What medicine to take for peanut allergy
The researchers who carried out the study were from Kings College London, Queen Mary University of London, Addenbrookes Hospital, every in the UK and Baylor College of Medicine in the US. It was funded by the Medical Research Council and the National Institute for Health Research.
The study was published in the peer-reviewed Journal of Allergy and Clinical Immunology.
The tale was reported on Mail Online and BBC News. Both reports appeared balanced and accurate.
What helpful of research was this?
This was an experimental laboratory-based study.
It used cells from the blood plasma of people who had been treated with peanut immunotherapy in a previous study. This type of study is useful to see what is happening at a cellular level before and after treatment. It helps researchers see how a treatment is working, rather than just whether it seems to be working.
What were the basic results?
The researchers found that mast cells washed of antibodies reacted to peanut in the same way, whether the samples were before or after treatment.
However, after treatment, the mast cells which still had antibodies in put reacted much less to the peanut than the pre-treatment mast cells.
This suggests that the antibodies produced during treatment are the key to its success, and that the underlying allergy is still in put.
This means people may need continuing treatment to hold producing the protective antibodies.
Immunotherapy may offer assist to people with life-threatening allergies, lowering their sensitivity to peanut so that they are less likely to own a serious allergic reaction to accidentally eating peanut. However, the results of the study propose that people may need to continue with long-term immunotherapy treatment in order to benefit.
The study has some limitations.
It’s an experimental study based on extremely few people. The people in the study had been having immunotherapy for a maximum of 24 months (2 years). It’s possible that a bigger study or one involving people who had been on therapy for longer might own found diverse results.
At present, there is no cure for peanut allergy and most people with peanut allergy own to avoid eating peanuts. Immunotherapy is not offered as a standard treatment on the NHS for peanut allergy because it is still being tested. Most people in the UK who own had immunotherapy for peanut allergy own been part of studies to discover out whether it works.
Find out more about food allergies and how to manage them.
Palforzia, a new drug to treat peanut allergies, is expected to get FDA approval.
The main ingredient of the drug is peanut flour. Marco Livolsi/EyeEm/Getty Images hide caption
toggle caption Marco Livolsi/EyeEm/Getty Images
Palforzia, a new drug to treat peanut allergies, is expected to get FDA approval. The main ingredient of the drug is peanut flour.
Marco Livolsi/EyeEm/Getty Images
A panel of experts earlier this month recommended that the U.S. Food and Drug istration approve a new drug for children and teens with peanut allergies.
The drug, called Palforzia, was developed by California startup Aimmune Therapeutics to be taken daily in a regimen known as oral immunotherapy. The therapy involves ingesting little doses of peanut protein, gradually increased over months, to blunt the immune system’s overreaction to peanuts. When it’s effective, patients can become biteproof — that is, capable to withstand little amounts of peanut that would own previously caused possibly dangerous allergic reactions.
With the FDA’s go-ahead, expected by January, Palforzia would become the nation’s first approved treatment for food allergies, which now afflict 1 in 13 children.
Many families and physicians are celebrating.
But some are also wondering how «new» Aimmune’s treatment really is. Some 200 of 5,000 board-certified U.S. allergists already offer oral immunotherapy to treat allergies to peanuts and other foods, using peanut flour or other products from retail vendors.
The treatment is not a cure, has side effects and doesn’t work for everyone. Yet over the past decade, more than 7,800 people own received it — and for those who do benefit, the therapy can be life-changing.
«The stress and anxiety as a result of food allergies is comparable to that of other chronic illnesses,» psychologist Linda Herbert of Children’s National Health System in Washington, D.C., said at final week’s FDA meeting.
Approval of Palforzia would permit doctors «to provide additional options for our families so we can empower them to make choices, to not feel so out of control when they go about their day-to-day lives.»
Some peanut allergy sufferers are already doing oral immunotherapy. It involves consuming prescribed doses of peanut flour — the main ingredient pre-measured and packaged into Aimmune’s colored capsules. So, some allergists are asking, what makes this pharmaceutical product any better?
«They are just packaging up what we already do, in a gold-plated capsule,» says Hugh Windom, an allergist in Sarasota, Fla.
