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