of one clinical trial found the following results after four weeks: Patients who had still reported symptoms after taking the standard-of-care treatment and then received a monoclonal antibody injection were much more likely to report mild or no nasal symptoms (62 percent) than people who were taking the placebo (39 percent). They scored significantly better on oral symptoms and other measures of efficacy without serious side effects. The drug in the clinical trial, Stapokibart, was recently approved for seasonal allergy treatment in China, and its developer, Keymed, has premised its business on developing and gaining approval for treatments in that country and then bringing them to the US. Monoclonal antibodies will continue to make inroads as more products come to the market. A new era for allergy treatment Monoclonal antibodies, by offering months of allergy relief in just one injection, could elide one of the biggest challenges in all pharmaceutical treatments: making sure people take medicines like they are supposed to. What to ask your doctor Omalizumab is a promising new treatment for seasonal allergies, but the FDA has not specifically approved it for seasonal allergy care yet. So far, doctors have been prescribing this 'off label' — meaning it has proven safe to use for a different purpose, but the science on its effectiveness for allergies is preliminary. A prescription is ultimately at your doctor's discretion, but if you suffer from severe allergies, it could be a fit for you. Here are some things to consider asking your physician if you're interested in this kind of treatment: Are there other existing treatments they would advise trying first? Do I have another condition for which Xolair is intended to treat? What steps should we take for my health plan to cover the cost? With antihistamines and nasal sprays, you must regularly buy them yourself and repeatedly remember to take them correctly to stave off allergy symptoms. That 2001 study in the UK found that many people who suffered seasonal allergy symptoms nonetheless did a poor job of taking medication as they should: Among the 54 percent of people who were experiencing poor allergy symptoms, 70 percent didn't use the conventional allergy medicines according to the clinical guidelines. But for allergy sufferers to make the jump from something like Claritin to an annual allergy shot that works even better, health insurance coverage will be critical: The list price on omalizumab is $1,500 a pop. This would be a new cost to health plans because patients often bear their own over-the-counter antihistamine med costs. Off-label coverage of any drug, including omalizumab for seasonal allergies, can be fickle. Some popular plans, such as United Healthcare, are not currently covering the drug for that use at this time because they consider it unproven. As more research comes in and more products come on the market, the insurers' value proposition may change. The FDA recently approved a generic version of omalizumab, which should help reduce prices for that injection. As they do, they could offer more value for the patients for whom conventional therapies aren't working. Seasonal allergies can significantly diminish a person's quality of life — during what should be one of the most enjoyable times on the calendar — and they come around every year.
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
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