Since 2012, Windom’s clinic has istered oral immunotherapy to more than 400 people with allergies to peanuts, cashews, walnuts, milk, eggs and other foods. A 1-pound bag of peanut flour costs $6 and provides for more than 100 patients. «It lasts us every year,» Windom says.
Analysts estimate that one year’s supply of Palforzia — pull-apart capsules containing unmodified peanut flour plus several inactive ingredients — would run $4,200 per patient, though Aimmune CEO Jayson Dallas says the company will not set a price until after a potential FDA approval.
No matter the cost, some allergists tell a standardized product is critical to ensure a predictable and hopefully safer experience for patients.
«What I select might be double or triple what the guy below the highway chooses. There’s a lot of people doing their own protocols,» says David Anmuth, an allergist at the Pediatric Lung and Allergy Middle in Fairfax, Va.
«The problem with store-bought peanut substances — whether it’s peanut butter or peanut flour or Reese’s Pieces — is you own absolutely no thought how much you’re giving,» Daniel Adelman, Aimmune’s chief medical officer, says.
Commercial peanut products can differ fairly a bit in their amounts of allergy-causing proteins, or allergens.
Aimmune’s product, on the other hand, «is characterized for its allergen content,» Adelman says. «We own specifications to ensure consistency from lot to lot and from capsule to capsule. So there is certainty that you are giving the correct dose to the correct patient at the correct time.»
But some researchers argue that this degree of precision is unnecessary.
For more than a century, allergists own safely and effectively delivered shots for pollen, trees and other environmental triggers, and the allergen content in those can vary considerably, writes allergist and researcher Richard Wasserman of Dallas in a letter to the editor published in the Journal of Allergy and Clinical Immunology. Wasserman has published several papers on oral immunotherapy using commercially available peanut products.
For clinicians who currently offer peanut allergy oral immunotherapy, dosing procedures vary. On the group Food Allergy Treatment Talk, parents shared that some clinics hire a compounding pharmacy to create pre-measured peanut flour capsules.
Others stir Jif or PB2 powdered peanut butter into Kool-Aid and own patients measure daily servings with a syringe. For larger doses, families may weigh their own peanuts at home on a scale.
Still, an FDA-approved product of standardized capsules could assuage academic institutions wary of risk to pediatric patients. «We own a lot of internal institutional regulatory issues when it comes to offering treatments for children that own potential for risk,» says Jaclyn Bjelac, an allergist at the Cleveland Clinic in Ohio. With an FDA-approved product, regulatory bodies «will likely be much more amenable to allowing us to move forward.»
If Palforzia’s approval can convince the Cleveland Clinic’s regulatory bodies that oral immunotherapy is becoming an significant part of clinical practice, Bjelac expects «it would expand our offerings rather than limit us only to this product.» The clinic would extremely likely include such therapy for other foods besides peanuts and consider additional therapies — such as liquid mouth drops that seemed to work comparably to OIT with fewer side effects in a recent little study.
Similarly, if the FDA does approve Palforzia, it may urge more allergists to start providing it to patients.
For example, Virginia private allergist Anmuth says he may rethink offering the treatment.
Currently he doesn’t provide oral immunotherapy, in part because of liability. If you offer a nonapproved treatment and the patient has a bad outcome, he says, «you don’t really own any legal way to back you up.» His clinic is unlikely to add OIT for foods besides peanuts until additional standardized therapies become available. «Maybe I’m just too much of a law follower, but I ponder the safest way to do these things are to let the studies declare themselves and use the products that are released,» he says.
Another way an FDA-approved product would assist legitimize food allergy treatments is by prompting the development of insurance codes.
Because oral immunotherapy-specific codes do not currently exist, some allergists will bill the treatment as oral food challenges, related desensitization protocols or prolonged office visits. Though the supplies — such as peanut flour or peanut butter — are simple to obtain, the protocol requires lengthy doctor visits to monitor for allergic reactions, which can include life-threatening anaphylaxis, as patients ramp up to higher doses every one to two weeks. Often patients must pay out of pocket for these supplies, as well as the office visits their insurance won’t cover.
Bona fide OIT codes would «improve reimbursement for every patients, especially those receiving Medicaid,» David Stukus, a pediatric allergist at Nationwide Children’s Hospital in Columbus, Ohio, told NPR via email.
