Peanut allergy in babies successfully treated in US with immunotherapy 

 

Immunotherapy has successfully treated babies with peanut allergy in a clinical trial conducted by researchers in the United States.
Of the 40 participants allergic to peanuts aged between nine and 36 months, nearly 80% incorporated foods containing peanuts into their diets after receiving peanut oral immunotherapy.
“This study provides critical evidence supporting the safety and effectiveness of peanut oral immunotherapy in treating young children newly diagnosed with peanut allergy,” said Marshall Plaut, from the National Institute of Allergy and Infectious Diseases.
Encouragingly, low-dose therapy was effective at suppressing allergic responses, Plaut said.
Peanut oral immunotherapy involves eating small, gradually increasing amounts of peanut protein daily.

Can my child’s peanut allergy be cured?

Each participant was assigned either high-dose peanut oral immunotherapy with a target daily dose of 3,000 milligrams of peanut protein or a low-dose regimen with a target dose of 300 milligrams.
Low-dose and high-dose oral immunotherapy were safe and equally effective at suppressing allergic immune responses to peanut, investigators found.
Nearly all participants experienced some side effects, such as abdominal pain, but these were generally mild and required little or no treatment.

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After receiving oral immunotherapy for 29 months on average, participants avoided peanut completely for four weeks before attempting to try it again.
Previous studies with older children showed the therapy could offer some protection against potentially life-threatening anaphylaxis.
The investigators at University of North Carolina will monitor the oral immunotherapy-treated participants to assess the long-term treatment outcomes.
Australia has a relatively high prevalence of peanut allergy: almost three in every 100 children are affected.
The most severe symptom of a peanut allergy is anaphylaxis, which can become life-threatening if not treated promptly.
The findings have been published in the Journal of Allergy and Clinical Immunology.

The 1-year results of an ongoing trial of a skin patch for treating peanut allergy shows it is safe and modestly effective for the treatment of children and young adults - especially younger children. The patch delivers small amounts of peanut protein into the skin.

The trial found the skin patch was safe and well-tolerated; nearly all participants used it daily, as directed, applying it either to the arm or between the shoulder blades.
Image credit: DBV Technologies

Peanut allergy is a type of food allergy, a condition where the immune system overreacts to a particular protein in that food. Even if someone with peanut allergy only ingests a little of the food, the reaction can be severe.
Many food allergies are first diagnosed in young children. Peanuts are among the top eight foods that cause the majority of allergic reactions. The other seven are: cow's milk, eggs, fish, shellfish, soy, tree nuts, and wheat.
Food allergy is not the same as food intolerance. While some symptoms are similar, the difference is very important. Food allergy reactions can be life-threatening, and people with food allergies must be very careful to avoid their food triggers.
Peanut allergy is a growing health concern. Some estimates suggest between 1-3 percent of children in many westernized countries suffer from the condition.
While various methods have been used to estimate the size of the problem, it seems to have increased in the past 10-15 years, suggesting prevalence may have tripled in some countries such as the United States.

Advice and evidence on peanut allergy prevention

There was a time when the advice from health experts was that young children with an allergy to peanuts should avoid the food.
However, evidence from research is leading experts to review the advice. For instance, following last year's publication of results from a randomized controlled trial of over 600 children, experts in the U.S. have issued interim guidance on early peanut introduction and the prevention of peanut allergy in high-risk infants.
More recently, a large review of research suggests feeding peanut and eggs to infants is likely to lower their risk of developing allergies to these foods later on.
Thus, experts are cautiously coming around to the view that training the immune system to tolerate exposure to the food that produces allergic reactions is a way forward. Now researchers need to find effective ways to do this.
The new study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), investigates the safety and effectiveness of a wearable skin patch that delivers small amounts of peanut protein through the skin.
The 1-year results from the ongoing trial of epicutaneous immunotherapy (EPIT) reveal that the patch shows promise in treating children and young adults with peanut allergy, but it was more effective in younger children.
The results, published in the Journal of Allergy and Clinical Immunology, also found the skin patch is safe and well-tolerated, and nearly all participants used it daily, as directed.

