Riccio Anna Maria, Mauri Pierluigi, De Ferrari Laura, Rossi Rossana, Di Silvestre Dario, Bartezaghi Marta, Saccheri Fabiana, Canonica Giorgio Walter
Allergy & Respiratory Diseases Clinic, DIMI, University of Genoa, Genoa, Italy.
Institute Biomedical Technologies, ITB-CNR, Segrate, Italy.
World Allergy Organ J. 2020 Jan 24;13(1):100095. doi: 10.1016/j.waojou.2019.100095. eCollection 2020 Jan.
Patients with severe allergic asthma (SAA) when treated with omalizumab may exhibit different extent of response. Identifying biomarkers that can predict the extent of treatment effectiveness in patients can be useful in personalizing omalizumab treatment.
Patients from the longitudinal phase of the PROXIMA study were selected for this ancillary study. After 12 months of omalizumab treatment, patients were categorized according to their response to treatment as: "clinical responder" (Asthma Control Questionnaire [ACQ] total score <1 at Month 12 and/or with a reduction in number of exacerbation versus the previous year); "functional responder" (an increment of ≥0.1 L in forced expiratory volume in 1 s [FEV] at Month 12 versus baseline); and "super responder" (among clinical responders group, who also showed a functional response). Plasma galectin-3 (GAL-3) levels were quantified using a micro titer plate-based enzyme linked immunosorbent assay kit.
The Majority of patients (86.36%) in sub-study population were identified as clinical responders. Of the total patients identified as clinical responders, 64.86% were identified as super responders A statistically significant difference in the baseline plasma GAL-3 levels between responders and non-responders was observed only in the functional responders group ( = 0.0446). Patients with plasma GAL-3 level of ≥11 ng/mL had a greater probability of being a super responder ( = 0.0118) or a functional responder ( = 0.0032).
Our findings support the use of plasma GAL-3 as a predictive marker to stratify responders and identify super responders and functional responders to omalizumab treatment in patients with severe allergic asthma using less invasive sample like plasma.
重度过敏性哮喘（SAA）患者接受奥马珠单抗治疗时可能表现出不同程度的反应。识别能够预测患者治疗效果程度的生物标志物，有助于奥马珠单抗治疗的个体化。
本辅助研究选取了PROXIMA研究纵向阶段的患者。奥马珠单抗治疗12个月后，根据患者对治疗的反应将其分类为：“临床反应者”（哮喘控制问卷[ACQ]总分在第12个月时<1，和/或与上一年相比发作次数减少）；“功能反应者”（第12个月时1秒用力呼气容积[FEV]较基线增加≥0.1L）；“超级反应者”（在临床反应者组中，同时也表现出功能反应）。使用基于微量滴定板的酶联免疫吸附测定试剂盒对血浆半乳糖凝集素-3（GAL-3）水平进行定量。
亚研究人群中的大多数患者（86.36%）被确定为临床反应者。在被确定为临床反应者的所有患者中，64.86%被确定为超级反应者。仅在功能反应者组中观察到反应者与无反应者之间基线血浆GAL-3水平存在统计学显著差异（P = 0.0446）。血浆GAL-3水平≥11 ng/mL的患者更有可能是超级反应者（P = 0.0118）或功能反应者（P = 0.0032）。
我们的研究结果支持使用血浆GAL-3作为预测标志物，以对反应者进行分层，并识别重度过敏性哮喘患者中对奥马珠单抗治疗有反应的超级反应者和功能反应者，所使用的样本如血浆具有微创性。
