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在美国商业索赔数据中,与其他多发性硬化症的疾病修正疗法相比,奥瑞珠单抗的持续使用和坚持使用。

Persistence and adherence to ocrelizumab compared with other disease-modifying therapies for multiple sclerosis in U.S. commercial claims data.

机构信息

Genentech, San Francisco, CA.

Oklahoma Medical Research Foundation, Oklahoma City.

出版信息

J Manag Care Spec Pharm. 2021 May;27(5):639-649. doi: 10.18553/jmcp.2021.20413. Epub 2021 Feb 24.

Abstract

Ocrelizumab (OCR) is the only disease-modifying therapy (DMT) for both relapsing and primary progressive forms of multiple sclerosis (MS). OCR is given by intravenous (IV) infusion twice a year, which may improve adherence to the dosing schedule relative to other MS DMTs that require more frequent administration. Real-world evidence on the persistence and adherence of patients with MS to OCR compared with other DMTs is limited. To examine the persistence and adherence to OCR compared with other DMTs for MS in the United States. This analysis was conducted in the PharMetrics Plus commercial claims database and included patients with MS who initiated a new DMT between April 2017 and September 2018. Patients were required to have health plan enrollment for ≥ 1 year before and after DMT initiation (a subgroup analysis was performed for those with ≥ 18 months' continuous enrollment after DMT initiation). Persistence was defined as not switching to another DMT and having no gap in coverage of the initiated DMT for ≥ 60 days during the postinitiation period. The proportion of days covered (PDC) was calculated as the total days covered by the DMT during the postinitiation period divided by the length of the time period (12 or 18 months); PDC ≥ 0.8 was considered adherent. Multivariable Poisson regression models compared discontinuation (nonpersistence) and nonadherence between OCR users and users of other DMTs grouped by administration route. A total of 4,587 patients (OCR, 1,319; injectable, 1,051; oral, 1,876; other IV, 341) were included. The OCR group had the lowest proportion of patients discontinuing at 12 months (8% vs. 28%, 32%, and 43% for other IV, oral, and injectable, respectively) and the highest mean PDC (93% vs. 76%, 74%, and 69%, respectively). Compared with patients initiating OCR, adjusted relative risks (RR) of 12-month discontinuation were 3.3 (95% CI = 2.3-4.6), 3.8 (95% CI = 3.0-4.9), and 5.5 (95% CI = 4.1-7.5) for patients initiating other IV, oral, and injectable DMTs, respectively. Similarly, patients initiating other IV, oral, and injectable DMTs had RRs of 4.9 (95% CI = 3.6-6.8), 5.1 (95% CI = 3.9-6.6), and 6.8 (95% CI = 5.0-9.3) for 12-month nonadherence compared with OCR. A subgroup of 2,913 patients with 18 months of continuous enrollment had similar trends, with 17% in the OCR group discontinuing compared with 40%, 41%, and 55% in the other IV, oral, and injectable groups, respectively. Trends over 18 months were consistent with the 12-month analysis in adjusted models. Patients initiating OCR had superior persistence and adherence at 12 and 18 months of follow-up compared with patients initiating other MS DMTs. Long-term persistence and adherence should be monitored as OCR experience accrues in a real-world setting. This study was funded by Genentech (South San Francisco, CA), a member of the Roche Group. Engmann, Sheinson, Bawa, and Ng are employees of Genentech and shareholders of F. Hoffman-La Roche (Basel, Switzerland).

摘要

奥瑞珠单抗(OCR)是唯一一种用于治疗复发型和原发性进行性多发性硬化症(MS)的疾病修正疗法(DMT)。OCR 通过静脉输注(IV)每年给药两次,与需要更频繁给药的其他 MS DMT 相比,这可能会提高患者对给药方案的依从性。关于与其他 DMT 相比,OCR 在真实世界中对 MS 患者的持续性和依从性的数据有限。

本研究旨在比较美国患者使用 OCR 与其他 DMT 治疗 MS 的持续性和依从性。

本分析在 PharMetrics Plus 商业索赔数据库中进行,纳入了 2017 年 4 月至 2018 年 9 月期间开始使用新 DMT 的 MS 患者。要求患者在 DMT 开始前和开始后至少有 1 年的健康计划参保(对 DMT 开始后至少有 18 个月连续参保的患者进行了亚组分析)。持续性定义为未转换为另一种 DMT,并且在起始 DMT 后的随访期内至少有 60 天无覆盖间隙。计算比例天数覆盖(PDC)为起始 DMT 后随访期内 DMT 覆盖的总天数除以时间段的长度(12 个月或 18 个月);PDC≥0.8 被认为是依从的。多变量泊松回归模型比较了 OCR 使用者和其他 DMT 使用者(按给药途径分组)之间的停药(不依从)和不依从的差异。

共纳入 4587 名患者(OCR 组 1319 人,注射剂组 1051 人,口服组 1876 人,其他 IV 组 341 人)。OCR 组在 12 个月时停药的患者比例最低(8%比其他 IV、口服和注射剂组分别为 28%、32%和 43%),平均 PDC 最高(93%比其他 IV、口服和注射剂组分别为 76%、74%和 69%)。与起始 OCR 的患者相比,起始其他 IV、口服和注射剂 DMT 的患者调整后的 12 个月停药相对风险(RR)分别为 3.3(95%CI=2.3-4.6)、3.8(95%CI=3.0-4.9)和 5.5(95%CI=4.1-7.5)。同样,起始其他 IV、口服和注射剂 DMT 的患者调整后的 12 个月不依从 RR 分别为 4.9(95%CI=3.6-6.8)、5.1(95%CI=3.9-6.6)和 6.8(95%CI=5.0-9.3),与 OCR 相比。在 18 个月的连续入组亚组中,2913 名患者也有类似的趋势,OCR 组中有 17%的患者停药,而其他 IV、口服和注射剂组分别有 40%、41%和 55%的患者停药。调整模型的 18 个月趋势与 12 个月分析一致。

与起始其他 MS DMT 的患者相比,起始 OCR 的患者在 12 个月和 18 个月的随访中具有更好的持续性和依从性。应监测 OCR 在真实环境中的经验积累,以确保长期的持续性和依从性。

本研究由罗氏集团(瑞士巴塞尔)的成员基因泰克(加利福尼亚州南旧金山)资助。Engmann、Sheinson、Bawa 和 Ng 是基因泰克的员工,也是 F. Hoffman-La Roche(瑞士巴塞尔)的股东。

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