Trial reportThe Journal of allergy and clinical immunology2017
Mechanistic correlates of clinical responses to omalizumab in the setting of oral immunotherapy for milk allergy.
Trial report in The Journal of allergy and clinical immunology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.
- Biologic-assisted immunotherapy for pediatric food allergy: a systematic review.Frontiers in allergy · 2026Pooled it
- Peanut oral immunotherapy differentially suppresses clonally distinct subsets of T helper cells.The Journal of clinical investigation · 2022Trial
- Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study.Lancet (London, England) · 2019Trial
- Anti-IgE treatment with oral immunotherapy in multifood allergic participants: a double-blind, randomised, controlled trial.The lancet. Gastroenterology & hepatology · 2018Trial
- Emerging Biomarkers in Pediatric Food Allergy: From Mechanistic Endotyping to Precision Diagnosis and Therapeutic Monitoring.Biomedicines · 2026Review
- Biologics in IgE-mediated food allergy: A systematic review and meta-analysis of interventional studies.The World Allergy Organization journal · 2025Review
- Omalizumab in Food Allergy in Children: Current Evidence and Future Perspectives.Life (Basel, Switzerland) · 2025Review
- Insights into the clinical, immunologic, and genetic underpinnings of food allergy.Immunological reviews · 2024Review
- The role of thymus- and extrathymus-derived regulatory T cells in maternal-fetal tolerance.Frontiers in immunology · 2023Article
- Mechanisms and biomarkers of successful allergen-specific immunotherapy.Asia Pacific allergy · 2022Review
- The rationale for development of ligelizumab in food allergy.The World Allergy Organization journal · 2022Review
- Combining Anti-IgE Monoclonal Antibodies and Oral Immunotherapy for the Treatment of Food Allergy.Clinical reviews in allergy & immunology · 2022Review
- Oral Immunotherapy for Children with Cow's Milk Allergy.Pathogens (Basel, Switzerland) · 2021Review
- Basophil activation test in food allergy: is it ready for real-time?Current opinion in allergy and clinical immunology · 2021Review
- Immune changes beyond Th2 pathways during rapid multifood immunotherapy enabled with omalizumab.Allergy · 2021Article
- New Insights in Therapy for Food Allergy.Foods (Basel, Switzerland) · 2021Review
- Use of biologics in allergen immunotherapy.Allergologie select · 2021Review
- Oral Immunotherapy in Children: Clinical Considerations and Practical Management.Journal of asthma and allergy · 2021Review
- Biomarkers for diagnosis and prediction of therapy responses in allergic diseases and asthma.Allergy · 2020Review
- New Developments in Non-allergen-specific Therapy for the Treatment of Food Allergy.Current allergy and asthma reports · 2020Review
Corrections and comments
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Authors and funding
11 authors at 8 institutions in 1 country.
Funding
Abstract
backgroundIn our recent clinical trial, the addition of omalizumab to oral immunotherapy (OIT) for milk allergy improved safety, but no significant clinical benefit was detected.
objectiveWe sought to investigate mechanisms by which omalizumab modulates immunity in the context of OIT and to identify baseline biomarkers that predict subgroups of patients most likely to benefit from omalizumab.
methodsBlood was obtained at baseline and multiple time points during a placebo-controlled trial of OIT for milk allergy in which subjects were randomized to receive omalizumab or placebo. Immunologic outcomes included measurement of basophil CD63 expression and histamine release and casein-specific CD4
resultsMilk-induced basophil CD63 expression was transiently reduced in whole blood samples from both omalizumab- and placebo-treated subjects. However, IgE-dependent histamine release increased in washed cell preparations from omalizumab- but not placebo-treated subjects. No increase in regulatory T-cell frequency was evident in either group. Subjects with lower rates of adverse reactions, regardless of arm, experienced better clinical outcomes. Pre-OIT basophil reactivity positively associated with occurrence of symptoms during OIT, whereas the baseline milk IgE/total IgE ratio correlated with the likelihood of achieving sustained unresponsiveness. A combination of baseline basophil and serologic biomarkers defined a subset of patients in which adjunctive therapy with omalizumab was associated with attainment of sustained unresponsiveness and a reduction in adverse reactions.
conclusionsCombining omalizumab therapy with milk OIT led to distinct alterations in basophil reactivity but not T-cell responses. Baseline biomarkers can identify subjects most likely to benefit from adjunctive therapy with omalizumab.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.