Zecca Chiara, Disanto Giulio, Mühl Sarah, Gobbi Claudio
Multiple Sclerosis Center, Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
Merck (Schweiz) AG, Zug, Switzerland.
BMC Neurol. 2017 Sep 4;17(1):171. doi: 10.1186/s12883-017-0952-9.
Patient adherence to treatment is key to preventing the worsening of neurological disability in multiple sclerosis (MS). The RebiSmart® autoinjector facilitates self-administration of subcutaneous interferon β-1a (sc IFN β-1a) and records objective adherence data. The CORE study was undertaken to evaluate the relationship between subjectively reported and objective adherence of MS patients using RebiSmart® in Switzerland and explore variables associated with objective adherence.
Patients with relapsing-remitting MS who were treated with sc IFN β-1a 44 or 22 μg three times weekly using RebiSmart® for at least 9 months participated in this phase IV non-interventional study. Neurologist questionnaires were used at month 0 to collect patient demographics, medical history and estimates of patients' adherence. Patient questionnaires were used to record subjective patient-reported adherence at month 0 and estimates of variables influencing adherence. Objective adherence data were obtained from the RebiSmart® log-files at months 0 and 6.
Of 56 patients who completed the observation period, 53 had evaluable data. Objective adherence differed significantly between self-reported compliant (n = 33) and non-compliant groups (n = 20) (p = 0.00001). Older age, greater disability, patient's perception of the importance of ease of use and storage, being well informed about RebiSmart® features and neurologists' estimations of adherence were all positively associated with treatment adherence.
We showed for the first time that subjective patient-reported adherence in MS was well in line with objective adherence, suggesting that the frequency of administration is reported accurately by patients to their neurologist. This observation may have implications for future treatment monitoring strategies and strategic medical decisions. Patients, particularly those who are younger and with lower levels of disability, may benefit from being better informed of the importance of being adherent to their treatments and receiving information about their medication and the device they are using.
患者坚持治疗是预防多发性硬化症（MS）神经功能障碍恶化的关键。RebiSmart®自动注射器便于皮下注射干扰素β-1a（sc IFN β-1a）的自我给药，并记录客观的依从性数据。CORE研究旨在评估瑞士使用RebiSmart®的MS患者主观报告的依从性与客观依从性之间的关系，并探索与客观依从性相关的变量。
复发缓解型MS患者使用RebiSmart®每周三次皮下注射44或22μg干扰素β-1a，治疗至少9个月，参与了这项IV期非干预性研究。在第0个月使用神经科医生问卷收集患者的人口统计学信息、病史以及患者依从性的估计值。使用患者问卷记录第0个月患者主观报告的依从性以及影响依从性的变量估计值。在第0个月和第6个月从RebiSmart®日志文件中获取客观依从性数据。
在完成观察期的56例患者中，53例有可评估数据。自我报告依从组（n = 33）和不依从组（n = 20）的客观依从性有显著差异（p = 0.00001）。年龄较大、残疾程度较高、患者对易用性和储存重要性的认知、对RebiSmart®功能的充分了解以及神经科医生对依从性的估计均与治疗依从性呈正相关。
我们首次表明，MS患者主观报告的依从性与客观依从性高度一致，这表明患者向神经科医生准确报告了给药频率。这一观察结果可能对未来的治疗监测策略和战略医疗决策有影响。患者，尤其是那些较年轻且残疾程度较低的患者，可能会从更好地了解坚持治疗的重要性以及获得有关其药物和所使用设备的信息中受益。
