{"doi":"10.1016/j.jaip.2021.07.048","title":"Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy","abstract":"Clinical ImplicationsEosinophilic esophagitis (EoE) occurring during peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) oral immunotherapy (OIT) was responsive to standard-of-care treatments and improved or resolved after PTAH discontinuation. The risk of developing EoE during OIT with PTAH in clinical trials was approximately 1% overall without inclusion of a portion of the 5% of participants who discontinued PTAH treatment because of gastrointestinal adverse events that were not further evaluated. Eosinophilic esophagitis (EoE) occurring during peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) oral immunotherapy (OIT) was responsive to standard-of-care treatments and improved or resolved after PTAH discontinuation. The risk of developing EoE during OIT with PTAH in clinical trials was approximately 1% overall without inclusion of a portion of the 5% of participants who discontinued PTAH treatment because of gastrointestinal adverse events that were not further evaluated. Eosinophilic esophagitis (EoE) is a chronic immune-inflammatory disease triggered by food and/or environmental allergens. EoE onset has been reported in patients given oral immunotherapy (OIT) for milk, egg, and peanut allergy.1Lucendo A.J. Arias A. Tenias J.M. Relation between eosinophilic esophagitis and oral immunotherapy for food allergy: a systematic review with meta-analysis.Ann Allergy Asthma Immunol. 2014; 113: 624-629Google Scholar Peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; previously AR101) is an approved OIT for peanut allergy. PTAH is contraindicated in patients with a history of EoE and per the product label should be discontinued if EoE develops while on treatment. Data for all participants in the PTAH clinical trial program were reviewed to identify participants with EoE as of December 15, 2018. Overall EoE incidence was calculated and outcomes were summarized along with baseline clinical characteristics, symptom presentation, and treatments received. The PTAH clinical trial program includes 2 phase 2 trials and 6 phase 3 trials in which 1217 participants (aged 4-55 years) received PTAH.2Vickery B. Vereda A. Casale T. Beyer K. du Toit G. et al.PALISADE Group of Clinical InvestigatorsAR101 oral immunotherapy for peanut allergy.N Engl J Med. 2018; 379: 1991-2001Google Scholar, 3Hourihane J.O.B. Beyer K. Abbas A. Fernandez-Rivas M. Turner P.J. Blumchen K. et al.Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial.Lancet Child Adolesc Health. 2020; 4: 728-739Google Scholar, 4Bird J. Welch M. Spergel J. Jones S. Rachid R. Wang J. et al.Oral desensitization to peanut using AR101 peanut oral immunotherapy in a roll-over safety study ARC002.Ann Allergy Asthma Immunol. 2018; 121: 476-485.e3Google Scholar, 5Bird J.A. Spergel J.M. Jones S.M. Rachid R. Assa'ad A.H. Wang J. et al.Efficacy and safety of AR101 in oral immunotherapy for peanut allergy: results of ARC001, a randomized, double-blind, placebo-controlled phase 2 clinical trial.J Allergy Clin Immunol Pract. 2018; 6: 476-485.e3Google Scholar Of the 1217 PTAH-treated participants, 62 patients withdrew from the studies owing to gastrointestinal (GI) symptoms, 28 were referred for gastroenterology evaluation, 17 of whom underwent esophagogastroduodenoscopy (EGD), and 12 of those were diagnosed with EoE, yielding an EoE incidence of approximately 1%. The overall exposure-adjusted EoE event rate was 0.9 per 100 patient-years. The 12 EoE cases occurred in 1 woman aged 33 years and 11 participants aged 4 to 17 years, 9 of whom were male (Table I). Asthma (n = 11) was the most common comorbid atopic disease, followed by allergic rhinitis (n = 10), other food allergies (n = 9), and atopic dermatitis (n = 5). Common presenting symptoms included globus sensation, gastroesophageal reflux, regurgitation, vomiting, and postprandial abdominal pain (Table II). In 11 case","journal":"The Journal of Allergy and Clinical Immunology In Practice","year":2021,"id":173666,"datarank":1.619500199458252,"base_score":3.2188758248682006,"endowment":3.2188758248682006,"self_citation_contribution":0.48283137373023016,"citation_network_contribution":1.136668825728022,"self_endowment_contribution":0.48283137373023016,"citer_contribution":1.136668825728022,"corpus_percentile":null,"corpus_rank":null,"citation_count":24,"citer_count":21,"citers_with_citation_signal":17,"citers_with_endowment":17,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9552,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT01987817","NCT02198664","NCT02635776","NCT02993107","NCT03126227","NCT03292484","NCT03201003","NCT03337542"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":280638,"name":"Amy M. Scurlock","orcid":"0000-0001-7786-2686","position":1,"is_corresponding":false},{"id":233047,"name":"Evan S. Dellon","orcid":"0000-0003-1167-1101","position":2,"is_corresponding":false},{"id":712397,"name":"J Brostoff","orcid":null,"position":3,"is_corresponding":false},{"id":712398,"name":"Trinh Pham","orcid":"0000-0002-8146-395X","position":4,"is_corresponding":false},{"id":711669,"name":"Robert Ryan","orcid":"0000-0003-0827-3153","position":5,"is_corresponding":false},{"id":710798,"name":"Kari Brown","orcid":null,"position":6,"is_corresponding":false},{"id":652082,"name":"Daniel C. Adelman","orcid":"0000-0002-0470-3235","position":7,"is_corresponding":false},{"id":233049,"name":"Seema S. Aceves","orcid":"0000-0002-2622-7081","position":8,"is_corresponding":false},{"id":711668,"name":"Caroline Nilsson","orcid":"0000-0003-2040-8428","position":0,"is_corresponding":true}],"reference_count":9,"raw_metadata":null,"created_at":"2026-07-18T23:46:49.903770Z","pmid":"34389504","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}