Oral immunotherapy can lead to remission of infant peanut allergies

Oral immunotherapy is associated with an increase in both desensitization and peanut allergy remission in children under 4 years of age, with younger children having greater success, according to the data published below. increase. Lancet..

“This result is important in that it is the first blinded trial of oral immunotherapy (OIT) focused on this infant’s age group,” the author said. Edwin H. Kim, MD, MS, Associate Professor of Pediatrics and Medicine at the University of North Carolina School of Medicine and Director of UNC Pediatric Allergy and Immunology told Healio.

Edwin H. Kim

“By those who introduce peanuts early based on the LEAP guidelines, we expect more recognition and diagnosis of peanut allergies at a very young age,” Kim added.

In a press release from NIH that funded the clinical trial, Anthony S. Forch, MD, The director of the National Institute of Infectious Diseases at NIH said the “breakthrough results” of this study indicate an opportunity for OIT to induce remission of peanut allergies in early childhood.

“We hope that the results of these studies will help develop treatments that reduce the burden of children with peanut allergies,” Fauci said.

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

After skin prick tests, a double-blind, placebo-controlled food challenge (DBPCFC), and immunoassay confirmed peanut allergies, researchers randomly assigned children. For peanut OIT (N = 96) or placebo (n = 50).

Participants received lightly roasted and partially degreased (12% fat) peanut flour or oat flour.

The daily dose increased from 0.1 mg to 2,000 mg, or about 6 peanuts, and increased from week 0 to about week 30. 30-134 weeks.. After that, OIT was suspended from 134 to 160 weeks. Participants were instructed to avoid consuming all other peanuts during the study period.

At week 134, 68 participants (71%; 95% CI, 61-80) in the peanut OIT group tolerated a cumulative dose of 5,000 mg of peanut protein and 1 (2%; 95% CI). Achieved the main results of desensitization compared to. , 0.05-11) Placebo group (risk difference, 69%; 95% CI, 59-79; P <.0001).

At week 160, 20 peanut OIT group participants (21%; 95% CI, 13-30) and one placebo group participant (2%; 95% CI, 0.05-11) (risk difference, 19). %; 95%) CI, 10-28; P = .0021) Passed 5,000 mg of DBPCFC (about 16 peanuts) and achieved remission. This served as another major result.

Results will vary by age. In the Peanut OIT group, researchers are 5 out of 7 children (71%) 12 to 23.9 months, 7 out of 20 children 24 to 35.9 months (35%), and 43 children. Eight (19%) reported remission. 36-47.9 months (P = .013).

“None of these do not seem to naturally exceed allergies, as only one of the children taking placebo was able to eat 5,000 mg without symptoms during the same period.” Kim said.

All participants who achieved remission subsequently participated in a 8,000 mg open-label peanut butter diet, and 17 of 20 peanut OIT patients (85%) and those receiving placebo were tested. Passed.

Also, 20 children who did not achieve remission were still able to tolerate between 1,755 mg and 3,755 mg at 160 weeks. Overall, 40 (57%) of the 70 children who completed treatment safely received about 6-12 peanuts compared to 1 of 23 (4%) in the placebo group. I was able to take it.

“We believe that most allergic reactions occur with exposure to less than one peanut. With this in mind, more than 80% (58 out of 70) stopped for 6 months. Later, I was able to eat almost three peanuts without symptoms, “Kim said.

Dosing responses occurred between 94 (98%) of peanut OIT participants and 40 (80%) of placebo participants. The most frequent reactions included mild or moderate skin, gastrointestinal and respiratory disorders.

Five of the peanut OIT participants experienced serious symptoms during home dosing, and one participant in the placebo group experienced serious adverse events during the 134-week DBPCFC.

“The findings show, first of all, that OIT is feasible in this young group and is at least as safe as, if not safer, than seen in older children in important PALISADE studies. I’m showing, “Kim said. “Second, as we expected and hypothesized, OIT seems to have a stronger effect in this younger group compared to older children.”

Kim keeps in mind that the FDA will ultimately decide if and when the clinic can treat children in this age group with peanut OIT, and doctors will provide patient education and this care. He said he could start preparing for.

Researchers may end the “enhanced window of remission” early, as age and remission results appear to be inversely related, furthering the risks and benefits of peanut OIT’s age definition. He said research is needed. Researchers will continue to work in three stages.

First, practical, large-scale, multicenter joint research will attempt to ensure the safety of treatment for this age group and bring it to the clinic, Kim said.

“The second is to dig deeper into the immunology of this age group to understand who is likely to respond to treatment and who is likely to be in remission, and to find ways to amplify these results.” He continued. “Third, beyond peanuts, deal with other common food allergies such as milk, eggs, nuts, and see how they are similar and how unique they are in terms of treatment. That is. ”

In the accompanying editorial, Matthew Greenhawt, MD, Researchers at the Colorado Children’s Hospital write that the results of this study suggest that early childhood peanut OITs are “ready for immediate real-world implementation.”

“Additional trials may increase the certainty of evidence of OIT in these times, but further delay the implementation of OIT risks that withhold proven benefits,” they wrote. “Waiting for regulatory approval of commercial products for very young children for this treatment to be considered ready does not benefit the family.”

For more information:

Edwin H. Kim, MD, MS, You can contact us at [email protected].

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