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在常规临床实践中基于早期维持阶段反应预测变应原免疫疗法的疗效。

Predicting allergen immunotherapy efficacy based on early maintenance phase response in routine clinical practice.

作者信息

Qin Rundong, Fu Wanyi, Huang Renbin, Xian Mo, Guo Yubiao, He Li, Shi Xu, Li Jing

机构信息

State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Department of Allergy and Clinical Immunology, The First Affiliated Hospital of Guangzhou Medical University, 151, Yanjiangxi Rd, Guangzhou, Guangdong, 510120, China.

出版信息

World Allergy Organ J. 2024 Nov 14;17(12):100986. doi: 10.1016/j.waojou.2024.100986. eCollection 2024 Dec.

Abstract

BACKGROUND

While allergen-specific immunotherapy (AIT) is acknowledged as an effective treatment, its efficacy varies, and consensus on predictive indicators for AIT responders remains elusive.

OBJECTIVE

This study aimed to identify alternative parameters for predicting AIT responders based on clinical data collected in daily practice.

METHOD

We conducted a retrospective analysis of patients with house-dust-mite-driven asthma and/or rhinitis who completed 3 years of subcutaneous AIT (3y-AIT). We assessed the efficacy of AIT using the estimated daily symptom and medication score (edSMS) during different treatment periods, including up-dosing, maintenance I, II, and III phases. These scores were derived from detailed records of symptoms and medication use for AIT injections. A responder was defined as an individual with a reduction in edSMS of at least 30% from up-dosing to maintenance III phase (ΔedSMS).

RESULTS

A cohort of 133 patients was analyzed, revealing a significant overall improvement in the disease condition after 3y-AIT. Responders demonstrated lower rates of polysensitization, daily tobacco smoke exposure, and milder pretreatment disease severity compared to non-responders (p = 0.003, p = 0.001, and p = 0.019, respectively). We observed 8 clinical response patterns among included subjects, but only a small group of patients (16/133, 12.03%) demonstrated consistent improvement throughout the 3y-AIT. Serum total immunoglobulin E (tIgE), specific immunoglobulin E (sIgE), sIgE/tIgE ratios, and edSMS during the up-dosing phase failed to differentiate the clinical response patterns or correlate with 3y-AIT efficacy. Notably, the reduction in edSMS from up-dosing phase to maintenance I phase (ΔedSMS) significantly associated with the 3y-AIT outcome (r = 0.443, p < 0.001). Receiver-operating characteristic curves indicated that ΔedSMS, with a cut-off of 18.40%, effectively predicted responders (AUC: 0.75, sensitivity: 76.20%, specificity: 76.70%).

CONCLUSION

The individualized clinical responses to AIT may pose challenges in identifying predictors for treatment efficacy. Nonetheless, despite this complexity, our study highlights that the effectiveness observed in the early maintenance phase serves as a suitable predictor of 3y-AIT outcomes.

摘要

背景

虽然变应原特异性免疫疗法(AIT)被公认为是一种有效的治疗方法,但其疗效存在差异,对于AIT反应者的预测指标仍未达成共识。

目的

本研究旨在基于日常临床实践收集的数据,确定预测AIT反应者的替代参数。

方法

我们对完成3年皮下AIT(3y-AIT)的屋尘螨诱发哮喘和/或鼻炎患者进行了回顾性分析。我们使用不同治疗阶段(包括剂量递增、维持I、II和III期)的估计每日症状和药物评分(edSMS)评估AIT的疗效。这些评分来自AIT注射的症状和药物使用的详细记录。反应者定义为从剂量递增到维持III期edSMS降低至少30%的个体(ΔedSMS)。

结果

分析了133例患者的队列,显示3y-AIT后疾病状况有显著的总体改善。与无反应者相比,反应者表现出较低的多致敏率、每日烟草烟雾暴露率,且治疗前疾病严重程度较轻(分别为p = 0.003、p = 0.001和p = 0.019)。我们在纳入的受试者中观察到8种临床反应模式,但只有一小部分患者(16/133,12.03%)在整个3y-AIT期间表现出持续改善。剂量递增阶段的血清总免疫球蛋白E(tIgE)、特异性免疫球蛋白E(sIgE)、sIgE/tIgE比值和edSMS未能区分临床反应模式,也与3y-AIT疗效无关。值得注意的是,从剂量递增阶段到维持I期edSMS的降低(ΔedSMS)与3y-AIT结果显著相关(r = 0.443,p < 0.001)。受试者工作特征曲线表明,ΔedSMS阈值为18.40%时可有效预测反应者(AUC:0.75,敏感性:76.20%,特异性:76.70%)。

结论

AIT的个体化临床反应可能对确定治疗疗效的预测指标构成挑战。尽管如此,尽管存在这种复杂性,我们的研究强调,在早期维持阶段观察到的有效性可作为3y-AIT结果的合适预测指标。

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