Omalizumab* / therapeutic use

Beyond Avoidance: Omalizumab and the Evolving Care of Pediatric Food Allergy

Nathan Hinkle — Fri, 09 Oct 2026 05:00:00 +0000

Date Added:

October 9, 2026

Journal/Publication:

Pediatric Annals

Publisher:

SLACK Incorporated

Publication Date:

October 1, 2026

Issue:

Volume:

Pages:

e374-377

URL:

Beyond Avoidance: Omalizumab and the Evolving Care of Pediatric Food Allergy

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

https://doi.org/10.3928/19382359-20260908-02

Keywords

Pediatric Food Allergies

omalizumab

children

MeSH

Omalizumab* / therapeutic use

Food Hypersensitivity* / diagnosis

allergens

RPR Commentary: Advice regarding how to evaluate and manage food allergies in children. James W. Mold, MD, MPH

View

Food allergy is familiar territory in primary care, but the therapeutic landscape is changing quickly. For years, our conversations with families centered on avoidance, label reading, emergency action plans, and ready access to epinephrine. Those remain essential. Yet, newer therapies now offer something different: the possibility of increasing the amount of allergen needed to trigger a reaction and thereby reducing some of the risk associated with accidental exposure. The recent randomized clinical trial by Wood et al.1 brings that shift into especially sharp focus. In patients with multiple food allergies, continued omalizumab treatment was more successful than omalizumab-facilitated multiallergen oral immunotherapy in the intention-to-treat analysis, largely because adverse events and treatment discontinuations limited completion of oral immunotherapy.

Author/s:

Lolita Alocer Alkureishi, Sai R. Nimmagadda, Joseph R. Hageman

Chronic urticaria: unmet needs, emerging drugs, and new perspectives on personalised treatment

Alex Haga — Sun, 04 Aug 2024 18:10:28 +0000

Date Added:

August 4, 2024

Journal/Publication:

Lancet

Publication Date:

July 27, 2024

Issue:

10450

Volume:

404

Pages:

393-404

URL:

Chronic urticaria: unmet needs, emerging drugs, and new perspectives on personalised treatment

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/S0140-6736(24)00852-3

Keywords

urticaria

chronic urticaria

omalizumab

PMID (1):

39004090

MeSH

Chronic Urticaria* / drug therapy

Agammaglobulinaemia Tyrosine Kinase / antagonists & inhibitors

Cyclosporine / therapeutic use

Mast Cells / drug effects

Omalizumab* / therapeutic use

A review of what we know and don't know about chronic urticaria and its treatment. James W. Mold, MD, MPH

Free full text

View

Chronic urticaria is a common and debilitating mast cell-driven skin disease presenting with itchy wheals, angio-oedema, or both. Chronic urticaria is classified as spontaneous (without definite triggers) and inducible (with definite and subtype-specific triggers; eg, cold or pressure). Current management guidelines recommend step-up administration of second-generation H1-antihistamines to four-fold the approved dose, followed by omalizumab and ciclosporin. However, in many patients, chronic urticaria does not respond to this linear approach due to heterogeneous underlying mechanisms. A personalised endotype-based approach is emerging based on the identification of autoantibodies and other drivers of urticaria pathogenesis. Over the past decade, clinical trials have presented promising options for targeted treatment of chronic urticaria with the potential for disease modification, including Bruton's tyrosine kinase inhibitors, anti-cytokine therapies, and mast cell depletion. This Therapeutics article focuses on the evidence for these novel drugs and their role in addressing an unmet need for personalised management of patients with chronic urticaria.

Author/s:

Torsten Zuberbier, Luis Felipe Ensina, Ana Giménez-Arnau, Clive Grattan

Omalizumab for the Treatment of Multiple Food Allergies

Alex Haga — Fri, 05 Apr 2024 01:11:55 +0000

Date Added:

April 4, 2024

Journal/Publication:

New England Journal of Medicine

Publication Date:

February 25, 2024

Issue:

Volume:

390

Pages:

889-899

URL:

Omalizumab for the Treatment of Multiple Food Allergies

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2312382

PMID (1):

38407394

An apparently effective (and probably very expensive) treatment for children with food allergies. James W. Mold, MD, MPH

Free full text

View

BACKGROUND
Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy.
METHODS
In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened. Inclusion required a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of the two other foods. Participants were randomly assigned, in a 2:1 ratio, to receive omalizumab or placebo administered subcutaneously (with the dose based on weight and IgE levels) every 2 to 4 weeks for 16 to 20 weeks, after which the challenges were repeated. The primary end point was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms. The first 60 participants (59 of whom were children or adolescents) who completed this first stage were enrolled in a 24-week open-label extension.

RESULTS
Of the 462 persons who were screened, 180 underwent randomization. The analysis population consisted of the 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons). Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group.
CONCLUSIONS
In persons as young as 1 year of age with multiple food allergies, omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT03881696.)

Author/s:

Wood RA, Togias A, Sicherer SH, Shreffler WG, Kim EH, Jones SM