Skin patch was more effective in younger children

The randomized clinical trial, which took place at five sites, recruited a total of 74 peanut-allergic volunteers aged 4-25 years. Participants were treated with patches containing either a high dose of peanut protein, a low dose, or a placebo.
The participants applied a new patch every day - either to their arm or between their shoulder blades.
The patches are not yet approved by the Food and Drug Administration. They have the trade name Viaskin and were provided for the trial by the biopharmaceutical company DBV Technologies.
After 1 year, the researchers assessed how well each participant was able to eat at least 10 times more peanut protein than they were able to consume before the study.
The results showed that 46 percent of participants on the low-dose patch and 48 percent on the high-dose patch were able to tolerate that amount of peanut protein, compared with only 12 percent of the placebo group.
The researchers also note that the peanut skin patches triggered immune responses similar to those seen in other types of experimental immunotherapy for food allergy.
The greatest benefit, however, was seen in the youngest participants - children from 4-11 years old. Treatment effects were significantly diminished in participants aged 12 years and over.
Some trials have used the oral route to administer the peanut protein, which the researchers note is difficult for around 10-15 percent of children and adults to tolerate. By using a skin patch, the new study overcomes this.
Another important result is the high level of adherence. Nearly all the participants followed the treatment as directed. None reported serious side effects. Most had mild skin reactions like itching or a rash at the patch site.

"The high adherence to the daily peanut patch regimen suggests that the patch is easy-to-use, convenient and safe. The results of this study support further investigation of epicutaneous immunotherapy as a novel approach for peanut allergy treatment."

Co-author Dr. Marshall Plaut, NIAID Division of Allergy, Immunology and Transplantation

The study is ongoing and will continue to assess the long-term safety and effectiveness of the peanut allergy skin patch.
The researchers also note that larger trials with larger groups of children will have to assess the treatment before it can be approved for clinical use.
Read how a high-fiber diet with vitamin A may prevent or reverse food allergies by changing gut bacteria.

Written by Catharine Paddock PhD

Peanut Allergy Treatment: The Earlier, the Better

Exposure therapy for infants and toddlers leaves 4 out of 5 'desensitized,' study finds

 A treatment for peanut allergies may work better if it's given to children earlier, even as young as 9 months, before the body's "allergic program" fully matures, new research suggests.

The treatment is called oral immunotherapy -- also known as exposure therapy. In this approach, peanut-allergic children are given very tiny amounts of peanut allergen as directed by a doctor. Over time, these small amounts of the allergen are thought to lessen the body's reaction to it.
"If you are peanut-allergic, treatment early in life can have a longer benefit after stopping the treatment," said study leader Dr. Wesley Burks. He's a pediatric allergist at the University of North Carolina at Chapel Hill School of Medicine.
The new study included 37 children between 9 months and 36 months old. They were given either high- or low-dose peanut exposure daily for about 29 months.
All of the children were given no peanuts for a month after the treatment. Then, peanut protein was reintroduced.
Nearly 80 percent of the infants and toddlers on either treatment dose were able to eat peanut-containing foods without having an allergic reaction, Burks said.
"After the study we have continued to follow them and the group is still doing well," he said. The follow-up period is now two years, and the benefits are longer-lasting than other studies have found, he said.
The results held whether the children got the low-dose therapy, 300 milligrams (mg) of peanut protein a day, or the high dose, 3,000 mg, the study showed.
Burks also compared the 37 children with 154 other peanut-allergic children, and found those who got exposure therapy were 19 times more likely to be able to eat peanuts without a problem.
Treating kids earlier may also spare them gastrointestinal symptoms, Burks said. While older children aged 5 to 7 often complain of stomach problems during exposure therapy and must drop out, "we didn't see that in these younger kids," he said.
Burks stressed that the point of exposure therapy is not so that children can eat peanuts carte blanche, but so kids can avoid a life-threatening reaction if they unknowingly eat a food with added peanut.

