A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy Satya D. Narisety,

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Presentation transcript:

A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy Satya D. Narisety, MD, Pamela A. Frischmeyer-Guerrerio, MD, PhD, Corinne A. Keet, MD, MS, Mark Gorelik, MD, John Schroeder, PhD, Robert G. Hamilton, PhD, Robert A. Wood, MD Journal of Allergy and Clinical Immunology Volume 135, Issue 5, Pages 1275-1282.e6 (May 2015) DOI: 10.1016/j.jaci.2014.11.005 Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 CONSORT diagram. Time points include T1 (baseline), T3 (end of dose build-up), T4 and T5 (after 6 and 12 months of maintenance, subjects unblinded at T5), T6 (completion of additional 6 months of maintenance), and T7 (4 weeks off therapy). Journal of Allergy and Clinical Immunology 2015 135, 1275-1282.e6DOI: (10.1016/j.jaci.2014.11.005) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Change in cumulative OFC dose after SLIT (A) and OIT (B). Red lines indicate active SLIT, blue lines indicate active OIT, and purple lines represent combined SLIT and OIT after unblinding. Open circles represent subjects with sustained unresponsiveness. Between groups, there were significantly greater changes in OFC thresholds with OIT compared with SLIT (P = .008 and P = .01 after 6 and 12 months of maintenance). Journal of Allergy and Clinical Immunology 2015 135, 1275-1282.e6DOI: (10.1016/j.jaci.2014.11.005) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Change in end point skin test results after SLIT (A) and OIT (B). Red lines indicate active SLIT, blue lines indicate active OIT, and purple lines represent combined SLIT and OIT after unblinding. Open circles represent subjects with sustained unresponsiveness. Comparison of the SLIT and OIT groups revealed similar changes in skin test results over time, with the exception of greater changes in the OIT group at T4 (P = .03). Journal of Allergy and Clinical Immunology 2015 135, 1275-1282.e6DOI: (10.1016/j.jaci.2014.11.005) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Change in peanut-specific IgE levels after SLIT (A) and OIT (B). Red lines indicate active SLIT, blue lines indicate active OIT, and purple lines represent combined SLIT and OIT after unblinding. Open circles represent subjects with sustained unresponsiveness. By 6 months, the decrease in peanut IgE levels was greater in the OIT group, and this difference widened by 12 months (P = .07 and P = .007, respectively). Journal of Allergy and Clinical Immunology 2015 135, 1275-1282.e6DOI: (10.1016/j.jaci.2014.11.005) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 5 Change in peanut-specific IgG4 levels after SLIT (A) and OIT (B). Red lines indicate active SLIT, blue lines indicate active OIT, and purple lines represent combined SLIT and OIT after unblinding. Open circles represent subjects with sustained unresponsiveness. Between groups, there was overall a greater change from baseline in peanut-specific IgG4 levels over time in the OIT group compared with the SLIT group at all time points (end of dose build-up [P = .003] after 6 and 12 months of maintenance [P < .001]). Journal of Allergy and Clinical Immunology 2015 135, 1275-1282.e6DOI: (10.1016/j.jaci.2014.11.005) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Study schematic indicating treatment groups and assignment of open-label treatment after the 12-month OFC. Journal of Allergy and Clinical Immunology 2015 135, 1275-1282.e6DOI: (10.1016/j.jaci.2014.11.005) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Change in SPT responses (median wheal size) for other food and environmental allergens after SLIT (A) and OIT (B). See Table E4 for P values for the individual allergens at each time point. Journal of Allergy and Clinical Immunology 2015 135, 1275-1282.e6DOI: (10.1016/j.jaci.2014.11.005) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions