Munsell Michael, Frean Molly, Menzin Joseph, Phillips Amy L
Boston Health Economics, Inc., Waltham, MA, USA.
Health Economics & Outcomes Research, EMD Serono Inc., Rockland, MA, USA.
Patient Prefer Adherence. 2016 Dec 30;11:55-62. doi: 10.2147/PPA.S118107. eCollection 2017.
As the multiple sclerosis (MS) disease-modifying drug (DMD) treatment options have expanded to include oral therapies, it is important to understand whether route of administration is associated with DMD adherence. The objective of this study was to compare adherence to DMDs in patients with MS newly initiating treatment with a self-injectable versus an oral DMD.
This retrospective database study used IMS Health Real World Data Adjudicated Claims - US data between July 1, 2010 and June 30, 2014. Adherence was measured by medication possession ratio (MPR), calculated as the total number of treated days divided by the total number of days from the first treated day until the end of 12-month follow-up. A binary measure representing adherence (MPR ≥0.8) versus nonadherence (MPR <0.8) to therapy was used. Logistic regression evaluated the likelihood of adherence to index DMD type (self-injectable vs oral). Covariates included patient baseline characteristics (ie, age, sex, comorbidities) and index DMD type.
The analysis included 7,207 self-injectable and 1,175 oral DMD-treated patients with MS. In unadjusted analyses, the proportion of patients adherent to therapy (MPR ≥0.8) did not differ significantly between the self-injectable (54.1%) and the oral DMD cohorts (53.0%; =0.5075). After controlling for covariates, index DMD type was not a significant predictor of adherence (odds ratio [OR] 1.062; 95% confidence interval [CI]: 0.937-1.202; =0.3473). Higher likelihood of adherence was associated with male sex (OR 1.20; 95% CI: 1.085-1.335; =0.0005) and age groups older than 18-34 years (ORs 1.220-1.331; <0.01). Depression was associated with a lower likelihood of adherence (OR 0.618; 95% CI: 0.511-0.747; <0.0001).
Male sex and age older than 18-34 years were significantly associated with a higher likelihood of adherence, while depression was associated with a lower likelihood of adherence. Index DMD type, stratified by the route of administration (self-injectable vs oral DMD), was not a significant predictor of DMD adherence.
随着多发性硬化症（MS）疾病修正药物（DMD）治疗选择已扩展至包括口服疗法，了解给药途径是否与DMD依从性相关很重要。本研究的目的是比较新开始使用自我注射型DMD与口服DMD治疗的MS患者对DMD的依从性。
这项回顾性数据库研究使用了艾美仕市场研究公司（IMS Health）真实世界数据判定索赔——2010年7月1日至2014年6月30日期间的美国数据。依从性通过药物持有率（MPR）衡量，计算方法为治疗天数总数除以从首次治疗日至12个月随访结束的天数总数。使用了一种表示对治疗依从（MPR≥0.8）与不依从（MPR<0.8）的二元指标。逻辑回归评估了对索引DMD类型（自我注射型与口服型）依从的可能性。协变量包括患者基线特征（即年龄、性别、合并症）和索引DMD类型。
分析纳入了7207例接受自我注射型DMD治疗和1175例接受口服DMD治疗的MS患者。在未调整分析中，自我注射型DMD组（54.1%）和口服DMD组（53.0%；P=0.5075）中治疗依从（MPR≥0.8）的患者比例无显著差异。在控制协变量后，索引DMD类型不是依从性的显著预测因素（比值比[OR]1.062；95%置信区间[CI]：0.937 - 1.202；P=0.3473）。依从可能性较高与男性性别（OR 1.20；95% CI：1.085 - 1.335；P=0.0005）以及年龄大于18 - 34岁的年龄组相关（OR为1.220 - 1.331；P<0.01）。抑郁症与较低的依从可能性相关（OR 0.618；95% CI：0.511 - 0.747；P<0.0001）。
男性性别和年龄大于18 - 34岁与较高的依从可能性显著相关，而抑郁症与较低的依从可能性相关。按给药途径分层的索引DMD类型（自我注射型与口服DMD）不是DMD依从性的显著预测因素。
