Julia Upton, Diana Toscano Rivero, Danbing Ke, Alireza Berenjy, Duncan Lejtenyi, Liane Beaudette, Xiaojun Yin, Carmen Li, Lucy Duan, Casey G. Cohen, Vy Kim, Shireen Marzouk, Eyal Grunebaum, Christine McCusker, Bruce Mazer, Thomas Eiwegger, Moshe Ben‐Shoshan
Background The lowest dose of peanut oral immunotherapy (P-OIT) has not been determined. Objective To evaluate if very low dose OIT (30mg) may safely and effectively increase tolerated doses and induce immunological changes. Methods Peanut-allergic children reactive to /=443 and >/=1043mg PP were compared to Group-Avoid by DBPCFC planned at 1yr. Safety and laboratory parameters (sIgE, sIgG4) were assessed. Results We enrolled 51 children (26 (51%) male, median age 10yrs (IQR 7-13)), with initial cumulative-tolerated dose of 44mg (IQR 14-144). In Group-30mg, 15/17 completed DBPCFC (2/17 withdrawn). In Group-300mg, 12/17 completed DBPCFC (5/17 withdrawn). In Group-Avoid, 12/17 completed DBPCFC (5/17 lost to follow-up). By intention to treat, Group-30mg, 13/17 (p<<0.001 vs. Group-Avoid) tolerated >/=443 and 7/17 (p=0.007 vs. Group-Avoid) tolerated >/=1043mg PP. In the Group-300mg 10/17 (p=<0.001 vs. Group-Avoid) tolerated >/=443 and 8/17 (p=0.003 vs Group-Avoid) tolerated >/=1043mg PP. No Group-Avoid (0/17) tolerated >/=443 or >/=1043mg PP. Laboratory parameters (sIgE, sIgG4) were similar between Group-30mg and Group-300mg and significantly improved from Group-Avoid. Systemic adverse events were fewer in Group-30mg vs Group-300mg. Conclusions A 30mg maintenance dose for P-OIT significantly increases threshold over strict avoidance, clinically similarly to 300mg, and may allow for a simplified and safer OIT regimen and less treatment drop-outs. NCT03532360