Department of Pharmaceutical Services, Vanderbilt University Medical Center, 726 Melrose Ave, Nashville, TN 37211.
Department of Pharmaceutical Services, Vanderbilt University Medical Center, 726 Melrose Ave, Nashville, TN 37211.
Mult Scler Relat Disord. 2022 Jul;63:103860. doi: 10.1016/j.msard.2022.103860. Epub 2022 May 10.
Patients with relapsing multiple sclerosis (RMS) are maintained on disease-modifying therapy (DMT) to prevent disease progression. Reported persistence rates to DMTs are varied and concerningly low. Limited data exists on long-term persistence rates and reasons for DMT discontinuation in patients with RMS. This study evaluated long-term DMT persistence, rates and reasons for DMT discontinuation or switch, specialty pharmacist involvement in DMT treatment transitions, and predictors associated with non-persistence in treatment naïve and experienced patients.
We performed a single-center retrospective, cross-sectional review of patients with RMS and ≥3 fills of DMT from a health-system specialty pharmacy (May-October 2017). Patients were followed for 3 years to determine DMT persistence, defined as the time a patient remained on index DMT. Descriptive statistics were used to summarize sample characteristics and outcomes. The Kaplan-Meier estimation method was used to estimate the probability of remaining persistent and we used the Cox proportional hazards regression model to analyze the primary outcome. Rates and reasons for DMT discontinuation were identified via pharmacy claims and confirmed via chart review of the electronic health record.
The study included 540 patients, of which 41 (7.6%) were treatment naïve. Over 3 years, 193 (36%) patients remained on index DMT. The probability of remaining persistent for 3 years was 0.51 (95% confidence interval [CI] 0.47-0.56) and median time on index DMT was 642 days (interquartile range 317-1096). For the 347 patients that did not continue index DMT: 91 (26%) discontinued, 136 (39%) switched to a new DMT, 92 (27%) transferred care to a new specialty pharmacy or provider, 21 (6%) were lost to follow-up, and 7 (2%) died. Common reasons for DMT discontinuation or switch were insurance formulary change, side effects, clinical decline, and stable disease. Specialty pharmacists initiated 6 (7%) DMT discontinuations and 49 (36%) DMT switches. A strong non-linear relationship existed between age and risk of non-persistence (p = 0.003). Patients on an injectable index DMT were 1.5 times more likely to be non-persistent than those on an oral DMT (95% CI 1.1-2.1, p = 0.012) and patients with non-commercial insurance were 1.4 times more likely to be non-persistent (95% CI 1.02-2.0, p = 0.040).
Long-term persistence to DMTs is low, with many patients switching or discontinuing DMT treatment. Specialty pharmacists identify the need for DMT discontinuation or switch and are uniquely positioned to assist during therapy transitions.
复发型多发性硬化症（RMS）患者需要接受疾病修正疗法（DMT）以预防疾病进展。已报道的 DMT 维持率存在差异且令人担忧地较低。关于 RMS 患者的 DMT 停药或换药的长期维持率和原因的数据有限。本研究评估了 DMT 维持率、停药或换药的原因、专业药剂师在 DMT 治疗转换中的参与度，以及与治疗初治和经验患者的不依从性相关的预测因素。
我们对来自医疗系统专科药房（2017 年 5 月至 10 月）的≥3 次 DMT 用药的 RMS 患者进行了单中心回顾性、横断面研究。患者随访 3 年以确定 DMT 维持率，定义为患者继续使用指数 DMT 的时间。使用描述性统计数据总结样本特征和结局。使用 Kaplan-Meier 估计法估计剩余持续时间的概率，并使用 Cox 比例风险回归模型分析主要结局。通过药房理赔确定 DMT 停药和换药的原因，并通过电子病历的图表回顾进行确认。
该研究纳入了 540 名患者，其中 41 名（7.6%）为初治患者。在 3 年期间，有 193 名（36%）患者继续使用指数 DMT。3 年的持续时间概率为 0.51（95%置信区间 [CI] 0.47-0.56），指数 DMT 的中位时间为 642 天（四分位距 317-1096）。对于未继续使用指数 DMT 的 347 名患者：91 名（26%）停药，136 名（39%）换用新的 DMT，92 名（27%）将治疗转移至新的专科药房或提供者，21 名（6%）失访，7 名（2%）死亡。DMT 停药或换药的常见原因包括保险方案变更、副作用、临床恶化和疾病稳定。专业药剂师发起了 6 次（7%）DMT 停药和 49 次（36%）DMT 换药。年龄与非依从性风险之间存在强烈的非线性关系（p=0.003）。使用注射用指数 DMT 的患者比使用口服 DMT 的患者更有可能不持续治疗（95%CI 1.1-2.1，p=0.012），非商业保险的患者比商业保险的患者更有可能不持续治疗（95%CI 1.02-2.0，p=0.040）。
DMT 的长期维持率较低，许多患者停药或换药。专业药剂师发现需要停止或转换 DMT 治疗，并在治疗转换期间处于独特的位置提供帮助。
