Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year.
Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year.
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DOI：
10.18553/jmcp.2017.23.8.844
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发表时间：
2017-08-01
影响因子：
2.1
通讯作者：
Herrera, Vivian
中科院分区：
文献类型：
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作者：
Johnson, Kristen M;Zhou, Huanxue;Herrera, Vivian
背景：疾病改善疗法（DMTs）被认为可以降低复发-缓解型多发性硬化症（MS）患者的复发率和减缓疾病进展。在现实环境中，不坚持或不坚持可能导致更大的负面临床结果风险。尽管先前的研究表明口服dmt的依从性和持久性比注射dmt强，但缺乏对口服dmt的比较。目的：比较新开口服dmt芬戈莫德、富马酸二甲酯或特立氟米特的MS患者的依从性、持久性和停药时间。方法：本回顾性研究使用MarketScan商业和医疗保险补充索赔数据库。选取2013年4月1日至2013年6月30日期间，对指定dmt索赔≥1例的MS患者。指标药物定义为在此期间首次口服DMT。为了捕获新启动索引dmt的患者，患者在过去12个月内不能对其索引药物进行索赔。描述了每个治疗队列中患者的基线特征。依从性，通过药物占有比（MPR）和覆盖天数比例（PDC）来衡量；坚持（允许30天的间隔）；在12个月的随访期间，对各治疗组的停药时间进行比较。采用调整后的logistic回归模型检验依从性，Cox回归模型估计停药风险。结果：1,498例新开始口服dmt的患者符合研究纳入标准：芬戈莫德（n = 185）、富马酸二甲酯（n = 1160）和特立氟米特（n = 143）。患者在大多数基线特征上相似，包括地区、复发史和卫生保健资源利用。在年龄、性别、既往注射/输注DMT使用和合并症等治疗队列中观察到统计学上的显著差异。依从性和停药时间根据年龄、性别、地区、既往口服和注射/输注DMT使用、复发史和Charlson合并症指数评分进行调整。相对于fingolimod患者，富马酸二甲酯和特立氟米特患者的MPR≥80%的可能性显著降低（OR = 0.18; 95% CI = 0.09-0.36; P < 0.001和OR = 0.19; 95% CI = 0.08-0.42; P < 0.001）。同样，相对于fingolimod患者，富马酸二甲酯和特立氟米特患者的PDC≥80%的可能性显著降低（OR = 0.47; 95% CI = 0.33-0.67; P < 0.001和OR = 0.37; 95% CI = 0.23-0.59; P < 0.001）。此外，富马酸二甲酯（HR = 1.93; 95% CI = 1.44-2.59; P < 0.001）和特立氟米特（HR = 2.27; 95% CI = 1.57-3.28; P < 0.001）患者的停药风险比fingolimod高约2倍。结论：在现实环境中，与服用其他口服dmt的患者相比，服用芬戈莫德的患者在12个月内具有更好的依从性和持久性。再加上临床因素，在确定MS患者的覆盖决策时，药物依从性和持久性应该是重要的考虑因素。披露：这项研究由诺华制药公司资助。Johnson、Lin、Ko和Herrera受雇于诺华制药公司，并持有诺华的股票。周焕雪就职于为诺华提供咨询服务的KMK咨询公司。研究概念和设计由Johnson、Lin、Ko和Herrera贡献。Zhou收集数据，Johnson、Lin、Ko和Herrera对数据进行解释。所有作者都参与了稿件的修改。这项研究的摘要发表在AMCP Nexus 2015；2015年10月26-29日；奥兰多,佛罗里达。
BACKGROUND: Disease-modifying therapies (DMTs) are indicated to reduce relapse rates and slow disease progression for relapsing-remitting multiple sclerosis (MS) patients when taken as prescribed. Nonadherence or non-persistence in the real-world setting can lead to greater risk for negative clinical outcomes. Although previous research has demonstrated greater adherence and persistence to oral DMTs compared with injectable DMTs, comparisons among oral DMTs are lacking.OBJECTIVE: To compare adherence, persistence, and time to discontinuation among MS patients newly prescribed the oral DMTs fingolimod, dimethyl fumarate, or teriflunomide.METHODS: This retrospective study used MarketScan Commercial and Medicare Supplemental claims databases. MS patients with ≥ 1 claim for specified DMTs from April 1, 2013, to June 30, 2013, were identified. The index drug was defined as the first oral DMT within this period. To capture patients newly initiating index DMTs, patients could not have a claim for their index drugs in the previous 12 months. Baseline characteristics were described for patients in each treatment cohort. Adherence, as measured by medication possession ratio (MPR) and proportion of days covered (PDC); persistence (30-day gap allowed); and time to discontinuation over a 12-month follow-up period were compared across treatment cohorts. Adjusted logistic regression models were used to examine adherence, and Cox regression models estimated risk of discontinuation.RESULTS: 1,498 patients newly initiated oral DMTs and met study inclusion criteria: fingolimod (n = 185), dimethyl fumarate (n = 1,160), and teriflunomide (n = 143). Patients were similar across most baseline characteristics, including region, relapse history, and health care resource utilization. Statistically significant differences were observed across the treatment cohorts for age, gender, previous injectable/infused DMT use, and comorbidities. Adherence and time to discontinuation were adjusted for age, gender, region, previous oral and injectable/infused DMT use, relapse history, and Charlson Comorbidity Index score. Relative to fingolimod patients, dimethyl fumarate and teriflunomide patients were significantly less likely to have an MPR ≥ 80% (OR = 0.18; 95% CI = 0.09-0.36; P < 0.001 and OR = 0.19; 95% CI = 0.08-0.42; P < 0.001, respectively). Similarly, relative to fingolimod patients, dimethyl fumarate and teriflunomide patients were significantly less likely to have PDC ≥ 80% (OR = 0.47; 95% CI = 0.33-0.67; P < 0.001 and OR = 0.37; 95% CI = 0.23-0.59; P < 0.001, respectively). Additionally, the HR for discontinuation was about 2 times greater for dimethyl fumarate (HR = 1.93; 95% CI = 1.44-2.59; P < 0.001) and teriflunomide patients (HR = 2.27; 95% CI = 1.57-3.28; P < 0.001) compared with fingolimod.CONCLUSIONS: In a real-world setting, patients taking fingolimod had better adherence and persistence compared with patients taking other oral DMTs over 12 months. Coupled with clinical factors, medication adherence and persistence should be important considerations when determining coverage decisions for MS patients.DISCLOSURES: This research was funded by Novartis Pharmaceuticals. Johnson, Lin, Ko, and Herrera are employed by Novartis Pharmaceuticals and own Novartis stock. Huanxue Zhou is employed by KMK Consulting, which provides consulting services to Novartis. Study concept and design were contributed by Johnson, Lin, Ko, and Herrera. Zhou collected the data, and data interpretation was performed by Johnson, Lin, Ko, and Herrera. All authors were involved in manuscript revision. The abstract for this study was presented at the AMCP Nexus 2015; October 26-29, 2015; Orlando, Florida.