Pediatric Allergy

Pediatric Allergy Outcomes


Food allergies significantly impair quality of life in those affected and their families and can be associated with potentially life-threatening allergic reactions. Management has traditionally focused on education, strict dietary elimination, and treatment of symptoms following accidental exposures because there is presently no cure. Over the past decade, oral immunotherapy (OIT) has emerged as a promising cutting-edge therapy for food allergy. OIT involves slowly exposing a trigger food to an individual in increasing amounts with the goal of reducing or preventing symptoms with accidental exposures. While desensitization is achieved in the majority of patients and the available data on OIT is rapidly growing, many questions remain regarding the safety and long term efficacy of OIT.

Pediatric Allergy Oral Immunotherapy (OIT) Outcomes


The Cleveland Clinic Children's Center for Pediatric Allergy, in conjunction with the Cleveland Clinic Food Allergy Center of Excellence (FACE), performs OIT in properly selected patients with food allergy. In 2020, 52 pediatric patients were receiving OIT and in 2021 this has grown to 111 pediatric patients. The majority of patients are receiving single food OIT with peanut (73%). However, an increasing number of patients are being treated with multi-food OIT (12.6%)


OIT Safety Outcomes

2020 - Number (% patients)

N = 52

2021 - Number (% patients)

N = 111

Adverse Reactions15 (28.8%)54 (48.6%)
Cutaneous (itching, eczema, hives, lip swelling)9 (17.3%)26 (23.4%)
Gastrointestinal (GI upset, heartburn, vomiting)5 (9.6%)31 (27.9%)
Cough2 (3.8%)12 (10.8%)
OIT-attributed reactions receiving treatment6 (11.5%)24 (21.6%)
Epinephrine2 (3.8%)8 (7.2%)
Antihistamine only4 (7.7%)16 (14.4%)
Accidental Ingestion3 (5.8%)5 (3.6%)
No reaction1 (1.9%)2 (1.8%)
Reaction requiring treatment2 (3.8%)
  1. (1.8%)
Discontinuation of OIT0 (0%)6 (5.4%)

Adverse reactions were reported by 49% of OIT patients in the year 2021 (n=54). Gastrointestinal side effects were most common followed by cutaneous side effects. Many of the mild side effects were addressed with dose adjustments or altering the strategy of dose administration (such as changing food vehicle, pretreatment with H1 or H2 antihistamines). OIT-attributed allergic reactions requiring treatment were reported in only 21.6% of individuals (n=24). Eight patients (7.2%) required treatment with epinephrine. Five of these patients required epinephrine during the build-up phase, 2 during maintenance and the final patient had reaction requiring epinephrine once during build-up and once again during maintenance. Accidental exposures were reported in 5 individuals during OIT treatment (n=2 no treatment; n=1 received antihistamines only; n=1 received epinephrine). There were 6 patients that discontinued OIT in the 2021 calendar year. One of these discontinued due to the impact of OIT on lifestyle, 3 due to episodes of anaphylaxis, and 2 due to persistent gastrointestinal symptoms. In summary, our data continue to demonstrate the importance of discussing the risks and benefits of OIT with patients and their families prior to initiating therapy. However the safety profile is overall favorable for patients selected using our current protocols.