AR101 Oral Immunotherapy for Peanut Allergy

Abstract

BACKGROUNDPeanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions. METHODS Randomization and BlindingEligible participants were randomly assigned, in a 3:1 ratio, to receive either AR101, a peanut-derived pharmaceutical product that was manufactured

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

“…desensitization, continued consumption or sustained unresponsiveness) are worth pursuing remains patients' prerogative, in line with the principle of patient autonomy It is supported by a large amount of consistent clinical evidence, which includes three metaanalyses [22][23][24] (together covering 31 published OIT controlled clinical trials), three additional RCTs [31,34,39] and two non-randomized controlled clinical trials (CCTs) [36,38], five large case series in clinical practice (N > 150) [29,30,32,33,40], and two smaller case series [35,37]. This body of evidence includes 10 RCTs rated as being at low risk of bias [34,[41][42][43][44][45][46][47][48][49] and is coherent with data from consultations. Level of evidence: HIGH OIT can be recommended for long term management since a sizable proportion of patients will continue to regularly consume a sufficient amount of the food to maintain desensitization after reaching maintenance, without reverting to complete avoidance This recommendation is based on the principle of beneficence.…”

“…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.…”

“…For desensitization, it is supported by only a small amount of consistent clinical evidence. The limited data available for patients 18 years of age and older, from one double-blind RCT that included a small number of adults [47,67] and one small case series [44] suggest that desensitization is possible in this age group. Level of evidence: LOW Table 1, Clinical dimension, criteria 8 to 12): A history of anaphylactic reactions to the targeted food allergen was generally not an exclusion criterion in OIT studies.…”

“…Previous history of anaphylaxis to the targeted food is not a contraindication for OIT This recommendation is based on the principle of equity in eligibility It is supported by a large amount of clinical evidence A history of anaphylactic reactions to the targeted food allergen was generally not an exclusion criterion in OIT studies. Some RCTs [43,46,47,49,59,63] and clinical practice case series [30] excluded patients with a history of severe anaphylaxis; others included them (RCTs [41,61,64]; case series [29,40]). Evidence from large case series on whether baseline history of anaphylaxis had an impact on OIT outcomes is inconsistent [32,40,53,54], but most patients with a history of anaphylaxis were able to achieve at least partial desensitization [32,40].…”