Boiled peanuts safe, effective as part of oral immunotherapy
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OIT that began with boiled peanuts before moving to roasted peanuts appeared pragmatic, safe and effective in inducing desensitization among children with peanut allergy, according to a study published in Clinical & Experimental Allergy.
Boiling reduces IgE antigenicity while retaining T-cell reactivity in peanuts, Luke E. Grzeskowiak, PhD, associate professor, Flinders Health and Medical Research Institute, College of Medicine and Public Health, Flinders University in Adelaide, South Australia, and colleagues wrote.
“The idea of using boiled peanuts as a treatment for peanut allergy originally came about based on observations that the prevalence of peanut allergy appeared lower in countries where peanuts were commonly boiled as part of the diet,” Grzeskowiak told Healio.
Follow-up investigations found that the boiling process changed the peanuts’ protein structure, significantly reducing allergenicity.
“The boiled peanuts still maintained their ability to stimulate T-cell activation and proliferation, providing promise as a potential safer strategy for introducing peanut allergens as part of oral immunotherapy,” Grzeskowiak said.
Study design
The open-label, phase 2 clinical trial involved 70 children aged 6 to 18 years (mean age, 10.5 years; standard deviation, 3.3) with a positive history of peanut allergy from a private food allergy clinic in South Australia.
Doses increased each week during the three-phase, 52-week protocol, with initial doses for the start of each phase administered in the outpatient clinic and subsequent doses given at home.
The study began with a 12-week phase where patients consumed increasing doses ranging from 62.5 mg of crushed boiled peanut powder to two peanuts, each weighing approximately 1 g and boiled for 12 hours, twice a day.
The second phase, which spanned 20 weeks, comprised increasing doses ranging from 62.5 mg of crushed boiled peanut powder to up to six peanuts, boiled for 2 hours, twice a day.
“Our research team developed the process for boiling the peanuts and completed strict quality-control measures before they were provided to study participants,” Grzeskowiak said.
In the 20-week third phase, doses increased from 31.5 mg of ground defatted peanut powder from roasted peanuts up to six roasted peanuts twice a day.
A 6- to 8-week maintenance phase followed the peanut OIT protocol, with participants advised to transition from eating six peanuts twice a day to eating 12 peanuts daily by adding one peanut each week.
Next, an oral food challenge included a cumulative dose of 12 roasted peanuts, or 12 g of peanuts with approximately 3,000 mg of peanut protein. The researchers considered participants who consumed all 12 peanuts without dose-limiting symptoms to have met the primary efficacy endpoint of the study.
Study results
Overall, 56 (80%) of the participants completed 12 months of treatment, took the OFC and achieved desensitization to 3,000 mg of peanut protein.
Only three of the 14 participants who withdrew from treatment did so because of treatment-related adverse events.
“The remainder were due to social reasons — eg, trial related burden, or family separation — or the dislike of eating peanut, highlighting the broader challenges associated with lengthy oral immunotherapy treatments,” Grzeskowiak said.
Also, 43 (61%) participants reported treatment-related adverse events — 73% of which were mild, 21% moderate and 6% severe — for an overall rate of treatment-related adverse events of 6.58 per 1,000 doses. The most common of these included gastrointestinal symptoms (n = 158; 2.73 per 1,000 doses) and skin symptoms (n = 145; 2.51 per 1,000 doses). Incident rates included 11.83 per 1,000 doses in the first phase, 4.55 in the second and 4.65 in the third.
Treatment-related adverse events included 16 (23%) patients who experienced symptoms consistent with anaphylaxis. The 29 total episodes of anaphylaxis included 25 mild and four moderate incidents.
Patients infrequently used medication for treatment-related adverse events, with oral antihistamines being most common (n = 103; 1.78 per 1,000 doses). Three participants (4%) used rescue epinephrine for a rate of 0.05 per 1,000 doses.
The proportions of children who required medication in the up-dosing and maintenance phases were relatively consistent, results showed.
“This represented a favorable effectiveness and safety profile in comparison to previous research,” Grzeskowiak said.
When the researchers contacted 45 of the 56 patients (80.4%) who passed the OFC after 6 months, 43 said they continued to consume peanuts, with 27 of 43 (63%) eating peanuts daily and the others eating peanuts less frequently. Seven (16%) of those who continued to eat peanuts reported allergy symptoms, but none included anaphylaxis.
Next steps
These results do not provide definite evidence that this protocol is safer than standard approaches with roasted peanuts, the researchers cautioned.
Grzeskowiak added that boiled peanuts are not expected to be part of therapy anytime soon.
“With no commercially available product, this isn’t something that is going to be adopted in clinical practice,” he said.
Additional research also is needed to determine optimal durations for boiling peanuts and administering them, the researchers continued, with head-to-head comparisons of different approaches.
“While the findings are extremely promising, there is a need for a larger definitive clinical trial to determine whether the process of using boiled peanuts as part of oral immunotherapy is safer and more effective than alternative treatment approaches,” Grzeskowiak said.
Next, the researchers aim to further refine the clinical process and better understand how boiling peanuts can assist with desensitization from an immunological perspective.
“Utilizing samples collected as part of the clinical trial, we are also aiming to explore factors associated with treatment response,” Grzeskowiak said. “This will be really important for assessing individual suitability for treatment and improve treatment decisions in the future.”
Reference:
- Clinical trial shows boiled peanuts could help overcome child peanut allergy. https://news.flinders.edu.au/blog/2023/01/12/boiled-peanuts-could-help-overcome-child-peanut-allergy/#:~:text=Boiling%20peanuts%20for%20up%20to,became%20desensitised%20to%20eating%20peanuts. Published Jan. 12, 2023. Accessed Jan. 12, 2023.
For more information:
Luke E. Grzeskowiak, PhD, can be reached at luke.grzeskowiak@flinders.edu.au.
Perspective
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These findings really are not that significant, nor are they groundbreaking, as up to 80% of the 70 patients in this study were able to eat the target dose of peanuts after 52 weeks. In my experience, this is not efficacious, taking almost twice as long to reach the target.
For example, I examined 492 patients (more than seven times the number in the study) who received OIT in our practice and found that 93% were able to reach the target dose in 31 weeks, on average.
Further, the average specific IgE level for peanut in our patients was 44.48 kU/L, and epinephrine was used in 0.04% of doses. This shows safety and efficacy in a much larger legitimate peanut allergy population. In sum, a greater percentage of our patients reached the target dose in almost half the time. This is why I do not find their results significant.
I would suggest considering other treatment options or approaches unless there is nothing else available in your country or geographic area. When in doubt, seek out experts who have experience in food allergy and can interpret data and know what is novel or perhaps what is not.
These researchers should consider looking at other more proven protocols, as there are many with almost a decade of experience that have produced more significant results.
When evaluating articles, clinicians and patients alike should look beyond the headline and consider the actual validity of the study and the results. Although using boiled peanuts may seem to be a “newer” approach, OIT is certainly not novel. It has more than a decade’s worth of research, with more tried-and-true protocols.
When clinicians look beyond the headline, it is not difficult to find hundreds of studies looking at various aspects of OIT. When the details of this study are examined, they really do not measure up to other studies. So, look beyond the headline and consider the actual details. When in doubt, seek the advice of an expert who has both the breadth and depth of understanding.
Cofounder and President, Food Allergy Support Team
Director, Rocky Mountain Allergy at Tanner Clinic
Healio Allergy/Asthma Peer Perspective Board Member
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