抗白介素-5/5Ra治疗嗜酸性粒细胞性哮喘中的累积糖皮质激素节约效应
2022/06/17
摘要
背景：既往研究结果显示，抗白介素-5/5Ra 治疗可减少严重嗜酸性粒细胞性哮喘患者口服糖皮质激素的维持剂量，但其对累积口服糖皮质激素暴露的影响以及提前口服糖皮质激素暴露如何影响机体对抗白细胞介-5/5Ra 治疗的反应，目前尚不明确。本文主要目的在于比较抗白介素-5/5Ra治疗开始前后 2 年累积口服糖皮质激素的暴露量，其次在于研究抗白介素 5/5Ra 治疗前口服糖皮质激素的时间和累积暴露量是否影响抗白介素-5/5Ra 治疗2 年内停用口服糖皮质激素。
方法：本研究为基于真实世界的全国观察性注册登记研究，评估了荷兰重症哮喘注册登记研究 (RAPSODI) 中纳入的 389 名罹患重症嗜酸性粒细胞性哮喘的成人在启用抗白介素-5/5Ra治疗 前后 2 年中所有分发的口服糖皮质激素。本研究采用Wilcoxon 符号秩检验和多变量回归分析。
结果：抗白介素-5/5Ra治疗前后 2 年的中位 (或四分位距) 累积口服糖皮质激素暴露量从 2.715 g (1.150-5.539) 降至 1.050 g (0.300-3.640)，p<0.001。 提前口服糖皮质激素暴露量减少和暴露时间缩短独立预测可得，52%的患者经过2年的抗白介素-5/5Ra治疗后可停用口服糖皮质激素。
结论：本真实世界研究表明，抗白介素-5/5Ra治疗可在2年内显著降低累积口服糖皮质激素暴露量。口服糖皮质激素暴露量较低和暴露时间较短的患者更有可能完全停用口服糖皮质激素。由于抗白介素-5/5Ra 治疗启用前累积口服糖皮质激素暴露量逐渐增加，本研究数据表明，早期干预可改善重症嗜酸性粒细胞性哮喘患者的长期预后。
Cumulative Corticosteroid Sparing Effect of Anti-Interleukin-5/5Ra In Eosinophilic Asthma.
Kroes JA, Zielhuis SW, De Jong K, Hashimoto S, Sont JK, Zielhuis SW, Van Roon EN, Bel EH, Ten Brinke A; RAPSODI team.
Abstract
BACKGROUND:Anti-interleukin-5/5Ra therapy has shown to reduce maintenance oral corticosteroid dose in severe eosinophilic asthma. However, the effect on cumulative oral corticosteroid exposure is currently unknown. Neither is it known how prior oral corticosteroid exposure affects response to anti-interleukin-5/5Ra treatment. We aimed primarily to compare the cumulative oral corticosteroid exposure over a 2-year period before and after anti-interleukin-5/5Ra initiation, and secondarily to investigate whether duration and cumulative oral corticosteroid exposure prior to anti-interleukin-5/5Ra influence the ability to discontinue oral corticosteroids within 2 years of anti-interleukin-5/5Ra therapy.
METHODS：This real-world nationwide observational registry-based study evaluated all dispensed oral corticosteroids from 389 adults with severe eosinophilic asthma included in the Dutch severe asthma registry (RAPSODI) 2 years before and 2 years after initiating anti- interleukin-5/5Ra. Wilcoxon-signed rank test and multivariable regression analyses were used.
RESULTS:Median (IQR) cumulative oral corticosteroid exposure in the 2 years before and after anti-interleukin-5/5Ra initiation decreased from 2.715 g (1.150-5.539) to 1.050 g (0.300-3.640), p<0.001. Fifty-two percent of patients were able to discontinue oral corticosteroids within 2 years anti-interleukin-5/5Ra therapy, which was independently predicted by lower and shorter prior oral corticosteroid exposure.
CONCLUSIONS:This real-world study showed that anti-interleukin-5/5Ra therapy leads to a significant reduction in cumulative oral corticosteroid exposure over a 2-year period. Patients with lower and shorter oral corticosteroids exposure were more likely to completely eliminate oral corticosteroids. Since cumulative exposure increased progressively prior to anti-interleukin-5/5Ra initiation, our data suggest that early intervention leads to a better long-term prognosis in patients with severe eosinophilic asthma.
