Infectious Disease

Oral immunotherapy can lead to remission of peanut allergy in young children

January 21, 2022

4 minutes read

Source/Disclosures

Disclosure:
Kim reports personal fees from Aimmune Therapeutics, Allakos, Allergenis, DBV Technologies, Duke Clinical Research Institute, Kenota Health, Ukko, and Vibrant America, as well as grants from Food Allergy Research & Education and the Wallace Research Foundation. The relevant financial information of all other authors can be found in the study.

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According to data published in The Lancet, oral immunotherapy was associated with an increase in both desensitization and remission of peanut allergy in children under the age of 4, with younger children having greater success.

“The results are significant in that they are the first blinded oral immunotherapy (OIT) study to focus on this age group of young children,” the author said Edwin H Kim, md, MRS, Associate Professor of Pediatrics and Medicine and Division Chair of UNC Pediatric Allergy & Immunology at the University of North Carolina School of Medicine, Healio said.

Data were adapted from Jones, SM, et al. Lancet. 2022; 399:359-71.

Edwin H Kim

“As people introduce peanuts earlier and earlier based on LEAP guidelines, we expect much more awareness and diagnosis of peanut allergies at a very young age,” Kim added.

A press release from the NIH, which funded the clinical trial, states: Anthony S Fauci, MD, Director of the NIH’s National Institute of Allergy and Infectious Diseases, said the study’s “pioneering results” indicate a possibility for OIT to induce remission of peanut allergy in early childhood.

“We hope that these study results will inform the development of treatment modalities that reduce the burden of peanut allergy in children,” said Fauci.

The multicenter, double-blind study included 146 children aged 12 to 48 months (mean age 39.3 months; 68% boys) who tolerated an average of 25 mg peanut protein.

After skin prick tests, double-blind placebo-controlled food challenges (DBPCFCs), and immunoassays confirming peanut allergy, researchers randomly assigned children to peanut OIT (n=96) or placebo (n=50).

Participants received lightly toasted, partially defatted (12% fat) peanut flour or oatmeal.

Daily doses increased from week 0 to about week 30 from 0.1 mg to 2,000 mg, or about six peanuts. A maintenance dose of 2,000 mg daily doses followed from week 30 to week 134. The OIT was then suspended from weeks 134 to 160. Participants were instructed to avoid any other peanut consumption during the study period.

At week 134, 68 (71%; 95% CI, 61-80) participants in the peanut OIT group tolerated a cumulative dose of 5,000 mg peanut protein and achieved the primary outcome of desensitization compared to one (2%; 95% CI ). , 0.05-11) in the placebo group (risk difference 69%; 95% CI 59-79; P<0.0001).

At week 160, 20 (21%; 95% CI, 13-30) participants in the peanut OIT group and one (2%; 95% CI, 0.05-11) in the placebo group (risk difference, 19 %; 95% CI, 10-28; P=0.0021) passed a 5,000 mg DBPCFC (approximately 16 peanuts) and achieved remission, which served as the other primary outcome.

Results varied by age. In the peanut OIT group, researchers reported remission in five (71%) of the seven children aged 12 to 23.9 months, seven (35%) of the 20 children aged 24 to 35.9 months, and eight (19%) of the 43 children aged 36 to 47.9 months (p=0.013).

“It doesn’t look like the allergy would naturally outgrow it, as only one of the children on placebo was able to eat the 5,000 mg without symptoms over the same period,” Kim said.

All participants who achieved remission then entered an open-label 8,000 mg peanut butter diet, with 17 (85%) of the 20 peanut OIT patients and the one receiving placebo passing the test.

Additionally, 20 children who did not achieve remission could still tolerate between 1,755 mg and 3,755 mg at 160 weeks. So overall, 40 out of 70 children (57%) who completed treatment were able to safely consume approximately 6 to 12 peanuts, compared to 1 out of 23 (4%) in the placebo group.

“We believe that most allergic reactions occur after exposure to less than one peanut. With that in mind, over 80% (58 out of 70) were able to eat almost three peanuts without symptoms after stopping for 6 months,” Kim said.

Dose responses occurred in 94 (98%) of the peanut OIT participants and 40 (80%) of the placebo participants. The most common reactions were mild or moderate skin, gastrointestinal and respiratory disorders.

Five of the peanut OIT participants experienced severe symptoms during home use, and one participant in the placebo group experienced a serious adverse event during a DBPCFC at week 134.

“Most importantly, the results show that OIT is feasible in this young cohort and is at least as safe, if not safer, than in older children in the pivotal PALISADE study,” said Kim. “Second, as we had hoped and assumed, OIT appears to have a greater effect in this younger group than in the older children.”

Noting that the FDA will ultimately decide if and when clinics can treat children in this age group with peanut OIT, Kim said doctors can begin to educate patients and prepare clinics to offer this care.

Because age and remission outcome appeared to be inversely associated, the researchers said an “extended window for remission” may be closing early and further studies on age-defined risks and benefits of peanut OIT are warranted. The researchers plan to continue their work in three steps.

First, a practical, larger, multi-center study will try to ensure the safety of the treatment in this age group to get them into a clinic, Kim said.

“Second would be to look deeper into the immunology of this age group to understand who is likely to respond to treatment, who is likely to go into remission, and to find ways we can amplify these results,” he continued. “Third, one would go beyond the peanut and address other common food allergies like milk, egg, and tree nuts to see how similar they are and how unique they are in terms of treatment.”

In an accompanying editorial matthew Greenhawk, MD, of Children’s Hospital Colorado, and colleagues wrote that the results of this study suggest that peanut OIT for early childhood is “ready for immediate implementation in the real world.”

“Although additional studies could increase the certainty of evidence for OIT at this age, further delay in the implementation of OIT risks withholding proven benefits,” they wrote. “Waiting for regulatory approval for commercial products for very young children for this treatment to be considered mature does not benefit families.”

For more informations:

Edwin H Kim, MD, MRS, reachable at edwinkim@email.unc.edu.

References:

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David R. Stukus, MD, FACAAI)

David R Stukus, MD, FACAAI

I am very happy to see that this study is being conducted in such a rigorous manner. It offers tremendous insight into advancing our understanding of the onset of OIT in younger age groups.

I’m not that surprised by the results as they seem to confirm what we know of OIT in older children with differential treatment response, risk for treatment reactions and a shift in immune response for those receiving higher doses from treatment can tolerate.

We have been reluctant to start OIT in younger children for several reasons, most notably the lack of data to guide us. But it’s exciting to see more research in this area.

Most importantly, I believe this study emphasizes that shared decision-making is critical to OIT to ensure families truly understand the risks, benefits, and expected outcomes. This process requires the monitoring and availability of the treating provider to answer questions and help families deal with some of the challenges involved.

I don’t think this study should be used as a “green light” to start OIT for peanuts in all infants or young children. But it paves the way for talking to families about risks and benefits. Also, OIT should never be performed without following specific protocols and under the supervision of an experienced allergist or specialist in the field.

Unfortunately, only a relatively small number of children under the age of 2 were included in this study, so it would be very helpful to see larger studies in this age group.

Ongoing research in this area is valuable in trying to identify some predictive factors for those children who may achieve long-term sustained unresponsiveness and those who are at risk for poor outcomes.

David R Stukus, MD, FACAAI

Professor of Clinical Pediatrics

Director, Food Allergy Treatment Center

Associate Director of the Pediatric Allergy and Immunology Fellowship Program

Nationwide Children’s Hospital and Ohio State University College of Medicine

Disclosure: Stukus does not report any relevant financial information.

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