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Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study

Open access
Chinthrajah, R Sharon, Purington, Natasha, Andorf, Sandra, Long, Andrew, O'Laughlin, Katherine L, Lyu, Shu Chen, Manohar, Monali, Boyd, Scott D, Tibshirani, Robert, Maecker, Holden, Plaut, Marshall, Mukai, Kaori, Tsai, Mindy, Desai, Manisha, Galli, Stephen J, Nadeau, Kari C·2019·The Lancet

Abstract

SUMMARY BACKGROUND Dietary avoidance is recommended for peanut allergies. We evaluated sustained effects of peanut allergy oral immunotherapy (OIT) in the first randomized long-term study in adults and children. METHODS Peanut allergic participants (7–55 years-old) underwent a double-blind, placebo-controlled, phase 2 study. Participants randomized 2·4:1·4:1 in a 2×2 block design received placebo (oat flour) or peanut protein. Active therapy participants were built up to and maintained on 4 g peanut protein through week 104 then either discontinued peanut (peanut-0) or ingested 300 mg daily (peanut-300) for 52 weeks. Double-blind, placebo-controlled, food challenges (DBPCFCs) to 4 g peanut protein were conducted at baseline and weeks 104, 117, 130, 143 and 156. The primary endpoint was passing DBPCFCs at 104 and 117 weeks. This trial is registered at ClinicalTrials.gov (). FINDINGS Participants recruited between April 15, 2014 and March 2, 2016 were enrolled into peanut-0 (60), peanut-300 (35) and placebo (25) arms. At week 117, 35% peanut-0 and 4% placebo participants achieved success (OR [95%CI] 12·7 [1·8, 554·8]). While time to treatment failure (i.e., failing DBPCFCs to 4 g peanut over time) was significantly longer in peanut-300 vs. peanut-0, the proportion of participants passing DBPCFCs in peanut-300 declined significantly from week 104 to 156 (weeks 104 vs 156; 83% vs. 37%, OR [95%CI] 7·9 [2·4, 29·9]). The most common adverse events (AEs) were mild gastrointestinal symptoms; AEs decreased over time in all arms. In peanut-0, in which 13% passed DBPCFCs at week 156, higher baseline peanut-specific IgG4/IgE and lower Ara h 2 IgE and basophil activation responses were associated with sustained unresponsiveness. INTERPRETATION Peanut OIT can desensitize most peanut-allergic individuals to 4 g peanut protein but discontinuation, or even reduction to 300 mg daily, increases the likelihood of regaining clinical reactivity to peanut. Baseline blood tests correlate with week 117 treatment outcomes.

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Metadata

Authors
Chinthrajah, R. S., Purington, N., Andorf, S., Long, A., O'Laughlin, K. L., Lyu, S. C., Manohar, M., Boyd, S. D., Tibshirani, R., Maecker, H., Plaut, M., Mukai, K., Tsai, M., Desai, M., Galli, S. J., & Nadeau, K. C.
Venue
The Lancet
Publisher
Elsevier BV
Published
2019-10
Volume
394
Issue
10207
Pages
1437-1449
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
OpenAlex
W2972623358
Cited by
331
References
36
FWCI
22.61
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study. https://app.cochat.ai/papers/10.1016/s0140-6736(19)31793-3
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Chinthrajah, R. S., Purington, N., Andorf, S., Long, A., O'Laughlin, K. L., Lyu, S. C., Manohar, M., Boyd, S. D., Tibshirani, R., Maecker, H., Plaut, M., Mukai, K., Tsai, M., Desai, M., Galli, S. J., & Nadeau, K. C. (2019). Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study. The Lancet. https://doi.org/10.1016/s0140-6736(19)31793-3

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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