This goal is usually what parents of peanut-allergic children want. "Most want protection from accidental ingestion," he said.
There was one important caveat: Parents should never try exposure therapy on their own, Burks said.
"It is not something a parent can do at home safely," he said. "If they did they would run the risk of serious allergic reactions."
In this study, parents were given special sealed packets of peanut protein and instructed to sprinkle it on foods such as pudding or ice cream.
The researchers think starting treatment early may disrupt the "allergic program" that takes time to set in children.
Children allergic to peanuts and other foods often begin producing antibodies known as IgE (immunoglobulin E) in infancy. These antibodies travel to cells that release chemicals and cause the allergic reaction. This allergic program takes a while to mature, and starting exposure therapy earlier might better interrupt this process before full maturation.
In the new study, "we could see that those with a lower peanut IgE at the start had better outcomes," Burks said.
This was true, he said, even though "the amount of IgE does not correlate with the severity of the reaction." The therapy is thought to work, Burks said, by gradually changing the reactions of the cells that trigger the allergic reaction.
The hope is that after early treatment is stopped, children will continue to have long-term results, Burks said. An ongoing, larger study is underway now, continuing to assess early treatment, he said, and to confirm the findings in the study.
According to Dr. Jefry Biehler, chair of pediatrics at Nicklaus Children's Hospital in Miami and at Florida International University College of Medicine, the new study shows that allergy experts ''are continuing to refine the treatments for children with peanut allergy and other potentially life-threatening reactions to food and other allergens." Biehler wasn't involved with the current study, but reviewed its findings.
The finding that even the low-dose therapy worked is more good news, he said. Biehler had one serious caveat, however. Children with potentially life-threatening allergies, including peanut allergies, should be managed with pediatricians, allergists and immunologists working together, he cautioned.
The study was published online Aug. 10 in the Journal of Allergy and Clinical Immunology.
 

Oral immunotherapy shows promise for treating peanut allergies

Relief may be on the way for children with peanut allergies. Researchers have found that by desensitizing children with controlled doses of peanut protein at a young age and for an extended period, they can tolerate peanut exposures without allergic reactions.

October 05, 2016

By Rachael Zimlich, RN

Food allergies affect many children, with peanut allergies being the most prominent and recognized. Fears over accidental exposure have led some parents to homeschool their kids, despite the fact that many schools across the United States are now “peanut-free” zones.

Even safeguards such as banning peanuts from cafeterias may not keep children safe, however, with 19% reporting allergic events in spite of interventions.

To reduce the risk of life-threatening allergic reactions, researchers have been studying the use of oral immunotherapy to reduce sensitivity to peanut proteins, and a new report has shown the therapy to be 81% effective in preschool-aged children.

Wesley Burks, MD, Curnen Distinguished Professor, Department of Pediatrics, and executive dean at the University of North Carolina School of Medicine, Chapel Hill, led the study, and says although the outcomes from the study need to be further evaluated as the research group ages, peanut oral immunotherapy is a promising long-term treatment for children with peanut allergies.

“We would anticipate that any child with a peanut allergy could do this if the outcome is validated,” Burks says.

Peanut allergies affect between 1.5% to 3% of children globally, and exposures can be life threatening. An estimated 15 million Americans have food allergies—including 1 in 13 children, who are also most at risk of anaphylactic reactions.

The Centers for Disease Control and Prevention has estimated that food allergies among children rose 50% between 1997 and 2011, and the American Academy of Allergy, Asthma, and Immunology says that peanut allergies are the most prevalent in children. Some children grow out of food allergies as they age, but many children with peanut allergies also have allergies to other foods as well.

Although the development of food-specific immunoglobulin E (IgE) begins in infancy, expression is unstable for the first 2 years of life. By targeting newly diagnosed, young peanut-allergic children, Burks says the research team hoped to increase efficacy of the oral immunotherapy, interrupting the allergic process before it had a chance to fully mature.

The National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) partially funded Burks’ study and affirms that about 80% of the preschool-aged study participants that took part in the peanut oral immunotherapy trial were successfully treated.

The study involved 40 children aged 9 to 36 months with peanut allergies who were randomly assigned to receive either low-dose (300 mg) or high-dose (3000 mg) administrations of peanut protein daily.

Peanut oral immunotherapy involves the ingestion of small, gradually increasing amounts of peanut protein each day. Both low-dose and high-dose amounts of protein were found to be safe and equally effective during the trial, according to NIAID.

The clinical trial lasted an average of 29 months, after which all peanut protein was avoided for 4 weeks. When reintroduced to peanuts after the 4-week hiatus, 80% of the study group had no allergic response to peanuts, both in the low-dose and high-dose groups.

Nearly all the participants in the study experienced some degree of adverse effects, mainly abdominal pain, but the goal of the study was to reduce extreme allergic reactions—such as anaphylaxis—in young children.

