严重过敏性哮喘患者应用奥马珠单抗后的现实研究
2017/11/20
摘要
引言：奥马珠单抗是一种人重组单克隆抗IgE抗体，广泛用于不受控制的严重哮喘患者。 已知奥马珠单抗治疗会减少恶化次数及降低GETE评分（治疗有效性的全球评估） - 但关于哪类患者受益最大知之甚少。 而且，中止使用奥马珠单抗治疗的时间还有待研究。我们在关于丹麦人的现实生活研究中探讨了这些重要的问题。
方法：在此回顾性研究中，包括54名在专科哮喘门诊接受奥马珠单抗治疗的患者。 对GETE评分的改变，停止治疗的时间及相关危险因素进行了分析。
结果：由于奥马珠的使用，大多数患者的GETE评分从差/恶化到优良。 女性的中位治疗时间为31个月（95％CI：4.6-57.4），大约50％的患者在500天后停止治疗。50%的男性在1500天后停止治疗。治疗前大于300/μL的嗜酸性粒细胞计数与奥马珠单抗的治疗中止时间呈正相关（HR 4.3 95％CI（1.22-15.28）p = 0.023）。
结论：总之，女性患者及嗜酸性粒细胞计数高于300个细胞/μL可能预示对奥马珠治疗反应更佳，因此治疗时间比目前指南推荐的最长48个月要更短。 此外，由于奥马珠的应用GETE评分也同时改善。需要更多的现实生活研究来确定哪些患者从治疗中获益最多。
Response to omalizumab in patients with severe allergic asthma: A real-life study
Louise Zierau, Emil Schwarz Walsted
Abstract
Introduction:Omalizumab is a humanized monoclonal anti-IgE antibody, which is widely used for patients with severe uncontrolled asthma. Treatment with omalizumab is known to decrease the number of exacerbations and GETE score (Global Evaluation of Treatment Effectiveness) - but little is known about which patients benefit the most. Moreover, the time to discontinuation of the treatment with omalizumab has yet to be investigated. In this real-life study on a Danish population we explore these important issues.
Method：In a retrospective real-life study, 54 patients treated with omalizumab at a specialized outpatient asthma clinic were included. Change in GETE score, time to discontinuation of treatment and associated risk factors were analysed.
Results：As a result of omalizumab treatment, most patients improved in GETE score from poor/worsening to excellent. Women were treated for a median time of 31 months (95% CI: 4.6–57.4) and approximately 50% of patients discontinued treatment after 500 days whilst, for men, 50% discontinued treatment after 1500 days. Eosinophil count above 300 cells/μL at treatment initiation was positively related to the discontinuation of omalizumab (HR 4.3 95%CI (1.22–15.28) p = 0.023).
Conclusion：In conclusion, female gender and an eosinophil count above 300 cells/μL may predict a better treatment response, leading to a shorter treatment time than the current guideline recommendation of maximum 48 months. Additionally, the GETE score improves with omalizumab. More real-life studies are needed to determine which patients will benefit the most from the treatment.
引言：奥马珠单抗是一种人重组单克隆抗IgE抗体，广泛用于不受控制的严重哮喘患者。 已知奥马珠单抗治疗会减少恶化次数及降低GETE评分（治疗有效性的全球评估） - 但关于哪类患者受益最大知之甚少。 而且，中止使用奥马珠单抗治疗的时间还有待研究。我们在关于丹麦人的现实生活研究中探讨了这些重要的问题。
方法：在此回顾性研究中，包括54名在专科哮喘门诊接受奥马珠单抗治疗的患者。 对GETE评分的改变，停止治疗的时间及相关危险因素进行了分析。
结果：由于奥马珠的使用，大多数患者的GETE评分从差/恶化到优良。 女性的中位治疗时间为31个月（95％CI：4.6-57.4），大约50％的患者在500天后停止治疗。50%的男性在1500天后停止治疗。治疗前大于300/μL的嗜酸性粒细胞计数与奥马珠单抗的治疗中止时间呈正相关（HR 4.3 95％CI（1.22-15.28）p = 0.023）。
结论：总之，女性患者及嗜酸性粒细胞计数高于300个细胞/μL可能预示对奥马珠治疗反应更佳，因此治疗时间比目前指南推荐的最长48个月要更短。 此外，由于奥马珠的应用GETE评分也同时改善。需要更多的现实生活研究来确定哪些患者从治疗中获益最多。
（中日友好医院呼吸与危重症医学科 张鑫 摘译 林江涛 审校）
（Respiratory Medicine 131 (2017) 109-113）
（Respiratory Medicine 131 (2017) 109-113）
Response to omalizumab in patients with severe allergic asthma: A real-life study
Louise Zierau, Emil Schwarz Walsted
Abstract
Introduction:Omalizumab is a humanized monoclonal anti-IgE antibody, which is widely used for patients with severe uncontrolled asthma. Treatment with omalizumab is known to decrease the number of exacerbations and GETE score (Global Evaluation of Treatment Effectiveness) - but little is known about which patients benefit the most. Moreover, the time to discontinuation of the treatment with omalizumab has yet to be investigated. In this real-life study on a Danish population we explore these important issues.
Method：In a retrospective real-life study, 54 patients treated with omalizumab at a specialized outpatient asthma clinic were included. Change in GETE score, time to discontinuation of treatment and associated risk factors were analysed.
Results：As a result of omalizumab treatment, most patients improved in GETE score from poor/worsening to excellent. Women were treated for a median time of 31 months (95% CI: 4.6–57.4) and approximately 50% of patients discontinued treatment after 500 days whilst, for men, 50% discontinued treatment after 1500 days. Eosinophil count above 300 cells/μL at treatment initiation was positively related to the discontinuation of omalizumab (HR 4.3 95%CI (1.22–15.28) p = 0.023).
Conclusion：In conclusion, female gender and an eosinophil count above 300 cells/μL may predict a better treatment response, leading to a shorter treatment time than the current guideline recommendation of maximum 48 months. Additionally, the GETE score improves with omalizumab. More real-life studies are needed to determine which patients will benefit the most from the treatment.
上一篇：
难治性/重症哮喘患者未来5年严重急性发作风险的不同轨迹
下一篇：
COPD住院患者的气流阻塞情况
