Continuous and Daily Oral Immunotherapy for Peanut Allergy: Results from a 2-Year Open-Label Follow-On Study
Creators: name: Sprikkelman, Aline B
name: Carr, Tara F
name: Muraro, Antonella
name: Lanser, Bruce J
name: Portnoy, Jay M
name: Anagnostou, Aikaterini
name: Adelman, Daniel C
name: Dorsey, Morna J
name: O'B Hourihane, Jonathan
name: Blümchen, Katharina
name: Wang, Julie
name: Vitalpur, Girish
name: Oude Elberink, Joanna N G
name: Greos, Leon S
name: Kachru, Rita
name: Chong, Hey Jin
name: Fernández-Rivas, Montserrat
name: Shreffler, Wayne G
name: Tsoumani, Marina
name: Rupp, Ned T
name: Ohayon, Jason A
name: Vereda, Andrea
name: Rachid, Rima
name: Leonard, Stephanie A
name: Ben-Shoshan, Moshe
name: Sher, Ellen R
name: Mansfield, Lyndon E
name: Hampel, Frank C
name: Fineman, Stanley M
name: Beyer, Kirsten
name: Petroni, Daniel H
name: Fritz, Stephen B
name: Smith, Alex
name: Sanders, Georgiana M
name: du Toit, George
name: Yang, William H
name: Sindher, Sayantani B
name: Carr, Warner W
name: Spergel, Jonathan M
name: Sussman, Gordon L
name: Ciaccio, Christina E
name: Kim, Edwin H
name: Ryan, Robert
name: Jones, Stacie M
name: Varshney, Pooja
name: Jeong, David K
name: Nilsson, Caroline
name: Sher, Lawrence
name: Ibáñez, Maria Dolores
name: Vickery, Brian P
name: Greiner, Alexander N
name: Assa'ad, Amal H
name: Pongracic, Jacqueline A
name: Bird, J Andrew
name: Johnston, Douglas T
name: Sharma, Hemant P
name: Siri, Dareen
name: Maier, Mary C
name: Zubeldia, José Manuel
name: Burks, A Wesley
name: Casale, Thomas B
name: Sharma, Vibha
Publisher: name: Elsevier
Year: 2020

description: <p>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&nbsp;= 256; PTAH-naive, n&nbsp;= 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.</p>