Overall, the treatment was well tolerated, according to the study. Allergic reactions related to oral immunotherapy occurred in 95% of the study participants, mainly during the build-up phase. The majority—85%—of the reactions were mild and mostly involved the gastrointestinal tract and upper airway. Another 15% of reactions were moderate and most often occurred in the low-dose group. A quarter of the allergic reactions required no treatment at all, and most others were treated with antihistamines alone. None of the cases required treatment with epinephrine, according to the report.

There is a chance that even oral immunotherapy can’t be tolerated in 20% of individuals with peanut allergies, and there is high potential for relapse if treatment is interrupted, according to the study.

It’s also possible that some of the children in the study group grew out of their allergy naturally, although it’s unlikely. Only a small majority of children—perhaps around 22%—grow out of their peanut allergies naturally, according to the report.

Researchers will continue to monitor the study group to see if the success of the clinical trial continues as the children age.

Long-term success with oral immunotherapy was associated with lower peanut-specific IgE levels in previous studies. In those studies, participants sustained their immunity 5 years after treatment with goal maintenance doses of 4 g of peanut protein daily.

Burks also stresses that, despite the seemingly simplistic nature of this therapy, this is not an intervention parents should attempt at home. “There are too many normal allergic side effects,” he says.

The Immune Tolerance Network, supported by NIAID, is currently conducting a similar clinical trial in peanut-allergic children aged 12 to 48 months. Participants will receive oral immunotherapy for 134 weeks, followed by a period of peanut avoidance for 26 weeks. The study is scheduled to be completed in September 2018.

 Peanut M&M dispensers stand in the waiting room of the New England Food Allergy Treatment Center. Hundreds of drawings plaster the walls, almost all done by children with peanut allergies. One shows a picture of a boy holding hands with Mr. Peanut. “Now we’re friends!” reads the caption.
The children coming to the center are openly flouting rules drilled into their heads for most of their lives: Avoid peanuts and potentially contaminated products at all costs. Instead, the children here eat carefully measured doses of peanut protein, usually mixed into yogurt, pudding or apple sauce, in a treatment known as oral immunotherapy. The idea is to gradually increase the doses to desensitize their bodies to peanuts so they no longer suffer allergic reactions. Immunotherapy is a popular treatment for people with environmental allergies, such as hay fever. But it is less common, and is a controversial practice, for treating food allergies.
“We’ve treated about 750 to 760 patients so far with a 90 to 92% success rate,” says Jeffrey Factor, founder and medical director of the center, which opened in 2010. Nearly all the patients, most of whom are children, come because of peanut allergies. But the center also has treated about 50 patients who have milk, egg or tree-nut allergies.

Matthew Sullivan, 12, of Longmeadow, Mass., in a treatment room at the New England Food Allergy Treatment Center. Earlier in February, Matthew passed a food challenge, in which he ate the equivalent of 46 peanuts in one sitting, and is now considered peanut tolerant. He no longer has to carry an EpiPen and can eat as many peanuts, and peanut M&M’s, as he wants. Photo: Julie Bidwell for The Wall Street Journal

Oral immunotherapy, often called OIT, isn’t approved by the U.S. Food and Drug Administration or endorsed by any professional organization of allergists. Some of the country’s leading allergists say that, despite promising evidence, more research and regulatory approval are needed before the process should be recommended as a treatment for food allergies. Studies have shown about 80% to 85% of patients who undergo oral immunotherapy are successfully desensitized to their allergen. But questions remain about its long-term effectiveness, and there are concerns some patients could have adverse reactions, these allergists say.
The therapy is a frequent topic of debate at medical conferences and in academic journals. Many academic institutions offer oral immunotherapy for food allergies, but only as part of ongoing clinical trials. Some trials are being sponsored by Aimmune Therapeutics, a biopharmaceutical company near San Francisco that is in Phase 3 clinical trials for its pharmaceutical-grade peanut formulation, the final stage needed for FDA approval.
“We absolutely don’t do OIT for treatment,” said Robert Wood, division chief for pediatric allergy and immunology at Johns Hopkins School of Medicine, in Baltimore, which is participating in about a dozen OIT trials for different foods. “In my mind doing so is pushing the envelope beyond the appropriate level of safety,” Dr. Wood says.
Some 15 million people in the U.S. have a food allergy, including nearly 8% of children, a rate that has jumped by half in recent decades. Peanut allergies are the most common and dangerous, with reactions ranging from skin rashes to anaphylactic shock, which can be fatal. About 80% of children don’t outgrow peanut allergies. There is no approved treatment for food allergies except avoidance.

