Wednesday, May 23, 2018

New therapy attacks allergies from the source

SARASOTA — Lily Scalabrin knows a single peanut could send her to the hospital.

At 10 years old, she has learned to read food labels and ask about ingredients. She doesn't share snacks at Tampa Palms Elementary. She brings her own cookies for classroom celebrations.

Yet, on this July afternoon, Lily waits in a Sarasota doctor's office for the very food she has been trained to avoid.

The treatment is called oral immunotherapy, or OIT for short. Patients consume tiny portions of their so-called trigger food in hopes of gradually building up a tolerance. If they are successful, they must eat the food every day to maintain immunity.

OIT, still in its infancy, remains highly controversial. While a growing body of research touts its success, some top physicians consider it too risky to be used in practice. Only one allergist in Florida offers the treatment.

Still, some parents are willing to take the risk, particularly if it means arming their child against a potentially fatal allergen.

"This is a long-term safety issue," said Lily's dad, Mark Scalabrin.

• • •

About 5 percent of children in the United States have food allergies, up from 3.4 percent in 1997, according to the Centers for Disease Control and Prevention.

The most common allergens are peanuts, tree nuts, eggs, milk, fish, shellfish, wheat and soy.

Food allergies have the potential to be serious. In some cases, they can trigger anaphylaxis, a sudden, whole-body reaction responsible for thousands of emergency-room visits and a handful of deaths each year.

For decades, allergists like Dr. Hugh Windom could do little more than teach patients to use an epinephrine shot.

"We saw food allergies all the time, but we were never very good at it," said Windom, who practices in Sarasota and teaches at the University of South Florida Morsani College of Medicine.

A few years ago, a battery of studies on oral immunotherapy caught his attention. The treatment hadn't been approved by the Food and Drug Administration, but Windom didn't think a formal endorsement was necessary. It entailed giving patients a food that could be purchased in the grocery store, not a drug developed in a laboratory.

He started offering OIT for peanut, milk, egg and wheat allergies about 18 months ago.

Windom says he is the only Florida doctor providing the therapy. His patients come from places like Tallahassee, Boca Raton and Atlanta. Most find their health insurance covers the visits, he said.

The treatment plan is simple. Peanut-allergic patients will start by consuming 1/1000th of a peanut — usually in the form of peanut flour diluted in water. Then, they wait 60 minutes to see if they have a reaction.

If they tolerate the dose, they continue taking it at home.

Patients return to Windom's office every two weeks to increase their dosage. Over 32 weeks, they work up to 10 full peanuts. To maintain the immunity over time, they must continue eating a handful of peanuts every day.

Windom stresses that OIT won't cure an allergy.

"We're just keeping it at bay," he said.

So far, 10 of his 30 peanut-allergic patients have made it to the top dose, he said.

• • •

Lily's peanut allergy became clear sometime around her first birthday, when a tiny piece of pad thai made the area around her lips turn red. The hand she used to grab the noodle turned red, too.

A doctor later confirmed what her parents suspected: Lily was allergic to peanuts and tree nuts.

Mark and Amy Scalabrin removed almost all of the peanut products from their Tampa home, and began asking restaurant servers to detail the ingredients in each dish. When Lily started school, they had her assigned to a classroom for children with allergies.

Still, the ubiquitous peanut proved hard to avoid.

During one Christmas party, a sugar cookie made Lily's throat swell. The cookie didn't contain any nuts, but it had been on a table with baked goods that did.

"We gave her two doses of Benadryl," her father recalled. "The EpiPen was ready."

Lily's parents worried about the future, when it would be more difficult to keep tabs on their daughter's food intake. So, after their Tampa allergist suggested a cutting-edge treatment known as oral immunotherapy, they connected with Windom.

During their first meeting, Windom assuaged the Scalabrins' fears about exposing Lily to peanuts.

"He was very sure of the procedure," Mark Scalabrin said.

Still, that first dose was nerve-wracking.

"I was like, if I die, this is going to be terrible," Lily recalled.

She tolerated it easily.

• • •

Among allergists, oral immunotherapy remains the subject of intense debate.

Dr. Robert A. Wood, the chief of pediatric allergy and immunology at Johns Hopkins in Baltimore, says the treatment has potential. But he believes it should win FDA approval before being made available to patients.

"This is, by far, the riskiest treatment that has ever been developed in the field of allergy," he said. "In most fields, you don't have any drug that has a high risk of causing anaphylaxis."

Wood would also like to see more studies on its long-term effectiveness.

The research has, so far, been mixed.

A study published in the February 2014 Journal of Allergy and Clinical Immunology found that 12 of 24 peanut-allergic patients who completed OIT maintained immunity a month after treatment.

A different study, also published in the Journal of Allergy and Clinical Immunology, found less than a third of 32 milk OIT patients could tolerate a full serving of milk up to five years later.

Other physicians, though, are ready to move forward.

Dr. Richard Lockey, director of the Division of Allergy and Immunology at the USF medical school, says he no longer considers the procedure experimental. He hopes to start an OIT program at USF within the next year.

Lockey called OIT "the newest and most up-to-date treatment with food allergies."

"But it has to be utilized in a very, very careful fashion with the appropriate warnings and risks outlined to the parents," he said.

The pharmaceutical world is also coming around. A company called Aimmune Therapeutics is working to bring "standardized, pharmaceutical-grade" peanut-protein capsules to the market specifically for OIT.

• • •

During a visit to Windom's office last week, Lily moved on to peanut dust sprinkled over strawberry applesauce.

The soon-to-be fifth-grader doesn't dream about eating peanuts. She has no idea what they taste like. But she is excited to eat ice cream without first studying the ingredients.

"I'm excited about M&Ms, too," she said, pointing out that even the plain ones come with a peanut warning.

Her family is equally enthusiastic.

"Her siblings are looking forward to the day when they can openly eat peanut butter and jelly sandwiches," her father said.

Contact Kathleen McGrory at [email protected] or (727) 893-8330. Follow @kmcgrory.

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