PDF(Pubmed)
Abstract：
UNASSIGNED: Effective and safe treatment options for multiple sclerosis (MS) are still needed. Montelukast, a leukotriene receptor antagonist (LTRA) currently indicated for asthma or allergic rhinitis, may provide an additional therapeutic approach.
UNASSIGNED: The study aimed to evaluate the effects of montelukast on the relapses of people with MS (pwMS).
UNASSIGNED: In this retrospective case-control study, two independent longitudinal claims datasets were used to emulate randomized clinical trials (RCTs). We identified pwMS aged 18-65 years, on MS disease-modifying therapies concomitantly, in de-identified claims from Optum\'s Clinformatics® Data Mart (CDM) and IQVIA PharMetrics® Plus for Academics. Cases included 483 pwMS on montelukast and with medication adherence in CDM and 208 in PharMetrics Plus for Academics. We randomly sampled controls from 35,330 pwMS without montelukast prescriptions in CDM and 10,128 in PharMetrics Plus for Academics. Relapses were measured over a 2-year period through inpatient hospitalization and corticosteroid claims. A doubly robust causal inference model estimated the effects of montelukast, adjusting for confounders and censored patients.
UNASSIGNED: pwMS treated with montelukast demonstrated a statistically significant 23.6% reduction in relapses compared to non-users in 67.3% of emulated RCTs.
UNASSIGNED: Real-world evidence suggested that montelukast reduces MS relapses, warranting future clinical trials and further research on LTRAs\' potential mechanism in MS.
UNASSIGNED: The study aimed to evaluate the effects of montelukast on the relapses of people with MS (pwMS).
UNASSIGNED: In this retrospective case-control study, two independent longitudinal claims datasets were used to emulate randomized clinical trials (RCTs). We identified pwMS aged 18-65 years, on MS disease-modifying therapies concomitantly, in de-identified claims from Optum\'s Clinformatics® Data Mart (CDM) and IQVIA PharMetrics® Plus for Academics. Cases included 483 pwMS on montelukast and with medication adherence in CDM and 208 in PharMetrics Plus for Academics. We randomly sampled controls from 35,330 pwMS without montelukast prescriptions in CDM and 10,128 in PharMetrics Plus for Academics. Relapses were measured over a 2-year period through inpatient hospitalization and corticosteroid claims. A doubly robust causal inference model estimated the effects of montelukast, adjusting for confounders and censored patients.
UNASSIGNED: pwMS treated with montelukast demonstrated a statistically significant 23.6% reduction in relapses compared to non-users in 67.3% of emulated RCTs.
UNASSIGNED: Real-world evidence suggested that montelukast reduces MS relapses, warranting future clinical trials and further research on LTRAs\' potential mechanism in MS.
摘要：
■仍然需要有效且安全的多发性硬化症（MS）治疗方案。孟鲁司特,白三烯受体拮抗剂（LTRA）目前用于哮喘或过敏性鼻炎，可以提供额外的治疗方法。
■该研究旨在评估孟鲁司特对MS（pwMS）患者复发的影响。
■在这项回顾性病例对照研究中，我们使用两个独立的纵向索赔数据集来模拟随机临床试验(RCTs).我们确定了年龄在18-65岁之间的pwMS，伴随MS疾病改善疗法，Optum的Clinformatics®DataMart(CDM)和IQVIAPharMetrics®PlusforAcademics的去识别索赔。病例包括孟鲁司特483例pwMS，CDM中的药物依从性和PharMetricsPlusforAcademics中的208例。我们从CDM中没有孟鲁司特处方的35,330pwMS和PharMetricsPlusforAcademics中的10,128个随机抽取了对照。通过住院和皮质类固醇索赔在2年内测量复发。一个双重稳健的因果推理模型估计了孟鲁司特的影响，调整混杂因素和审查患者。
用孟鲁司特治疗的pwMS与67.3%的仿真随机对照试验中的非使用者相比,在复发方面显示出统计学上显著的23.6%的减少。
■现实世界的证据表明孟鲁司特减少MS复发，保证未来的临床试验和对LTRAs潜在机制的进一步研究。
■该研究旨在评估孟鲁司特对MS（pwMS）患者复发的影响。
■在这项回顾性病例对照研究中，我们使用两个独立的纵向索赔数据集来模拟随机临床试验(RCTs).我们确定了年龄在18-65岁之间的pwMS，伴随MS疾病改善疗法，Optum的Clinformatics®DataMart(CDM)和IQVIAPharMetrics®PlusforAcademics的去识别索赔。病例包括孟鲁司特483例pwMS，CDM中的药物依从性和PharMetricsPlusforAcademics中的208例。我们从CDM中没有孟鲁司特处方的35,330pwMS和PharMetricsPlusforAcademics中的10,128个随机抽取了对照。通过住院和皮质类固醇索赔在2年内测量复发。一个双重稳健的因果推理模型估计了孟鲁司特的影响，调整混杂因素和审查患者。
用孟鲁司特治疗的pwMS与67.3%的仿真随机对照试验中的非使用者相比,在复发方面显示出统计学上显著的23.6%的减少。
■现实世界的证据表明孟鲁司特减少MS复发，保证未来的临床试验和对LTRAs潜在机制的进一步研究。
