The Use of Omalizumab in Food Oral Immunotherapy

Labrosse, Roxane; Graham, François; Roches, Anne Des; Bégin, Philippe

doi:10.1007/s00005-016-0420-z

Cited by 29 publications

(22 citation statements)

References 75 publications

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“…Omalizumab is one of the most promising adjunctive therapies for food allergy. The allergens studied in omalizumab-enabled OIT trials include peanuts, cow’s milk, eggs, or mixes of multiple foods [ 25 ]. Results from several studies suggest that omalizumab allows the use of more efficient rapid dose-escalation protocols for OIT.…”

Section: Discussionmentioning

confidence: 99%

The effect of omalizumab treatment on severe allergic asthma and allergic comorbidities: real-life experience from the Czech Anti-IgE Registry

Hutyrová

Bystroň

2018

pdia

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IntroductionOmalizumab is indicated for the treatment of severe allergic asthma (SAA) and chronic spontaneous urticaria, although a number of studies have confirmed the effectiveness of this therapy also for other IgE-mediated diseases.AimTo assess the impact of anti-IgE therapy on SAA and comorbid IgE-mediated allergic diseases in patients treated with omalizumab for SAA enrolled in the CAR (Czech Anti-IgE Registry).Material and methodsThree hundred and ten patients with SAA treated with omalizumab were enrolled in the CAR. Two hundred and twenty-nine individuals were evaluated after 12 months of omalizumab treatment for asthma control test (ACT), examination of fractional exhaled nitric oxide (FENO), forced expiratory volume in 1 s (FEV1), the use of systemic corticosteroids, side effects of treatment and clinical effect of omalizumab on allergic comorbidities (allergic rhinitis, chronic urticaria, atopic dermatitis and food allergy).ResultsAfter 12 months of treatment with omalizumab, patients experienced a significant improvement of ACT and FEV1, reduction of FENO, use of systemic corticosteroids for asthma exacerbations and dose of maintenance oral corticosteroid therapy. The positive effect of treatment with omalizumab was observed in 82.2% of patients with allergic rhinitis, in 85.7% of patients with chronic urticaria, in 82.1% of patients with atopic dermatitis, and in 67.3% of patients with food allergy.ConclusionsIn the CAR registry, patients with SAA treated with omalizumab showed a significant positive effect of anti-IgE therapy not only on the asthma control, but also on allergic comorbidities.

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Section: Discussionmentioning

confidence: 99%

The effect of omalizumab treatment on severe allergic asthma and allergic comorbidities: real-life experience from the Czech Anti-IgE Registry

Hutyrová

Bystroň

2018

pdia

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“…158 In particular, the potential role of omalizumab in improving the safety profile of OIT is promising. 154,156,[159][160][161] In the context of OIT and multi-OIT, omalizumab changes the allergic reaction threshold. 162 In a recent phase 2 randomized controlled study 163 in 48 eligible children who underwent multifood OIT, 83% of the omalizumab group and only 33% of the placebo group passed DBPCFC to 2 grams of 2 or more of the foods, equivalent to an odds ratio of 10.0 (95% CI 1.8-58.3, P = .0044).…”

