Walnut oral immunotherapy for desensitisation of walnut and additional tree nut allergies (Nut CRACKER): a single-centre, prospective cohort study

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

“…This recommendation is based on the principle of nonmaleficence It is supported by a large amount of consistent clinical evidence indicating that there is a risk of anaphylactic reactions during OIT [22][23][24]. A proportion of these reactions occur outside the healthcare setting [29,32,36,[38][39][40]. This is coherent with data from consultations.…”

“…There is no convincing evidence of a clinically significant difference between food allergens in terms of safety and efficacy outcomes in OIT for the treatment of IgEmediated food allergy. Therefore, all recommendations in these CPGs are generally applicable to all food allergens, unless there is specific evidence to demonstrate otherwise This recommendation is based on the principle of equity of eligibility It is supported by large amount of consistent clinical evidence, considering the absence of demonstrated lack of efficacy or of a consistent safety issue for any specific food despite a large number of clinical studies for a variety of foods [22][23][24][29][30][31][32][33][34][35][36][37][38]. Level of evidence: HIGH It is also supported by the lack of biological plausibility that the mechanism of OIT would differ from one allergen to another.…”

“…Whether or not the outcomes (i.e. 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.…”

“…Whether or not the outcomes (i.e. 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 moderate amount of consistent clinical evidence, from three long-term, 2-arm follow-up studies of RCTs (high risk of bias due to open-label; mean follow-up 2.5 to 5 years; completeness of follow-up: 77 to 90%) [50][51][52], three large case series in clinical practice (N ≥ 145) (moderate risk of bias using the IHE tool due to single-center, retrospective design; median follow-up: 1.5 to 6.5 years; completeness of follow-up: 83 to 99%) [33,53,54], and four smaller single-arm, follow-up studies (N = 43 to 100) at low to high risk of bias (completeness of follow-up: 82 to 100%) [35][36][37]55]. This is coherent with data from consultations.…”

“…• 0 to 18% of patients discontinued due to adverse events during the build-up and 0 to 5.3% during the maintenance phase of OIT for peanut, 40 egg, 55 137 sesame, 38 or walnut 36 or wheat 34 allergy. In one wheat study, 23% of patients discontinued during the build-up and 26% during the maintenance phase; however, discontinuations due to severe reactions declined from 7.0% to 2.6% (case series: N=100 build-up, 77 maintenance 35 ) 143 for these patients, doses were reduced or dose increases deferred or suspended; in long-term follow-up, they were more likely to fail OIT (P=0.04) and less likely to reach full desensitization (P<0.001) compared to patients who did not have such symptoms 144…”