Known as sublingual immunotherapy, or SLIT, this treatment works by having study subjects take tiny, daily doses of an allergen – in this case, peanut – in steadily increasing amounts over an extended period of time.

The new study, published in the January edition of the Journal of Allergy and Clinical Immunology, involved 40 peanut-allergic patients between the ages of 12 and 37 in five U.S. cities. The subjects were randomly divided in half, with one group taking liquid drops containing peanut powder under the tongue and the other taking drops with a placebo.

After 44 weeks of the daily doses, 70 percent of those getting the peanut powder could tolerate at least 10 times more peanut in an oral food challenge before showing symptoms than they could have at the outset of the study. In a follow-up challenge at 68 weeks, they could tolerate about twice as much again. (Patients were also to be retested at 88 weeks.)

This suggests that longer treatment could lead to even better results. The end goal is to slowly build up tolerance until the individual is no longer sensitized to the allergen.

“It gives us hope that this type of therapy might be used in the future for some type of treatment,” Dr. Wesley Burks, lead author of the study and Chair of the Department of Pediatrics at The University of North Carolina, told Allergic Living.

But Burks is quick to acknowledge the hurdles that remain. First, the treatment was not effective for 30 percent of the subjects. He believes this has to do with finding the proper dosage for those individuals, which could be related to their specific immune and gastrointestinal systems.

He says it shows that more and larger studies are required before this type of treatment – currently only done with strict medical supervision – becomes widely available.

The second issue is that, after 44 weeks, the average amount of peanut one of the responding allergic patients could consume was still fairly small: 496 milligrams. That equates to about two peanuts (a single peanut typically contains 250 to 300 mg of protein).

The treatment “is not ready for practical day-to-day usage,” says Burks. “There is some efficacy, but it is not the right thing to do right now”.

Even if SLIT’s results are being measured in incremental successes, that is still significant and promising, especially when compared to the sole, current allergy treatment of strict avoidance of peanuts.

While no food allergy “cure” looms around the corner, there was an encouraging sense that treatments and new tests are coming. Researchers are unlocking more secrets of allergies and the immune system – and finding better predictors of true allergies.

In one noteworthy media conference, leading researchers Dr. Wesley Burks (Duke University, North Carolina), Dr. Hugh Sampson (Mount Sinai School of Medicine, New York), and Dr. Robert Wood (Johns Hopkins University, Baltimore) spoke about results that they found “surprising” in a population study of allergies in young children.

This continuing study of 512 infants showed a very high level of peanut sensitization among 244 milk-allergic children.

“We estimated going in that about 20 per cent might already have peanut allergy that we didn’t know about yet,” said Dr. Wood. “But it turned out to be more like 65 per cent, so we were very surprised at the initiation of the study that such a high proportion of these babies already appeared to be either fully peanut allergic or on their way to peanut allergy.”

Dr. Sampson added that in this study, which is part of the five-site COFAR (Consortium of Food Allergy Research) project, he was particularly struck “by how high some of the levels [of IgE allergy antibodies] were in some of these infants.”

The sensitization shown in the skin tests doesn’t necessarily mean allergy – so researchers will give the children oral food allergy challenges when they are a little older to determine whether these findings are, in fact, true allergy.

Sampson notes that when they looked at test levels consistent with peanut allergy, the number of children affected dropped to 30 per cent.

“But that’s an extraordinarily high number for such young children who have not themselves ingested peanut.”

We will have more on these findings and the factors involved in the Summer 2011 issue of Allergic Living.

Next: Allergy Reactions to DPT Vaccine

“I kind of freaked out,” she admits, since her son had previously had an anaphylactic reaction to cottage cheese. Theo didn’t react to the crackers, but avoidance remained the family watchword.

The boy, however, turns out to be among the 75 per cent of kids allergic to dairy whom researchers now believe can actually tolerate milk – provided it has been extensively heated through baking. The same holds true for egg.

While under supervision at Johns Hopkins University School of Medicine in Baltimore, Theo on separate occasions was able to eat one-twelfth of an egg and a quarter cup of milk, both of which were baked into a cake. Emergency treatment was at the ready, but he didn’t react. By May, the boy had started a new diet at home that includes muffins, breads, even croissants; foods thoroughly baked at 350 degrees for at least 30 minutes. There has been a sanctioned bite of lasagna and, in the next phase, Theo will be testing out pizza, which isn’t cooked as long.

Allergists have long heard stories of allergic children who have accidentally eaten milk or egg – perhaps grandma fed the child an off-limits cupcake, or a daycare provider didn’t realize that cookies contained egg – without reactions.

But researchers are getting closer to understanding why kids like Theo can tolerate milk or egg that has been baked, while others still will react immediately. They’re also finding that introducing the baked food into the diet may actually help the child outgrow the allergy.

At Johns Hopkins, some dairy-allergic kids, including those who have had significant reactions to milk in the past, have even moved on to unheated foods such as yogurt and chocolate milk.

