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美泊利单抗和贝那利单抗用于治疗重度哮喘且有嗜酸性肉芽肿性多血管炎病史的患者。

Mepolizumab and benralizumab in patients with severe asthma and a history of eosinophilic granulomatosis with polyangiitis.

作者信息

Desaintjean Charlene, Ahmad Kaïs, Traclet Julie, Gerfaud-Valentin Mathieu, Durel Cecile-Audrey, Glerant Jean-Charles, Hot Arnaud, Lestelle François, Mainbourg Sabine, Nasser Mouhamad, Seve Pascal, Turquier Ségolène, Devouassoux Gilles, Cottin Vincent

机构信息

Department of Respiratory Medicine, National Reference Centre for Rare Pulmonary Diseases, Member of ERN-LUNG, Louis Pradel Hospital, Hospices Civils de Lyon, Lyon, France.

Department of Internal Medicine, Hôpital Saint-Joseph Saint-Luc, Lyon, France.

出版信息

Front Med (Lausanne). 2024 Mar 22;11:1341310. doi: 10.3389/fmed.2024.1341310. eCollection 2024.

Abstract

INTRODUCTION

Asthma associated with eosinophilic granulomatosis with polyangiitis (EGPA) is often severe and corticosteroid-dependent, leading to significant morbidity. Mepolizumab and benralizumab are humanized monoclonal antibodies targeting interleukin 5 (IL-5) and its receptor, respectively. They have been shown to be effective in steroid-sparing in patients with severe eosinophilic asthma.

OBJECTIVE

Our aim was to evaluate the efficacy and safety of mepolizumab and benralizumab prescribed for severe asthma in patients with EGPA under "real-world" conditions.

METHODS

This was a retrospective analysis of patients with EGPA and persistent asthma who received either mepolizumab 100 or 300 mg administered every 4 weeks, or benralizumab 30 mg administered every 4 weeks for the initial 3 injections and followed by an injection every 8 weeks thereafter, whilst combined with oral glucocorticoids. The follow-up every 6 ± 3 months included an assessment of clinical manifestations, pulmonary function tests and eosinophil cell count. The primary outcome was the proportion of patients at 12 months receiving a daily oral dose of prednisone or equivalent of 4 mg or less with a BVAS of 0.

RESULTS

Twenty-six patients were included. After 12 months of treatment with mepolizumab or benralizumab, 32% of patients met the primary outcome and were receiving less than 4 mg of prednisone per day with a BVAS of 0. The median dose of prednisone was 10 mg per day at baseline, 9 mg at 6 months, and 5 mg at 12 months ( ≤ 0.01). At 12 months, 23% of patients were weaned off corticosteroids, while an increase or no change in dose was observed in 27% of patients. The median eosinophil count was significantly reduced from 365 cells/mm to 55 cells/mm at 6 months and 70 cells/mm at 12 months, respectively. No significant change was observed in FEV1. After 12 months of treatment, 14% of patients had had an average of 1 exacerbation of asthma, compared with 52% of patients before baseline. The tolerability profile was favorable.

CONCLUSION

In this real-world study in patients with severe asthma and a history of EGPA asthma, mepolizumab and benralizumab had a significant steroid-sparing effect and reduced asthma exacerbation, but no significant effect on lung function.

摘要

引言

与嗜酸性肉芽肿性多血管炎(EGPA)相关的哮喘通常较为严重且依赖皮质类固醇,导致显著的发病率。美泊利珠单抗和贝那利珠单抗分别是靶向白细胞介素5(IL-5)及其受体的人源化单克隆抗体。它们已被证明在重度嗜酸性粒细胞性哮喘患者中具有减少类固醇使用的效果。

目的

我们的目的是评估在“真实世界”条件下,为患有EGPA的重度哮喘患者开具的美泊利珠单抗和贝那利珠单抗的疗效和安全性。

方法

这是一项对患有EGPA和持续性哮喘患者的回顾性分析,这些患者接受每4周一次的100或300mg美泊利珠单抗治疗,或每4周一次的30mg贝那利珠单抗治疗,最初3次注射后改为每8周一次,同时联合口服糖皮质激素。每6±3个月的随访包括对临床表现、肺功能测试和嗜酸性粒细胞计数的评估。主要结局是在12个月时每日口服泼尼松或等效剂量4mg或更低且疾病活动度评分(BVAS)为0的患者比例。

结果

纳入了26例患者。在用美泊利珠单抗或贝那利珠单抗治疗12个月后,32%的患者达到主要结局,每日接受少于4mg泼尼松且BVAS为0。泼尼松的中位剂量在基线时为每日10mg,6个月时为9mg,12个月时为5mg(P≤0.01)。在12个月时,23%的患者停用了皮质类固醇,而27%的患者剂量增加或无变化。嗜酸性粒细胞计数中位数在6个月时从365个细胞/mm显著降至55个细胞/mm,在12个月时降至70个细胞/mm。第一秒用力呼气容积(FEV1)未观察到显著变化。治疗12个月后,14%的患者平均哮喘发作1次,而基线前为52%。耐受性良好。

结论

在这项针对重度哮喘且有EGPA哮喘病史患者的真实世界研究中,美泊利珠单抗和贝那利珠单抗具有显著的减少类固醇使用效果并减少哮喘发作,但对肺功能无显著影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a447/10998444/6034211d2bda/fmed-11-1341310-g001.jpg

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