Salvetti Marco, Wray Sibyl, Nelles Gereon, Belviso Nicholas, Kumar Achint, Koster Thijs, Castro-Borrero Wanda, Vignos Megan
Department of Neurosciences, Mental Health and Sensory Organs, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy; IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Molise, Italy.
Hope Neurology MS Center, Knoxville, TN, USA.
Mult Scler J Exp Transl Clin. 2024 May 23;10(2):20552173241238632. doi: 10.1177/20552173241238632. eCollection 2024 Apr-Jun.
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.
To explore the real-world safety and effectiveness of peginterferon beta-1a in patients with relapsing multiple sclerosis, including factors influencing treatment discontinuation.
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.
Mean (SD) treatment duration in the overall population ( = 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; < 0.0001). The adjusted annualized relapse rate was 0.09, and at the end of 5 years, 77.1% of patients were relapse-free.
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.
干扰素β-1a仍然是治疗多发性硬化症的重要选择,尤其是当安全性或耐受性问题可能超过高效疾病修正疗法的益处时。为期五年的4期Plegridy观察项目(POP)研究(NCT02230969)收集了Plegridy®(聚乙二醇化干扰素β-1a)治疗复发型多发性硬化症患者的真实世界安全性和有效性数据。
探讨聚乙二醇化干扰素β-1a在复发型多发性硬化症患者中的真实世界安全性和有效性,包括影响治疗中断的因素。
前瞻性收集年龄≥18岁的复发型多发性硬化症患者的数据,用于总体人群分析以及包括新诊断/既往诊断患者、年龄和聚乙二醇化干扰素β-1a使用经验的亚组分析。观察指标包括年化复发率、不良事件以及治疗中断时间的预测因素。
总体人群(n = 1172)的平均(标准差)治疗持续时间为896.0(733.15)天。新使用者的不良事件发生率高于有使用经验者(79.4%对57.0%)。新使用者比有使用经验者更有可能停药(风险比 = 1.60;P < 0.0001)。调整后的年化复发率为0.09,在5年结束时,77.1%的患者无复发。
聚乙二醇化干扰素β-1a是治疗复发型多发性硬化症的有效疗法。确定停药的预测因素有助于制定提高治疗依从性的策略。