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重度哮喘患者从其他生物制剂转换为度普利尤单抗且无治疗间隔:一项多中心回顾性研究

Switching to Dupilumab from Other Biologics without a Treatment Interval in Patients with Severe Asthma: A Multi-Center Retrospective Study.

作者信息

Higo Hisao, Ichikawa Hirohisa, Arakawa Yukako, Mori Yoshihiro, Itano Junko, Taniguchi Akihiko, Senoo Satoru, Kimura Goro, Tanimoto Yasushi, Miyake Kohei, Katsuta Tomoya, Kataoka Mikio, Maeda Yoshinobu, Kiura Katsuyuki, Miyahara Nobuaki

机构信息

Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama 700-8558, Japan.

Department of Hematology, Oncology, and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama 700-8558, Japan.

出版信息

J Clin Med. 2023 Aug 9;12(16):5174. doi: 10.3390/jcm12165174.

Abstract

BACKGROUND

Dupilumab is a fully humanized monoclonal antibody that blocks interleukin-4 and interleukin-13 signals. Several large clinical trials have demonstrated the efficacy of dupilumab in patients with severe asthma. However, few studies have examined a switch to dupilumab from other biologics.

METHODS

This retrospective, multi-center observational study was conducted by the Okayama Respiratory Disease Study Group. Consecutive patients with severe asthma who were switched to dupilumab from other biologics without a treatment interval between May 2019 and September 2021 were enrolled. Patients with a treatment interval of more than twice the standard dosing interval for the previous biologic prior to dupilumab administration were excluded.

RESULTS

The median patient age of the 27 patients enrolled in this study was 57 years (IQR, 45-68 years). Eosinophilic chronic rhinosinusitis (ECRS)/chronic rhinosinusitis with nasal polyp (CRSwNP) was confirmed in 23 patients. Previous biologics consisted of omalizumab (n = 3), mepolizumab (n = 3), and benralizumab (n = 21). Dupilumab significantly improved FEV (median improvement: +145 mL) and the asthma control test score (median improvement: +2). The overall response rate in patients receiving dupilumab for asthma as determined using the Global Evaluations of Treatment Effectiveness (GETE) was 77.8%. There were no significant differences in the baseline characteristics of the GETE-improved group vs. the non-GETE-improved group. ECRS/CRSwNP improved in 20 of the 23 patients (87.0%). Overall, 8 of the 27 patients (29.6%) developed transient hypereosinophilia (>1500/μL), but all were asymptomatic and able to continue dupilumab therapy.

CONCLUSIONS

Dupilumab was highly effective for the treatment of severe asthma and ECRS/CRSwNP, even in patients switched from other biologics without a treatment interval.

摘要

背景

度普利尤单抗是一种全人源单克隆抗体,可阻断白细胞介素-4和白细胞介素-13信号。多项大型临床试验已证明度普利尤单抗对重度哮喘患者有效。然而,很少有研究探讨从其他生物制剂转换为度普利尤单抗的情况。

方法

本回顾性、多中心观察性研究由冈山呼吸系统疾病研究组开展。纳入2019年5月至2021年9月期间从其他生物制剂转换为度普利尤单抗且无治疗间隔的连续性重度哮喘患者。排除在度普利尤单抗给药前治疗间隔超过前一种生物制剂标准给药间隔两倍的患者。

结果

本研究纳入的27例患者的中位年龄为57岁(四分位间距,45 - 68岁)。23例患者确诊为嗜酸性粒细胞性慢性鼻-鼻窦炎(ECRS)/伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)。既往使用的生物制剂包括奥马珠单抗(n = 3)、美泊利单抗(n = 3)和贝那利珠单抗(n = 21)。度普利尤单抗显著改善了第1秒用力呼气容积(FEV,中位改善:+145 ml)和哮喘控制测试评分(中位改善:+2)。使用治疗效果全球评估(GETE)确定的接受度普利尤单抗治疗哮喘患者的总体缓解率为77.8%。GETE改善组与未改善组的基线特征无显著差异。23例患者中有20例(87.0%)的ECRS/CRSwNP得到改善。总体而言,27例患者中有8例(29.6%)出现短暂性嗜酸性粒细胞增多(>1500/μL),但均无症状且能够继续度普利尤单抗治疗。

结论

度普利尤单抗对重度哮喘和ECRS/CRSwNP的治疗非常有效,即使是在无治疗间隔从其他生物制剂转换而来的患者中也是如此。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2956/10455072/a04b62f8fdc2/jcm-12-05174-g001.jpg

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