Is early MIDAS reduction at 3 months the best indicator predictor for erenumab treatment continuation? A open-label trial

This database includes the raw data linked with the paper “Is early MIDAS reduction at 3 months the best indicator predictor for erenumab treatment continuation? A open-label trial”, published on The Journal of Headache and Pain.

In this paper, we described migraine disability, quantified as a MIgraine Disability ASsessment (MIDAS).

•             A moderate to severe disability, MIDAS score  11, is required for prescription.

•             Score reduction of at least 50% after the first three months (T3) is mandatory to continue treatment.

•             Primary aim of this study:

•             - to evaluate whether 50% MIDAS reduction at T3 (MIDASRes) is a reliable response predictor of one-year erenumab treatment (classified as a reduction of baseline MMDs 50%).

•             The 50% reduction of monthly migraine days (MMD) at T3 Co-primary outcome

•             Secondary outcomes:

•             - the search of other predictors represents

•             Methods:

•             In this prospective, open-label study, 77 CM patients (mean age 49.8±9.5 years, chronicity history 13.1±10.3years, 93.5% of medication overuse headache) were treated with erenumab 70-140mg subcutaneous injections every 28 days for one year (T13). We assessed demographic and headache features, monthly migraine and headache days (MMD and MHDs respectively), days and doses of symptomatic intake. Patients also completed questionnaires evaluating migraine related disability (MIDAS and HIT-6), psychological comorbidities (HADS-A and HADS-D), quality of life (MSQ and 0 to 100 visual analogue scale) and allodynia (ASC-12). ANOVA for repeated measures was performed for quantifying erenumab efficacy and logistic regression model was used for evaluating one-year predictors of response.

•             Results:

•             Erenumab induced a sustained reduction of MMDs, MHDs and symptomatic intake during treatment. At T13 64.9% of patients presented MMDs baseline reduction 50% (RespondersT13). At T3, 55.8% of patients were MIDASRes. Contextually, 55.4% of patients were MMD Responders, these were also more likely to qualify as RespondersT13 when compared to non-responders (83.3% vs 42.9%; p=0.001). MMD response at T3 also demonstrated to be a predictor of long-term outcome according to a multivariate analysis ((Exp(B)=7.128; p=0.001)). When MIDAS reduction at T3 is considered as decision-making predictor of long-term outcome, 36.0% of patients who may benefit from 1-year erenumab administration are early excluded. By contrast, a lower percentage of Responders T13 (16%) would be discontinued if MIDASRes or MMD responders at T3 were alternatively considered.

本数据库关联发表于《头痛与疼痛杂志》（The Journal of Headache and Pain）的论文《3个月时早期偏头痛残疾评估量表（Migraine Disability Assessment, MIDAS）评分降低是否为依瑞奈尤单抗（erenumab）治疗持续的最佳预测指标？一项开放标签试验》。

本研究对偏头痛残疾程度进行了描述，采用偏头痛残疾评估量表（Migraine Disability Assessment, MIDAS）进行量化。
• 处方需满足中度至重度残疾标准，即MIDAS评分≥11分。
• 初始治疗前三个月（T3）后，MIDAS评分至少降低50%是继续治疗的必要条件。
• 本研究的主要目的：
• - 评估T3时MIDAS评分降低50%（MIDASRes）是否为依瑞奈尤单抗一年治疗的可靠反应预测指标（定义为基线每月偏头痛天数（monthly migraine days, MMD）降低≥50%）。
• T3时每月偏头痛天数（MMD）降低50%为共同主要结局指标
• 次要结局指标：
• - 探索其他潜在的治疗反应预测因素

• 方法：
• 本项前瞻性开放标签研究共纳入77例慢性偏头痛（chronic migraine, CM）患者，平均年龄49.8±9.5岁，慢性头痛病程13.1±10.3年，其中93.5%存在药物过度使用性头痛。受试者接受依瑞奈尤单抗70~140mg皮下注射，每28天一次，持续一年（至T13时点）。研究评估了受试者的人口学特征与头痛相关特征、每月偏头痛天数（MMD）与每月头痛天数（monthly headache days, MHDs）、症状性用药天数与剂量。受试者同时完成了以下评估工具：偏头痛相关残疾量表（MIDAS与头痛影响测试-6（Headache Impact Test-6, HIT-6））、心理共病评估量表（医院焦虑与抑郁量表-焦虑亚量表（Hospital Anxiety and Depression Scale-Anxiety, HADS-A）与医院焦虑与抑郁量表-抑郁亚量表（Hospital Anxiety and Depression Scale-Depression, HADS-D））、生活质量评估工具（偏头痛特异性生活质量问卷（Migraine-Specific Quality of Life Questionnaire, MSQ）与0~100分视觉模拟评分）以及异常性疼痛筛查量表12（Allodynia Screening Checklist-12, ASC-12）。采用重复测量方差分析量化依瑞奈尤单抗的疗效，采用逻辑回归模型评估一年治疗反应的预测因素。

• 结果：
• 依瑞奈尤单抗在治疗期间可持续降低MMD、MHDs与症状性用药天数及剂量。至T13时点，64.9%的患者实现基线MMD降低≥50%（T13应答者）。T3时点，55.8%的患者符合MIDASRes标准。同期，55.4%的患者为MMD应答者，相较于非应答者，该类患者更易被归类为T13应答者（83.3% vs 42.9%；p=0.001）。多变量分析显示，T3时点的MMD应答可作为长期治疗结局的预测指标（Exp(B)=7.128；p=0.001）。若将T3时MIDAS评分降低作为长期治疗结局的决策预测指标，则36.0%可能从一年依瑞奈尤单抗治疗中获益的患者会被早期排除。相较而言，若以T3时MIDASRes或MMD应答作为停药标准，则被停用治疗的T13应答者比例更低（16%）。