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真实世界中多发性硬化症患者使用奥法妥木单抗与口服和注射用疾病修正治疗药物的持续性和依从性。

Real-world persistence and adherence of ofatumumab versus oral and injectable disease-modifying therapies in patients with multiple sclerosis.

机构信息

Cleveland Clinic Lou Ruvo Center for Brain Health, 888 W Bonneville Ave, Las Vegas, NV 89106, USA.

IQVIA, 650 Swedesford Rd, Wayne, PA 19087, USA.

出版信息

Mult Scler Relat Disord. 2024 Nov;91:105888. doi: 10.1016/j.msard.2024.105888. Epub 2024 Sep 12.

DOI:10.1016/j.msard.2024.105888
PMID:39388747
Abstract

BACKGROUND

Ofatumumab (OMB) was approved as a self-injectable disease-modifying therapy (DMT) for relapsing multiple sclerosis (MS) in August 2020. This study aimed to examine treatment persistence and adherence of OMB to oral and platform self-injectable DMTs in a real-world setting.

METHODS

This was a retrospective cohort study using IQVIA Pharmetrics Plus® in adults diagnosed with MS and treated with OMB, oral DMTs, or platform self-injectable DMTs (index treatment) between August 2020 and November 2021. Patients had at least 12 months of continuous enrollment before the index date and 6 months of follow-up after the index date; the index date was defined as the date of the first pharmacy claim for an index treatment. Inverse probability of treatment weighting (IPTW) analysis was used to account for differences in baseline characteristics among patients initiating OMB versus oral DMTs and, separately, OMB versus platform self-injectable DMTs. Persistence was defined as the number of days from the index date until the earliest time of discontinuation (>60-day gap) or switch to a new DMT. Adherence was calculated based on proportion of days covered (PDC) with adherence defined as PDC ≥0.8. Persistence and adherence were compared between OMB versus oral DMTs and OMB versus platform self-injectable DMTs. Persistence was assessed via Kaplan-Meier analyses of the weighted sample, and log-rank tests were used to compare time to treatment discontinuation and treatment switch. The proportion of patients adherent at 6 and 12 months post index were compared using chi-square tests.

RESULTS

A total of 11,167 patients were identified with an incident claim of OMB, an oral DMT, or a platform self-injectable DMT. After applying all inclusion and exclusion criteria and IPTW, two sets of study cohorts were created. For the oral DMT analysis, 577 patients treated with OMB and 2,468 patients treated with oral DMTs were identified. For the self-injectable DMT analysis, 574 patients treated with OMB and 578 patients treated with a platform self-injectable DMT were identified. At 6- and 12-month follow-up, the proportion of patients who were persistent on DMT was higher in the OMB cohort compared with the oral DMT cohort (6 months: 79.9% vs. 75.4 %, 12 months: 71.4% vs. 62.9 %; p < 0.05), as well as in the OMB cohort compared with the self-injectable DMT cohort (6 months: 79.3% vs. 60.4 %, 12 months: 71.5% vs. 48.7 %; p < 0.0001). A similar proportion of patients were adherent to OMB versus oral DMTs at 6- and 12-months post index, whereas a higher proportion of patients treated with OMB versus platform self-injectable DMTs were adherent at 6- and 12-months post index.

CONCLUSIONS

OMB showed better persistence and adherence compared with platform self-injectable DMTs, as well as better persistence compared with oral DMTs. This real-world analysis provides additional insights into OMB utilization among patients with MS in clinical practice and demonstrates that OMB is a valuable treatment option for these patients.

摘要

背景

奥法妥木单抗(OMB)于 2020 年 8 月获批用于治疗复发性多发性硬化症(MS)的自我注射疾病修正疗法(DMT)。本研究旨在考察 OMB 在真实世界环境下与口服 DMT 和平台型自我注射 DMT 的治疗持久性和依从性。

方法

这是一项回顾性队列研究,使用 IQVIA Pharmetrics Plus®分析 2020 年 8 月至 2021 年 11 月期间被诊断为 MS 并接受 OMB、口服 DMT 或平台型自我注射 DMT(索引治疗)治疗的成年人。患者在索引日期前至少有 12 个月的连续入组和索引日期后 6 个月的随访;索引日期定义为首次使用索引治疗的药房配药日期。采用逆概率治疗加权(IPTW)分析来调整起始接受 OMB 与口服 DMT 和 OMB 与平台型自我注射 DMT 患者之间的基线特征差异。持久性定义为从索引日期起至最早停药时间(>60 天的间隔)或转换为新 DMT 的天数。依从性基于覆盖率比例(PDC)计算,定义为 PDC≥0.8。比较 OMB 与口服 DMT 和 OMB 与平台型自我注射 DMT 之间的持久性和依从性。通过加权样本的 Kaplan-Meier 分析评估持久性,并使用对数秩检验比较治疗停药和治疗转换的时间。使用卡方检验比较索引后 6 个月和 12 个月时的依从性患者比例。

结果

共纳入 11167 例患者,发生 OMB、口服 DMT 或平台型自我注射 DMT 的新发病例。应用所有纳入和排除标准以及 IPTW 后,创建了两组研究队列。对于口服 DMT 分析,确定了 577 例接受 OMB 治疗和 2468 例接受口服 DMT 治疗的患者。对于自我注射 DMT 分析,确定了 574 例接受 OMB 治疗和 578 例接受平台型自我注射 DMT 治疗的患者。在 6 个月和 12 个月的随访中,与口服 DMT 队列相比,接受 OMB 治疗的患者的 DMT 持久性比例更高(6 个月:79.9%比 75.4%,12 个月:71.4%比 62.9%;p<0.05),与平台型自我注射 DMT 队列相比也是如此(6 个月:79.3%比 60.4%,12 个月:71.5%比 48.7%;p<0.0001)。在索引后 6 个月和 12 个月,接受 OMB 治疗的患者与口服 DMT 治疗的患者的依从性比例相似,而接受 OMB 治疗的患者与平台型自我注射 DMT 治疗的患者的依从性比例更高。

结论

与平台型自我注射 DMT 相比,与 OMB 相比,显示出更好的持久性和依从性,与口服 DMT 相比,显示出更好的持久性。这项真实世界分析提供了更多关于 MS 患者在临床实践中使用 OMB 的见解,并表明 OMB 是这些患者的一种有价值的治疗选择。

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