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Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study
European Respiratory Journal ( IF 16.6 ) Pub Date : 2022-12-22 , DOI: 10.1183/13993003.03226-2021
Andrew Menzies-Gow 1 , Mark Gurnell 2 , Liam G Heaney 3 , Jonathan Corren 4 , Elisabeth H Bel 5 , Jorge Maspero 6 , Timothy Harrison 7, 8 , David J Jackson 9, 10 , David Price 11, 12 , Njira Lugogo 13 , James Kreindler 14 , Annie Burden 15 , Alex de Giorgio-Miller 16 , Sarai Faison 17 , Kelly Padilla 17 , Ubaldo J Martin 18 , Esther Garcia Gil 19 ,
Affiliation  

Background

Oral corticosteroid (OCS) dependence among patients with severe eosinophilic asthma can cause adverse outcomes, including adrenal insufficiency. PONENTE's OCS reduction phase showed that, following benralizumab initiation, 91.5% of patients eliminated corticosteroids or achieved a final dosage ≤5 mg·day–1 (median (range) 0.0 (0.0–40.0) mg).

Methods

The maintenance phase assessed the durability of corticosteroid reduction and further adrenal function recovery. For ~6 months, patients continued benralizumab 30 mg every 8 weeks without corticosteroids or with the final dosage achieved during the reduction phase. Investigators could prescribe corticosteroids for asthma exacerbations or increase daily dosages for asthma control deteriorations. Outcomes included changes in daily OCS dosage, Asthma Control Questionnaire (ACQ)-6 and St George's Respiratory Questionnaire (SGRQ), as well as adrenal status, asthma exacerbations and adverse events.

Results

598 patients entered PONENTE; 563 (94.1%) completed the reduction phase and entered the maintenance phase. From the end of reduction to the end of maintenance, the median (range) OCS dosage was unchanged (0.0 (0.0–40.0) mg), 3.2% (n=18/563) of patients experienced daily dosage increases, the mean ACQ-6 score decreased from 1.26 to 1.18 and 84.5% (n=476/563) of patients were exacerbation free. The mean SGRQ improvement (–19.65 points) from baseline to the end of maintenance indicated substantial quality-of-life improvements. Of patients entering the maintenance phase with adrenal insufficiency, 32.4% (n=104/321) demonstrated an improvement in adrenal function. Adverse events were consistent with previous reports.

Conclusions

Most patients successfully maintained maximal OCS reduction while achieving improved asthma control with few exacerbations and maintaining or recovering adrenal function.



中文翻译:

PONENTE 研究中使用贝那利珠单抗进行持久口服皮质类固醇治疗后肾上腺功能恢复

背景

严重嗜酸性粒细胞性哮喘患者对口服皮质类固醇(OCS)的依赖可能导致不良后果,包括肾上腺功能不全。PONENTE 的 OCS 减量阶段显示,在贝那利珠单抗开始治疗后,91.5% 的患者消除了皮质类固醇或达到最终剂量≤5 mg·day –1(中位(范围)0.0 (0.0–40.0) mg)。

方法

维持阶段评估皮质类固醇减少的持久性和进一步肾上腺功能恢复。在约 6 个月的时间里,患者每 8 周继续服用贝那利珠单抗 30 mg,不使用皮质类固醇,或在减量阶段达到最终剂量。研究人员可以开皮质类固醇治疗哮喘恶化,或增加每日剂量以治疗哮喘控制恶化。结果包括每日 OCS 剂量、哮喘控制问卷 (ACQ)-6 和圣乔治呼吸问卷 (SGRQ) 的变化,以及肾上腺状态、哮喘恶化和不良事件。

结果

598名患者进入PONENTE;563(94.1%)完成削减阶段并进入维持阶段。从减量结束到维持结束,中位(范围)OCS剂量不变(0.0(0.0-40.0)mg),3.2%(n=18/563)的患者经历每日剂量增加,平均ACQ- 6 分从 1.26 下降至 1.18,84.5% (n=476/563) 的患者未出现病情加重。从基线到维护结束的平均 SGRQ 改善(–19.65 分)表明生活质量显着改善。在进入维持期的肾上腺功能不全患者中,32.4% (n=104/321) 的肾上腺功能有所改善。不良事件与之前的报告一致。

结论

大多数患者成功地维持了最大程度的 OCS 减少,同时实现了哮喘控制的改善,几乎没有恶化,并维持或恢复了肾上腺功能。

更新日期:2022-12-22
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