Evidence map›Paper›PMID 26581915›Full record

Trial reportThe Journal of allergy and clinical immunology2016

A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy.

Robert A Wood, Jennifer S Kim, Robert Lindblad, Kari Nadeau, Alice K Henning, Peter Dawson, Marshall Plaut, Hugh A Sampson

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 135 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
135citing papers in PubMed, 5 pooled it
21.2field-weighted citation impact, top 1% of its field
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.

NCT01157117 phase2completednot on this map

Oral Immunotherapy Combined With Humanized Monoclonal Anti-IgE Antibody Xolair® (Omalizumab)in the Treatment of Cow's Milk Allergy

TypeinterventionalSponsorHugh A Sampson, MDRan2010 to 2015Enrolled77ConditionsMilk AllergyArmsPlacebo for omalizumab, Omalizumab, Milk powder
NCT03462030 phase2completednot on this mapstarted 2018, after this paper: background citation

Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy

TypeinterventionalSponsorJohns Hopkins UniversityRan2018 to 2024Enrolled41ConditionsCow's Milk AllergyArmsBaked non-fat cow's milk powder, Placebo: Tapioca Powder
3 · Its place in the literature

Who cites it

135 citing papers in PubMed, 5 syntheses or guidelines pooled it, 376 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Omalizumab for the Treatment of Multiple Food Allergies.The New England journal of medicine · 2024
    Trial
  7. Trial
  8. Trial
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  14. Omalizumab facilitates rapid oral desensitization for peanut allergy.The Journal of allergy and clinical immunology · 2017
    Trial
  15. Eosinophilic esophagitis during peanut oral immunotherapy with omalizumab.The journal of allergy and clinical immunology. In practice
    Trial
  16. Review
  17. 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
  18. Article
  19. The Food Allergy-Eosinophilic Esophagitis Continuum: Implications for Food Allergy Immunotherapy.The journal of allergy and clinical immunology. In practice · 2026
    Review
  20. Review

75 more citing papers are in PubMed but not listed here.

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

8 authors at 6 institutions in 1 country.

Robert A WoodJohns Hopkins University School of Medicine, Baltimore, Md.
Jennifer S KimNorthShore University HealthSystem, Evanston, Ill.
Robert LindbladEMMES Corporation, Rockville, Md.
Kari NadeauStanford University School of Medicine, Stanford, Calif.
Alice K HenningEMMES Corporation, Rockville, Md.
Peter DawsonEMMES Corporation, Rockville, Md.
Marshall PlautNational Institute of Allergy and Infectious Diseases, Bethesda, Md.
Hugh A SampsonIcahn School of Medicine at Mount Sinai, New York, NY. Electronic address: hugh.sampson@mssm.edu.
Emmes (United States) · USIcahn School of Medicine at Mount Sinai · USJohns Hopkins University · USNational Institute of Allergy and Infectious Diseases · USNorthShore University HealthSystem · USStanford University · US

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Tolerance vs. Allergenicity; Factors Dictating Differing ResponsesU19AI044236 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI SAMPSON, HUGH A · 2008 to 2014
$9.8M
ORAL TOLERANCE AND COW MILK ALLERGYP01AI044236 · NIAID · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI SAMPSON, HUGH · 1999 to 2007
$7.5M
NCATS NIH HHS UL1 TR 001079NCATS NIH HHS UL1 TR001079NCRR NIH HHS RR-026134NIAID NIH HHS P01 AI044236NIAID NIH HHS U19 AI044236
6 · The paper itself

Abstract

backgroundAlthough studies of oral immunotherapy (OIT) for food allergy have shown promise, treatment is frequently complicated by adverse reactions and, even when successful, has limited long-term efficacy because benefits usually diminish when treatment is discontinued.

objectiveWe sought to examine whether the addition of omalizumab to milk OIT reduces treatment-related reactions, improves outcomes, or both.

methodsThis was a double-blind, placebo-controlled trial with subjects randomized to omalizumab or placebo. Open-label milk OIT was initiated after 4 months of omalizumab/placebo with escalation to maintenance over 22 to 40 weeks, followed by daily maintenance dosing through month 28. At month 28, omalizumab was discontinued, and subjects passing an oral food challenge (OFC) continued OIT for 8 weeks, after which OIT was discontinued with rechallenge at month 32 to assess sustained unresponsiveness (SU).

resultsFifty-seven subjects (7-32 years) were randomized, with no significant baseline differences in age, milk-specific IgE levels, skin test results, or OFC results. At month 28, 24 (88.9%) omalizumab-treated subjects and 20 (71.4%) placebo-treated subjects passed the 10-g "desensitization" OFC (P = .18). At month 32, SU was demonstrated in 48.1% in the omalizumab group and 35.7% in the placebo group (P = .42). Adverse reactions were markedly reduced during OIT escalation in omalizumab-treated subjects for percentages of doses per subject provoking symptoms (2.1% vs 16.1%, P = .0005), dose-related reactions requiring treatment (0.0% vs 3.8%, P = .0008), and doses required to achieve maintenance (198 vs 225, P = .008).

conclusionsIn this first randomized, double-blind, placebo-controlled trial of omalizumab in combination with food OIT, we found significant improvements in measurements of safety but not in outcomes of efficacy (desensitization and SU).

Indexed as

Administration, OralAdolescentAdultAnti-Allergic AgentsChildCombined Modality TherapyDesensitization, ImmunologicDouble-Blind MethodDrug Administration ScheduleFemaleHumansLogistic ModelsMaleMilk HypersensitivityOmalizumabTreatment OutcomeAnti-Allergic AgentsOmalizumabdesensitizationdose-related adverse reactionsdouble-blindMilk allergyomalizumaboral immunotherapyplacebo-controlled trialsustained unresponsiveness

Identifiers

PMID26581915
PMCPMC5395304
OpenAlexW2118769673

What OpenQuestion holds

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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.