Köhler Wolfgang, Bayer-Gersmann Kirsten, Neußer Thomas, Schürks Markus, Ziemssen Tjalf
Department of Neurology, University of Leipzig Medical Center, Leipzig, Germany.
Institut Dr. Schauerte, Munich, Germany.
Front Neurol. 2021 Feb 24;12:643126. doi: 10.3389/fneur.2021.643126. eCollection 2021.
In patients with multiple sclerosis (MS), non-adherence to disease-modifying drug therapy is associated with an increased rate of MS relapses. Early identification of patients at risk of non-adherence would allow provision of timely and individualized support. The aim of the BETAPREDICT study was to investigate potential predictors of adherence in patients with MS in Germany treated with interferon β-1b (IFNβ-1b) using the BETACONNECT® autoinjector. BETAPREDICT was a national, multi-center, prospective, non-interventional, single-arm, 24-month cohort study of patients with relapsing-remitting MS or clinically isolated syndrome receiving IFNβ-1b via the BETACONNECT® autoinjector (ClinicalTrials.gov: NCT02486640). Injection data were captured by the autoinjector. The primary objective was to determine baseline predictors of compliance, persistence, and adherence to IFNβ-1b treatment after 12- and 24 months using multivariable-adjusted regression. Secondary objectives included evaluation of satisfaction with the autoinjector, injection site pain, vitamin and nutrient supplementation, clinical course, and patient-related outcome measures. Of 165 patients enrolled, 153 were available for analysis (120 with autoinjector data). Seventy-two patients left the study prematurely. Compliance ( = 120), persistence ( = 153), and adherence ( = 120) at 24 months were 89.1, 53.6, and 41.7%, respectively. Compliance at 12- and 24 months was predicted by intake of vitamin D supplements and absence of specific injection site reactions. Positive predictors of persistence included age (at 12- and 24 months) and previous duration of treatment (at 12 months), while intake of vitamins/nutrients other than vitamin D was a negative predictor (at 12 months). Positive predictors of adherence at 24 months were age and being experienced with IFNβ-1b. Higher scores in specific SF-36 subscales were positive predictors of medication-taking behavior at 24 months. Satisfaction with the autoinjector was high at baseline and 24 months (median score: 9 out of 10). Compliance with IFNβ-1b treatment among participants still under observation remained high over a 24-month period, while persistence and adherence continuously declined. Multiple factors affected medication-taking behavior, including patient characteristics, treatment history, injection site reactions, patients' perception of their health and support programs. The importance of these factors may differ among patients according to their individual situation.
在多发性硬化症（MS）患者中，不坚持疾病修正药物治疗与MS复发率增加相关。早期识别有不坚持治疗风险的患者将有助于提供及时且个性化的支持。BETAPREDICT研究的目的是使用BETACONNECT®自动注射器，调查在德国接受β-1b干扰素（IFNβ-1b）治疗的MS患者中坚持治疗的潜在预测因素。BETAPREDICT是一项全国性、多中心、前瞻性、非干预性、单臂、为期24个月的队列研究，研究对象为复发缓解型MS或临床孤立综合征患者，他们通过BETACONNECT®自动注射器接受IFNβ-1b治疗（ClinicalTrials.gov：NCT02486640）。注射数据由自动注射器记录。主要目标是使用多变量调整回归确定12个月和24个月后IFNβ-1b治疗依从性、持续性和坚持性的基线预测因素。次要目标包括评估对自动注射器的满意度、注射部位疼痛、维生素和营养补充、临床病程以及与患者相关的结局指标。在登记的165名患者中，153名可供分析（120名有自动注射器数据）。72名患者提前退出研究。24个月时的依从性（n = 120）、持续性（n = 153）和坚持性（n = 120）分别为89.1%、53.6%和41.7%。12个月和24个月时的依从性可通过维生素D补充剂的摄入情况和是否存在特定注射部位反应来预测。持续性的积极预测因素包括年龄（12个月和24个月时）和既往治疗时长（12个月时），而除维生素D外的维生素/营养补充剂的摄入是一个消极预测因素（12个月时）。24个月时坚持性的积极预测因素是年龄和有使用IFNβ-1b的经验。特定SF-36子量表中较高的分数是24个月时服药行为的积极预测因素。在基线和24个月时对自动注射器的满意度较高（中位得分：十分制中的9分）。在24个月期间，仍在观察的参与者中IFNβ-1b治疗的依从性保持较高水平，而持续性和坚持性持续下降。多种因素影响服药行为，包括患者特征、治疗史、注射部位反应、患者对自身健康的认知以及支持项目。这些因素的重要性可能因患者的个体情况而异。
