Two-year Post-Treatment Outcomes Following Peanut Oral Immunotherapy in the Probiotic and Peanut Oral Immunotherapy-003 Long-Term (PPOIT-003LT) Study

The probiotic and peanut oral immunotherapy (PPOIT)-003 randomized control trial showed probiotics plus peanut (PP) oral immunotherapy (OIT) and peanut OIT to be effective at inducing remission and desensitization compared with placebo (remission: PPOIT 46%, OIT 51%, placebo 5%; desensitization: PPOIT 77%, OIT 73%, placebo 5%). This study examined the long-term benefits and limitations associated with each clinical outcome.Children aged 1 to 10 years with peanut allergy confirmed by double-blind placebo-controlled food challenge and originally randomized 2:2:1 as PPOIT:OIT:placebo were evaluated for 2 years after completing PPOIT-003.Peanut consumption, reactions, and health-related quality of life (HRQOL) were monitored prospectively at 1 and 2 years after trial completion and were examined by treatment group and clinical outcome (remission, desensitization without remission, and allergic).Of the 86% (151/176) of eligible children observed, peanut consumption 2 years after completion was similar for PPOIT (86.7%) and OIT (78.7%, P = .48) and lower for placebo (10.3%). More PPOIT and OIT children consumed peanut vs placebo at 1 and 2 years (risk difference [RD] range 0.68-0.76, all P < .001). In year 2, more PPOIT children consumed peanut vs OIT children (RD 0.08, P = .017). Allergic reactions decreased over time in all groups: (PPOIT 31.7% to 23.3%, OIT 37.7% to 19.7%, placebo 13.8% to 6.9%; remission 27.5% to 15.9%; desensitization 57.9% to 36.8%; allergic 11.6% to 7%). After 2 years, similar proportions of remission and allergic children reported reactions (RD 0.09 [95% CI −0.03, 0.20], P = .127); more desensitized children reported reactions: (remission vs desensitized: RD −0.21 [95% CI −0.39; −0.03], P = .02) and (desensitized vs allergic: RD 0.30 [95% CI 0.13, 0.47], P = .001), and epinephrine use: 0% in remission, 5.3% of desensitized, and 2.3% of allergic children. Children in remission had greater HRQOL improvement than desensitized (Mean difference [MD] −0.54 [95% CI −0.99, −0.10], P = .017) and allergic (MD −0.82 [95% CI −1.25, −0.38], P < .001) children.Two years after PPOIT-003 completion, children with peanut allergy in remission reported fewer allergic reactions and greater HRQOL improvement. Desensitization allowed similar peanut consumption with less improvement in allergic reactions and HRQOL.In this study, remission of peanut allergy optimized consumption of peanut, caused fewer allergic reactions, and improved quality of life. Desensitization, the most common outcome, had limitations regarding improvement of allergic reactions and quality of life. These findings offer detailed follow-up regarding OIT and demonstrate the ongoing importance of providing children and families with information to allow them to choose the mode of treatment that best meets their needs.