University of Florence, Florence, Italy.
San Raffaele Hospital, IRCCS, Vita-Salute San Raffaele University, Milan, Italy.
Arthritis Rheumatol. 2022 Feb;74(2):295-306. doi: 10.1002/art.41943. Epub 2021 Dec 30.
Mepolizumab proved to be an efficacious treatment for eosinophilic granulomatosis with polyangiitis (EGPA) at a dose of 300 mg every 4 weeks in the randomized, controlled MIRRA trial. In a few recently reported studies, successful real-life experiences with the approved dose for treating severe eosinophilic asthma (100 mg every 4 weeks) were observed. We undertook this study to assess the effectiveness and safety of mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks in a large European EGPA cohort.
We included all patients with EGPA treated with mepolizumab at the recruiting centers in 2015-2020. Treatment response was evaluated from 3 months to 24 months after initiation of mepolizumab. Complete response to treatment was defined as no disease activity (Birmingham Vasculitis Activity Score [BVAS] = 0) and a prednisolone or prednisone dose (or equivalent) of ≤4 mg/day. Respiratory outcomes included asthma and ear, nose, and throat (ENT) exacerbations.
Two hundred three patients, of whom 191 received a stable dose of mepolizumab (158 received 100 mg every 4 weeks and 33 received 300 mg every 4 weeks) were included. Twenty-five patients (12.3%) had a complete response to treatment at 3 months. Complete response rates increased to 30.4% and 35.7% at 12 months and 24 months, respectively, and rates were comparable between mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks. Mepolizumab led to a significant reduction in BVAS score, prednisone dose, and eosinophil counts from 3 months to 24 months, with no significant differences observed between 100 mg every 4 weeks and 300 mg every 4 weeks. Eighty-two patients (40.4%) experienced asthma exacerbations (57 of 158 [36%] who received 100 mg every 4 weeks; 17 of 33 [52%] who received 300 mg every 4 weeks), and 31 patients (15.3%) experienced ENT exacerbations. Forty-four patients (21.7%) experienced adverse events (AEs), most of which were nonserious AEs (38 of 44).
Mepolizumab at both 100 mg every 4 weeks and 300 mg every 4 weeks is effective for the treatment of EGPA. The 2 doses should be compared in the setting of a controlled trial.
在随机对照 MIRRA 试验中，美泊利珠单抗（mepolizumab）在治疗嗜酸性肉芽肿性多血管炎（EGPA）时，每 4 周 300mg 的剂量被证明是一种有效的治疗方法。在最近的几项研究报告中，观察到了批准剂量（每 4 周 100mg）治疗严重嗜酸性粒细胞性哮喘的成功真实世界经验。我们进行这项研究是为了评估美泊利珠单抗在一个大型欧洲 EGPA 队列中每 4 周 100mg 和每 4 周 300mg 的疗效和安全性。
我们纳入了 2015 年至 2020 年在招募中心接受美泊利珠单抗治疗的所有 EGPA 患者。在开始美泊利珠单抗治疗后 3 至 24 个月评估治疗反应。完全治疗反应定义为无疾病活动（Birmingham Vasculitis Activity Score [BVAS] = 0）和泼尼松龙或泼尼松剂量（或等效剂量）≤4mg/天。呼吸道结局包括哮喘和耳鼻喉（ENT）恶化。
共纳入 203 例患者，其中 191 例患者接受了稳定剂量的美泊利珠单抗（158 例患者接受每 4 周 100mg，33 例患者接受每 4 周 300mg）。25 例患者（12.3%）在 3 个月时达到完全治疗反应。在 12 个月和 24 个月时，完全反应率分别增加至 30.4%和 35.7%，并且两种剂量之间的反应率没有差异。美泊利珠单抗可显著降低 BVAS 评分、泼尼松剂量和嗜酸性粒细胞计数，从 3 个月到 24 个月，两种剂量之间没有显著差异。82 例患者（40.4%）发生哮喘恶化（57 例接受每 4 周 100mg [36%]；33 例接受每 4 周 300mg [52%]），31 例患者（15.3%）发生 ENT 恶化。44 例患者（21.7%）发生不良事件（AE），大多数为非严重 AE（44 例中的 38 例）。
每 4 周 100mg 和每 4 周 300mg 的美泊利珠单抗均能有效治疗 EGPA。两种剂量应在对照试验中进行比较。
