Dr. Wasserman: Dallas doctors fight fire with fire using experimental desensitizing therapy; Dallas Morning News, 2014

Allergies put on notice – Dallas doctors fight fire with fire using experimental desensitizing therapy
Published January 11, 2014


Not long ago, a sip of milk would have sent Brianna to the ER.

“She used to get big hives when it even touched her,” says her grandmother, Sylvia Rabin.

Since March, Brianna’s family has been bringing her to DallasAllergyImmunology, a private practice at Medical City Children’s Hospital, in hopes that a new treatment might help her.

“I have two children with multiple severe food allergies and have been reading research on [oral immunotherapy] for nine years now. Although I agree that further research needs to be done to assess all of the factors involved, I am personally thankful for the doctors who are brave enough to offer OIT in clinical practice before the medical community approves of the treatment.”

“We are hoping to go through the OIT program in two years when my son is mature enough to handle it. We are so blessed to live in Dallas. People travel thousands of miles and sometimes relocate just to get their kids treatment. … It truly affects our daily lives — who my son sees, where we go, his preschool/church class. It also affects our entire family and who they interact with and what they can eat. It’s very stressful.”

Known as oral immunotherapy, or OIT, it requires patients to consume larger and larger amounts of a food to which they are allergic until their bodies become desensitized to it.

While the treatment has shown promise in clinical trials, it remains experimental. Some medical researchers have criticized the clinic for making OIT available too soon, before rigorous studies have proved its safety and effectiveness.

Oral immunotherapy patients start with the largest serving they can tolerate without a reaction — a dose sometimes as tiny as 1/10,000th of an egg — and slowly build up from there over the course of months.

Once they reach their target dose — usually a meal-sized portion such as a peanut butter sandwich, or a whole egg — patients must eat the food every day to keep their bodies from regaining the allergy.

The treatment doesn’t work for everyone; some patients have severe reactions along the way, and all are at risk for seeing their allergies return once treatment stops.

So far, things have gone well for Brianna. On her first visit to the clinic, she could tolerate no more than a drop of diluted milk. Today, she drinks a daily maintenance dose of 8 ounces of milk (with a dash of chocolate syrup), plus all the ice cream, pizza and Hershey’s Kisses she wants — or that her parents will allow. This spring, she plans to tackle a second allergy: wheat.

DallasAllergyImmunology, run by pediatric allergists Richard Wasserman, Robert Sugerman and Stacy Silvers, is one of only a handful of practices in the country to offer oral immunotherapy outside of clinical trials.

In a study published this month in a top immunology journal, Dr. Wasserman, who founded DallasAllergyImmunology in 1988, and physicians from four other private practices report an 85 percent success rate treating patients with peanut allergies.

Of 352 patients, 298 were able to consume doses ranging from three to 24 peanuts at the end of treatment. Within Wasserman’s own practice, 83 percent of 98 patients consumed the highest dose in the study: 24 peanuts, or the equivalent of a peanut butter sandwich.

The paper appeared in the January issue of The Journal of Allergy and Clinical Immunology: In Practice, accompanied by a critical editorial by two leading pediatric allergists.

“Putting this out at this stage is premature and puts patients at risk,” says Dr. Robert Wood, chief of pediatric allergy and immunology at the Johns Hopkins University School of Medicine, who co-wrote the editorial with Hugh Sampson, director of the Jaffe Food Allergy Institute at New York City’s Icahn School of Medicine at Mount Sinai.

About 10 percent of patients suffered reactions severe enough to require an epinephrine injection, the last-ditch emergency treatment for life-threatening attacks. By comparison, about 5 percent of people with peanut allergies have to resort to such a measure in daily life.

“Clinical trials are really important and we depend on them to provide us with more rigorous information. But children are suffering now. I don’t think every ‘i’ must be dotted and every ‘t’ crossed before you help people.”
Dr. Richard Wasserman, pediatric allergist

In their editorial, Wood and Sampson argue that the side effects might be acceptable “if the treatment resulted in a significant long-term reduction in reactions from accidental exposures.” But too few OIT patients have been followed long enough for clinicians to know if those patients are any safer or better off. “We remain convinced that food OIT is not ready for clinical practice,” they wrote.

Wasserman, who attended medical school at Mount Sinai and earned a Ph.D. in immunology there before transferring to UT Southwestern to follow a mentor, says oral immunotherapy is safe and effective if performed under an allergist’s close supervision.

The treatment has been around for at least 100 years, and clinical studies have been underway for the last 10.

“Clinical trials are really important, and we depend on them to provide us with more rigorous information,” says Wasserman. “But children are suffering now. I don’t think every ‘i’ must be dotted and every ‘t’ crossed before you help people.”

The recent interest in OIT parallels the rise of food allergies. The Centers for Disease Control and Prevention reported last year that the rate of food allergy in children increased 50 percent between 1997 and 2011. The condition now affects 1 out of 13 children, or “two per classroom,” says John Lehr, CEO of the nonprofit patient advocacy group Food Allergy Research & Education.

People with food allergies have heightened levels of an antibody known as Immunoglobulin E, or IgE.

“IgE is thought to be related to helping get rid of parasites,” says Wesley Burks, chief of pediatrics and a food allergy researcher at the University of North Carolina. Now that we have fewer parasites bombarding us, “our IgE is left to do other things, like react to innocuous substances,” he says. That idea forms the basis for the Hygiene Hypothesis, one of many theories behind the rise of allergies.

