Probiotic 和花生口服免疫治疗-003 长期（PPOIT-003LT）研究中花生口服免疫治疗后的两年治疗结果。

Two-year post-treatment outcomes following peanut oral immunotherapy in the Probiotic and Peanut Oral Immunotherapy-003 Long-Term (PPOIT-003LT) study.

机构信息

Murdoch Children's Research Institute, Parkville, Victoria, Australia.

Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.

出版信息

Allergy. 2024 Oct;79(10):2759-2774. doi: 10.1111/all.16262. Epub 2024 Aug 4.

DOI:10.1111/all.16262

PMID:39099231

Abstract

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.

摘要

背景

鲜有研究关注口服免疫治疗（OIT）后的长期结果；也没有研究过与不同临床结果（脱敏、缓解）相关的长期风险和获益。

方法

完成益生菌和花生口服免疫治疗（PPOIT）-003 随机试验的参与者被纳入后续研究 PPOIT-003LT。前瞻性监测花生摄入、反应和健康相关生活质量（HRQOL）。通过治疗组和 OIT 后临床结果（缓解、脱敏但未缓解[DWR]、过敏）检查治疗后 1 年和 2 年的结果。

结果

符合条件的儿童中有 86%（151/176）入组。治疗后 2 年，PPOIT（86.7%）和 OIT（78.7%）组的花生摄入均高于安慰剂组（10.3%）。所有治疗和临床结果组的反应均随时间减少（PPOIT 31.7%降至 23.3%，OIT 37.7%降至 19.7%，安慰剂 13.8%降至 6.9%；缓解 27.5%降至 15.9%；DWR 57.9%降至 36.8%；过敏 11.6%降至 7%）。治疗后 2 年，缓解和过敏参与者报告反应的比例相似（RD 0.09（95%CI-0.03，0.20），p=0.127），而 DWR 参与者报告反应的比例高于缓解参与者（缓解 vs DWR：RD-0.21（95%CI-0.39；-0.03），p=0.02）和过敏参与者（缓解 vs 过敏：RD-0.30（95%CI-0.13，0.47），p=0.001）。治疗后 2 年，0%的缓解参与者与 5.3%的 DWR 参与者和 2.3%的过敏参与者报告使用肾上腺素注射器。与 DWR（MD-0.54（95%CI-0.99，-0.10），p=0.017）和过敏（MD-0.82（95%CI-1.25，-0.38），p<0.001）相比，缓解参与者的 HRQOL 改善（经基线调整）显著更大。