Safety
During up-dosing, mild to moderate adverse effects were observed in eight (33%) patients with CN allergy, including mild oral pruritus and moderate reactions like abdominal pain or rhino-conjunctivitis. The remaining 16 patients reported no adverse reactions. Comparatively, 24 (63%) peanut OIT patients experienced adverse effects during up-dosing, with 19 (79%) experiencing mild or moderate adverse reactions like oral pruritus and abdominal pain (Fig. 3A). Notably, five (13%) children experienced severe reactions, indicated by an oFASS-5 score of ≥4, with four of these reactions occurring at home, and one in the outpatient clinic. Intramuscular adrenaline was administered to three of these children.
In the peanut group, two patients reported symptoms consistent with eosinophilic esophagitis (EoE). One patient discontinued therapy but declined an endoscopy. The other patient ceased therapy, no longer met EoE criteria after an endoscopy four weeks later, and successfully resumed OIT with Omalizumab. Furthermore, among peanut OIT patients, four (10%) couldn’t complete the therapy according to the protocol due to adverse effects. One of these four patients successfully restarted with Omalizumab, two continued on a lower maintenance dose, and the remaining patient opted to discontinue the therapy. Notably, none of the CN OIT patients modified or discontinued their treatment due to adverse effects.
The presence of other food allergies, atopic dermatitis, asthma/wheeze, or any allergic disease did not influence the severity of adverse reactions (Fig. 3B). However, nearly all patients with severe reactions (oFASS ≥4) and the majority of those with moderate reactions (oFASS 2-3), had high initial nut-specific storage protein IgE levels (>30 kU/L) (Fig. 3C).