嗜酸性粒细胞增多症和度普利尤单抗用于呼吸适应症的不良反应：真实世界的背景
2024/10/29
摘要
背景：度普利尤单抗在治疗哮喘和慢性鼻窦炎伴鼻息肉（CRSwNP）方面具有显著疗效。3期临床试验已证明一过性嗜酸性粒细胞增多症和罕见的嗜酸性粒细胞相关不良反应等。
目的：本研究旨在描述美国真实世界哮喘和CRSwNP患者中与度普利尤单抗相关的嗜酸性粒细胞增多症（杜普单抗开始使用后36周内嗜酸性粒细胞绝对计数[AEC]≥1.5x103/μL）和相关不良反应等。
方法：本研究对251名在单中心接受度普利尤单抗治疗的哮喘和/或CRSwNP患者进行回顾性分析。
结果：本研究共有142名患者在治疗前后检测AECs，其中16名（11.3%）患者在治疗后出现嗜酸性粒细胞增多，其中11名（7.7%）在开始使用度普利尤单抗后新出现嗜酸性粒细胞增多。13名治疗后新发嗜酸性粒细胞增多的患者继续应用度普利尤单抗，其中10名嗜酸性粒细胞增多消退。嗜酸性粒细胞相关不良反应罕见，嗜酸性肉芽肿性多血管炎（EGPA）病例仅见于1名嗜酸性粒细胞增多症患者和1名应用全身糖皮质激素且嗜酸性粒细胞正常的患者。其他不良反应包括关节痛（13/251，5.2%）、皮疹（8/251，3.2%）和结膜炎（7/251，2.8%）。度普利尤单抗在所有治疗前合并嗜酸性粒细胞增多症的和大多数治疗后出现嗜酸性粒细胞增多症的呼吸系统疾病患者中疗效显著。
结论：虽然度普利尤单抗相关嗜酸性粒细胞增多症在部分患者中可见，但持续性嗜酸性粒细胞增多症或嗜酸性粒淋巴细胞相关不良反应很罕见。此外，尽管出现嗜酸性粒细胞增多，但度普利尤单抗的治疗效果支持其继续应用于哮喘和CRSwNP。
Eosinophilia and Adverse Effects of Dupilumab for Respiratory Indications: A Real-World Setting.
Li SH, Nehme KF, Moshkovich A, Suh L, Pawlowski A, Ali Y, Patel GB, Kuang FL, Peters AT.
Abstract
BACKGROUND:Dupilumab has been used with significant benefit in the treatment of asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Phase 3 clinical trials have demonstrated transient eosinophilia and rare eosinophil-related and other adverse effects.
OBJECTIVES：To characterize dupilumab-associated eosinophilia (absolute eosinophil count [AEC] ≥ 1.5 x 103/μL within 36 weeks of dupilumab initiation) and adverse effects associated in real-world patients with asthma and CRSwNP in the United States.
METHODS:Retrospective chart review of 251 patients on dupilumab for asthma and/or CRSwNP seen at a single institution.
RESULTS:Among the 142 patients who had AECs checked before and after treatment, 16 (11.3%) patients had post-treatment eosinophilia, including 11 (7.7%) patients who had new eosinophilia upon dupilumab initiation. Thirteen patients with post-treatment eosinophilia remained on dupilumab, 10 of whom had resolution of eosinophilia. Eosinophil-related adverse effects were rare and cases of eosinophilic granulomatous polyangiitis (EGPA) were limited to 1 patient with eosinophilia and 1 patient with normal eosinophil levels on systemic steroids. Other adverse effects included arthralgias (13/251, 5.2%), rash (8/251, 3.2%), and conjunctivitis (7/251, 2.8%). All patients with pre-treatment eosinophilia and the majority of patients with post-treatment eosinophilia received significant treatment benefit for their respiratory disease with dupilumab.
CONCLUSION:While dupilumab-associated eosinophilia is seen in a subset of patients, persistent eosinophilia or eosinophil-related adverse effects are rare. Furthermore, treatment benefit on dupilumab despite eosinophilia supports its continued use in both asthma and CRSwNP.