The best news: this is research that doesn’t have to wait for clinical trials and government approvals. As long as you begin at the office of your allergist, and he or she has the resources to perform food challenges safely, introducing baked milk or egg into your child’s diet is “something that can be done right now,” Dr. Wesley Burks, head of pediatric allergy and immunology at Duke University Medical Center, told the American Academy of Allergy, Asthma & Immunology conference in New Orleans earlier this year. He called this new way of treating milk and egg allergy a “paradigm change.”

Added Dr. Hugh Sampson, chief of allergy and immunology at New York’s Mount Sinai School of Medicine and leader of the research: “What it means is that as opposed to going to birthday parties and not being able to eat cake, or going to school and worrying about somebody eating a cookie that has milk or – they can suddenly do all this.”

***

THE CONCEPT of feeding allergic kids baked milk or egg goes against longstanding food allergy management practice and what parents like the Glaubers have been doing to protect their children. That is, they do everything in their power to ensure that not a morsel of the allergenic food crosses their child’s lips. A shift in thinking began a few years ago with a study performed by Sampson and his colleagues at Mount Sinai.

They gave each of 100 milk-allergic kids a muffin to eat that contained 1.3 grams of milk protein, in the form of dry milk powder. If a child was able to eat the muffin, baked for 30 minutes, without a reaction, two hours later he or she was served a waffle, which was only cooked for three minutes.

Sampson and his team found that 75 of the 100 children tolerated milk that had been extensively heated, and they were told to keep it in their diet.

While in the past it had been believed that kids were more likely to outgrow a milk allergy if they successfully avoided it, this study suggested otherwise. In follow-up appointments three months later, those children who had continued to eat baked milk products showed a significantly smaller

Idea: Peanut Allergy Vaccine

What’s Involved: The treatment is based on immunotherapy – that is, by slowly introducing the immune system to something it is allergic to, the system will eventually learn to tolerate the allergen. The problem is, with food allergy, anaphylaxis can occur.

To eliminate that risk, researchers have altered a peanut to “trick” the immune system. Dr. Scott Sicherer, an associate professor of pediatrics at the Mount Sinai School of Medicine in New York and a researcher at the school’s Jaffe Food Allergy Institute, explains the concept. He likens the changed peanut to a baby bracelet that spells the word “Peanut”.

“If you altered that bracelet a little bit, let’s say you changed the ‘A’ in peanut to a ‘D’, then it would say PEDNUT instead of PEANUT,” he says. His theory is that the allergic person’s immune system won’t recognize “pednut” and therefore will be less likely to mount an allergic reaction to it. Over time, if it sees “pednut” enough, the immune system might also learn to accept “peanut”. He does not yet know how often the treatment would need to be taken to make this happen.

Where We Stand: Researchers have developed the optimal “altered peanut” and the vaccine has, in fact, reversed peanut allergy in mice. They’ve also determined that the vaccine is best taken rectally, as a suppository. Along with the altered peanut, the vaccine contains heat-killed E. coli bacteria, to signal the immune system that it should react to a bacteria, rather than an allergen.

Now, teams at Mount Sinai and at Johns Hopkins Children’s Center in Baltimore have started a Phase 1 clinical trial with a small group of people to ensure the vaccine is safe. If all goes well, the researchers will move on to Phase 2 studies, which will determine if the vaccine actually helps to reduce peanut allergy in humans.

Idea: Herbal Formula for Food Allergy

What’s Involved: Dr. Xiu-Min Li has been toiling in her lab at the Mount Sinai School of Medicine for years, trying to zero in on the perfect concoction of Chinese herbs that can increase a person’s threshhold for allergenic foods.

She and her colleagues have tested the formula, which includes dried ginger root, processed plums, Chinese peppers and ginseng, extensively in mice. After they stopped the treatment, the mice still did not react to their former allergen six months later. Li hopes the herbal remedy will allow people to come in accidental contact with their allergens and not have a serious reaction.

Where We Stand: Li has tested the treatment in humans and concluded the formula called FAHF-2 is safe and well-tolerated. She also found that people who took FAHF-2 tablets for six months had a reduction of basophil blood cell activity, which suggests a reduction in a person’s allergic tendency.

Now, the work ahead is to prove the treatment is effective, and to determine how much and how often a person should take it. Li was set to begin a Phase 2 study in March in which patients will take FAHF-2 or a placebo for several months. At the moment, this entails taking 24 tablets a day, but Li is working on reducing that number. The theory is that the effect of the treatment will last some time after the person stops taking the tablets.

Li’s goal is to develop a drug that can be taken by prescription, but she says that once the formula is proven effective, she could begin marketing it as a dietary supplement in the U.S. and Canada, perhaps as early as next year, while she continues to get drug approval.

Idea: Oral Immunotherapy or Desensitization

What’s Involved: In this experimental food allergy treatment, doctors give allergic patients increasingly larger doses of their allergen, starting with tiny amounts, to teach their immune systems to build up tolerance to it.

Allergists Dr. Wesley Burks and Dr. Stacie Jones are running numerous trials of oral immunotherapy (OIT) in Arkansas and North Carolina. Most (but not all) children have been able to build up a tolerance to allergens like peanuts, eggs and milk.