Other possible culprits include air pollution from diesel exhaust, which studies have shown increases IgE levels in animals; the overuse of antibiotics, which have altered the mix of good bacteria in our bodies that regulate immunity; and a trend over the last 15 to 20 years of delaying infants’ exposure to allergenic foods.

There is no approved treatment for food allergies. Doctors tell families to avoid the allergen and to carry an antihistamine like Benadryl and an epinephrine auto-injector like an EpiPen with them at all times.

Neha Mathew, 6, of Sunnyvale, busies herself with a tablet computer as she waits for an hour after her oral immunotherapy at DallasAllergyImmunology, a private practice at Medical City Children’s Hospital.

A new life

That advice is of little comfort to parents like Parisa Massoidi of San Ramon, Calif.. When her son, Sebastian Hadaegh, was 8 months old, she gave him his first bottle of formula after nursing him since birth.

“He didn’t know how to drink, so it spilled on his face and chin,” she says.

She went to the kitchen to wash her hands and returned to find a frightening sight: Sebastian’s lips were swollen, and hives covered his chin, chest and every other spot where the formula had touched him. He turned out to have a severe contact allergy to cow’s milk.

Over the next several years, Massoidi struggled to keep Sebastian safe while allowing him to lead a normal toddler’s existence. She carefully washed his hands and face after he played with friends’ toys or visited the playground. Family get-togethers became sources of stress.

“If anybody had anything with dairy, and if they kissed him, he would get hives,” she recalls.

The one time she let him sample food outside the house, at a preschool graduation party, he ate something with cheese, and she had to rush him to the doctor for an epinephrine shot.

In 2010, when Sebastian was 5, Massoidi read about DallasAllergyImmunology in an online group for parents of children with food allergies.

She called up the practice, flew Sebastian to Dallas for a consultation, and then weighed the risks with her husband. She knew the treatment was experimental and controversial. But she also knew, based on Sebastian’s high IgE levels, that he was unlikely to outgrow his allergy anytime soon.

“I decided we could not live in a bubble,” she says. “He was going to get exposed and have reactions anyway, so I decided it might as well be in a controlled environment when I expect it.”

In February 2011, Massoidi took Sebastian out of kindergarten and moved with him and his younger brother to Dallas for six months. Her husband, a Silicon Valley engineer, stayed behind in California while she homeschooled Sebastian and drove him to doctor’s appointments.

Relocating may have been the easiest part of the next several months. As Sebastian’s doses of dairy scaled up, he began suffering allergic reactions. On six or seven occasions, Massoidi had to use his EpiPen, then rush him to the emergency room late at night. “He also had lots of other smaller reactions, like hives,” she says.

Wasserman says that about 15 percent of his patients drop out of OIT for reasons including severe reactions; stomachaches or vomiting hours after dosing; an aversion to the foods to which they are allergic; and anxiety. It typically takes three months to one year for patients to reach their maintenance dose.

In part because of Sebastian’s extreme sensitivity to dairy, his treatment took far longer. By August 2011, when it was time to move back to California for first grade, Sebastian was able to drink only 1 ounce of milk, so the family commuted back and forth to Dallas. He finally reached his target dose, 8 ounces, in April 2013, more than two years after starting treatment.

Massoidi says the ordeal, which cost her more than $40,000 in travel and other expenses, was well worth it. (Insurance covers many of the doctor’s visits and DallasAllergyImmunology provides food free of charge during the treatment’s early stages). “I feel like we have a new life,” she says.

Too long to wait

Since 2005, DallasAllergyImmunology has treated nearly 200 patients with oral immunotherapy. Many of their faces smile down from a giant bulletin board of OIT grads, which displays photos of beaming kids holding “graduation” certificates.

Individual success stories, however, are not enough to quiet critics. Wood of Johns Hopkins has a peanut allergy but would not consider signing up for oral immunotherapy.

“It wouldn’t even cross my mind that it would be worth doing,” he says.

Burks, of the University of North Carolina, worries that OIT patients are living with a false sense of security. Daily maintenance may be OK for 5-year-olds, he says, but can 19-year-olds in college remember to take their doses?

In clinical trials, OIT has been shown to reduce IgE levels and to make the body less responsive to allergens. The rate of reactions decreases as the treatment goes on.

However, the effects are rarely permanent. A study that Burks conducted on egg allergies found that 75 percent of patients treated with OIT could eat three eggs after two years of treatment, as compared with zero in a control group. However, after he took the successful patients off their egg maintenance doses for a month, only 27 percent maintained their ability to eat the three eggs without suffering an allergic reaction.

In clinical trials, Wood, Burks and colleagues at other institutions are tweaking the OIT protocol, experimenting with delivering it for multiple food allergens at one time; with administering it below the tongue, which may reduce side effects; and with giving it to much younger patients between the ages of 1 and 3. (Wasserman’s patients are 5 years old and older).

While oral immunotherapy shows the greatest promise, researchers are also evaluating many other treatments. There are trials underway with Chinese herbs; with a patch that delivers treatment through the skin, and with synthetic allergens that might come with fewer side-effects.

“I would bet in 20 years we wouldn’t be doing anything like OIT and will have much better ways to deal with this,” says Wood.

For the parents of patients like Brianna and Sebastian, 20 years was just too long to wait.

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