Mansur Adel H, Srivastava Sapna, Mitchell Verity, Sullivan Julie, Kasujee Ismail
Birmingham Regional Severe Asthma Service, Birmingham Heartlands Hospital, Birmingham B9 5SS, UK.
Birmingham Regional Severe Asthma Service, Birmingham Heartlands Hospital, Birmingham B9 5SS, UK.
Respir Med. 2017 Mar;124:36-43. doi: 10.1016/j.rmed.2017.01.008. Epub 2017 Jan 25.
Omalizumab has been shown to be an effective add-on therapy for patients with uncontrolled severe persistent allergic asthma. There has been a steady accumulation of evidence on the long-term effectiveness of omalizumab; however, data on real-life outcomes beyond one year of treatment is limited. In this study, we report on long-term outcomes of omalizumab treatment. We collected data from our severe asthma registry on hospitalisations, exacerbations, corticosteroid sparing, asthma control, lung function, biomarkers and side effects, to determine if the benefit was sustained and treatment was safe on the long term. Forty-five patients [mean age 44.9 years (range 19-69), females 37/45 (82%), mean duration of omalizumab treatment = 60.7 ± 30.9 months (range 23-121) were included in the analysis. We observed a reduction in the annual acute asthma related hospital admissions for the total population from 207 at baseline to 40 on treatment (80.7% reduction), whilst the per patient annual hospitalisations were reduced from a mean of 4.8 to 0.89 post-omalizumab treatment (p < 0.00001). There was a 76.7% reduction in daily mean maintenance OCS dose (prednisolone equivalent) from 25.8 mg (n = 43) to 6.0 mg (p < 0.0001), associated with clinically significant improvement in asthma control questionnaire (ACQ) from mean score of 4.1 (range 3.7-4.7) to 2.27 (range 0.5-4.1) p < 0.0001. The mean % predicted FEV has improved from 59.2% at baseline to 75.7% on treatment (p = 0.001). There was a statistically non-significant reduction in median peripheral blood eosinophils (PBE) from 300 cells/μl (range 40-1050) at baseline to 175 cells/μl (range 0-1500) post-treatment (p = 0.068), and statistically significant reduction of median fraction exhaled nitric oxide (FeNO) level from 37 parts per billion (range 12-178) to 24 ppb (range 7-50) (p = 0.0067). The work/school missed days were reduced in 17/19 patients who were at employment or school. The overall safety profile of the treatment seemed acceptable and was consistent with published experience. In conclusion, results from this real-life study demonstrate that improved outcomes in patients with severe allergic asthma are sustained with longer-term omalizumab therapy.
奥马珠单抗已被证明是一种有效的附加治疗方法，用于治疗未得到控制的重度持续性过敏性哮喘患者。关于奥马珠单抗长期疗效的证据一直在稳步积累；然而，关于治疗一年以上的实际疗效数据有限。在本研究中，我们报告了奥马珠单抗治疗的长期疗效。我们从严重哮喘登记处收集了有关住院、病情加重、皮质类固醇使用减少、哮喘控制、肺功能、生物标志物和副作用的数据，以确定其益处是否能持续以及长期治疗是否安全。45名患者（平均年龄44.9岁，范围19 - 69岁；女性37/45名，占82%；奥马珠单抗平均治疗时长 = 60.7 ± 30.9个月，范围23 - 121个月）纳入分析。我们观察到，总体人群中与急性哮喘相关的年度住院次数从基线时的207次降至治疗后的40次（减少了80.7%），而每位患者的年度住院次数从奥马珠单抗治疗前的平均4.8次降至0.89次（p < 0.00001）。每日平均维持性口服糖皮质激素（OCS）剂量（以泼尼松等效剂量计）从25.8毫克（n = 43）降至6.0毫克，减少了76.7%（p < 0.0001），同时哮喘控制问卷（ACQ）从平均得分4.1（范围3.7 - 4.7）改善至2.27（范围0.5 - 4.1），具有临床显著改善（p < 0.0001）。预计第一秒用力呼气容积（FEV）的平均百分比从基线时的59.2%提高到治疗后的75.7%（p = 0.001）。外周血嗜酸性粒细胞（PBE）中位数从基线时的300个细胞/微升（范围40 - 1050）降至治疗后的175个细胞/微升（范围0 - 1500），差异无统计学意义（p = 0.068），而呼出一氧化氮（FeNO）分数中位数从37十亿分之一（范围12 - 178）降至24十亿分之一（范围7 - 50），差异有统计学意义（p = 0.0067）。19名就业或上学的患者中有17名减少了缺勤/缺课天数。该治疗的总体安全性似乎可以接受，且与已发表的经验一致。总之，这项实际研究的结果表明，长期使用奥马珠单抗治疗可使重度过敏性哮喘患者持续获得更好的疗效。
