Dhib-Jalbut Suhayl, Markowitz Clyde, Patel Payal, Boateng Francis, Rametta Mark
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA (SDJ); University of Pennsylvania, Philadelphia, PA, USA (CM); and Bayer HealthCare, Wayne, NJ, USA (PP, FB, MR).
Int J MS Care. 2012 Winter;14(4):198-208. doi: 10.7224/1537-2073-14.4.198.
There is limited clinical evidence on the impact of nurse support and adverse event (AE) mitigation techniques on adherence to interferon beta-1b (IFNβ-1b) therapy in multiple sclerosis (MS) in a real-world setting. The aim of the Success of Titration, analgesics, and BETA nurse support on Acceptance Rates in MS Treatment (START) trial was to assess the combined effect of titration, analgesics, and BETA (Betaseron Education, Training, Assistance) nurse support on adherence to IFNβ-1b therapy in patients with early-onset MS and to evaluate safety. Participants were instructed to titrate IFNβ-1b and use analgesics to minimize flu-like symptoms. All received BETA nurse follow-up at frequent intervals: live training, two telephone calls during the first month of therapy, and monthly calls thereafter. Participants were considered adherent if they took at least 75% of the total prescribed doses over 12 months (≥75% compliance). Safety was monitored via reported AEs and laboratory test results. Participants who took at least one IFNβ-1b dose over 12 months were analyzed (N = 104); 73.8% of participants completed the study. The mean age of participants was 37.2 years; 72.1% were women and 78.8% were white. Ninety participants had relapsing-remitting MS and 14 had clinically isolated syndrome. The mean compliance rate, reported for 96 participants with complete dose interruption records, was 84.4%. At 12 months, 78.1% of participants were considered adherent. The serious adverse event rate was 9.6%; most events were unrelated to therapy. Thus in the START study, in which participants received nursing support combined with dose titration and use of analgesics, the majority of participants were adherent to therapy.
在真实临床环境中，关于护士支持和不良事件（AE）缓解技术对多发性硬化症（MS）患者坚持使用β-1b干扰素（IFNβ-1b）治疗的影响，临床证据有限。MS治疗中滴定、镇痛药及BETA护士支持对接受率的影响（START）试验的目的是评估滴定、镇痛药及BETA（倍泰龙教育、培训、协助）护士支持对早发型MS患者坚持IFNβ-1b治疗的综合效果，并评估安全性。指导参与者滴定IFNβ-1b并使用镇痛药以减轻流感样症状。所有参与者均接受频繁的BETA护士随访：现场培训、治疗第一个月两次电话随访以及此后每月一次电话随访。如果参与者在12个月内服用了至少75%的总处方剂量（依从性≥75%），则被视为依从。通过报告的AE和实验室检查结果监测安全性。对在12个月内至少服用一剂IFNβ-1b的参与者进行分析（N = 104）；73.8%的参与者完成了研究。参与者的平均年龄为37.2岁；72.1%为女性，78.8%为白人。90名参与者患有复发缓解型MS，14名患有临床孤立综合征。96名有完整剂量中断记录的参与者报告的平均依从率为84.4%。在12个月时，78.1%的参与者被视为依从。严重不良事件发生率为9.6%；大多数事件与治疗无关。因此，在START研究中，参与者接受了护理支持、剂量滴定和镇痛药使用，大多数参与者坚持了治疗。