背景：度普利尤单抗在治疗哮喘和慢性鼻窦炎伴鼻息肉（CRSwNP）方面具有显著疗效。3期临床试验已证明一过性嗜酸性粒细胞增多症和罕见的嗜酸性粒细胞相关不良反应等。
目的：本研究旨在描述美国真实世界哮喘和CRSwNP患者中与度普利尤单抗相关的嗜酸性粒细胞增多症（杜普单抗开始使用后36周内嗜酸性粒细胞绝对计数[AEC]≥1.5x103/μL）和相关不良反应等。
方法：本研究对251名在单中心接受度普利尤单抗治疗的哮喘和/或CRSwNP患者进行回顾性分析。
结果：本研究共有142名患者在治疗前后检测AECs，其中16名（11.3%）患者在治疗后出现嗜酸性粒细胞增多，其中11名（7.7%）在开始使用度普利尤单抗后新出现嗜酸性粒细胞增多。13名治疗后新发嗜酸性粒细胞增多的患者继续应用度普利尤单抗，其中10名嗜酸性粒细胞增多消退。嗜酸性粒细胞相关不良反应罕见，嗜酸性肉芽肿性多血管炎（EGPA）病例仅见于1名嗜酸性粒细胞增多症患者和1名应用全身糖皮质激素且嗜酸性粒细胞正常的患者。其他不良反应包括关节痛（13/251，5.2%）、皮疹（8/251，3.2%）和结膜炎（7/251，2.8%）。度普利尤单抗在所有治疗前合并嗜酸性粒细胞增多症的和大多数治疗后出现嗜酸性粒细胞增多症的呼吸系统疾病患者中疗效显著。
结论：虽然度普利尤单抗相关嗜酸性粒细胞增多症在部分患者中可见，但持续性嗜酸性粒细胞增多症或嗜酸性粒淋巴细胞相关不良反应很罕见。此外，尽管出现嗜酸性粒细胞增多，但度普利尤单抗的治疗效果支持其继续应用于哮喘和CRSwNP。
(中日友好医院呼吸与危重症医学科 张婧媛 摘译 林江涛 审校)
(J Allergy Clin Immunol Pract. 2024 Sep 23:S2213-2198(24)00939-5. doi: 10.1016/j.jaip.2024.09.013.)
(J Allergy Clin Immunol Pract. 2024 Sep 23:S2213-2198(24)00939-5. doi: 10.1016/j.jaip.2024.09.013.)
Eosinophilia and Adverse Effects of Dupilumab for Respiratory Indications: A Real-World Setting.
Li SH, Nehme KF, Moshkovich A, Suh L, Pawlowski A, Ali Y, Patel GB, Kuang FL, Peters AT.
Abstract
BACKGROUND:Dupilumab has been used with significant benefit in the treatment of asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Phase 3 clinical trials have demonstrated transient eosinophilia and rare eosinophil-related and other adverse effects.
OBJECTIVES：To characterize dupilumab-associated eosinophilia (absolute eosinophil count [AEC] ≥ 1.5 x 103/μL within 36 weeks of dupilumab initiation) and adverse effects associated in real-world patients with asthma and CRSwNP in the United States.
METHODS:Retrospective chart review of 251 patients on dupilumab for asthma and/or CRSwNP seen at a single institution.
RESULTS:Among the 142 patients who had AECs checked before and after treatment, 16 (11.3%) patients had post-treatment eosinophilia, including 11 (7.7%) patients who had new eosinophilia upon dupilumab initiation. Thirteen patients with post-treatment eosinophilia remained on dupilumab, 10 of whom had resolution of eosinophilia. Eosinophil-related adverse effects were rare and cases of eosinophilic granulomatous polyangiitis (EGPA) were limited to 1 patient with eosinophilia and 1 patient with normal eosinophil levels on systemic steroids. Other adverse effects included arthralgias (13/251, 5.2%), rash (8/251, 3.2%), and conjunctivitis (7/251, 2.8%). All patients with pre-treatment eosinophilia and the majority of patients with post-treatment eosinophilia received significant treatment benefit for their respiratory disease with dupilumab.
CONCLUSION:While dupilumab-associated eosinophilia is seen in a subset of patients, persistent eosinophilia or eosinophil-related adverse effects are rare. Furthermore, treatment benefit on dupilumab despite eosinophilia supports its continued use in both asthma and CRSwNP.
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