Department of Neurology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
Department of Clinical Immunology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
Front Immunol. 2024 Oct 2;15:1457202. doi: 10.3389/fimmu.2024.1457202. eCollection 2024.
Mepolizumab (MPZ) has demonstrated efficacy in clinical trials for eosinophilic granulomatosis with polyangiitis (EGPA); however, few studies compare the disease course between patients treated with MPZ (MPZ group) and those who were not treated with MPZ (non-MPZ group) in real-world settings.
This study aimed to compare the disease course and outcomes between the two groups and assess the long-term efficacy of MPZ in a multicenter cohort in Japan. Methods: We enrolled 113 EGPA patients registered in the cohort until June 2023. Data on clinical characteristics, disease activity, organ damage, treatments, and outcomes were retrospectively collected. To minimize potential confounding factors, we conducted propensity score matching (PSM).
After PSM, 37 pairs of matched patients were identified. Clinical characteristics, including age at disease onset, sex, disease duration at last observation, antineutrophil cytoplasmic antibody positivity at disease onset, Birmingham Vasculitis Activity Score (BVAS) at disease onset, and Five-factor score at disease onset, were comparable between the groups. The median BVAS at the last observation was 0 in both groups; however, more cases in the non-MPZ group exhibited elevated BVAS, resulting in a significantly higher BVAS in the non-MPZ group at the last observation (median; MPZ group: 0, non-MPZ group: 0, p=0.028). The MPZ group had significantly lower glucocorticoid (GC) doses at the last observation (median; MPZ group: 4 mg/day, non-MPZ group: 5 mg/day, p=0.011), with a higher proportion achieving a GC dose ≤ 4 mg/day at the last observation (MPZ group: 51.4%, non-MPZ group: 24.2%, p=0.027). Three models of multivariable logistic regression analyses were performed to identify factors associated with GC doses ≤ 4 mg/day at the last observation. In all models, achieving a GC dose ≤ 4 mg/day was positively associated with MPZ administration and inversely associated with asthma at disease onset. Finally, we evaluated the survival rates between the groups, and the 5-year survival rates were significantly higher in the MPZ group compared to the non-MPZ group (MPZ group: 100%, non-MPZ group: 81.3%, p=0.012).
Mepolizumab not only contributes to disease activity control but also reduces the GC dose, which may lead to improved survival in EGPA patients.
美泊利珠单抗(MPZ)在嗜酸性肉芽肿性多血管炎(EGPA)的临床试验中显示出疗效;然而,在真实世界环境中,很少有研究比较接受 MPZ 治疗的患者(MPZ 组)和未接受 MPZ 治疗的患者(非 MPZ 组)之间的疾病过程。
本研究旨在比较两组之间的疾病过程和结局,并评估多中心日本队列中 MPZ 的长期疗效。方法:我们纳入了截至 2023 年 6 月在该队列中登记的 113 例 EGPA 患者。回顾性收集临床特征、疾病活动度、器官损害、治疗和结局数据。为了最小化潜在的混杂因素,我们进行了倾向评分匹配(PSM)。
PSM 后,确定了 37 对匹配的患者。两组之间的临床特征,包括疾病发病年龄、性别、最后观察时的疾病持续时间、疾病发病时抗中性粒细胞胞质抗体阳性、疾病发病时伯明翰血管炎活动评分(BVAS)和疾病发病时五因子评分,均无差异。两组的最后观察时的中位 BVAS 均为 0;然而,非 MPZ 组更多的病例出现 BVAS 升高,导致非 MPZ 组的最后观察时的 BVAS 显著更高(中位数;MPZ 组:0,非 MPZ 组:0,p=0.028)。MPZ 组的最后观察时的糖皮质激素(GC)剂量显著较低(中位数;MPZ 组:4mg/天,非 MPZ 组:5mg/天,p=0.011),并且在最后观察时达到 GC 剂量≤4mg/天的比例更高(MPZ 组:51.4%,非 MPZ 组:24.2%,p=0.027)。进行了三种多变量逻辑回归分析模型,以确定与最后观察时 GC 剂量≤4mg/天相关的因素。在所有模型中,达到 GC 剂量≤4mg/天与 MPZ 给药呈正相关,与疾病发病时的哮喘呈负相关。最后,我们评估了两组之间的生存率,MPZ 组的 5 年生存率显著高于非 MPZ 组(MPZ 组:100%,非 MPZ 组:81.3%,p=0.012)。
美泊利珠单抗不仅有助于控制疾病活动度,还可减少 GC 剂量,从而可能改善 EGPA 患者的生存。