Respiratory Research Unit, Bispebjerg Hospital, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Respiratory Research Unit, Bispebjerg Hospital, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Respir Med. 2017 Oct;131:109-113. doi: 10.1016/j.rmed.2017.08.011. Epub 2017 Aug 12.
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.
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.
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).
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.
奥马珠单抗是一种人源化单克隆抗 IgE 抗体,广泛用于治疗严重未控制的哮喘患者。奥马珠单抗治疗已知可减少恶化次数和 GETE 评分(治疗效果全球评估)-但对于哪些患者受益最大知之甚少。此外,奥马珠单抗治疗的停药时间尚未得到研究。在这项针对丹麦人群的真实生活研究中,我们探讨了这些重要问题。
在一项回顾性真实生活研究中,纳入了在专门的门诊哮喘诊所接受奥马珠单抗治疗的 54 名患者。分析了 GETE 评分的变化、治疗停药时间和相关的危险因素。
由于奥马珠单抗治疗,大多数患者的 GETE 评分从差/恶化改善为优。女性接受治疗的中位数时间为 31 个月(95%CI:4.6-57.4),约 50%的患者在 500 天后停止治疗,而男性在 1500 天后停止治疗的比例约为 50%。治疗开始时嗜酸性粒细胞计数高于 300 个/μL 与奥马珠单抗停药呈正相关(HR 4.3,95%CI(1.22-15.28)p=0.023)。
总之,女性和嗜酸性粒细胞计数高于 300 个/μL 可能预示着治疗反应更好,导致治疗时间比目前指南建议的最长 48 个月更短。此外,奥马珠单抗可改善 GETE 评分。需要更多的真实生活研究来确定哪些患者将从治疗中获益最大。