Outcome measures
Efficacy endpoints
A DBPCFC (cumulative 4950 mg peanut protein) was performed at the end-of-treatment to assess for desensitization (T2), and at 8-weeks post-treatment (T3) with strict peanut elimination between T2 and T3 to assess for SU. Subjects who achieved SU at T3 were evaluated for persistence of 8-week SU at 3-years post-treatment (T5) by DBPCFC (cumulative 4950mg peanut protein, performed after 8-weeks of peanut elimination). An optional DBPCFC was offered at 12-months post-treatment (T4) to assess for persistence of SU to 12-months post-treatment in those subjects who achieved SU at T3.
Participants who passed the T2 DBPCFC were classified as desensitized. Participants who passed both the T2 and T3 DBPCFCs were classified as having attained SU and were instructed to include peanut in their dietad libitum . Participants who were desensitized but failed to achieve SU and participants who failed the T2 DBPCFC resumed strict peanut avoidance. Participants with SU at T3 who passed the T5 DBPCFC were classified as having persistent SU at 3-years post-treatment.