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Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo-controlled multicenter trial
Open accessAbstract
Background There are presently no available therapeutic options for peanut-allergic patients. Objective To investigate the safety, efficacy, and immunologic effects of peanut sublingual immunotherapy (SLIT). Methods After a baseline oral food challenge (OFC) of up to 2g of peanut powder (~50% protein) (median successfully consumed dose [SCD] 46mg), 40 subjects, aged 12–37 (median 15) years, were randomized 1:1 across 5 sites to daily peanut or placebo SLIT. A 5g OFC was performed after 44 weeks followed by unblinding; placebo subjects then crossed over to higher dose peanut SLIT, followed by a subsequent crossover Week 44 5g OFC. Week 44 OFCs from both groups were compared to baseline OFCs; subjects successfully consuming 5g or at least 10-fold more peanut powder than the baseline OFC threshold were considered responders. Results After 44 weeks of SLIT, 14/20 (70%) subjects receiving peanut SLIT were responders compared to 3/20 (15%) subjects receiving placebo (p<0.001). In peanut-SLIT responders, median SCD increased from 3.5mg to 496mg. After 68 weeks of SLIT, median SCD significantly increased to 996mg (compared to week 44, p=0.05). The median SCD at the Week 44 crossover OFC was significantly higher than baseline (603mg vs 71mg; p=0.02). 7/16 (44%) crossover subjects were responders; median SCD increased from 21mg to 496mg among responders. Of 10,855 peanut doses through Week 44 OFCs, 63.1% were symptom-free; excluding oral/pharyngeal symptoms, 95.2% were symptom-free. Conclusions Peanut SLIT safely induced a modest level of desensitization in a majority of subjects compared to placebo. Longer duration of therapy showed statistically significant increases in the SCD.
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Sampson, H. A., Muñoz-Furlong, A., Campbell, R. L., Adkinson, N. F., Bock, S. A., Branum, A., Brown, S. G. A., Camargo, C. A., Cydulka, R., Galli, S. J., et al. (2006) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2005.12.1303 · Cited by 2,313
Self-citationFatalities due to anaphylactic reactions to foods
Bock, S. A., Muñoz-Furlong, A., & Sampson, H. A. (2001) · Journal of Allergy and Clinical Immunology · doi:10.1067/mai.2001.112031 · Cited by 1,566
Self-citationFurther fatalities caused by anaphylactic reactions to food, 2001-2006
Bock, S. A., Muñoz-Furlong, A., & Sampson, H. A. (2007) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2006.12.622 · Cited by 987
Self-citationUS prevalence of self-reported peanut, tree nut, and sesame allergy: 11-year follow-up
Sicherer, S. H., Muñoz-Furlong, A., Godbold, J. H., & Sampson, H. A. (2010) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2010.03.029 · Cited by 932
Self-citationSampson, H. A., Muñoz-Furlong, A., Campbell, R. L., Adkinson, N. F., Allan Bock, S., Branum, A., Brown, S. G. A., Camargo, C. A., Cydulka, R., Galli, S. J., et al. (2006) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2006.01.018 · Cited by 748
Self-citationClinical efficacy and immune regulation with peanut oral immunotherapy
Jones, S. M., Pons, L., Roberts, J. L., Scurlock, A. M., Perry, T. T., Kulis, M., Shreffler, W. G., Steele, P., Henry, K. A., Adair, M., et al. (2009) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2009.05.022 · Cited by 715
Self-citationOral Immunotherapy for Treatment of Egg Allergy in Children
Burks, A. W., Jones, S. M., Wood, R. A., Fleischer, D. M., Sicherer, S. H., Lindblad, R. W., Stablein, D., Henning, A. K., Vickery, B. P., Liu, A. H., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1200435 · Cited by 700
Self-citationSublingual immunotherapy for allergic rhinitis: systematic review and meta‐analysis*
Wilson, D. R., Torres Lima, M., & Durham, S. R. (2005) · Allergy · doi:10.1111/j.1398-9995.2005.00699.x · Cited by 660
Symposium on the Definition and Management of Anaphylaxis: Summary report
Sampson, H. A., Muñoz-Furlong, A., Bock, S. A., Schmitt, C., Bass, R., Chowdhury, B. A., Decker, W. W., Furlong, T. J., Galli, S. J., Golden, D. B., et al. (2005) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2005.01.009 · Cited by 641
Self-citationThe natural history of peanut allergy
Skolnick, H. S., Conover-Walker, M. K., Koerner, C. B., Sampson, H. A., Burks, W., & Wood, R. A. (2001) · Journal of Allergy and Clinical Immunology · doi:10.1067/mai.2001.112129 · Cited by 611
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Sampson, H. A., Aceves, S., Bock, S. A., James, J., Jones, S., Lang, D., Nadeau, K., Nowak-Wegrzyn, A., Oppenheimer, J., Perry, T. T., et al. (2014) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2014.05.013 · Cited by 845
Self-citationFood allergy: immune mechanisms, diagnosis and immunotherapy
Yu, W., Freeland, D. M. H., & Nadeau, K. C. (2016) · Nature Reviews Immunology · doi:10.1038/nri.2016.111 · Cited by 659
EAACI Molecular Allergology User's Guide 2.0
Dramburg, S., Hilger, C., Santos, A. F., de las Vecillas, L., Aalberse, R. C., Acevedo, N., Aglas, L., Altmann, F., Arruda, K. L., Asero, R., et al. (2023) · Pediatric Allergy and Immunology · doi:10.1111/pai.13854 · Cited by 298
World Allergy Organization Anaphylaxis Guidelines: 2013 update of the evidence base
Simons, F. E. R., Ardusso, L. R. F., Dimov, V., Ebisawa, M., El-Gamal, Y. M., Lockey, R. F., Sanchez-Borges, M., Senna, G. E., Sheikh, A., Thong, B. Y., et al. (2013) · International Archives of Allergy and Immunology · doi:10.1159/000354543 · Cited by 269
Bégin, P., Dominguez, T., Wilson, S. P., Bacal, L., Mehrotra, A., Kausch, B., Trela, A., Tavassoli, M., Hoyte, E., O’Riordan, G., et al. (2014) · Allergy, Asthma & Clinical Immunology · doi:10.1186/1710-1492-10-7 · Cited by 239
Metadata
- Authors
- Fleischer, D. M., Burks, A. W., Vickery, B. P., Scurlock, A. M., Wood, R. A., Jones, S. M., Sicherer, S. H., Liu, A. H., Stablein, D., Henning, A. K., Mayer, L., Lindblad, R., Plaut, M., & Sampson, H. A.
- Venue
- Journal of Allergy and Clinical Immunology
- Publisher
- Elsevier BV
- Published
- 2013-01
- Volume
- 131
- Issue
- 1
- Pages
- 119-127.e7
- ISSN
- 0091-6749 (ISSN-L)
- OpenAlex
- W2097001981
- Cited by
- 309
- References
- 51
- FWCI
- 21.06
- Type
- journal article
- Language
- en
- Open access
- green
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- Fleischer, D. M., Burks, A. W., Vickery, B. P., Scurlock, A. M., Wood, R. A., Jones, S. M., Sicherer, S. H., Liu, A. H., Stablein, D., Henning, A. K., Mayer, L., Lindblad, R., Plaut, M., & Sampson, H. A. (2013). Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo-controlled multicenter trial. Journal of Allergy and Clinical Immunology. https://doi.org/10.1016/j.jaci.2012.11.011
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