BACKGROUND Few studies have examined long-term outcomes following oral immunotherapy (OIT); none have examined long-term risks and benefits associated with distinct clinical outcomes (desensitization, remission). METHODS Participants completing the probiotic and peanut oral immunotherapy (PPOIT) -003 randomized trial were enrolled in a follow-on study, PPOIT-003LT. Peanut ingestion, reactions, and health-related quality of life (HRQOL) were monitored prospectively. Outcomes at 1-year and 2-years post-treatment were examined by treatment group and by post-OIT clinical outcome (remission, desensitization without remission [DWR], allergic). RESULTS 86% (151/176) of eligible children enrolled. Post-treatment peanut ingestion at 2-years post-treatment were similar for PPOIT (86.7%) and OIT (78.7%) groups, both higher than placebo (10.3%). Reactions reduced over time for all treatment and clinical outcome 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%; DWR 57.9% to 36.8%; allergic 11.6% to 7%). At 2-years post-treatment, similar proportions of remission and allergic participants reported reactions (RD 0.09 (95%CI -0.03, 0.20), p = .127), whereas more DWR participants reported reactions than remission (remission vs DWR: RD -0.21 (95%CI -0.39; -0.03), p = .02) and allergic (DWR vs allergic: RD 0.30 (95%CI 0.13, 0.47), p = .001) participants. At 2-years post-treatment, 0% remission versus 5.3% DWR versus 2.3% allergic participants reported adrenaline injector usage. Remission participants had significantly greater HRQOL improvement (adjusted for baseline) compared with both DWR (MD -0.54 (95%CI -0.99, -0.10), p = .017) and allergic (MD -0.82 (95%CI -1.25, -0.38), p < .001). CONCLUSION By 2-years post-treatment, remission participants reported fewer reactions, less severe reactions and greater HRQOL improvement compared with DWR and allergic participants, indicating that remission is the patient-preferred treatment outcome over desensitization or remaining allergic.

中文翻译：

---

益生菌和花生口服免疫疗法-003 长期 （PPOIT-003LT） 研究中花生口服免疫疗法后两年的治疗后结果。


背景 很少有研究检查口服免疫疗法 （OIT） 后的长期结局;没有研究过与不同临床结局（脱敏、缓解）相关的长期风险和益处。方法 完成益生菌和花生口服免疫疗法 （PPOIT） -003 随机试验的参与者被纳入一项后续研究 PPOIT-003LT。前瞻性监测花生摄入、反应和健康相关生活质量 （HRQOL）。按治疗组和 OIT 后临床结局 （缓解、无缓解脱敏 [DWR]、过敏）检查治疗后 1 年和 2 年的结局。结果 86% （151/176） 的符合条件的儿童入学。PPOIT （86.7%） 和 OIT （78.7%） 组在治疗后 2 年的治疗后花生摄入量相似，均高于安慰剂 （10.3%）。所有治疗和临床结局组的反应均随时间推移而减少（PPOIT 31.7% 至 23.3%，OIT 37.7% 至 19.7%，安慰剂组 13.8% 至 6.9%;缓解率 27.5% 至 15.9%;DWR 57.9% 至 36.8%;过敏 11.6% 至 7%）。在治疗后 2 年，相似比例的缓解和过敏参与者报告了反应 （RD 0.09 （95%CI -0.03， 0.20），p = .127），而报告反应的 DWR 参与者多于缓解 （缓解 vs DWR： RD -0.21 （95%CI -0.39;-0.03），p = .02） 和过敏 （DWR vs 过敏： RD 0.30 （95%CI 0.13， 0.47），p = .001） 参与者。在治疗后 2 年，0% 缓解 vs 5.3% DWR vs 2.3% 过敏参与者报告了肾上腺素注射器的使用。与 DWR （MD -0.54 （95% CI -0.99， -0.10）， p = .017） 和过敏 （MD -0.82 （95% CI -1.25， -0.38），p < .001） 相比，缓解参与者的 HRQOL 改善（根据基线调整）显著更大。 结论 到治疗后 2 年，与 DWR 和过敏参与者相比，缓解参与者报告的反应更少、反应更轻、HRQOL 改善更大，表明缓解是患者首选的治疗结果，而不是脱敏或保持过敏。