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Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study)

机译：坚持使用电子注射设备进行皮下干扰素β-1a治疗：一项前瞻性开放标签的斯堪的纳维亚非介入研究（ScanSmart研究）

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Background: Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes. Objective: To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart? and assess injection-site reactions and treatment satisfaction. Methods: This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS. Adherence was measured over 12 weeks. Items 13–23, 35, 37, and 38 of the Multiple Sclerosis Treatment Concerns Questionnaire (injection-site reactions and treatment satisfaction) were recorded at 12 weeks. Results: Sixty patients were recruited (mean age 43.7 [±SD 7.9] years; 83% female; mean years since multiple sclerosis diagnosis 6.7 [SD 4.5]). Adherence data were obtained in 54 patients only due to technical problems with six devices. Over 12 weeks, 89% (n=48) of patients had ≥90% adherence to treatment. Most patients experienced mild influenza-like symptoms and injection-site reactions, and global side effects were minimal. Most patients (78%) rated the convenience as the most important aspect of the device, and most experienced no or mild pain. Conclusion: RRMS patients treated with subcutaneous interferon beta-1a, administered with RebiSmart, demonstrated generally good adherence, and the treatment was generally well tolerated.
机译：背景：疾病改良药物有助于控制复发缓解多发性硬化症（RRMS）的进程;但是，长期结果需要良好的依从性。目的：使用RebiSmart 评价患者对皮下干扰素β-1a治疗的依从性？ 并评估注射部位的反应和治疗满意度。方法：这项前瞻性，单臂，开放标签，非介入性的多中心IV期临床试验纳入了经验丰富，经验丰富的可移动药物的RRMS流动患者。在12周内测量粘附性。在第12周记录多发性硬化症治疗关注问卷（注射部位反应和治疗满意度）的13-23、35、37和38项目。结果：招募了60名患者（平均年龄43.7 [±SD 7.9]岁;女性83％;自多发性硬化症诊断以来的平均年龄6.7 [SD 4.5]）。仅由于六台设备的技术问题而获得了54例患者的依从性数据。在12周内，有89％（n = 48）的患者坚持治疗≥90％。大多数患者出现轻度的流感样症状和注射部位反应，总体副作用很小。大多数患者（78％）认为便利性是设备的最重要方面，并且大多数患者没有疼痛或轻微疼痛。结论：皮下注射干扰素β-1a的RRMS患者，与RebiSmart一起使用，表现出良好的依从性，并且治疗耐受性良好。

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