Year Published: 2018
N Engl J Med
PALISADE Group of Clinical Investigators, Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibáñez MD, Tilles S, Assa’ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernández-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW
The PALISADE study was designed to test the safety, efficacy, and effectiveness of the AR101 pill, which uses graded doses of peanut protein in allergic patients to test its results. In this phase 3 trial, 551 children/adolescents who were highly allergic to peanuts received either AR101 or a placebo, with the treatment group receiving graduated doses from 6mg to 300mg.
Most of the participants (77%) tolerated the 300 mg pill, and 50% tolerated up to 1000mg. Authors note that the results of the trial show that AR101 treatment could result in higher doses of peanut protein being ingested in allergic patients. There may also be lower symptom severity during peanut exposure than in a placebo group.