Scott Sicherer, MD, FAAAAI

What CAFETERIA Means for Long-Term OIT Goals, with Scott Sicherer, MD

Months after topline results from the CAFETERIA study demonstrated the ability to instill high levels of tolerance in children with high-threshold peanut allergy, questions remain about how its findings fit within traditional oral immunotherapy (OIT) goals and how it highlights the distinction between desensitization and sustained unresponsiveness.

The CAFETERIA study was highlighted in a session given by Scott H. Sicherer, MD, Director of the Elliot and Roslyn Jaffe Food Allergy Institute and the Elliot and Roslyn Jaffe Professor of Pediatric Allergy and Immunology at the Icahn School of Medicine at Mount Sinai, at the 

American Academy of Allergy, Asthma & Immunology (AAAAI)

 2026 Annual Meeting held in Philadelphia, Pennsylvania.

sat down with Sicherer to discuss how clinicians should interpret the study’s results in real-world practice. He noted that terms like “remission” and “sustained unresponsiveness” are often used loosely, but in research they are highly protocol-specific. In many OIT trials, sustained unresponsiveness is defined by a relatively short avoidance period of often 6 weeks before re-challenge. In CAFETERIA, the team sought to mirror a more realistic scenario. After children demonstrated the ability to tolerate the equivalent of a peanut butter sandwich, they were asked to incorporate peanut more naturally into their diets for 16 weeks, consuming modest amounts weekly rather than adhering to a strict daily regimen. Only after that period were they instructed to completely avoid peanut for eight weeks before undergoing a final oral food challenge.

Most participants maintained tolerance after that extended, real-world–informed approach. Still, Sicherer is cautious about framing the results as a “cure.” In practice, he continues to counsel families that ongoing ingestion is important. Even if 1 to 2 tablespoons per week appears sufficient to maintain benefit, prolonged avoidance could allow clinical reactivity to return. For that reason, he advises continued dietary inclusion and routine follow-up rather than declaring the allergy resolved.

While CAFETERIA was a single-site study can not be generalized across food allergies, Sicherer believes the core principle of the study, that individuals with lower baseline IgE levels and higher initial tolerance thresholds may respond more readily to low-intensity OIT, likely extends beyond peanut. The concept may be applicable to other common allergens such as milk, egg, or tree nuts and would benefit from broader replication. Whether larger, multi-center trials will test that hypothesis remains to be seen, but the phenotype-driven approach introduced by CAFETERIA may signal a broader evolution in food allergy management.

“There's nothing so special about peanut. In fact, it might be that peanut would have been a harder case to approach. So would this apply to egg or milk or or other nuts and just other foods in general? I think the answer is yes. But are the studies going to be done? We'll wait and see,” Sicherer said.

Sicherer SH, Bunyavanich S, Berin MC, et al. Peanut Oral Immunotherapy in Children with High-Threshold Peanut Allergy. 

. Published online February 10, 2025. doi: 10.1056/evidoa2400306

Sicherer S. FAED Presents: The Potential for Tolerance After Oral Immunotherapy in High-Threshold Patients: The CAFETERIA Study. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Session 1705.

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Sicherer discussed how the study might shift clinical thinking in pediatric food allergy. 

CAFETERIA: Expanding Treatment Pathways for High-Threshold Peanut Allergy, with Scott Sicherer, MD

In late 2025, the NIH-sponsored CAFETERIA trial, published in 

, demonstrated that gradually increasing, home-measured doses of store-bought peanut butter over approximately 18 months enabled 100% of participating children with high-threshold peanut allergy to tolerate 9 grams of peanut protein, or the equivalent of 3 tablespoons of peanut butter, during supervised challenge.

 Even more striking, more than 2/3 achieved sustained unresponsiveness after a period of avoidance. For a population historically told that strict avoidance was their only option, the findings marked a meaningful shift.

Scott H. Sicherer, MD, Director of the Elliot and Roslyn Jaffe Food Allergy Institute and the Elliot and Roslyn Jaffe Professor of Pediatric Allergy and Immunology at the Icahn School of Medicine at Mount Sinai, gave a talk at the 

 2026 Annual Meeting held in Philadelphia, Pennsylvania, on February 27-March 2, discussing the data and takeaways from the CAFETERIA study.

sat down with Sicherer at the meeting, who co-led the trial at the Elliot and Roslyn Jaffe Food Allergy Institute at Mount Sinai, to learn more about  CAFETERIA and its importance in addressing a long-overlooked gap in peanut allergy. Prior peanut immunotherapy trials focused primarily on children reactive to trace amounts, or those unable to tolerate even half a peanut. But roughly half of peanut-allergic children can already tolerate more than that threshold. For them, the question had long been: if they are already relatively protected against trace exposures, should clinicians simply advise continued avoidance?

Historically, the answer was yes. Children who reacted mildly at modest doses during an oral food challenge were typically labeled “still allergic” and sent home with instructions to avoid peanut entirely. CAFETERIA challenges that reflex. Sicherer noted that children with higher thresholds, often with lower peanut-specific IgE levels, proved highly responsive to a structured, low-cost oral immunotherapy approach using everyday products measured at home. The safety profile was favorable, and the success rate was high.

One year later, Sicherer says the study has reshaped his clinical thinking. Instead of defaulting to annual reassessment and continued avoidance, clinicians can now view high-threshold peanut allergy as a treatment opportunity.

