Egg OIT in clinical practice (SEICAP II): Maintenance patterns and desensitization state after normalizing the diet

Abstract

Background It is unknown which are the most suitable maintenance pattern and egg consumption to maintain the desensitization state after ending the oral immunotherapy (OIT). This multicenter, randomized, controlled trial compared two OIT maintenance patterns with pasteurized egg white (PEW), evaluating the egg consumption effect on the desensitization state after ending the OIT. Methods One hundred and one children with confirmed egg allergy were randomized: 25 to an egg‐free diet (CG) and 76 to an OIT year with PEW and two maintenance patterns, 38 patients to daily 3.3 g proteins (AG) and 38 to every two days (BG). PEW challenge (DBPCFC), adverse reactions, and immune markers were assessed at baseline, at the end of the OIT, and at 6 and 12 months later on ad libitum egg consumption (T0, T12, T18, and T24). A questionnaire evaluated the egg consumption at T18. Results At T12, 64 of 76 (84.21%) OIT patients had reached total desensitization (32 AG and 32 BG) vs 4 of 25 (16.00%) CG who passed the PEW DBPCFC. Thirty (93.75%) AG vs 25 (78.12%) BG patients completed an OIT year. At T18, 27 of 29 (93.1%) AG vs 20 of 24 (83.3%) BG passed the PEW DBPCFC, 96% consuming at least two egg servings/week. At T24, 97.43% OIT patients passed the challenge. Most patients had adverse reactions, more frequent in the BG patients; frequency and severity of reactions decreased through the study. PEW skin prick test wheal and sIgE antibody serum levels similarly decreased in AG or BG, but AG patients had greater increase in PEW sIgG4 (P < 0.05). Conclusions Daily OIT maintenance achieves better adherence, effectiveness, and safety. Two egg servings/week ensure maintained desensitization after the end of an OIT year.

Continuous and Daily Oral Immunotherapy for Peanut Allergy: Results from a 2-Year Open-Label Follow-On Study

“…4 There remains a need for longer-term data on the safety and efficacy of OIT 6,7 in the peanut-allergic population. Based on similar preliminary research related to OIT for other food allergies, [8][9][10] an investigation into whether nondaily PTAH maintenance regimens can match or improve the clinical benefits of a daily maintenance regimen was warranted. The key objectives of ARC004, the exploratory open-label extension to the PALISADE study, were to evaluate the safety/ tolerability of daily and nondaily maintenance regimens, to explore the efficacy of different PTAH regimens with a double-blind placebo-controlled food challenge (DBPCFC) of up to a single 2000-mg dose (cumulative dose, 4034 mg) of peanut protein, and to evaluate the long-term immunologic effects of PTAH.…”

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

“…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.…”

“…In one clinical study, there was no difference in maintaining desensitization between eating the maintenance dose daily or every other day (tolerating 1 raw egg white after 6 months of maintenance: 93% vs 83%) (RCT: 55 N=29 daily, 24 every other day)…”

Update on food allergy

“…Reassuringly, consumption of an egg twice a week has proven sufficient to sustain tolerance in the Spanish SEICAP study. 91 In the large long-term follow-up Finnish cohort of children who completed milk OIT, only a quarter of the children returned to milk avoidance diet during the median 6.5-year-long observation period. 92 Regarding ongoing peanut consumption, 64% of previous Route In the large phase 3 study on epicutaneous IT to peanut, 35.3% of participants achieved predefined response rate compared with 13.6% of children in placebo group; despite the difference being statistically significant, the 95% CI exceeded pre-specified lower cut-off, which means the study did not meet its primary end-point.…”