Centonze Diego, Fantozzi Roberta, Buttari Fabio, Grimaldi Luigi Maria Edoardo, Totaro Rocco, Corea Francesco, Marrosu Maria Giovanna, Confalonieri Paolo, Cottone Salvatore, Trojano Maria, Zipoli Valentina
Scientific Institute for Research, Hospitalization and Healthcare (IRCCS) Neuromed, Pozzilli, Isernia, Italy.
Synaptic Immunopathology Lab, Department of Systems Medicine, Tor Vergata University, Rome, Italy.
Front Neurol. 2021 Apr 22;12:637615. doi: 10.3389/fneur.2021.637615. eCollection 2021.
Subcutaneous (SC) interferons beta (IFN-beta) are effective therapies for the treatment of relapsing-remitting multiple sclerosis (RRMS). Factors such as dosing schedule, needle intolerance/fatigue, and side effects may impact patient satisfaction with treatment. Improvement of patient satisfaction may increase the adherence to treatment and the patient quality of life. This study was aimed at evaluating the impact of switching to "Peginterferon beta-1a (Peg-IFN beta-1a)" in patients with RRMS unsatisfied with other SC interferons. The multicenter, open-label, phase IV PLATINUM study was conducted in 32 Italian centers. The primary endpoint was changes from baseline in the score of a convenience satisfaction domain of the TSQM-9 questionnaire at 12 weeks. The secondary endpoints were patients' global satisfaction, short-term adherence to treatment, satisfaction with the injection system, effect on fatigue, disease activity, and patient inability score. A total of 193 patients were enrolled and 166 (86%) completed the study, receiving Peg-IFN beta-1a for 24 weeks. Patients switching to Peg-IFN beta-1a from other SC interferons reported a significant improvement ( < 0.001) of Convenience Score and all other scores of the TSQM-9 questionnaire at 12 and 24 weeks ( < 0.001). Peg IFN beta-1a attained very high adherence to the treatment (92 and 86% at 12 and 24 weeks, respectively) with a stable annualized relapse rate (ARR). At 24 weeks, 94% of the participants were relapse free. Adverse events (AEs), recorded on 82 patients (42%), were mild or moderate. The most common AE was flu-like syndrome (29.2%). Patients switching from SC IFN beta therapy to Peg IFN beta-1a showed high treatment satisfaction with a positive safety profile, comparable with that of other currently approved first-line injectable SC interferons. This study suggests that Peg IFN beta-1a might represent a treatment choice to improve adherence in RRMS patients unsatisfied with other SC interferons.
皮下注射（SC）干扰素β（IFN-β）是治疗复发缓解型多发性硬化症（RRMS）的有效疗法。给药方案、注射不耐受/疲劳以及副作用等因素可能会影响患者对治疗的满意度。提高患者满意度可能会增加治疗依从性并改善患者生活质量。本研究旨在评估改用“聚乙二醇化干扰素β-1a（Peg-IFN β-1a）”对那些对其他皮下注射干扰素不满意的RRMS患者的影响。这项多中心、开放标签的IV期PLATINUM研究在意大利的32个中心进行。主要终点是12周时TSQM-9问卷便利性满意度领域得分相对于基线的变化。次要终点包括患者的总体满意度、短期治疗依从性、对注射系统的满意度、对疲劳的影响、疾病活动度以及患者失能评分。总共193名患者入组，166名（86%）完成了研究，接受Peg-IFN β-1a治疗24周。从其他皮下注射干扰素改用Peg-IFN β-1a的患者在12周和24周时便利性得分以及TSQM-9问卷的所有其他得分均有显著改善（<0.001）。Peg IFN β-1a的治疗依从性非常高（12周和24周时分别为92%和86%），年化复发率（ARR）稳定。在24周时，94%的参与者无复发。82名患者（42%）记录到不良事件（AE），均为轻度或中度。最常见的AE是流感样综合征（29.2%）。从SC IFN β治疗改用Peg IFN β-1a的患者对治疗满意度高，安全性良好，与目前其他已批准的一线皮下注射干扰素相当。本研究表明，Peg IFN β-1a可能是提高那些对其他皮下注射干扰素不满意的RRMS患者依从性的一种治疗选择。
