Nilsson Caroline, Vereda Andrea, Borres Magnus P, Andersson Mats, Södergren Eva, Rudengren Magnus, Smith Alex, Simon Reyna J, Ryan Robert, Fernández-Rivas Montserrat, Adelman Daniel, Vickery Brian P
Clinical Research and Education, Karolinska Institutet, Sachs' Children and Youth Hospital, Stockholm, Sweden.
Aimmune Therapeutics, a Nestlé Health Science Company, London, UK.
Clin Transl Allergy. 2024 Jan;14(1):e12326. doi: 10.1002/clt2.12326.
Immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) to peanut and its components may influence the clinical reactivity to peanut. Allergen-specific immunotherapy is known for modifying both IgE and IgG4. Peanut oral immunotherapy may influence these serological parameters.
Exploratory analyses of serological data from participants receiving peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) and placebo in the double-blind, randomized, phase 3 PALISADE trial were conducted to evaluate potential relationships between peanut-specific and peanut component-specific (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, and Ara h 9) IgE and IgG4 levels and clinical outcomes.
A total of 269 participants (PTAH, n = 202; placebo, n = 67) were analyzed. No relationship was observed between specific IgE and IgG4 levels at screening and maximum tolerated peanut protein dose during screening or response status during exit double-blind placebo-controlled food challenge (DBPCFC). In PTAH-treated participants, no relationship was observed between IgE and IgG4 levels at screening and maximum symptom severity during exit DBPCFC. Postscreening ratios (ie, postscreening/screening) in the PTAH group were significant at the end of updosing and exit visit for most components. Postscreening changes in specific IgE levels were more pronounced with PTAH versus placebo for most components.
Specific IgE and IgG4 levels at screening are not correlated with screening or exit DBPCFC results, and are not predictive of clinical response to PTAH. Peanut (Arachis hypogaea) allergen powder-dnfp contains the relevant and immunodominant allergens, inducing immunological changes with the treatment.
ClinicalTrials.gov identifier: NCT02635776.
针对花生及其成分的免疫球蛋白E（IgE）和免疫球蛋白G4（IgG4）可能会影响对花生的临床反应性。变应原特异性免疫疗法以改变IgE和IgG4而闻名。花生口服免疫疗法可能会影响这些血清学参数。
对双盲、随机、3期PALISADE试验中接受花生（落花生）变应原粉末-dnfp（PTAH）和安慰剂的参与者的血清学数据进行探索性分析，以评估花生特异性和花生成分特异性（Ara h 1、Ara h 2、Ara h 3、Ara h 6、Ara h 8和Ara h 9）IgE和IgG4水平与临床结局之间的潜在关系。
共分析了269名参与者（PTAH组，n = 202；安慰剂组，n = 67）。在筛查时的特异性IgE和IgG4水平与筛查期间的最大耐受花生蛋白剂量或退出双盲安慰剂对照食物激发试验（DBPCFC）期间的反应状态之间未观察到相关性。在接受PTAH治疗的参与者中，筛查时的IgE和IgG4水平与退出DBPCFC期间的最大症状严重程度之间未观察到相关性。在加量期结束和退出访视时，PTAH组中大多数成分的筛查后比率（即筛查后/筛查时）具有显著性。对于大多数成分，与安慰剂相比，PTAH组中特异性IgE水平的筛查后变化更为明显。
筛查时的特异性IgE和IgG4水平与筛查或退出DBPCFC结果无关，也不能预测对PTAH的临床反应。花生（落花生）变应原粉末-dnfp包含相关的和免疫显性变应原，治疗可诱导免疫变化。
ClinicalTrials.gov标识符：NCT02635776。