“For those individuals who typically have lower IG levels, who might be ones that you'd want to do a feeding test for a food challenge, or discovering that they …don't react to the smallest amounts, is really a pathway, an opportunity to try to treat them. And so that's changed the thinking for us, and I hope for everyone,” Sicherer said.

Sicherer discussed how findings from CAFETERIA may inform treatment decisions for children with high-threshold allergy.

Credit: Food Allergy Research & Education

2025 American Academy of Allergy, Asthma, & Immunology (AAAAI)

 in San Diego, Scott Sicherer, MD, from Mt. Sinai School of Medicine, presented the 

, “Randomized Trial of High Dose, Home Measured Peanut Oral Immunotherapy in Children with High Threshold 

His team’s phase 2 trial compared the tolerance levels of peanut oral immunotherapy vs avoiding peanuts altogether in 73 children aged 4 – 11 years with a high threshold peanut allergy (> 143 mg) The study assessed whether patients on oral immunotherapy could tolerate 3400 mg of store-bought peanuts and then 9043 mg during the oral challenge.

100% of children on oral immunotherapy tolerated 9043 mg of peanuts, compared with 10% in the avoidant arm. 

 spoke with Sicherer at AAAAI 2025 about these promising findings.

: What prompted this research, and does it address a significant gap in peanut allergy management?

 All of the products that [the FDA has approved]—which are two omalizumab and also a commercial version of peanut oil immunotherapy—specifically brought people into the study if they reacted to half of a peanut or less. [This] makes sense because they're very sensitive to small amounts [and] more prone to have a reaction if there's a little bit of peanut in a cookie, a little mistake like that. But [these studies are] ignoring the half of the children who have a peanut allergy but could already eat half a peanut…who might be what we call “bite safe.”

[This group] could represent almost half of the peanut-allergic population. We figured that [they] would even be easier to treat, and maybe treatable with very simple measures, [such as] peanut butter. Something that you could just buy in the store…measure…[and] use as a medicine, except that obviously would have to be done under doctor supervision. That's what brought the study together.

: Your trial found that participants who underwent peanut oral immunotherapy had a significantly higher rate of desensitization compared to those who avoided peanuts. What are some of the key factors that contributed to this success, and what does this mean for the future of peanut allergy treatment?

 We randomized the group that was already identified as [having a] higher threshold, [meaning they could] eat more than half of the peanut before they would react. We randomized them to either go through this process of oral immunotherapy using home-measured amounts of peanut, but under allergy supervision versus [to] just avoid it.

The group that did not go through the…gradual increases under doctor supervision… had the same threshold at the end of the study. Some…actually showed a lower threshold than they started with. Some showed a higher threshold than they started with, but on average, they had no change. They were [often] still bite-safe, but they couldn't eat peanut butter.

For the ones who had the feeding test, all of [them] were able to eat a peanut butter and jelly sandwich worth of peanut butter—so they were basically able to eat it like regular food.

We wanted to also ask the question: is this a durable response? What would happen in real life if they stopped taking it as a daily dose? Because they were taking…a tablespoon a day as a daily dose as treatment? We had them spend 4 months eating it… so we encouraged them to have peanut butter and to hopefully have about two tablespoons a week, but we didn't give them a specific plan. We had them completely stop any peanut butter for 2 months so they wouldn't have any exposure. Then we brought them back to a feeding test, and for all the ones that came back for that feeding test, almost 90% were able to still ingest that whole peanut butter sandwich worth of peanut butter.

Typically, you would have said, “Oh, gee, you’re allergic to peanuts, don't eat it.” But with this information, you can make a very strong argument that if the family and child were interested in raising their threshold and eating the food more like regular food, although I would not call it a cure, it's still a treatment. They could go through a process that's relatively simple, not a lot of visits with the doctor, and could end up having them eat peanut butter like regular food.

Is there anything else you want to add about the findings?

 The starting point here is to determine [a] threshold. Is this person sensitive to tiny amounts or not? If you don't figure that out, you would never want to apply this particular protocol. Secondly, it's important to have allergist supervision. I do worry that people will look at this and say, ‘Oh, home measured, home purchase’ [and interpreting it could mean] you just do this all on your own, like you're a family. No, that could be risky and dangerous. You have the allergy. You have to work with an allergist if you're going to approach something like this.

Sicherer, S, Bunyavanich, S, Berin, C, et al. Randomized Trial of High Dose, Home Measured Peanut Oral Immunotherapy in Children with High Threshold Peanut Allergy Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB445

Derman, C. Peanut Oral Immunotherapy Boosts Tolerance in Children with High-Threshold Peanut Allergy. HCPLive. March 3, 2025. 

https://www.hcplive.com/view/peanut-oral-immunotherapy-boosts-tolerance-children-high-threshold-peanut-allergy

Articles

A phase 2 trial presented at the 2025 AAAAI meeting explored high-dose, home-measured peanut oral immunotherapy in children with high-threshold peanut allergies. The study demonstrated that 100% of children undergoing oral immunotherapy tolerated 9043 mg of peanuts, compared to 10% in the avoidance group. The research addresses a gap in peanut allergy management by focusing on children who can already tolerate small amounts of peanuts. The findings suggest that oral immunotherapy could enable these children to consume peanuts like regular food, though allergist supervision is crucial.

A phase 2 trial found that 100% of children on peanut oral immunotherapy tolerated 9043 mg of peanuts, vs 10% in the avoidant group.