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生物疗法在重度哮喘中的真实世界比较疗效:欧盟优势研究。

Real-world comparative effectiveness of biologic therapies in severe asthma: EU-ADVANTAGE.

作者信息

Canonica Giorgio Walter, Virchow Johann Christian, Bourdin Arnaud, Jacob-Nara Juby, Borsos Kinga, Stanford Richard H, Wang Zhixiao, Soliman Mena, Huynh Lynn, Haque Fariha, Duh Mei Sheng, Cheng Wei-Han

机构信息

Personalized Medicine, Asthma and Allergy, Humanitas University and Research Hospital IRCCS, Milan, Italy.

Departments of Pneumology/Intensive Care Medicine, Universitätsmedizin Rostock, Rostock, Germany.

出版信息

ERJ Open Res. 2025 Aug 4;11(4). doi: 10.1183/23120541.01217-2024. eCollection 2025 Jul.

Abstract

BACKGROUND

In Europe, although multiple biologics have been approved for the treatment of severe asthma (SA), comparative data from real-world settings remain limited. This study compared the real-world effectiveness of dupilumab with that of omalizumab, benralizumab and mepolizumab in European patients with SA.

METHODS

In the EU-ADVANTAGE study, physicians from France, Italy, Germany, Spain and the Netherlands were recruited to review medical charts of patients (aged ≥12 years) who had physician-confirmed SA and initiated dupilumab, omalizumab, benralizumab or mepolizumab (index) between May 2019 and February 2022. Patients with ≥12 months of pre- and post-index records were included. Differences in baseline covariates were balanced with inverse probability of treatment weighting (IPTW) between dupilumab and other biologics. Reductions in SA exacerbations and oral corticosteroid (OCS) prescriptions during the 12-month post-index period were estimated using a doubly robust regression.

RESULTS

A total of 2739 patients met all study criteria; 1281, 638, 406 and 414 received dupilumab, omalizumab, benralizumab and mepolizumab, respectively. After IPTW, the majority of baseline covariates were balanced (standardised difference <10%) between dupilumab and other biologics in a pairwise manner. After regression, dupilumab was associated with a lower risk of SA exacerbations during the 12-month post-index period, as follows: 22% omalizumab, 35% benralizumab and 23% mepolizumab. Additionally, dupilumab significantly reduced OCS prescriptions by 25% omalizumab, 27% benralizumab and 21% mepolizumab.

CONCLUSIONS

The findings suggest that dupilumab may reduce severe exacerbations and OCS use in patients with SA better than omalizumab, benralizumab and mepolizumab in European real-world settings.

摘要

背景

在欧洲,尽管多种生物制剂已被批准用于治疗重度哮喘(SA),但来自真实世界的数据仍然有限。本研究比较了度普利尤单抗与奥马珠单抗、贝那利珠单抗和美泊利珠单抗在欧洲SA患者中的真实世界疗效。

方法

在欧盟优势研究中,招募了来自法国、意大利、德国、西班牙和荷兰的医生,以回顾2019年5月至2022年2月期间确诊为SA并开始使用度普利尤单抗、奥马珠单抗、贝那利珠单抗或美泊利珠单抗(索引药物)的患者(年龄≥12岁)的病历。纳入索引药物治疗前后记录均≥12个月的患者。使用治疗权重逆概率(IPTW)平衡度普利尤单抗与其他生物制剂之间基线协变量的差异。使用双重稳健回归估计索引药物治疗后12个月内SA加重次数和口服糖皮质激素(OCS)处方的减少情况。

结果

共有2739例患者符合所有研究标准;分别有1281例、638例、406例和414例接受了度普利尤单抗、奥马珠单抗、贝那利珠单抗和美泊利珠单抗治疗。经过IPTW后,度普利尤单抗与其他生物制剂之间的大多数基线协变量在两两比较中达到平衡(标准化差异<10%)。回归分析后,度普利尤单抗与索引药物治疗后12个月内SA加重风险较低相关,具体如下:奥马珠单抗降低22%,贝那利珠单抗降低35%,美泊利珠单抗降低23%。此外,度普利尤单抗显著减少OCS处方量,奥马珠单抗减少25%,贝那利珠单抗减少27%,美泊利珠单抗减少21%。

结论

研究结果表明,在欧洲真实世界环境中,度普利尤单抗在减少SA患者严重加重次数和OCS使用方面可能优于奥马珠单抗、贝那利珠单抗和美泊利珠单抗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6304/12320101/451570e41ad2/01217-2024.01.jpg

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