RATIONALE Reslizumab is a humanized anti-IL-5 monoclonal antibody used as add-on maintenance treatment for patients with uncontrolled eosinophilic asthma. OBJECTIVES To predict response and nonresponse to intravenous reslizumab at 52 weeks with an algorithm we developed based on clinical indicators from pivotal clinical trials. METHODS Patients aged 18 years and older who met Global Initiative for Asthma 4 or 5 criteria and received intravenous reslizumab (n = 321) in two trials ( www.clinicaltrials.gov identifiers, NCT01287039 and NCT01285323) were selected as the data source. A mathematical model was constructed that was based on change from baseline to 16 weeks in Asthma Control Questionnaire and Asthma Quality of Life Questionnaire scores and FEV1, and number of clinical asthma exacerbations during the year before enrollment and in the first 16 weeks of treatment, and these measures were evaluated for their ability to predict the outcome at 52 weeks: responder, nonresponder, or indeterminate. MEASUREMENTS AND MAIN RESULTS The algorithm predicted that 276 patients would be classified as responders; in 248 (89.9%), the prediction was correct. In comparison, 26 patients were predicted to be nonresponders; 50.0% of these predictions were correct. Nineteen patients were classified as indeterminate. The algorithm had 95.4-95.5% sensitivity and 40.6-54.1% specificity. Jackknife and cross-study validation confirmed the robustness of the algorithm. CONCLUSIONS Our algorithm enabled prediction at 16 weeks of treatment of the response to intravenous reslizumab treatment at 52 weeks, but it was not suitable for predicting nonresponse. A positive score at 16 weeks should encourage continued treatment, and a negative score should prompt close monitoring to determine whether discontinuation is warranted.

中文翻译：

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使用源自严重嗜酸性哮喘患者的临床研究的算法，预测治疗16周后对Reslizumab的反应者。

RATIONALE Reslizumab是一种人源化抗IL-5单克隆抗体，可用于嗜酸性粒细胞性哮喘不受控制的患者的附加维持治疗。目的为了预测52周时对静脉使用reslizumab的反应和无反应，我们基于关键临床试验的临床指标开发了一种算法。方法选择两项试验（www.clinicaltrials.gov标识符，NCT01287039和NCT01285323）中符合全球哮喘4或5标准并接受静脉使用瑞舒单抗（n = 321）的18岁及18岁以上患者作为数据源。建立了一个数学模型，该模型基于哮喘控制问卷从基线到16周的变化以及哮喘生活质量问卷得分和FEV1，入组前一年和治疗前16周的临床哮喘急性发作次数和数量，并评估了这些指标在52周时预测结局的能力：反应者，无反应者或不确定。测量和主要结果该算法预测276名患者将被归类为反应者；在248（89.9％）中，该预测是正确的。相比之下，预计有26名患者无反应；这些预测中有50.0％是正确的。19名患者被分类为不确定。该算法的灵敏度为95.4-95.5％，特异性为40.6-54.1％。折刀和交叉研究验证证实了该算法的鲁棒性。结论我们的算法可以预测在第16周治疗52周时对静脉使用reslizumab治疗的反应，但是它不适合预测无响应。16周时阳性评分应鼓励继续治疗，而阴性评分应促使密切监测以确定是否需要停药。