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).