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度普利尤单抗治疗慢性鼻-鼻窦炎伴鼻息肉:真实世界回顾性 12 个月有效性数据。

Dupilumab for chronic rhinosinusitis with nasal polyps: real-life retrospective 12-month effectiveness data.

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, Carl-von-Ossietzky University of Oldenburg, Oldenburg, Germany; Department of Otorhinolaryngology, Head and Neck Surgery, University of Lubeck, Lubeck, Germany.

Department of Otorhinolaryngology, Head and Neck Surgery, University of Lubeck, Lubeck, Germany.

出版信息

Rhinology. 2023 Jun 1;61(3):203-213. doi: 10.4193/Rhin22.469.

DOI:10.4193/Rhin22.469
PMID:36946589
Abstract

BACKGROUND

Dupilumab, an IL-4/13 receptor inhibitor, is approved for the treatment of uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP).

METHODOLOGY

We evaluated the effectiveness and safety of dupilumab for CRSwNP based on retrospective 12-month follow-up data of 41 patients. We analysed nasal endoscopy scores, patient-reported outcome measures (PROMs), 12-item SniffinSticks odor identification test (SSIT-12), total serum IgE, serum Eosinophilic Cationic Protein (ECP), and total blood eosinophil count (BEC). We performed statistical analysis using non-parametric ANOVA-type models and Spearman's correlation.

RESULTS

At month 1, endoscopy scores, PROMs and SSIT-12 showed meaningful improvements that were maintained until month 12. Initial elevations in both median ECP and BECs returned to near baseline levels by month 12. The percentage of patients withBEC ≤ 0.6 remained increased at month 12 (42.1%) compared to baseline (19.5%). Total serum IgE levels decreased progressively and correlated with nasal polyp scores at month 12. "Adequate response" was reached in 86.8% of our cohort.

CONCLUSIONS

Our data suggest that dupilumab is effective for the treatment of CRSwNP. The potential for short- and long-term BEC elevations in some CRSwNP patients should be carefully monitored.

摘要

背景

白细胞介素 4/13 受体抑制剂度普利尤单抗获批用于治疗未控制的慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)。

方法

我们基于 41 例患者的 12 个月回顾性随访数据评估了度普利尤单抗治疗 CRSwNP 的有效性和安全性。我们分析了鼻内镜评分、患者报告的结局测量(PROMs)、12 项鼻闻测试(SSIT-12)、总血清 IgE、血清嗜酸性粒细胞阳离子蛋白(ECP)和总血嗜酸性粒细胞计数(BEC)。我们使用非参数 ANOVA 型模型和 Spearman 相关性进行了统计分析。

结果

在第 1 个月,内镜评分、PROMs 和 SSIT-12 均显示出有意义的改善,且这些改善一直持续到第 12 个月。初始 ECP 和 BEC 的中位数升高在第 12 个月时恢复到接近基线水平。第 12 个月时,BEC≤0.6 的患者比例(42.1%)仍高于基线时(19.5%)。总血清 IgE 水平逐渐下降,与第 12 个月时的鼻息肉评分相关。我们队列中的 86.8%达到了“充分应答”。

结论

我们的数据表明,度普利尤单抗对 CRSwNP 的治疗有效。在一些 CRSwNP 患者中,BEC 短时间和长时间升高的可能性应仔细监测。

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