A phase II, randomized, double‑blind, parallel‑group, placebo‑controlled oral food challenge trial of Xolair (omalizumab) in peanut allergy

Sampson, Hugh A.; Leung, Donald Y.M.; Burks, A. Wesley; Lack, Gideon; Bahna, Sami L.; Jones, Stacie M.; Wong, Dennis A.

doi:10.1016/j.jaci.2011.01.051

Cited by 244 publications

(156 citation statements)

References 7 publications

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“…Although 25% of patients had markedly improved tolerance after treatment, another 25% had no change in their threshold of reactivity, indicating that the treatment response can be variable. Investigation of another anti-IgE preparation, omalizumab (Xolair; Genentech), for the treatment of peanut allergy was initiated, but discontinued for safety concerns related to the pretreatment oral peanut challenge (100).…”

Section: Allergen-nonspecific Therapiesmentioning

confidence: 99%

Food allergy

Wang¹,

Sampson²

2011

J. Clin. Invest.

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152

117

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Food allergies affect up to 6% of young children and 3%-4% of adults. They encompass a range of disorders that may be IgE and/or non-IgE mediated, including anaphylaxis, pollen food syndrome, food-protein-induced enterocolitis syndrome, food-induced proctocolitis, eosinophilic gastroenteropathies, and atopic dermatitis. Many complex host factors and properties of foods are involved in the development of food allergy. With recent advances in the understanding of how these factors interact, the development of several novel diagnostic and therapeutic strategies is underway and showing promise. Conflict of interest: Hugh A. Sampson is an investor in and paid consultant forAllertein Therapeutics and an investor in Herbal Springs LLC, a holding company for the patents on FAHF-2. Hugh A. Sampson receives research support from the Food Allergy Initiative, a nonprofit foundation supporting food allergy research.

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Section: Allergen-nonspecific Therapiesmentioning

confidence: 99%

Food allergy

Wang¹,

Sampson²

2011

J. Clin. Invest.

Self Cite

152

117

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“…Among the 14 patients who had completed the study, nine had been receiving treatment with omalizumab and five had been receiving placebo. While trends in increased threshold doses for peanut-induced allergic reactions were seen, the study was not able to confirm findings from the previous study [14]. & In 2012, the results of an open-label trial of omalizumab in adult peanut allergic patients looked again for a protective effect as measured by response to DBPCPC.…”

Section: Treatment Peanut Allergymentioning

confidence: 63%

Omalizumab Treatment for Prevention of Anaphylaxis

Rodríguez¹,

Fahrenholz²

2014

Curr Treat Options Allergy

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Opinion StatementRCTs utilizing a specific treatment followed by meta-analysis of multiple RCTs for the specific treatment are the cornerstone of evidence-based medicine. This approach provides key insights into the average response of a therapeutic agent in the selected patient population for the target disease. Generally speaking, a developing trend is more investigations of medical therapies aiming to describe individual patient variability; further, such investigations typically aim to discover and subsequently understand this variability based on biomarkers or even disease-specific genetic polymorphisms among patients. This research returns us to the examination room where we treat individual patients. Given the complexity of idiopathic anaphylaxis and the currently available literature, we believe the time is now to initiate treatment trials of omalizumab in patients not well controlled with prior standard therapy. The use of prolonged systemic steroids should be avoided in favor of a trial of omalizumab. We do not intend to minimize the importance of double-blind placebo-controlled trials. However, based on the full spectrum of current evidence, we do not want to be blinded at the present time by the absence of a published RCT specific to idiopathic anaphylaxis.

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“…The predicted success rate in the placebo group was based on a prior study where a greater than 4-fold increase in threshold dose was reported in 20% of the placebo group. [17] Comparison of categorical data was performed with Fisher's exact test with a 2-tailed p value, while comparison of continuous data was performed with a t-test. Analysis of Covariance (ANCOVA) models were used to assess whether the change from baseline to post-therapy in various outcome variables (sIgE, sIgG 4 , IL-5, IL-10, IFN-γ, basophil activation, SPTs) differed between treatment groups.…”

Section: Discussionmentioning

confidence: 99%