A Phase 2 Randomized Controlled Multisite Study Using Omalizumab-facilitated Rapid Desensitization to Test Continued vs Discontinued Dosing in Multifood Allergic Individuals.
EClinicalMedicine
; 7: 27-38, 2019 Jan.
Article
em En
| MEDLINE
| ID: mdl-31193674
ABSTRACT
BACKGROUND:
As there is limited data on the sustainability of desensitization of multifood-oral immunotherapy (multifood-OIT), we conducted a multisite multifood-OIT study to compare the efficacy of successful desensitization with sustained dosing vs discontinued dosing after multifood-OIT.METHODS:
We enrolled 70 participants, aged 5-22â¯years with multiple food allergies confirmed by double-blind placebo-controlled food challenges (DBPCFCs). In the open-label phase of the study, all participants received omalizumab (weeks 1-16) and multi-OIT (2-5 allergens; weeks 8-30) and eligible participants (on maintenance dose of each allergen by weeks 28-29) were randomized 111 to 1â¯g, 300â¯mg, or 0â¯mg arms (blinded, weeks 30-36) and then tested by food challenge at week 36. Success was defined as passing 2â¯g food challenge to at least 2 foods in week 36.FINDINGS:
Most participants were able to reach a dose of 2â¯g or higher of each of 2, 3, 4, and 5 food allergens (as applicable to the participant's food allergens in OIT) in week 36 food challenges. Using an intent-to-treat analysis, we did not find evidence that a 300â¯mg dose was effectively different than a 1â¯g dose in maintaining desensitization, and both together were more effective than OIT discontinuation (0â¯mg dose) (85% vs 55%, Pâ¯=â¯0.03). Fifty-five percent of the intent-to-treat participants and 69% of per protocol participants randomized to the 0â¯mg arm showed no objective reactivity after 6â¯weeks of discontinuation. Cross-desensitization was found between cashew/pistachio and walnut/pecan when only one of the foods was part of OIT. No statistically significant safety differences were found between the three arms.INTERPRETATION:
These results suggest that sustained desensitization after omalizumab-facilitated multi-OIT best occurs through continued maintenance OIT dosing of either 300â¯mg or 1â¯g of each food allergen as opposed to discontinuation of multi-OIT.FUNDING:
Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Jeff and MacKenzie Bezos, NIAID AADCRC U19AI104209. TRIAL REGISTRATION NUMBER ClinicalTrials.gov number, NCT02626611.
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Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Guideline
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article