一种新型多模块方法对奥马珠单抗治疗反应的真实世界长期评估：奥马珠单抗治疗的真实效果研究（REALITY 研究）。
Long-term evaluation of response to omalizumab therapy in real life by a novel multimodular approach: The Real-life Effectiveness of Omalizumab Therapy (REALITY) study.
机构信息
Allergy and Asthma Research Center, San Antonio, Texas; Department of Medicine-Pulmonary Division, University of Texas Health at San Antonio, San Antonio, Texas.
Department of Medicine-Pulmonary Division, University of Texas Health at San Antonio, San Antonio, Texas.
出版信息
Ann Allergy Asthma Immunol. 2019 Nov;123(5):476-482.e1. doi: 10.1016/j.anai.2019.07.026. Epub 2019 Aug 2.
BACKGROUND
The evidence on long-term real-life response measures to omalizumab therapy in moderate to severe asthma is limited. A universal assessment tool is needed to adequately evaluate response to omalizumab in these patients.
OBJECTIVE
To design a multimodular response assessment tool and use it to measure and define response to omalizumab therapy in real-world settings.
METHODS
The Real-life Effectiveness of Omalizumab Therapy (REALITY) study is a retrospective, long-term, real-life clinical study that evaluates response in individuals with allergic asthma who received omalizumab between 2004 and 2011. The Standardized Measure to Assess Response to Therapy (SMART) tool was designed to define response (1 year before to after treatment) by 3 modules: (1) physician's subjective assessment of asthma symptoms and control; (2) objective assessment of 6 parameters: improvement by 50% or more for asthma exacerbation, steroid bursts, emergency department visits, and hospitalizations; increase in forced expiratory volume in 1 second of 200 mL or greater; and improved Asthma Control Test score of 3 or higher; -and (3) true responders (patient meeting both module 1 and 2 criteria). Response was assessed and compared for 3 modules at desired time points.
RESULTS
A total of 198 patients (mean age, 31.7 years [range, 3-77 years]; 98 [49%] female; mean omalizumab therapy duration, 2.49 years [range, 3 months to 8 years]; mean omalizumab dosage, 473 mg every 4 weeks; median baseline IgE level, 433 IU/mL) were included in this analysis. Overall visit adherence was 78%, although the adherence rate decreased annually by 20%. Response rates assessed by SMART modules were 61.3%, 60.8%, and 41.8% at 16 weeks, 84.8%, 72.2%, and 64.6% at 1 year, 82.4%, 71.2%, and 63.2% at 2 years, and 95.1%, 87.8%, and 85.4% at 5 years for modules 1, 2, and 3, respectively. There were no significant adverse reactions.
CONCLUSION
The REALITY study has demonstrated long-term effectiveness of omalizumab therapy in individuals with allergic asthma in real-life settings. The SMART tool is promising as a potential standard assessment tool to measure and define response to asthma therapy.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01776177.
背景
奥马珠单抗治疗中度至重度哮喘的长期真实生活应答措施的证据有限。需要一种通用的评估工具来充分评估这些患者对奥马珠单抗的应答。
目的
设计一种多模块应答评估工具，并用于测量和定义真实环境中奥马珠单抗治疗的应答。
方法
真实生活中奥马珠单抗治疗效果（REALITY）研究是一项回顾性、长期、真实生活的临床研究，评估了 2004 年至 2011 年间接受奥马珠单抗治疗的过敏性哮喘患者的应答。标准化治疗应答评估工具（SMART）旨在通过 3 个模块定义应答（治疗前 1 年至治疗后 1 年）：（1）医生对哮喘症状和控制的主观评估；（2）6 个参数的客观评估：哮喘恶化、皮质类固醇冲击治疗、急诊就诊和住院的 50%或更多改善；用力呼气量增加 200 mL 或更多；和哮喘控制测试评分提高 3 分或更高；-和（3）真正的应答者（符合模块 1 和 2 标准的患者）。在所需的时间点评估和比较 3 个模块的应答。
结果
共有 198 例患者（平均年龄 31.7 岁[范围，3-77 岁]；98[49%]为女性；奥马珠单抗治疗时间的平均持续时间为 2.49 年[范围，3 个月至 8 年]；奥马珠单抗的平均剂量为每 4 周 473 mg；中位基线 IgE 水平为 433 IU/mL）纳入本分析。总体就诊依从率为 78%，尽管每年的依从率下降了 20%。SMART 模块评估的应答率分别为 16 周时的 61.3%、60.8%和 41.8%，1 年时的 84.8%、72.2%和 64.6%，2 年时的 82.4%、71.2%和 63.2%，和 5 年时的 95.1%、87.8%和 85.4%，分别为模块 1、2 和 3。没有发生严重不良反应。
结论
REALITY 研究证明了奥马珠单抗治疗过敏性哮喘患者在真实环境中的长期有效性。SMART 工具有望成为衡量和定义哮喘治疗应答的潜在标准评估工具。
试验注册
ClinicalTrials.gov 标识符：NCT01776177。
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