Nuts About Peanuts

Matthew Sullivan, 12, has gone from severe peanut allergy to eating a peanut butter and jelly sandwich for school lunch.

• May 2004: At 13 months old, Matthew develops hives on his arms and legs after biting into a peanut-butter cracker.
• June 2004: An allergist confirms Matthew has an allergy to peanuts. His parents decide to avoid exposing him to peanuts, fearing a possible anaphylactic reaction.
• November 2010: At age 7, Matthew begins immunotherapy treatment. He gradually increases his intake of peanut protein over several months, suffering occasional headaches and stomachaches.
• July 2011: Matthew eats three peanut M&M’s at the clinic, after two weeks of ingesting the equivalent amount of peanut-protein powder.
• October 2013: Skin tests continue to show Matthew is allergic to peanuts. But he continues to eat three or so peanut M&M’s daily.
• January 2016: Tests indicate Matthew is no longer allergic to peanuts. He passes a food challenge at the clinic, eating the equivalent of 46 peanuts in one sitting.
• Feb. 4, 2016: Matthew brings a peanut butter and strawberry jelly sandwich to school for lunch.

A growing number of allergists in private practice offer OIT for food allergies, though the numbers are still low—about 50 across the country, according to a popular Facebook group of parents interested in the therapy. The West Hartford center is the only one in New England and patients drive from as far as Ohio, Pennsylvania and Maryland for appointments.
Dr. Factor, of the New England center, says his patients typically start with a 0.1-milligram dose of peanut protein—just a few flecks of peanut flour that look like grains of sand. Over the next five hours or so, the dose is gradually increased to about 6 milligrams. If the peanut protein is tolerated, patients are sent home with a plastic bin holding individual containers of the dose, which they take daily. They return to the center every two weeks for ever-larger doses until they graduate to whole peanuts or peanut M&M’s. They are considered desensitized when they can tolerate about 10 peanuts daily and then must continue a maintenance dose indefinitely. Treatment usually lasts 10 to 12 months and is often covered by private insurance, he says.
Precautions include avoiding exercise for two hours after a dose, calling the center for advice if a patient is sick or has asthma, and avoiding hot showers and NSAIDs, like Advil, at the time of a dose, Dr. Factor says. While it isn’t uncommon to have some symptoms during treatment, most are minor, such as itchy mouth or stomachaches. Systemic or anaphylactic reactions have occurred in less than 10% of patients, Dr. Factor says. “So it’s not without any risk at all,” he says.
Matthew Sullivan, now 12, started oral immunotherapy for a peanut allergy at the New England center in 2010. The first picture he drew there was of him and a peanut, with the caption: “Can we be friends?” The boy had his first allergic reaction to peanuts, including hives on his arms and legs, at 13 months old.
His mother, Heather Sullivan, drove them to appointments from their Longmeadow, Mass., home every other week. After nine months Matthew was successfully desensitized and has been on a maintenance dose of three to four peanut butter or peanut M&M’s a day. He no longer carries an EpiPen in case of an anaphylactic reaction, Ms. Sullivan says. And earlier in February, Matthew passed a food challenge at the treatment center, in which he ate the equivalent of 46 peanuts in one sitting.
“On Tuesday he brought a Reese’s peanut butter cup to school and the whole lunch table applauded,” Ms. Sullivan says. For his lunch two days later, Matthew brought a peanut butter and jelly sandwich.
“It was totally worth it,” Matthew says. “It worked!”  

Michael Donoghue, 6, with parents Christopher and Laura, in the waiting room at the New England Food Allergy Treatment Center, where the boy is being treated for peanut allergy. The family has been coming to the center from their home in Oceanside, N.Y., about three hours away, for more than a year. Michael completed his treatment in December and is now eating 10 peanuts a day as part of his posttreatment maintenance diet. Photo: Julie Bidwell for The Wall Street Journal

