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A Phase 2 Randomized Controlled Multisite Study Using Omalizumab-facilitated Rapid Desensitization to Test Continued vs Discontinued Dosing in Multifood Allergic Individuals.
Andorf, Sandra; Purington, Natasha; Kumar, Divya; Long, Andrew; O'Laughlin, Katherine L; Sicherer, Scott; Sampson, Hugh; Cianferoni, Antonella; Whitehorn, Terri Brown; Petroni, Daniel; Makhija, Melanie; Robison, Rachel G; Lierl, Michelle; Logsdon, Stephanie; Desai, Manisha; Galli, Stephen J; Rael, Efren; Assa'ad, Amal; Chinthrajah, Sharon; Pongracic, Jacqueline; Spergel, Jonathan M; Tam, Jonathan; Tilles, Stephen; Wang, Julie; Nadeau, Kari.
Afiliação
  • Andorf S; Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, CA, USA.
  • Purington N; Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA, USA.
  • Kumar D; Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, CA, USA.
  • Long A; Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, CA, USA.
  • O'Laughlin KL; Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA, USA.
  • Sicherer S; Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, CA, USA.
  • Sampson H; Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, CA, USA.
  • Cianferoni A; Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA, USA.
  • Whitehorn TB; Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, CA, USA.
  • Petroni D; Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, CA, USA.
  • Makhija M; Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA, USA.
  • Robison RG; Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, CA, USA.
  • Lierl M; Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, CA, USA.
  • Logsdon S; Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA, USA.
  • Desai M; Division of Allergy, Immunology and Rheumatology, Stanford University, Stanford, CA, USA.
  • Galli SJ; Division of Allergy and Immunology, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Rael E; Division of Allergy and Immunology, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Assa'ad A; Division of Allergy and Immunology, The Children's Hospital of Philadelphia Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania, Philadelphia, PA, USA.
  • Chinthrajah S; Division of Allergy and Immunology, The Children's Hospital of Philadelphia Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania, Philadelphia, PA, USA.
  • Pongracic J; ASTHMA Inc. Clinical Research Center, Northwest Asthma and Allergy Center, University of Washington, Seattle, WA, USA.
  • Spergel JM; Division of Allergy and Immunology, the Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.
  • Tam J; Division of Allergy and Immunology, the Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.
  • Tilles S; Division of Allergy and Immunology, Cincinnati Children's Medical Center, Cincinnati, OH, USA.
  • Wang J; Division of Allergy and Immunology, Cincinnati Children's Medical Center, Cincinnati, OH, USA.
  • Nadeau K; Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, CA, USA.
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 5-22 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 1 g, 300 mg, or 0 mg arms (blinded, weeks 30-36) and then tested by food challenge at week 36. Success was defined as passing 2 g food challenge to at least 2 foods in week 36.

FINDINGS:

Most participants were able to reach a dose of 2 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 300 mg dose was effectively different than a 1 g dose in maintaining desensitization, and both together were more effective than OIT discontinuation (0 mg dose) (85% vs 55%, P = 0.03). Fifty-five percent of the intent-to-treat participants and 69% of per protocol participants randomized to the 0 mg arm showed no objective reactivity after 6 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 300 mg or 1 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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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Guideline Idioma: En Revista: EClinicalMedicine Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Guideline Idioma: En Revista: EClinicalMedicine Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos