Division of Hematology, Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.
Université de Lille, CHU Lille, Institut d'Immunologie, Centre de Référence National des Syndromes Hyperéosinophiliques, Institute for Translational Research in Inflammation Infinite-U1286, Inserm, Lille, France.
Front Immunol. 2022 Aug 26;13:935996. doi: 10.3389/fimmu.2022.935996. eCollection 2022.
In patients with hypereosinophilic syndrome (HES), mepolizumab reduces the incidence of HES-related clinical signs and symptoms (flares). However, reports characterizing flare manifestations are limited. The double-blind, parallel-group 200622 trial (NCT02836496) enrolled patients ≥12 years old with HES for ≥6 months, ≥2 flares in the previous year, and screening blood eosinophil count ≥1000 cells/μL. Patients maintained ≥4 weeks stable HES therapy, before randomization (1:1) to 4-weekly subcutaneous mepolizumab (300 mg) or placebo, plus baseline HES therapy, for 32 weeks. This analysis investigated flare manifestations and duration by re-examining the Core Assessments form and narrative recorded for each flare during the study. Flare symptoms were retrospectively categorized into constitutional, dermatological, respiratory, nasal, gastrointestinal, neurologic and other. The most frequently reported flare symptoms were constitutional (94% of flares), dermatological (82% of flares) and respiratory (72% of flares); flares reported in patients receiving mepolizumab compared with placebo were generally similar in terms of the frequency of symptoms reported. Mepolizumab was associated with a shorter median (range) duration of flares (10.0 [4, 126] days) versus placebo (26.0 [1, 154] days). In patients with HES, flares were associated with symptoms linked to multiple organ systems highlighting the challenges faced for treating flares.
https://clinicaltrials.gov/ct2/show/NCT02836496, identifier NCT02836496.
在嗜酸性粒细胞增多综合征（HES）患者中，美泊利珠单抗可降低 HES 相关临床体征和症状（发作）的发生率。然而，有关发作表现的报告有限。这项双盲、平行分组的 200622 试验（NCT02836496）纳入了≥12 岁、嗜酸性粒细胞计数≥1000 个/μL、≥6 个月的 HES 患者，这些患者在过去 1 年中≥2 次发作且接受了≥4 周稳定的 HES 治疗，随后按 1:1 随机分配至每周皮下注射美泊利珠单抗（300mg）或安慰剂，同时接受基线 HES 治疗，共 32 周。本分析通过重新检查研究期间记录的每个发作的核心评估表和叙述，研究了发作表现和持续时间。回顾性将发作症状分为全身性、皮肤病学、呼吸、鼻、胃肠道、神经和其他。最常报告的发作症状是全身性（94%的发作）、皮肤病学（82%的发作）和呼吸（72%的发作）；与安慰剂相比，接受美泊利珠单抗治疗的患者报告的发作症状频率相似。与安慰剂相比，美泊利珠单抗与较短的中位（范围）发作持续时间（10.0[4，126]天）相关，而安慰剂为 26.0[1，154]天。在 HES 患者中，发作与涉及多个器官系统的症状相关，突出了治疗发作面临的挑战。
https://clinicaltrials.gov/ct2/show/NCT02836496，标识符 NCT02836496。
