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首页> 外文期刊>Allergy >Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma.
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Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma.

机译：在严重变应性（IgE介导）哮喘中对奥马珠单抗治疗的反应持续存在。

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BACKGROUND: The physician's global evaluation of treatment effectiveness (GETE) at 16 weeks has been shown to be the most effective assessment of response to omalizumab (XOLAIR(R)). This randomized, open-label, parallel-group study evaluated the persistency of treatment responder classification in patients receiving omalizumab added to optimized asthma therapy (OAT). METHODS: Patients (12-75 years, n = 400) with severe allergic asthma, uncontrolled despite Global Initiative for Asthma 2004 Step 4 therapy, received OAT and omalizumab (n = 272) or OAT (n = 128) for 32 weeks. Response or nonresponse was evaluated at Weeks 16 and 32. Response was defined as an investigator's (physician's) GETE rating of excellent or good; nonresponse was defined as a rating of moderate, poor or worsening. RESULTS: Three hundred and forty-nine patients had GETE ratings available at Weeks 16 and 32 (omalizumab n = 258, OAT n = 91). Omalizumab responders of about 171/187 (91.4%)and 44/71 (62.0%) omalizumab nonresponders at Week 16 persisted as responders or nonresponders at Week 32. The investigator's GETE at Week 16 predicted persistency of response or nonresponse to omalizumab at Week 32 for 83.3% (215/258) of patients. OAT patients showed a lower persistency of response (18/28 [64.3%]) and a higher persistency of nonresponse (57/63 [90.5%]) than omalizumab patients. Excellent and good GETE ratings in omalizumab-treated patients were reflected by improvements in exacerbation rates (P < 0.001), severe exacerbation rates (P = 0.023), hospitalizations (P = 0.003), total emergency visits (P = 0.026) and Asthma Control Questionnaire overall score (P < 0.001). CONCLUSION: Response to omalizumab, as assessed by a physician's GETE at 16 weeks, is an effective predictor of continuing persistent response to omalizumab for the majority of patients.
机译：背景：已经证明，医师在16周时对治疗效果（GETE）的整体评估是对奥马珠单抗（XOLAIR（R））响应的最有效评估。这项随机，开放标签，平行分组的研究评估了接受奥马珠单抗联合优化哮喘治疗（OAT）的患者中治疗反应者分类的持久性。方法：患有严重过敏性哮喘的患者（12-75岁，n = 400），尽管进行了哮喘全球倡议2004步骤4治疗，仍未得到控制，接受了OAT和omalizumab（n = 272）或OAT（n = 128）治疗32周。在第16周和第32周评估反应或无反应。反应定义为研究者（医师）对GETE的评价为优秀或良好;无反应的定义为中度，较差或恶化。结果：349名患者在第16周和第32周获得了GETE评分（奥马珠单抗n = 258，OAT n = 91）。在第16周时，约171/187（91.4％）和44/71（62.0％）omalizumab无反应者的Omalizumab反应者持续作为反应者或无反应者。研究人员的GETE在第16周预测在第32周时反应或无反应的持续性对奥马珠单抗。占83.3％（215/258）的患者。与奥马珠单抗患者相比，OAT患者表现出较低的反应持久性（18/28 [64.3％]）和较高的无反应持久性（57/63 [90.5％]）。加用奥马珠单抗治疗的患者的GETE评分良好，其恶化率（P <0.001），严重加重率（P = 0.023），住院（P = 0.003），急诊就诊（P = 0.026）和哮喘控制得到改善问卷总体得分（P <0.001）。结论：由医生的GETE在16周时评估的对奥马珠单抗的反应是大多数患者对奥马珠单抗持续持续反应的有效预测指标。

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