Low-dose oral immunotherapy in peanut allergic children: a placebo-controlled trial
Published online: November 10, 2018
Oral immunotherapy (OIT) has been studied as a new treatment option for children with peanut allergy. Most of the placebo-controlled trials on peanut- OIT use a relatively high maintenance dose of peanut protein. These studies show good efficacy but mild to moderate adverse reactions are reported in the majority of the patients. Some patients even suffer from anaphylactic reactions associated to OIT dosing. Therefore, safety concerns have been raised. A low-dose approach might hypothetically improve safety.
Blumchen et al recently published a study in The Journal of Allergy and Clinical Immunology: In Practice, describing a multicenter, placebo-controlled trial investigating the efficacy, safety, quality of life and immune outcomes of peanut-OIT using the lowest maintenance dose so far reported.
Sixty-two children aged 3-17 years with IgE-mediated peanut allergy confirmed by positive food challenge were recruited. They were randomized to either receive peanut-OIT with a planned maintenance dose of 125-250 mg peanut protein or placebo. After a median of 13 months of up-dosing and 9.5 weeks of the maintenance phase, 28 patients in the peanut-OIT group and 24 patients in the placebo-OIT group finished the study with a final oral food challenge. The median maintenance dose patients reached was 125 mg peanut protein (less than half a peanut kernel)/placebo. They found 23 of 31 (74.2%) children in the peanut-OIT group tolerated at least 300 mg peanut protein (equals approximately one peanut kernel) at the final oral challenge compared to only 5 of 31 (16.1%) in the placebo group. 13 of 31 (41.9%) children in the peanut-OIT versus 1 of 31 (3.2%) in the placebo group tolerated the highest dose of 4.5 g peanut protein (approx. 15 peanut kernels) at the final challenge. Ten patients discontinued during the study, two patients in each group due to adverse events. Subjective symptoms like tingling in the mouth, globus sensation, throat clearing, and abdominal pain were reported in a significantly higher number in patients receiving peanut-OIT than in those receiving placebo. None of these symptoms had to be treated. However, there was no significant difference between the groups in the number, severity and treatment of objective symptoms like generalized hives, angioedema, vomiting, diarrhea, rhinoconjunctivitis, coughing, shortness of breath or unconsciousness. Wheezing related to OIT was the only symptom reported significantly more often in the peanut-OIT group than in the placebo group. But treatment of this symptom did not differ between groups. In contrast to the placebo-OIT group significant immunomodulation pointing towards tolerance development, as well as improvement of quality of life could be demonstrated within the peanut-OIT group.
The authors concluded that low-dose OIT is a promising treatment option for peanut allergic children. It is not only effective and has an excellent safety profile but also leads to improvement of quality of life, seems to be feasible, and modulates the immune system towards tolerance development.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.