背景:很少有研究检查口服免疫治疗(OIT)后的长期结果;没有研究检查与不同临床结果相关的长期风险和益处(脱敏,residence).
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.花生摄入,reactions,并对健康相关生活质量(HRQOL)进行前瞻性监测.治疗后1年和2年的结果按治疗组和OIT后的临床结果(缓解,脱敏无缓解[DWR],过敏)。
结果:86%(151/176)的合格儿童登记。PPOIT(86.7%)和OIT(78.7%)组治疗后2年的花生摄入相似,两者均高于安慰剂(10.3%)。所有治疗和临床结果组的反应随着时间的推移而减少(PPOIT31.7%至23.3%,OIT37.7%至19.7%,安慰剂13.8%至6.9%;缓解27.5%至15.9%;DWR57.9%至36.8%;过敏11.6%至7%)。治疗后2年,缓解和过敏参与者报告反应的比例相似(RD0.09(95CI-0.03,0.20),p=.127),而更多的DWR参与者报告的反应比缓解(缓解与DWR:RD-0.21(95CI-0.39;-0.03),p=.02)和过敏(DWR与过敏:RD0.30(95CI0.13,0.47),p=.001)参与者。治疗后2年,0%缓解与5.3%DWR和2.3%过敏参与者报告使用肾上腺素注射器。与两个DWR相比,缓解参与者的HRQOL改善(基线校正)明显更大(MD-0.54(95CI-0.99,-0.10),p=.017)和过敏(MD-0.82(95CI-1.25,-0.38),p<.001)。
结论:治疗后2年,缓解的参与者报告反应较少,与DWR和过敏参与者相比,严重的反应较少,HRQOL改善较大,表明缓解是患者首选的治疗结果,而不是脱敏或保持过敏。
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).
CONCLUSIONS: 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.