Laura Donoghue has been bringing her 6-year-old son, Michael, to the center for more than a year from their home in Oceanside, N.Y., about three hours away. Before he began treatment, Michael had several anaphylactic reactions after being exposed to food containing peanut products. The quiet kindergartner completed his treatment in December and is now eating 10 peanuts a day as part of his posttreatment maintenance diet. The family hopes Michael will be ready to do a food challenge by the summer.
There is no uniform protocol for OIT for food allergies, which is a reason critics say it shouldn’t be recommended for treatment. At the Dallas Food Allergy Center in Texas patients come in every week for about 6½ months, on average, says Richard L. Wasserman, the center’s director. At home they take twice-daily doses. The center, which opened 8½ years ago, has begun treatment on more than 400 patients, mostly children, with about 62 dropping out before completion. More than half have peanut allergies; the rest come in mostly for milk and egg allergies. Systemic reactions have occurred. About one in 1,000 doses of food has resulted in an epinephrine-treated anaphylactic reaction.
A study published last year in the journal Lancet found that 84% of children could safely eat the equivalent of five peanuts a day after six months of OIT compared with none in a control group. The study included 99 children between the ages of 7 and 16.
Whether the treatment lasts is the subject of research by some prominent allergists. Kari Nadeau, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, oversees about 15 clinical trials involving OIT and food allergies around the country. Her team at Stanford has performed clinical research on more than 700 patients using OIT and she has a wait list of 4,000 people interested in joining the trials.
So far the researchers have followed patients as long as nine years and found that as many as 90% of the participants become desensitized, though for some patients that can take a few years. Nearly a third of those reach the point of “sustained unresponsiveness,” meaning they appear to be allergy-free, according to skin and blood tests.
Given the level of demand for OIT, and because private physicians are already practicing it, researchers should be “sharing what we’ve learned so that people get treated effectively and safely,” Dr. Nadeau says.
Mark Weinstein, an allergist in Belleville, N.J., plans to open an office using OIT for food allergies this summer. He says about 40 patients have already signed up for treatment.
Natalie Hower, 5 years old, will be one of Dr. Weinstein’s patients. Her mother, Cynthia Hower, says the girl was diagnosed as allergic to peanuts and tree nuts when she was 2. Ms. Hower, of Rutherford, N.J., says she is hoping for a day when she doesn’t have to scrutinize labels and call companies to ask if a product was made in a facility with peanuts.
“I know it’s a risk. I know it’s not a cure. I’ve heard of some children not being able to continue with the process. But I’ve also heard of many success stories,” Ms. Hower says.

 A study last week in The New England Journal of Medicine suggests that exposing infants to peanuts can provide lasting protection against peanut allergy. But what about peanut-allergic children right now? They and their parents live a life of precautions — from pre-screening birthday party menus to segregation at the school lunch table — to avoid life-threatening consumption of even trace amounts of peanut.
Now, a multicenter study reports on a protocol combining the allergy medication omalizumab (Xolair) with controlled, gradually increasing peanut consumption. After 20 weeks, most initially allergic children could safely consume the equivalent of 8 to 10 peanuts at a time. Three months after stopping the medication, most had worked up to 16 to 20 peanuts.
This might not seem like much, but it’s incredibly liberating for kids with peanut allergy, who tend to have more severe reactions than those with milk or egg allergy and usually remain allergic for a lifetime.
“Patients can react to even small amounts of peanut in foods, and often avoid many processed foods because of labeling indicating possible peanut contamination,” says Andrew MacGinnitie, MD, PhD, clinical director of the Division of Allergy and Immunology at Boston Children’s Hospital, which led the study. “The need for constant vigilance can negatively impact quality of life.”

PRROTECT-ing kids from peanut reactions

Doctors have tried desensitizing children by gradually exposing them to peanuts, but this approach alone can cause severe reactions, particularly with rapid increases in peanut doses. The double-blind PRROTECT study, reported this week at the American Academy of Allergy, Asthma & Immunology meeting, added Xolair into the mix. The results validate the two-pronged approach for the first time in a controlled trial.
Extending a pilot study published in 2013, MacGinnitie, co-leader Rima Rachid, MD, and colleagues randomized 37 peanut-allergic children to begin treatment with either Xolair (29 children) or placebo (eight children) for 12 weeks. The medication was injected subcutaneously every two or four weeks depending on the child’s weight and level of IgE, the antibody that causes allergy.
Then:

• At week 12, the children underwent a single-day challenge, consuming escalating doses of peanut protein over six hours (spaced 30 minutes apart) as tolerated, under supervision. Twenty-three of the 27 Xolair-treated children still enrolled in the study were able to weather the highest dose (250 mg, the equivalent of one peanut), versus just 1 of 8 children given placebo. The kids then kept taking their maximum tolerated dose at home for one week; if they had no reactions, their peanut dose was increased weekly for eight weeks.

• At week 20, 21 Xolair-treated children and 1 of 8 placebo-treated children could safely consume 2,000 mg (eight to 10 peanuts). Drug (or placebo) treatment was then stopped.

• At week 26, 23 of the 27 Xolair-treated children (85 percent) could still safely consume eight to 10 peanuts, versus 1 of 8 of those given placebo (12.5 percent).

• At week 32, 12 weeks after stopping medication, came the biggest challenge: 4,000 mg or 16 to 20 peanuts. Twenty-two of 27 children who had received Xolair passed the challenge, versus 1 of 8 placebo-treated children.

“This study has proven that patients can be desensitized to higher peanut doses at a faster rate than conventional oral immunotherapy,” says Rachid. “However, the optimal duration of combined therapy remains to be further evaluated. Also, omalizumab is given by injections and is very expensive, so it should be determined which patients would benefit best from adding it to oral immunotherapy.”

Could there be hope for children suffering from food allergies? A new clinical trial from University of North Carolina researchers found that immunotherapy successfully treated babies diagnosed with peanut allergies.
The study examined 40 participants — all with peanut allergies — aged between nine and 36 months. After receiving peanut oral immunotherapy, nearly 80 percent of participants were able to incorporate foods containing peanuts into their diets.
Could the future hold a cure for peanut allergies? Photo courtesy of Pixabay
“This study provides critical evidence supporting the safety and effectiveness of peanut oral immunotherapy in treating young children newly diagnosed with peanut allergy,” said Marshall Plaut, from the National Institute of Allergy and Infectious Diseases. Encouragingly, low-dose therapy was effective at suppressing allergic responses, Plaut added.So, what is peanut oral immunotherapy? It involves eating small, gradually increasing amounts of peanut protein daily. The Guardian reported that nearly all participants experienced some side effects, such as abdominal pain, but these were generally mild and required little or no treatment.
On average, all study participants received oral immunotherapy for 29 months. They then avoided peanuts completely for four weeks before trying to eat the nuts again. Moving forward, the researchers at University of North Carolina will monitor the oral immunotherapy-treated participants to assess the long-term treatment outcomes.
“Peanut allergies are severe, and they impact more children than ever,” Dr. Brian P. Vickery, lead investigator of the trial and assistant professor of pediatrics at UNC-Chapel Hill, said according to Triangle Business Journal. “We hypothesized that newly-diagnosed preschool children would better respond to treatment, and our findings suggest that they indeed do. Early oral immunotherapy is a very promising approach to an urgently needed disease-modifying treatment for peanut allergy.”
Previous studies with older children showed that immunotherapy could offer some protection against potentially life-threatening anaphylaxis.
Until recently, experts have recommended parents whose children are at risk avoid peanuts altogether until they reach age 3. However, waiting so long could reinforce the allergies.
Source: Vickery BP, et al. UNC researchers near breakthrough in treating peanut allergy. The Journal of Allergy and Clinical Immunology. 2016.

Young children with a peanut allergy may be treated effectively through controlled exposure, according to a new study of an investigational treatment.
Researchers found nearly 80% of those enrolled in the clinical trial eventually were able to eat foods containing peanut.
“These findings, if confirmed in larger studies, could transform the care of peanut-allergic children early in life,” Brian P. Vickery, M.D., lead author and assistant professor of pediatrics at the University of North Carolina at Chapel Hill, said in a news release.

 

