Sustained unresponsiveness following long term Epicutaneous Immunotherapy (EPIT) with VIASKIN® peanut: Results of the OLFUS-VIPES PHASE IIb Study

Author(s):  
Terri Brown-Whitehorn
Author(s):  
Terri F. Brown-Whitehorn ◽  
Frédéric de Blay ◽  
Jonathan M. Spergel ◽  
Todd D. Green ◽  
Aurélie Peillon ◽  
...  

Author(s):  
Paxton Loke ◽  
Kuang-Chih Hsiao ◽  
Adriana Lozinsky ◽  
Sarah Ashley ◽  
Melanie Lloyd ◽  
...  

Background: Combined treatment with probiotic and peanut oral immunotherapy (PPOIT) was shown to induce sustained unresponsiveness (SU) in a proof-of-concept randomized trial. Additional data on safety and long-term outcomes are needed. This study aimed to evaluate the safety and long-term effects of PPOIT in children with peanut allergy. Methods: Open-label study of 20 children aged 1-12 years with challenge-confirmed peanut allergy; all children received 18-months of PPOIT. Efficacy endpoints were desensitization, 8-week SU, and persistence of 8-week SU at 3-years post-treatment, assessed by double-blind placebo-controlled food challenge (cumulative 4950mg peanut protein). Treatment emergent adverse events and relationship to study treatment were recorded. Immunologic measures and health related quality of life (HRQL) were evaluated at screening, end-of-treatment and 3-years post-treatment. Results: Sixteen children (75%) completed treatment. By intention-to-treat analysis, 75% (15/20) achieved desensitization and 60% (12/20) achieved 8-week SU. Ten of 12 participants with SU at end-of-treatment consented to the 3-year SU challenge; 6 (60%) had persistence of SU. PPOIT was associated with significantly reduced peanut skin prick test wheal size and serum peanut specific-IgE levels at end-of-treatment, 12-months and 3-years post-treatment. There were no serious adverse events. HRQL scores improved (exceeding the Minimal Clinically Important Difference of 0.45) at 12-months post-treatment with benefit sustained at 3-years post-treatment. Conclusions: Eighteen months of PPOIT induced high rates of desensitization and SU, and SU persisted to 3-years post-treatment in a majority of initial responders. PPOIT led to long-lasting suppression of peanut sIgE and long-lasting clinically important improvement in HRQL.


2019 ◽  
Vol 68 (4) ◽  
pp. 527-528 ◽  
Author(s):  
Tetsuharu Manabe ◽  
Sakura Sato ◽  
Noriyuki Yanagida ◽  
Noriko Hayashi ◽  
Makoto Nishino ◽  
...  

2020 ◽  
Vol 124 (4) ◽  
pp. 403-405.e1
Author(s):  
Whitney Reid Fink ◽  
Peter Capucilli ◽  
Megan O. Lewis ◽  
Courtney B. Rooney ◽  
Terri F. Brown-Whitehorn

2016 ◽  
Vol 68 (Suppl. 1) ◽  
pp. 18-31 ◽  
Author(s):  
Elizabeth Feuille ◽  
Anna Nowak-Węgrzyn

Oral immunotherapy (OIT) is a promising investigational therapy for food allergy. Clinical trials in peanut, milk, egg, and wheat allergy provide evidence that OIT can effectively desensitize a majority of individuals to a food allergen. While a portion of subjects demonstrate sustained unresponsiveness, the majority regain sensitivity with allergen avoidance. The safety and tolerability of OIT continue to limit its use in some patients. Virtually all studies report adverse reactions that are more frequent during dose escalation but may also occur during maintenance therapy. Recent studies have identified adjunctive therapies (such as omalizumab) which may mitigate adverse effects. There is a paucity of data on the long-term safety and efficacy of OIT. Further study is required before OIT is ready for routine clinical practice. This review is intended to provide the reader with an up-to-date understanding of OIT, including its mechanisms, efficacy, safety profile, and potential utility in clinical practice.


2020 ◽  
Vol 146 (4) ◽  
pp. 863-874 ◽  
Author(s):  
David M. Fleischer ◽  
Wayne G. Shreffler ◽  
Dianne E. Campbell ◽  
Todd D. Green ◽  
Sara Anvari ◽  
...  

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