Gender differences in asthma perception and control have been reported. The PROXIMA observational study assessed these outcomes in a cohort of Italian severe allergic asthma (SAA) patients. This post hoc analysis of the PROXIMA results was aimed at assessing gender differences in SAA in a real-world setting, focusing on disease perception and impact on quality of life (QoL). The PROXIMA study was an observational, multicenter study, consisting of a cross-sectional and a prospective longitudinal phase, including adult outpatients diagnosed with SAA at step 4 requiring a therapeutic step-up. Patients on omalizumab treatment at baseline were included in the 12-month longitudinal phase. Disease control was assessed by the Asthma Control Questionnaire (ACQ) score, patients’ disease perception by the Brief Illness Perception Questionnaire (BIPQ), and QoL by the EuroQoL five-dimensional three-level questionnaire (EQ-5D-3 L) at baseline and after 6 and 12 months. Two regression models were used to evaluate the association between gender and BIPQ total score and EQ-5D-3L score, respectively. 357 patients (65% females) were analyzed for the cross-sectional phase and 99 (62.6% females) for the longitudinal phase. The prevalence of perennial and seasonal aeroallergens was similar between genders. ACQ score decreased similarly during omalizumab treatment at 6 and 12 months in both genders; no gender differences were observed in control rates. Asthma perception was worse among females at all study visits reaching statistical significance at 12 months (mean (SD) B-IPQ total score 41.8 (9.4) vs 35.6 (12.0); T test p-value (males vs females) < 0.05). Statistically significant gender differences were observed for some specific items, with males reporting less symptom experience, concern about the disease, and emotional impact at 12-months. The results of the multivariate regression model for repeated measures showed that overall treatment with omalizumab improved disease perception overtime regardless from gender. Males reported a significantly better QoL compared to females at both 6 and 12 months. In this real-world setting, females confirmed to have a worse perception of asthma, feel it as more symptomatic and suffer a greater impact on their QoL, even though having similar baseline severity and obtaining similar level of control.

中文翻译：

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哮喘感知的性别差异及其对生活质量的影响：PROXIMA（患者报告的结果和 Xolair® 哮喘管理）研究的事后分析

已经报道了哮喘感知和控制的性别差异。PROXIMA 观察性研究在一组意大利严重过敏性哮喘 (SAA) 患者中评估了这些结果。这项对 PROXIMA 结果的事后分析旨在评估现实环境中 SAA 的性别差异，重点关注疾病感知和对生活质量 (QoL) 的影响。PROXIMA 研究是一项观察性、多中心研究，包括横断面和前瞻性纵向阶段，包括在第 4 步诊断为 SAA 的成人门诊患者，需要进行治疗升级。基线时接受奥马珠单抗治疗的患者被纳入 12 个月的纵向阶段。通过哮喘控制问卷 (ACQ) 评分评估疾病控制，通过简要疾病感知问卷 (BIPQ) 评估患者的疾病感知，通过 EuroQoL 五维三级问卷 (EQ-5D-3 L) 在基线和 6 个月和 12 个月后的生活质量和生活质量。两个回归模型分别用于评估性别与 BIPQ 总分和 EQ-5D-3L 评分之间的关​​联。对 357 名患者（65% 女性）进行了横断面分析，99 名患者（62.6% 女性）进行了纵向分析。常年和季节性气源性过敏原的流行率在性别之间相似。在 6 个月和 12 个月的 omalizumab 治疗期间，两性的 ACQ 评分下降相似；在对照率中未观察到性别差异。在所有研究访问中，女性的哮喘感知更差，在 12 个月时达到统计学显着性（平均 (SD) B-IPQ 总分 41.8 (9.4) vs 35.6 (12.0)；T 检验 p 值（男性 vs 女性）<0.05）。在某些特定项目上观察到统计学上显着的性别差异，男性在 12 个月时报告的症状体验、对疾病的担忧和情绪影响较少。重复测量的多元回归模型的结果表明，无论性别如何，奥马珠单抗的整体治疗都能改善疾病感知。在 6 个月和 12 个月时，男性报告的生活质量明显优于女性。在这个现实世界的环境中，女性被证实对哮喘的感知更差，感觉它更有症状，并且对她们的生活质量的影响更大，即使具有相似的基线严重程度并获得相似的控制水平。重复测量的多元回归模型的结果表明，无论性别如何，奥马珠单抗的整体治疗都能改善疾病感知。在 6 个月和 12 个月时，男性报告的生活质量明显优于女性。在这个现实世界的环境中，女性被证实对哮喘的感知更差，感觉它更有症状，并且对她们的生活质量的影响更大，即使具有相似的基线严重程度并获得相似的控制水平。重复测量的多元回归模型的结果表明，无论性别如何，奥马珠单抗的整体治疗都能改善疾病感知。在 6 个月和 12 个月时，男性报告的生活质量明显优于女性。在这个现实世界的环境中，女性被证实对哮喘的感知更差，感觉它更有症状，并且对她们的生活质量的影响更大，即使具有相似的基线严重程度并获得相似的控制水平。