Amy M Scurlock1, A Wesley Burks2, Scott H Sicherer3, Donald Y M Leung4, Edwin H Kim2, Alice K Henning5, Peter Dawson5, Robert W Lindblad5, M Cecilia Berin3, Christine B Cho4, Wendy F Davidson6, Marshall Plaut6, Hugh A Sampson3, Robert A Wood7, Stacie M Jones8. 1. Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. Electronic address: ScurlockAmyM@uams.edu. 2. UNC School of Medicine, University of North Carolina, Chapel Hill, NC. 3. Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY. 4. Department of Pediatrics, National Jewish Health, Denver, Colo. 5. Emmes, Rockville, Bethesda. 6. National Institutes of Health (National Institute of Allergy and Infectious Diseases), Bethesda, Md. 7. Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Md. 8. Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
Abstract
BACKGROUND: Consortium for Food Allergy Research investigators previously reported 52-week outcomes from a randomized controlled trial of peanut epicutaneous immunotherapy, observing modest and statistically significant induction of desensitization, highest in children ages 4 to 11 years. OBJECTIVE: We sought to evaluate changes in efficacy, safety, and mechanistic parameters following extended open-label peanut epicutaneous immunotherapy. METHODS: Peanut-allergic participants (4-25 years) received 52 weeks of placebo (PLB), Viaskin Peanut 100 μg (VP100) or 250 μg (VP250), and then crossed over to VP250 for PLB (PLB-VP250) and VP100 (VP100-VP250) participants and continued treatment for VP250 participants (total = 130 weeks of active epicutaneous immunotherapy). Efficacy was assessed by double-blind, placebo-controlled food challenge (5044 mg peanut protein), and adherence, safety, and mechanistic parameters were evaluated. RESULTS: At week 130, desensitization success was achieved in 1 of 20 (5%) PLB-VP250, 5 of 24 (20.8%) VP100-VP250, and 9 of 25 (36%) VP250 participants, with median successfully consumed dose change from baseline of 11.5 mg, 141.5 mg, and 400 mg, respectively. Median age (years) for week 130 desensitization success was 6.2 years (interquartile range, 5.2-9.1) versus 9.4 years (interquartile range, 7.6-12.8) for failures (P < .001). Adherence was 96%. Adverse reactions were predominantly local patch-site reactions. Significant increases in peanut- and Ara h2-specific IgG4 observed at week 52 persisted to week 130. By a post hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or successfully consumed dose. CONCLUSIONS: Extended treatment with VP250 was well tolerated, and desensitization observed at week 52 persisted between weeks 52 and 130. Treatment success was observed predominantly in younger participants, with younger age at initiation of active therapy an important predictor of success.
BACKGROUND: Consortium for Food Allergy Research investigators previously reported 52-week outcomes from a randomized controlled trial of peanut epicutaneous immunotherapy, observing modest and statistically significant induction of desensitization, highest in children ages 4 to 11 years. OBJECTIVE: We sought to evaluate changes in efficacy, safety, and mechanistic parameters following extended open-label peanut epicutaneous immunotherapy. METHODS: Peanut-allergic participants (4-25 years) received 52 weeks of placebo (PLB), Viaskin Peanut 100 μg (VP100) or 250 μg (VP250), and then crossed over to VP250 for PLB (PLB-VP250) and VP100 (VP100-VP250) participants and continued treatment for VP250 participants (total = 130 weeks of active epicutaneous immunotherapy). Efficacy was assessed by double-blind, placebo-controlled food challenge (5044 mg peanut protein), and adherence, safety, and mechanistic parameters were evaluated. RESULTS: At week 130, desensitization success was achieved in 1 of 20 (5%) PLB-VP250, 5 of 24 (20.8%) VP100-VP250, and 9 of 25 (36%) VP250 participants, with median successfully consumed dose change from baseline of 11.5 mg, 141.5 mg, and 400 mg, respectively. Median age (years) for week 130 desensitization success was 6.2 years (interquartile range, 5.2-9.1) versus 9.4 years (interquartile range, 7.6-12.8) for failures (P < .001). Adherence was 96%. Adverse reactions were predominantly local patch-site reactions. Significant increases in peanut- and Ara h2-specific IgG4 observed at week 52 persisted to week 130. By a post hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or successfully consumed dose. CONCLUSIONS: Extended treatment with VP250 was well tolerated, and desensitization observed at week 52 persisted between weeks 52 and 130. Treatment success was observed predominantly in younger participants, with younger age at initiation of active therapy an important predictor of success.
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Authors: A Wesley Burks; Robert A Wood; Stacie M Jones; Scott H Sicherer; David M Fleischer; Amy M Scurlock; Brian P Vickery; Andrew H Liu; Alice K Henning; Robert Lindblad; Peter Dawson; Marshall Plaut; Hugh A Sampson Journal: J Allergy Clin Immunol Date: 2015-02-03 Impact factor: 10.793
Authors: M Cecilia Berin; Charuta Agashe; A Wesley Burks; David Chiang; Wendy F Davidson; Peter Dawson; Alexander Grishin; Alice K Henning; Stacie M Jones; Edwin H Kim; Donald Y M Leung; Madhan Masilamani; Amy M Scurlock; Scott H Sicherer; Robert A Wood; Hugh A Sampson Journal: J Allergy Clin Immunol Date: 2021-10-13 Impact factor: 14.290