Where We Stand: Burks and Jones continue to research the intricacies of OIT, including who should and shouldn’t try it. They’ve found the most common side effects include runny nose, itchy skin, mild wheezing, or abdominal symptoms. They also found that children react to their daily peanut dose less than 5 per cent of the time, but the reactions that do occur are unpredictable. However, it was discovered that more reactions will occur if a child has a viral infection and more if he or she eats the food on an empty stomach. Trials at other centres are also taking place.

In Canada, Dr. Susan Waserman of McMaster University and Dr. Wade Watson of Dalhousie University have secured a grant from the research network AllerGen to start up a small Canadian trial of peanut oral immunotherapy in Hamilton and Halifax. The study will enroll patients 6 years of age and older. In each city, five patients in a “low-dose” group will work their way up to a fraction of a peanut a day, and 10 higher-dose patients will aim to eat the equivalent of 10 peanuts a day. (There will also be a peanut-allergic control group.)

Investigators will draw blood and give patients an oral challenge every three months in order to pin down the stage at which desensitization truly begins. Waserman hopes to begin recruiting patients this spring. Burks suggests that having a desensitization protocol in place that can be widely used by allergists is still several years away.

Since she had an anaphylactic reaction to a peanut butter cracker at the age of 2, Isabella has been avoiding peanut. But that all changed when her mother, Kathy, saw a report on “Good Morning America” last summer. It was about a team of researchers at Duke University in North Carolina who are trying to desensitize children with allergies to egg and peanut.

The Uknises had seen many doctors who told them there was nothing they could do; Isabella would have to avoid peanut for life. But the doctor and nurse couple always thought desensitization should, in theory, work. They called the university, and before long Isabella was accepted into the study under Dr. Wesley Burks.

Burks and his team at Duke first examined egg allergy and desensitization in a pilot study with seven participants. Over a two-year study period, and working in tiny, sequential increases of egg exposure, four of the children built up enough tolerance to eat two scrambled eggs without a reaction. The others were able to eat just under that amount.

The peanut study, which began three years ago, has 25 children enrolled at various stages. Eight have finished the first phase. After 18 months of being “on peanut,” seven of those eight were able to eat 15 peanuts over the course of an hour. They are now on a higher maintenance dose and will stay on that for more testing.

Isabella began the study last August. The nurses at Duke start by feeding her a minuscule amount of peanut powder, the equivalent of 1/3000th of a peanut, and slowly increased the dose over the course of one day, carefully monitoring her for reactions. The goal was to eat a cumulative 50 mg of peanut powder, the equivalent of 1⁄6th of a peanut.

“She didn’t do as well as we had hoped,” says her mother. At one point Isabella got a belly ache, then her nose started running and eventually, she broke out in hives, ending the day. All told, Isabella ate 25 mg of peanut. “I was really scared,” says Kathy, “I’d seen her go into anaphylaxis before.” The life-threatening potential of allergic reactions hits home for this family. In fact, the night before Isabella anaphylaxed after eating the peanut butter cracker, her father, a transplant surgeon, had done a procurement on a 21-year-old who had died of an allergic reaction.

But at the clinic, when Isabella felt symptoms the nurses treated them with Benadryl, or waited for them to subside before giving her another dose. Their knowledge, and the attention they gave to Isabella, put Kathy at ease. According to Burks, two participants weren’t able to tolerate the buildup phase, and were dropped from the study. But Isabella’s results were good enough to keep going.

After determining each child’s individual tolerance over a day, Burks and his team send them home on a maintenance dose of peanut, which they eat every day for two weeks. Then they return to the research unit for a higher dose, and are watched a few hours to make sure they’re not reacting. The kids being tested go about their regular day but, of course, take all the normal precautions, such as having an EpiPen handy. If a child has a reaction of any significance while taking the dose at home, he or she goes into the research clinic the next day and takes their next dose under the watchful eye of the clinic’s nurses.

The goal of the study is twofold. “We’re trying to desensitize them,” Burks says. “That means that if they’re on the treatment and had an accidental exposure, they would not have symptoms.” But Burks wants to go beyond desensitization, and hopes to make previously allergic people tolerant, even after they’re finished with the treatment. “We will essentially have made [the allergy] go away.”

The allergist hopes to have published results from the peanut study by mid-2007, but the early indications show that desensitization is possible. He acknowledges that proving the ‘tolerating’ part will take a little longer. But a new study, with different doses and lengths of treatment, has already begun.

Burks sees a treatment evolving in the next three to five years. He hopes that at that point, allergists could administer this “oral immunotherapy” to their patients in their offices. Although yet to be studied, Burks believes the treatment would work in adults as well as kids, and for food allergens other than peanut and egg.

Naturally, there is great interest and demand for this type of treatment. Burks has a long waiting list of local parents who want their children enrolled in the studies, in the hope that one day they will be desensitized. For the Uknises and Isabella, that once unreachable goal seems within grasp. Now it’s a matter of wait-and-see: will Isabella be one of the lucky ones?

Excerpted from the Spring 2007 issue of Allergic Living magazine.
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