Already, a national allergy organization is offering a webinar to demystify OIT billing codes.
Some warn that expanding access also carries risk — it can put a complicated therapy into possibly untrained hands. Just as you wouldn’t desire your heart surgery done by someone with minimal expertise following a standardized protocol, «why would we desire a complicated procedure love immunotherapy made available in that way?» says allergist Nikhila Schroeder of Allergenuity Health, a food allergy clinic in Charlotte, N.C. «Maybe there’s a standardized product, but it still has to be managed in an expert way.»
But widespread adoption could assist researchers collect larger volumes of data to study more about OIT’s long-term safety and effectiveness.
«When patients are treated extremely differently — with diverse products and protocols — that critically significant scientific chance is lost, along with potential key learnings to improve treatment for patients,» Brian Vickery, an allergist at Emory University in Atlanta who formerly worked at Aimmune, wrote in an email.
The move toward FDA approval could also unite disparate camps every seeking the same goal: finding solutions to children’s debilitating food allergies. In the years leading up to the anticipated approval of Palforzia, funding for oral immunotherapy research has gone to academic institutions, but numerous of the therapy’s biggest proponents own been allergists in private practice.
These practitioners own gathered at meetings to share experiences and publish best practices. Some will contribute their learnings to the wider allergy community in a November OIT summit organized by Food Allergy Research and Education, the advocacy organization that helped fund Aimmune’s launch.
«Collaboration is incredibly significant in this field correct now,» says Kimberley Yates, CEO of Latitude Food Allergy Care in Redwood City, Calif.
«The more that people can come together to attempt and solve this problem, the better we can provide for the patients within the allergy community.»
Correction Sept. 23, 2019
A previous version of this tale misspelled the name of Jif peanut butter as Jiff.
A new biologic drug to treat a peanut allergy, known as Palforzia, cleared a regulatory hurdle on September 13, when an advisory committee of the Food and Drug istration (FDA) voted to support use of the drug.
The therapy, developed by Aimmune Therapeutics, is designed to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental peanut exposure in children age 4 through 17 who own a confirmed diagnosis of a peanut allergy.
Because accidental exposure with even a part of a single peanut can trigger a life-threatening allergic reaction for a kid with a severe allergy, numerous children and parents must be vigilant in virtually every aspect of daily life.
“It's extremely exciting that we now own something.
Current treatment for a peanut allergy is avoiding peanuts,” says Alice Hoyt, MD, an allergist at Independence Family Health Middle, part of the Cleveland Clinic Health System in Ohio. “One of the most hard parts for families to manage food allergies is the anxiety associated with that treatment plan of simply avoidance, which is more easily said than done,” says Dr. Hoyt. Numerous families desire the level of protection that this medication can provide, she adds.
What did the research involve?
In the first study, 22 people aged 4 to 18 with moderate to severe peanut allergy were given tiny, then increasing, doses of peanut, under medical supervision so they could be treated if they had allergic symptoms.
By the finish of the study they were eating the equivalent of 4 to 5 peanuts a day. They then continued on this «maintenance» dose.
For this study, researchers took blood samples from 14 of these patients. They used plasma from the blood and looked in specific at mast cells, which initiate the allergic reaction. They carried out tests from samples before and after treatment.
In one set of tests, the mast cells were «washed» to remove antibodies around them, before being exposed to peanut. In the second, the mast cells were tested with the antibodies still in put. This was to discover out whether the mast cells themselves had changed in the way they reacted to peanut, or whether the presence of antibodies was what allowed people to tolerate little amounts of peanut.
How did the researchers interpret the results?
The researchers said peanut immunotherapy «induced blocking antibodies that suppressed mast cell activation … but did not change the functional characteristics of allergen-specific IgE» (an antibody that is involved in allergic reaction and is found on the mast cells).
They added: «A better understanding of the mechanisms underlying the patient’s clinical response to treatment will assist address the question of whether OIT (oral immunotherapy) induces long-term oral tolerance and assist in the decision of whether treated patients can eat the food to which they were previously allergic … or need to follow a specific OIT regimen in the endless term.»