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Major review calls for new approach to evidence-based food allergy research
Mark Gould
Friday, April 26, 2019
A major study * on children with peanut allergies concluded that current oral immunotherapy treatments resulted in a sharp increase in anaphylaxis and other allergic reactions, rather than preventing them as expected.
The systematic review comprising 12 studies of more than 1,000 patients followed for one year shows that, compared with allergen avoidance or placebo, current oral immunotherapy increases the risk.
Authors writing in The lancetstate that their results are in favor of avoiding current forms of oral immunotherapy if a patient wishes to avoid peanut-induced allergic reactions and anaphylaxis, and that the increased risk of reactions badociated with these dosage regimens could constitute a major obstacle to widespread adoption by peanut patients allergies.
They claim that their results highlight the gap between the results measured in the clinic and the allergy relief results that patients want after oral immunotherapy for peanut allergy.
Oral immunotherapy studies currently measure treatment success by determining whether or not a treated patient may succeed in a supervised dietary challenge, but this does not predict the future risk and frequency of the patient's allergic reactions in the real world. . The authors advocate safer peanut allergy treatment methods and rigorous randomized controlled trials, which use more appropriate measures of allergy reduction based on patient desired outcomes.
Lead author Dr. Derek Chu of McMaster University in Canada says the study shows that current peanut oral immunotherapy regimens can achieve the immunological goal of desensitization, "but this result does not translate into the clinical objective and desired by the patient to reduce allergic reactions and anaphylaxis over time ".
"Instead, the opposite result occurs, with more allergic and adverse reactions badociated with oral immunotherapy compared with avoidance or placebo," he said.
"Our results do not denounce current research in oral immunotherapy, but the method needs to be examined more closely, safety improvements and success measures must be aligned with the wishes of patients."
The study combined the results of 12 randomized controlled trials conducted in the United States, United Kingdom, Europe and Australia (including three unpublished trials) including 1,041 patients to compare the results after oral immunotherapy to those after no oral immunotherapy. The trials compared oral immunotherapy versus placebo, avoidance or other types of immunotherapy, and used different products and doses of peanut.
The average age of study participants was about nine years (between 5 and 12 years) and participants were followed for an average of one year. The study measured anaphylaxis, allergic or adverse reactions, the use of epinephrine and quality of life.
The results suggest with high and medium quality evidence that, compared with the absence of oral immunotherapy, oral peanut immunotherapy increases the risk and frequency of anaphylaxis (d & # 39; 39, about three times, from 7.1% without oral immunotherapy to 22.2% with oral immunotherapy), the use of epinephrine (about twice, from 3.7% without to 8, 2% with), and serious adverse events (about twice, from 6.2% without to 11.9% with) to a similar extent during badembly and maintenance. Allergic reactions in the gastrointestinal tract (vomiting, abdominal pain, itching in the mouth), skin and mucous membranes (hives and swelling or angioedema), nose (congestion or rhinitis) and lungs (wheezing or asthma) have also increased.
However, they found that the quality of life was not better in people receiving oral immunotherapy than in those who did not. The authors note that this contrasts with observational studies, which may be due to the fact that these studies are not controlled for confusion and bias. They note that large-scale, well-conducted randomized controlled trials are needed to clarify the possible effect of peanut oral immunotherapy on quality of life.
In future research, it will be important to clarify patients' values and preferences regarding general food allergy treatments – understanding what patients expect from treatment and what outcomes are desirable and undesirable. Measures to estimate the benefits and harms of food allergy interventions should be patient-centered, such as the risk and rate of allergic and anaphylactic reactions over time, as recommended by GRADE, National Institute of Allergy and Infectious Diseases of the FDA, in the United States. (Food and Drug Administration) and other organizations.
"Given the current view of peanut allergic oral immunotherapy as a model for other food allergies and the increasing global prevalence of food allergies, these findings are significant and important to ongoing development." food allergy treatments, "concludes Dr. Chu.
* Chu KD, Wood RA, French S, et al. Peanut allergy oral immunotherapy (PACE): systematic review and meta-badysis of efficacy and safety. Posted: April 25, 2019. DOI: 10.1016 / S0140-6736 (19) 30420-9
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