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Randomized Controlled Trial
. 2021 May;9(5):1879-1889.e13.
doi: 10.1016/j.jaip.2020.12.029. Epub 2020 Dec 24.

Continuous and Daily Oral Immunotherapy for Peanut Allergy: Results from a 2-Year Open-Label Follow-On Study

Brian P Vickery  1 , Andrea Vereda  2 , Caroline Nilsson  3 , George du Toit  4 , Wayne G Shreffler  5 , A Wesley Burks  6 , Stacie M Jones  7 , Montserrat Fernández-Rivas  8 , Katharina Blümchen  9 , Jonathan O'B Hourihane  10 , Kirsten Beyer  11 , Aikaterini Anagnostou  12 , Amal H Assa'ad  13 , Moshe Ben-Shoshan  14 , J Andrew Bird  15 , Tara F Carr  16 , Warner W Carr  17 , Thomas B Casale  18 , Hey Jin Chong  19 , Christina E Ciaccio  20 , Morna J Dorsey  21 , Stanley M Fineman  22 , Stephen B Fritz  23 , Alexander N Greiner  24 , Leon S Greos  25 , Frank C Hampel Jr  26 , Maria Dolores Ibáñez  27 , David K Jeong  28 , Douglas T Johnston  29 , Rita Kachru  30 , Edwin H Kim  31 , Bruce J Lanser  32 , Stephanie A Leonard  33 , Mary C Maier  34 , Lyndon E Mansfield  35 , Antonella Muraro  36 , Jason A Ohayon  37 , Joanna N G Oude Elberink  38 , Daniel H Petroni  39 , Jacqueline A Pongracic  40 , Jay M Portnoy  41 , Rima Rachid  42 , Ned T Rupp  43 , Georgiana M Sanders  44 , Hemant P Sharma  45 , Vibha Sharma  46 , Ellen R Sher  47 , Lawrence Sher  48 , Sayantani B Sindher  49 , Dareen Siri  50 , Jonathan M Spergel  51 , Aline B Sprikkelman  52 , Gordon L Sussman  53 , Marina Tsoumani  54 , Pooja Varshney  55 , Girish Vitalpur  56 , Julie Wang  57 , William H Yang  58 , José Manuel Zubeldia  59 , Alex Smith  60 , Robert Ryan  2 , Daniel C Adelman  61
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Free article
Randomized Controlled Trial

Continuous and Daily Oral Immunotherapy for Peanut Allergy: Results from a 2-Year Open-Label Follow-On Study

Brian P Vickery et al. J Allergy Clin Immunol Pract. 2021 May.
Free article

Erratum in

  • Corrections.
    [No authors listed] [No authors listed] J Allergy Clin Immunol Pract. 2022 Feb;10(2):647-650. doi: 10.1016/j.jaip.2021.11.019. J Allergy Clin Immunol Pract. 2022. PMID: 35144777 No abstract available.

Abstract

Background: The randomized, controlled PALISADE trial demonstrated the benefit of daily oral immunotherapy with Peanut (Arachis Hypogaea) allergen powder-dnfp (PTAH, formerly AR101) in peanut-allergic children and adolescents.

Objective: ARC004, the open-label follow-on study to PALISADE, used 5 dosing cohorts to explore PTAH treatment beyond 1 year and alternative dosing regimens in peanut-allergic individuals.

Methods: Active arm (PTAH-continuing) PALISADE participants who tolerated 300-mg peanut protein at the exit double-blind placebo-controlled food challenge and placebo arm (PTAH-naive) participants could enter ARC004. PTAH-continuing participants were assigned to receive daily (cohorts 1 and 3A) or non-daily (cohorts 2, 3B, and 3C) dosing regimens; PTAH-naive participants were built up to 300 mg/d PTAH, followed by maintenance dosing. At study completion, participants underwent an exit double-blind placebo-controlled food challenge with doses up to 2000 mg peanut protein. Data were assessed using descriptive statistics.

Results: Overall, 358 (87.5%) eligible participants (4-17 years) entered ARC004 (PTAH-continuing, n = 256; PTAH-naive, n = 102). Among PTAH-continuing participants, exposure-adjusted adverse event rates were 12.94 to 17.54/participant-year and 25.95 to 42.49/participant-year in daily and non-daily dosing cohorts, respectively; most participants (83%) experienced mild or moderate adverse events. Daily dosing cohorts appeared to have higher desensitization rates than non-daily dosing cohorts. Of all PTAH-continuing cohorts, cohort 3A had the longest daily dosing duration and the highest desensitization rates. Changes in immune markers with PTAH continuation demonstrated ongoing immunomodulation. Outcomes in PTAH-naive participants mirrored those of the PALISADE active arm.

Conclusions: Continued daily PTAH treatment beyond 1 year showed sustained safety and efficacy. Ongoing immunomodulation was observed during the second year of treatment.

Keywords: Allergic reactions; Desensitization; Dosing regimens; Oral immunotherapy; Peanut allergy.

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