Roughly 1.5% to 3% of children are allergic to peanuts and typically develop the allergy early in life, according to the study “Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective” (Vickery BP, et al. J Allergy Clin Immunol. Aug. 10, 2016, http://dx.doi.org/10.1016/j.jaci.2016.05.027).
Researchers set out to study early oral immunotherapy through a double-blind study of 37 children ages 9 to 36 months who were allergic to peanut. Children received either 300 milligrams or 3,000 milligrams of peanut protein daily, while a control group of 154 children with peanut allergies avoided peanut.
During the treatment, which lasted a median of 29 months, most experienced allergic side effects, but they were mild to moderate. After treatment, they abstained from peanut for four weeks, then consumed it in a controlled setting. If successful, peanut was introduced into their diet.
Roughly 78% were able to consume peanut without experiencing allergic symptoms, including 85% of the low-dose group and 71% of the high-dose group. Children who received treatment were 19 times more likely to be able to eat peanut than the control group.
The success of the treatment may be attributable to “the lower average psIgE (peanut-specific immunoglobulin E) levels typically seen in young children and/or the plasticity of a relatively immature immune response,” authors wrote. They are continuing to study the long-term effectiveness of the treatment.
Early peanut exposure also has been found to be beneficial to infants who are at risk of peanut allergy. Last year, the Academy was one of 10 medical organizations that endorsed Consensus Communication on Early Peanut Introduction and the Prevention of Peanut Allergy in High-risk Infants, which stemmed from findings of the Learning Early About Peanut allergy (LEAP) study. The interim guidance says high-risk infants ages 4 to 6 months may benefit from evaluation for a possible peanut allergy. If they are not allergic, a clinician may introduce them to peanut products that do not pose a risk of choking.
Scott H. Sicherer, M.D., FAAP, co-author of the consensus statement and past chair of the AAP Section on Allergy and Immunology Executive Committee, said he was interested to see that in the new study from Vickery and his colleagues, so many young children already determined to have an allergy were able not only to tolerate the treatment but maintain protection even after not eating peanut for a month. He called the study results “promising.”
“They were very good results and it may well be that this younger age group is the time to get started on this strategy once this strategy is FDA (Food and Drug Administration) approved,” Dr. Sicherer said.

CHAPEL HILL, NC – Researchers at the UNC School of Medicine found that nearly 80 percent of peanut-allergic preschool children were successfully treated with peanut oral immunotherapy (OIT), allowing them to safely stop treatment and incorporate peanut-containing foods into their diets. This study confirms and extends previous results demonstrating that peanut OIT can offer protection against potentially life-threatening anaphylaxis caused by peanut exposure.
The phase two clinical trial results, published online today in the Journal of Allergy and Clinical Immunology, show that one month after completing the OIT protocol, almost 80 percent of trial participants achieved “sustained unresponsiveness,” the highest rate yet reported.
“These findings, if confirmed in larger studies, could transform the care of peanut-allergic children early in life,” said Brian P. Vickery, MD, lead investigator of the trial and assistant professor of pediatrics at UNC-Chapel Hill.
Approximately three million people in the United States report having allergies to peanuts and tree nuts. According to a study released in 2013 by the Centers for Disease Control and Prevention, food allergies among children increased approximately 50 percent between 1997 and 2011. The initial allergic reaction to peanut commonly occurs within the first year or two of life, and the condition persists in 80 percent of affected patients, placing them at life-long risk of anaphylaxis.
Based on other studies suggesting that peanut allergies strengthen over time, Vickery and his team enrolled 40 peanut-allergic children aged 9 to 36 months in the trial, the first study to specifically target children under the age of three. Participants were randomly assigned to high-dose peanut OIT with a target daily dose of 3,000 milligrams of peanut protein or a low-dose regimen with a target dose of 300 milligrams.
The trial was double-blinded. Participants took 3,000 mg of study protein, but for the low-dose group, 2,700 mg of placebo was added to the OIT medication. As in previous studies, nearly all participants experienced some side effects, most of which were mild and required little or no treatment.
After receiving OIT for 29 months on average, participants abstained from peanut exposure for four weeks before undergoing a final peanut challenge -- when participants ingest a small amount of peanut in a controlled setting.
If the challenge is successful, then doctors reintroduce normal amounts of peanuts – such as in a peanut butter and jelly sandwich – into the diets of participants. After the four-week period, nearly 80 percent of children in both the high- and low-dose groups consumed peanut with no allergic response and achieved sustained unresponsiveness.
The OIT-treated children were compared with a matched control group of 154 peanut-allergic children who avoided peanut. The OIT-treated children experienced beneficial changes in their immune responses to peanut and were 19 times more likely to successfully incorporate peanut into their diets.
“Peanut allergies are severe, and they impact more children than ever,” Vickery said. “We hypothesized that newly-diagnosed preschool children would better respond to treatment, and our findings suggest that they indeed do. Early oral immunotherapy is a very promising approach to an urgently needed disease-modifying treatment for peanut allergy.”
Vickery led the study with assistance from Wesley Burks, MD, executive dean for the UNC School of Medicine. Burks heads a larger research team working to identify the mechanisms of adverse food reactions and develop several forms of treatment for food allergy.