Evidence map›Paper›PMID 39282750›Full record

Observational studyAllergy2025

Omalizumab reduces anaphylactic reactions and allows food introduction in food-allergic in children with severe asthma: An observational study.

Stefania Arasi, Arianna Cafarotti, Francesca Galletta, Valentina Panetta, Carla Riccardi, Veronica Calandrelli, Vincenzo Fierro, Lamia Dahdah, Maria Cristina Artesani, Rocco Luigi Valluzzi and 5 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06316414 (Effects of Omalizumab on Food Allergy in Children With Severe Asthma), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

NCT06316414 completednot on this map

Effects of Omalizumab on Food Allergy in Children With Severe Asthma: A Real Life Study

TypeobservationalSponsorBambino Gesù Hospital and Research InstituteRan2018 to 2023Enrolled65ConditionsFood, Allergy, Anaphylactic Shock, Asthma in ChildrenArmsOmalizumab
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Update on biologic and small molecules treatments in pediatric allergic diseases.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Using Biologics in the Prevention of Anaphylaxis.Current allergy and asthma reports · 2025
    Review
  12. Article
  13. Article
  14. The Expanding Role of Omalizumab: From Food Allergy to Drug Desensitization.International journal of molecular sciences · 2025
    Review
  15. Review
  16. Review
  17. Observational
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Stefania ArasiAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-8135-0568
Arianna CafarottiAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-0232-3511
Francesca GallettaAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-4166-2030
Valentina PanettaL'altrastatistica S.r.l., for GB Pharma Services & Consulting S.r.l, Rome, Italy.ORCID https://orcid.org/0000-0001-6058-5045
Carla RiccardiAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-4903-6296
Veronica CalandrelliAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0003-0643-0864
Vincenzo FierroAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-5296-3349
Lamia DahdahAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-4079-5317
Maria Cristina ArtesaniAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0003-2970-1591
Rocco Luigi ValluzziAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0003-0029-6254
Valentina PecoraAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.
Valeria TallaricoAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0009-0000-1575-1905
Giulio DinardoAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-9952-1206
Lucia Lo ScalzoAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.
Alessandro FiocchiAllergy Division, Pediatric Hospital Bambino Gesu IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-2549-0523

Funding

Allegriallergia ONLUS - Milano -Italy
6 · The paper itself

Abstract

backgroundIn Europe, Omalizumab (anti-IgE) is indicated for the treatment of moderate to severe asthma, but not for IgE-mediated food allergy (FA).

objectiveWe assessed the impact of Omalizumab on efficacy, safety, and quality of life (FA-QoL) in patients with moderate to severe asthma and who have a history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat.

methodsFood-allergic children (6-18 years) with moderate to severe asthma underwent oral food challenges (OFCs) to establish the threshold of reaction to the culprit food(s) at baseline (T0) and at 4-month intervals (T1, T2, and T3) during their first year of treatment with Omalizumab. We recorded the number and severity of food-allergic reactions, Asthma Control Test (ACT) scores, FA-QoL, and total IgE levels.

resultsIn 65 patients allergic to 107 foods, the No Observed Adverse Events Level (NOAEL) at T1 increased: 243- and 488-fold for fresh and baked milk, respectively; 172- and 134-fold for raw and baked egg; 245-fold for hazelnut; 55-fold for peanut; 31-fold for wheat; and 10-fold for fish. Full tolerance was achieved in 66.4% of OFCs at T1, 58.3% at T2, and 75% at T3. Ninety-five foods were liberalized in the diet of 55 patients; the remaining 12 were introduced by 10 patients at least in traces. Throughout the study, 40 out of 65 were able to get a free diet. ACT increased from 17 (Q1-Q3: 15-17) to 23.6 (Q1-Q3: 23-25). The FA-QoL score in children ≤12 years decreased from 4.63 ± 0.74 to 2.02 ± 1.13, and in adolescents from 4.68 ± 0.92 to 1.90 ± 1.50.

conclusionsDuring Omalizumab therapy, a safe reintroduction of allergenic foods is feasible. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT06316414.

Indexed as

AnaphylaxisAnti-Allergic AgentsAnti-Asthmatic AgentsAsthmaFood HypersensitivityOmalizumabAdolescentAllergensChildFemaleFoodHumansImmunoglobulin EMaleQuality of LifeSeverity of Illness IndexAllergensAnti-Allergic AgentsAnti-Asthmatic AgentsImmunoglobulin EOmalizumaballergyanti IgEasthmachildrenfoodIgEimmunologic desensitizationomalizumab

Identifiers

PMID39282750
PMCPMC11969307

What OpenQuestion holds

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LicenceCC BY-NC
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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.