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2013

First Long-Term Study of Food Allergy Treatment: 'Proceed with Caution'

MEDIA CONTACT: Ekaterina Pesheva
EMAIL: epeshev1@jhmi.edu
PHONE: (410) 502-9433

MEDIA CONTACT: Gary Logan
EMAIL: glogan@jhmi.edu
PHONE: 410-502-9431

June 27, 2013

-Johns Hopkins Children’s Center research shows some kids lose tolerance over time

The first long-term study of children allergic to milk treated with an experimental approach based on giving them progressively higher doses of milk confirms what allergy experts suspected all along — the treatment is not ready for prime time.

This is the verdict from a Johns Hopkins Children’s Center study of children treated with oral immunotherapy, which involves repeated exposures to tiny amounts of milk designed to eventually “teach” an allergic child’s hypervigilant immune system to ignore the food protein that sends it into overdrive. The approach had shown promise in early studies and fueled excitement among physicians and parents alike.

The findings, published online June 27, 2013 in the Journal of Allergy and Clinical Immunology, reveal that while the treatment offered long-term protection for some children, others lost their tolerance to milk over time. In addition, many continued to have intermittent symptoms, and some had severe reactions even after experiencing improvement early on.

The findings are certainly not a fatal blow to the approach, the researchers say, but are decidedly mixed and do indicate the need for more studies with longer follow-up.

“While many children were clearly better off with treatment, our results raise troubling questions about the long-term risk for future reactions among children treated with this approach,” says lead investigator Corinne Keet, M.D., a pediatric allergist at the Johns Hopkins Children’s Center.

“Our results are a clear ‘proceed with caution’ sign,” says senior investigator Robert Wood, M.D., director of the Division of Pediatric Allergy and Immunology at the Johns Hopkins Children’s Center. “While we’ve been excited about this treatment, we also knew there were many questions that had to be answered. Our findings provide some of those critical answers.”

Notably, the results highlight an important caveat about oral immunotherapy — it is an approach best reserved for use in rigorous research settings and as part of FDA-approved protocols, the investigators say.

For the study, investigators followed 32 children treated with oral immunotherapy over a period of three to five years after completing treatment. By the end of the original treatment, all but three children had experienced some improvement and were able to consume at least some milk in their diet.

Follow-up revealed that eight children remained symptom-free long term, while 12 had frequent symptoms with milk consumption. Seven children eventually ceased milk consumption altogether or consumed only very small amounts, including some who initially had been able to tolerate significant amounts of milk. More disturbingly, the investigators found, six children went on to have serious allergic reactions, and three of them reported having to use injectable epinephrine — or an EpiPen in common parlance — at least once to interrupt a life-threatening allergic reaction.

The research was funded in part by the National Institutes of Health under grant number 1K23AI103187. Additional support for the study came from private philanthropy.

Co-investigators included Shannon Seopaul, B.S., and Sarah Knorr, R.N., M.P.H., C.C.R.P., of Johns Hopkins, and Satya Narisety, M.D., and Justin Skripak, M.D., former pediatric allergy fellows at Johns Hopkins.                           

Related on the Web:

Egg Therapy Benefits Children Allergic to Eggs
http://www.hopkinschildrens.org/Egg-Therapy-Benefits-Children-Allergic-to-Eggs.aspx

Drinking Milk to Ease Milk Allergy?
http://www.hopkinschildrens.org/drinking-milk-to-ease-milk-allergy.aspx

Warning: Food Allergy Blood Tests Sometimes Unreliable
http://www.hopkinschildrens.org/newsDetail.aspx?id=1896&LangType=1033&terms=Allergy+tests

 

Founded in 1912 as the children's hospital of the Johns Hopkins Medical Institutions, the Johns Hopkins Children's Center offers one of the most comprehensive pediatric medical programs in the country, with more than 92,000 patient visits and nearly 9,000 admissions each year. Hopkins Children’s is consistently ranked among the top children's hospitals in the nation. Hopkins Children’s is Maryland's largest children’s hospital and the only state-designated Trauma Service and Burn Unit for pediatric patients. It has recognized Centers of Excellence in dozens of pediatric subspecialties, including allergy, cardiology, cystic fibrosis, gastroenterology, nephrology, neurology, neurosurgery, oncology, pulmonary, and transplant. For more information, visit www.hopkinschildrens.org   

 

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Founded in 1912 as the children's hospital of the Johns Hopkins Medicine, the Johns Hopkins Children's Center offers one of the most comprehensive pediatric medical programs in the country, with more than 92,000 patient visits and nearly 9,000 admissions each year. Johns Hopkins Children Center is consistently ranked among the top children's hospitals in the nation by U.S. News & World Report. It is Maryland's largest children’s hospital and the only state-designated Trauma Service and Burn Unit for pediatric patients. It has recognized Centers of Excellence in dozens of pediatric subspecialties, including allergy, cardiology, cystic fibrosis, gastroenterology, nephrology, neurology, neurosurgery, oncology, pulmonary, and transplant. For more information, visit www.hopkinschildrens.org.


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