Section: Clinic Al Mark Er S and Pro Cedur Al Fac Tor S Of Tre Atmementioning

confidence: 99%

Recent developments and highlights in food allergy

Eiwegger

Hung

Diego

et al. 2019

Allergy

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The achievement of long-lasting, safe treatments for food allergy is dependent on the understanding of the immunological basis of food allergy. Accurate diagnosis is essential for management. In recent years, data from oral food challenges have revealed that routine allergy testing is poor at predicting clinical allergy for tree nuts, almonds in particular. More advanced antigen-based tests including component-resolved diagnostics and epitope reactivity may lead to more accurate diagnosis and selection of therapeutic intervention. Additional diagnostic accuracy may come from cellular tests such as the basophil activation test or mast cell approaches. In the context of clinical trials, cellular tests have revealed specific T-cell and B-cell populations that are more abundant in food-allergic individuals with distinct mechanistic features.Awareness of clinical markers, such as the ability to eat baked forms of milk and egg, continues to inform the understanding of natural tolerance development.Mouse models have allowed for investigation into multiple mechanisms of food allergy including modification of epithelial metabolism, and the induction of regulatory cell subsets and the microbiome. Increasing numbers of children who underwent food immunotherapy enlarged the body of evidence on mechanisms and predictors of treatment success. Experimental immunological markers in conjunction with clinical determinants such as lower age and lower initial specific IgE appear to be of benefit.More research on the optimal dose, preparation, and route of application integrating a high-level safety and efficacy is demanded. Alternatively, biologics blocking TSLP, IL-33, IL-4 and IL-13, or IgE may help to achieve that. K E Y W O R D Sallergy treatment, biologics, food allergy, immune tolerance, immunotherapy | 2357 EIWEGGER Et al.

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“…The use of omalizumab as adjunct therapy to OIT has been reviewed previously [25][26][27][28]. There are 6 uncontrolled trials to date currently indexed in MEDLINE conducted for milk (n = 26) [29][30][31], peanut (n = 39) [32,33], egg (n = 12) [30,34] and multiple food allergens (n = 25) [19].…”

Section: Use Of Omalizumab In Oral Immunotherapymentioning

confidence: 99%

Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy

Langlois

Lavergne

Leroux

et al. 2020

Allergy Asthma Clin Immunol

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Background: Previous proof-of-concept studies have shown that a short course of omalizumab can safely accelerate the oral immunotherapy schedule for multiple allergens simultaneously. Considering the high cost of medication, the dose-related efficacy of omalizumab at decreasing the duration of oral immunotherapy up-dosing phase must be objectively quantified before cost-benefit analyses can be performed. The primary objective of this trial will be to compare the efficacy of 2 omalizumab dosages to placebo at decreasing time-to-maintenance dose during a symptom-driven multi-food OIT protocol. Methods: A total of 90 participants aged 6 to 25 with multiple food allergies (3 or more) will be enrolled at four sites in Canada. Participants will be randomized to: (A) Omalizumab 8 mg/kg per month (n = 36); (B) Omalizumab 16 mg/kg per month (n = 36); or (C) Placebo (n = 18). Study drug will be administered at full dosage for 12 weeks, then progressively tapered at 50% dosage (8 mg/kg vs 4 mg/kg vs placebo) for 4 weeks and at 25% dosage (4 mg/kg vs 2 mg/kg vs placebo) for another 4 weeks. After a pre-treatment period of 8 weeks, participants will undergo an initial food escalation (IFE) to an OIT mix containing 3 allergens and start daily home dosing with biweekly increases until a target daily maintenance of 1500 mg protein is achieved. The amount escalated at each visit will vary based on treatment tolerance according to a standardized up-dosing algorithm. Participants will be followed for at least 12 months following the initial food escalation. The primary endpoint will be time from IFE to the target maintenance dose of 1500 mg protein. Time-toevent analytic methods, including the log-rank test, will be used to compare the 3 arms. Discussion: This trial uses a novel pragmatic approach to compare OIT with omalizumab to OIT without omalizumab in a blinded manner, which allows to single out the effect of this anti-IgE medication on treatment effectiveness speed without the recourse to predetermined schedules. The innovative patient-centered up-dosing algorithm allows to maximise treatment effectiveness speed without compromising patient safety, regardless of whether the patient is on omalizumab or not. This study will also provide novel prospective data to inform on the optimal and most costeffective dosage for this indication. Trial registration ClinicalTrials.gov, NCT04045301, Registered 5 August 2019, https ://clini caltr ials.gov/ct2/show/NCT04 04530 1

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The Use of Omalizumab in Food Oral Immunotherapy

Cited by 29 publications

References 75 publications

The effect of omalizumab treatment on severe allergic asthma and allergic comorbidities: real-life experience from the Czech Anti-IgE Registry

The effect of omalizumab treatment on severe allergic asthma and allergic comorbidities: real-life experience from the Czech Anti-IgE Registry

Recent developments and highlights in food allergy

Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy

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