Safety and clinical effectiveness of peginterferon beta-1a for relapsing multiple sclerosis in a real-world setting: Final results from the Plegridy Observational Program.

IF 2.3 Q2 CLINICAL NEUROLOGY Multiple Sclerosis Journal - Experimental, Translational and Clinical Pub Date : 2024-05-23 eCollection Date: 2024-04-01 DOI:10.1177/20552173241238632
Marco Salvetti, Sibyl Wray, Gereon Nelles, Nicholas Belviso, Achint Kumar, Thijs Koster, Wanda Castro-Borrero, Megan Vignos
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Abstract

Background: Interferon beta-1a remains an important treatment option for multiple sclerosis, particularly when safety or tolerability concerns may outweigh the benefits of higher-efficacy disease-modifying therapies. The five-year phase 4 Plegridy Observational Program (POP) study (NCT02230969) collected data on real-world safety and effectiveness of Plegridy® (peginterferon beta-1a) treatment in patients with relapsing multiple sclerosis.

Objective: To explore the real-world safety and effectiveness of peginterferon beta-1a in patients with relapsing multiple sclerosis, including factors influencing treatment discontinuation.

Methods: Data were collected prospectively from patients ≥ 18 years old with relapsing multiple sclerosis for overall population analysis and for subpopulations including newly/previously diagnosed patients, age, and experience with peginterferon beta-1a. Outcome measures included annualized relapse rates, adverse events, and predictors of time to treatment discontinuation.

Results: Mean (SD) treatment duration in the overall population (N = 1172) was 896.0 (733.15) days. Incidence of adverse events was higher in new than experienced users (79.4% vs. 57.0%). New users were more likely than experienced users to discontinue (hazard ratio = 1.60; P < 0.0001). The adjusted annualized relapse rate was 0.09, and at the end of 5 years, 77.1% of patients were relapse-free.

Conclusions: Peginterferon beta-1a is an effective therapy for managing relapsing multiple sclerosis. The identification of predictors of discontinuation can help inform strategies to enhance treatment persistence.

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在真实世界环境中,peginterferon beta-1a 治疗复发性多发性硬化症的安全性和临床有效性:Plegridy 观察项目的最终结果。
背景:干扰素β-1a仍然是多发性硬化症的重要治疗选择,尤其是当安全性或耐受性方面的问题可能超过疗效更高的疾病改变疗法的益处时。为期五年的4期Plegridy观察项目(POP)研究(NCT02230969)收集了复发性多发性硬化症患者接受Plegridy®(peginterferon beta-1a)治疗的实际安全性和有效性数据:探讨peginterferon beta-1a在复发性多发性硬化症患者中的实际安全性和有效性,包括影响治疗中止的因素:前瞻性地收集了年龄≥18岁的复发性多发性硬化症患者的数据,用于总体人群分析和亚人群分析,包括新诊断/既往诊断患者、年龄和使用peginterferon beta-1a的经验。结果测量包括年化复发率、不良事件和终止治疗时间的预测因素:总体患者(N = 1172)的平均(标度)治疗时间为 896.0 (733.15) 天。新用药者的不良反应发生率高于老用药者(79.4% 对 57.0%)。新用药者比老用药者更有可能停药(危险比 = 1.60;P 结论:新用药者比老用药者更有可能停药:培根干扰素 beta-1a 是治疗复发性多发性硬化症的有效疗法。识别中断治疗的预测因素有助于制定提高治疗持久性的策略。
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来源期刊
CiteScore
4.70
自引率
0.00%
发文量
54
审稿时长
15 weeks
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