背景：既往研究结果显示，抗白介素-5/5Ra 治疗可减少严重嗜酸性粒细胞性哮喘患者口服糖皮质激素的维持剂量，但其对累积口服糖皮质激素暴露的影响以及提前口服糖皮质激素暴露如何影响机体对抗白细胞介-5/5Ra 治疗的反应，目前尚不明确。本文主要目的在于比较抗白介素-5/5Ra治疗开始前后 2 年累积口服糖皮质激素的暴露量，其次在于研究抗白介素 5/5Ra 治疗前口服糖皮质激素的时间和累积暴露量是否影响抗白介素-5/5Ra 治疗2 年内停用口服糖皮质激素。
方法：本研究为基于真实世界的全国观察性注册登记研究，评估了荷兰重症哮喘注册登记研究 (RAPSODI) 中纳入的 389 名罹患重症嗜酸性粒细胞性哮喘的成人在启用抗白介素-5/5Ra治疗 前后 2 年中所有分发的口服糖皮质激素。本研究采用Wilcoxon 符号秩检验和多变量回归分析。
结果：抗白介素-5/5Ra治疗前后 2 年的中位 (或四分位距) 累积口服糖皮质激素暴露量从 2.715 g (1.150-5.539) 降至 1.050 g (0.300-3.640)，p<0.001。 提前口服糖皮质激素暴露量减少和暴露时间缩短独立预测可得，52%的患者经过2年的抗白介素-5/5Ra治疗后可停用口服糖皮质激素。
结论：本真实世界研究表明，抗白介素-5/5Ra治疗可在2年内显著降低累积口服糖皮质激素暴露量。口服糖皮质激素暴露量较低和暴露时间较短的患者更有可能完全停用口服糖皮质激素。由于抗白介素-5/5Ra 治疗启用前累积口服糖皮质激素暴露量逐渐增加，本研究数据表明，早期干预可改善重症嗜酸性粒细胞性哮喘患者的长期预后。
(中日友好医院呼吸与危重症医学科 张婧媛 摘译 林江涛 审校)
(Eur Respir J. 2022 May 20:2102983. doi: 10.1183/13993003.02983-2021.)
(Eur Respir J. 2022 May 20:2102983. doi: 10.1183/13993003.02983-2021.)
Cumulative Corticosteroid Sparing Effect of Anti-Interleukin-5/5Ra In Eosinophilic Asthma.
Kroes JA, Zielhuis SW, De Jong K, Hashimoto S, Sont JK, Zielhuis SW, Van Roon EN, Bel EH, Ten Brinke A; RAPSODI team.
Abstract
BACKGROUND:Anti-interleukin-5/5Ra therapy has shown to reduce maintenance oral corticosteroid dose in severe eosinophilic asthma. However, the effect on cumulative oral corticosteroid exposure is currently unknown. Neither is it known how prior oral corticosteroid exposure affects response to anti-interleukin-5/5Ra treatment. We aimed primarily to compare the cumulative oral corticosteroid exposure over a 2-year period before and after anti-interleukin-5/5Ra initiation, and secondarily to investigate whether duration and cumulative oral corticosteroid exposure prior to anti-interleukin-5/5Ra influence the ability to discontinue oral corticosteroids within 2 years of anti-interleukin-5/5Ra therapy.
METHODS：This real-world nationwide observational registry-based study evaluated all dispensed oral corticosteroids from 389 adults with severe eosinophilic asthma included in the Dutch severe asthma registry (RAPSODI) 2 years before and 2 years after initiating anti- interleukin-5/5Ra. Wilcoxon-signed rank test and multivariable regression analyses were used.
RESULTS:Median (IQR) cumulative oral corticosteroid exposure in the 2 years before and after anti-interleukin-5/5Ra initiation decreased from 2.715 g (1.150-5.539) to 1.050 g (0.300-3.640), p<0.001. Fifty-two percent of patients were able to discontinue oral corticosteroids within 2 years anti-interleukin-5/5Ra therapy, which was independently predicted by lower and shorter prior oral corticosteroid exposure.
CONCLUSIONS:This real-world study showed that anti-interleukin-5/5Ra therapy leads to a significant reduction in cumulative oral corticosteroid exposure over a 2-year period. Patients with lower and shorter oral corticosteroids exposure were more likely to completely eliminate oral corticosteroids. Since cumulative exposure increased progressively prior to anti-interleukin-5/5Ra initiation, our data suggest that early intervention leads to a better long-term prognosis in patients with severe eosinophilic asthma.
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