Efficacy, Safety, and Quality of Life in a Multicenter, Randomized, Placebo-Controlled Trial of Low-Dose Peanut Oral Immunotherapy in Children with Peanut Allergy

Abstract

Efficacy, safety and quality of life in a multi-center, randomized, placebo-controlled trial on low-dose peanut oral immunotherapy in peanut allergic children

Sustained successful peanut oral immunotherapy associated with low basophil activation and peanut-specific IgE

“…6 Such studies have demonstrated that immunotherapy can successfully desensitize patients to peanut. [7][8][9][10][11][12][13][14][15][16] However, it is not clear whether longterm tolerance is sustainable without continuous peanut dosing after active therapy.…”

CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy

“…Caregivers should be included in shared decision-making about, whether to initiate OIT early for these foods and based on individual prognosis, considering that OIT is well tolerated and has high efficacy in this age group This recommendation is based on the principle of equity in eligibility as well as proportionality between risks and benefits, considering patient's goals and perspectives For desensitization, it is supported by a large amount of consistent clinical evidence. Many OIT studies (RCTs [34,41,43,47,49,59,60] as well as large clinical practice case series [32,33,40,54]) enrolled children starting from the age of 4 or 5 years; some have started enrolment from age three [29,61] or one [46,62]. In addition, there is a moderate amount of consistent evidence specifically for this age group from one RCT of milk OIT (unclear risk of bias-Cochrane) [63], one large (N = 270) prospective, multi-center case series in clinical practice of peanut OIT (low risk of bias-IHE tool) [30] and one small (N = 37) prospective, uncontrolled clinical trial of peanut OIT [58].…”

“…For desensitization, it is supported by a large amount of consistent clinical evidence. Most of the evidence for desensitization stems from studies that enrolled children and adolescents with median/mean ages in the range of 6 to 12 years (RCTs [31, 34, 39, 41, 43, 46, 49, 59-61, 64, 65] and large clinical practice case series [32,33,40,54]) In nine RCTs [34,39,41,43,44,47,59,61,64] and five large clinical practice case series [29,32,33,40,54], the upper age limit for enrolment was 16 years or older (up to 27 years [32]). This is coherent with data from consultations.…”

Future research trends in understanding the mechanisms underlying allergic diseases for improved patient care

“…The major issues in treating food allergy by immunotherapy are safety, the low rate of tolerance induction, a high rate of side effects and dropouts, a lack of understanding of the optimal dose and time of treatment, and the existence of only few, suboptimal biomarkers that predict treatment response and how to perform multifood OIT . These limitations are addressed in numerous treatment approaches: (a) peptide immunotherapy targeting the T‐cell compartment and lacking IgE cross‐linking; (b) hypoallergenic variants of allergens or extracts by chemical or thermal modification or mutations which combine reduced desensitization with a minimally altered T‐cell epitope diversity; (c) the usage of immunomodulatory substances and/or particles; (d) the addition of prebiotics and/or probiotics; (e) the application of biologics either alone or as adjuvants of OIT; (g) very low dose OIT; and (h) sublingual OIT.…”

“…155 The major issues in treating food allergy by immunotherapy are safety, the low rate of tolerance induction, 155 a high rate of side effects and dropouts, 153 a lack of understanding of the optimal dose and time of treatment, and the existence of only few, suboptimal biomarkers that predict treatment response and how to perform multifood OIT. 13,157,158 addition of prebiotics and/or probiotics 76,166 ; (e) the application of biologics either alone 167,168 or as adjuvants of OIT 169,170 ; (g) very low dose OIT 171,172 ; and (h) sublingual OIT.…”