a Department of Neuroscience, Imaging and Clinical Sciences , G. 'd'Annunzio University' - S.S. Annunziata Hospital , Chieti , Italy.
b Department of Neurology , AUSL 'Vito Fazzi' , Lecce , Italy.
Expert Opin Drug Deliv. 2016 Jul;13(7):931-5. doi: 10.1517/17425247.2016.1148029. Epub 2016 Feb 24.
The BRIDGE study has previously shown a high short-term (12 weeks) adherence rate (>85%) of patients with relapsing-remitting multiple sclerosis (RRMS) to subcutaneous self-injections of interferon β-1a using an electronic auto-injection device (RebiSmart®). The primary goal of the RIVER study was to investigate in a real-life setting the long-term adherence to the use of RebiSmart among patients enrolled in the parent BRIDGE study.
The RIVER study was designed as a real-life extension study of the BRIDGE trial. RRMS patients who completed BRIDGE and still had an indication for treatment were included. Data were collected prospectively through the RebiSmart device, and analyzed retrospectively. Long term adherence (administration of ≥ 80% of injections) to and safety of RebiSmart were assessed. The expected follow-up period ranged from 19 to 26 months.
A total of 57 RRMS patients participated in the follow-up study. The mean observation period was 20.5 ± 5.7 months. The overall adherence to the use of RebiSmart in the entire study cohort was 79.8% (median = 85.2%, range = 16-100%). There were 36 patients (63.2%) who completed at least 80% of the scheduled injections. No statistically significant differences were found between adherent and non-adherent patients in terms of age, sex, duration of the observation period, and occurrence of relapses. No serious treatment-related adverse events occurred.
This study showed a high level of long-term adherence to the use of RebiSmart, with 63.2% of participants meeting the criterion for adherence to treatment.
BRIDGE 研究先前显示，接受复发缓解型多发性硬化症（RRMS）治疗的患者对皮下自我注射干扰素 β-1a 的短期（12 周）依从率（>85%）较高，使用电子自动注射装置（RebiSmart®）。RIVER 研究的主要目的是在真实环境中研究接受 BRIDGE 研究入组的患者长期使用 RebiSmart 的依从性。
RIVER 研究是 BRIDGE 试验的真实扩展研究。纳入完成 BRIDGE 研究且仍有治疗指征的 RRMS 患者。数据通过 RebiSmart 设备前瞻性收集，并进行回顾性分析。评估长期（注射次数≥80%）使用 RebiSmart 的依从性和安全性。预期随访期为 19 至 26 个月。
共有 57 例 RRMS 患者参加了随访研究。平均观察期为 20.5±5.7 个月。整个研究队列中 RebiSmart 的总体使用率为 79.8%（中位数=85.2%，范围=16-100%）。有 36 名患者（63.2%）完成了至少 80%的计划注射。在依从性和非依从性患者中，年龄、性别、观察期长短和复发发生情况均无统计学差异。未发生严重的与治疗相关的不良事件。
这项研究显示，RebiSmart 的长期使用率较高，63.2%的参与者符合治疗依从性标准。
