Štrosová Daniela, Tužil Jan, Turková Barbora Velacková, Pilnáčková Barbora Filková, de Souza Lada Lžičařová, Doležalová Helena, Rašková Michaela, Dufek Michal, Doležal Tomáš
Value Outcomes Ltd., Vaclavska 316/12, 12000 Prague, Czech Republic.
Medical Informatics, First Medical Faculty, Charles University, Kateřinská 1660/32, 12000 Prague, Czech Republic.
Pharmaceuticals (Basel). 2022 Oct 11;15(10):1248. doi: 10.3390/ph15101248.
A poor patient adherence often limits the real-world effectiveness of an oral disease-modifying therapy (DMT) for multiple sclerosis (MS). In the present study, we aimed to map patient preferences, attitudes toward treatment, and quality of life to identify the predictors of non-adherence to teriflunomide. This was a single-arm, non-interventional, multicenter study (Czech Act 378/2007 Coll.) consisting of three visits: the first at treatment initiation (teriflunomide 14 mg), and then after 3 and 9 months of therapy. We enrolled both DMT-naïve and patients who had undergone a DMT diagnosed with a clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS). The functional status and MS activity were estimated using the Expanded Disability Status Scale (EDSS) and annualized relapse rate (ARR); the quality of life via the Multiple Sclerosis Impact Scale (MSIS-29); the medication adherence with the Morisky Medication Adherence Scale (MMAS-8); the confidence in the ability to take medications by the Self-Efficacy for Appropriate Medication Score (SEAMS); and the attitude to the therapy via the Beliefs about Medicines Questionnaire (BMQ). After nine months of therapy, we predicted the adherence to teriflunomide (MMAS-8) by fitting a multivariate ordinal logistic model with EDSS changes, gender, previous DMT, MSIS-29, BMQ, and SEAMS as the explanatory variables. Between 2018 and 2019, 114 patients were enrolled at 10 sites in the Czech Republic. The mean age was 41.2 years, 64.8% were diagnosed with a CIS, 52.4% were DMT-naïve, and 98.1% of patients preferred an oral administration at the baseline. The mean EDSS baseline was 1.97 and remained constant during the 9 months of therapy. The ARR baseline was 0.72 and dropped to 0.19 and 0.15 after 3 and 9 months, respectively. Despite a more than 4-fold higher ARR baseline, the treatment-naïve patients achieved an ARR at 9 months comparable with those previously treated. There were ten non-serious adverse reactions. After nine months of teriflunomide therapy, 63.3%, 21.2%, and 15.4% of patients had a high, medium, and low adherence, respectively, as per the MMAS-8; 100% of patients preferred an oral administration. The SEAMS score (odds ratio (OR) = 0.91; = 0.013) and previous DMT (OR = 4.28; = 0.005) were the only significant predictors of non-adherence. The disability, the quality of life, and beliefs about medicines had no measurable effect on adherence. After nine months of teriflunomide therapy, both the disability and quality of life remained stable; the relapse rate significantly decreased, 63.3% of patients had a high adherence, and 100% of patients preferred an oral administration. A low adherence was associated with previous DMT experiences and a low self-efficacy for the appropriate medication (i.e., the confidence in one's ability to take medication correctly).
患者依从性差往往会限制口服疾病修正疗法(DMT)对多发性硬化症(MS)的实际疗效。在本研究中,我们旨在梳理患者的偏好、对治疗的态度和生活质量,以确定对特立氟胺不依从的预测因素。这是一项单臂、非干预性、多中心研究(捷克第378/2007号法案),包括三次就诊:第一次在治疗开始时(特立氟胺14毫克),然后在治疗3个月和9个月后。我们纳入了未接受过DMT治疗的患者以及被诊断为临床孤立综合征(CIS)或复发缓解型多发性硬化症(RRMS)且接受过DMT治疗的患者。使用扩展残疾状态量表(EDSS)和年化复发率(ARR)评估功能状态和MS活动;通过多发性硬化症影响量表(MSIS - 29)评估生活质量;通过Morisky药物依从性量表(MMAS - 8)评估药物依从性;通过适当用药自我效能量表(SEAMS)评估对服药能力的信心;通过药物信念问卷(BMQ)评估对治疗的态度。在治疗9个月后,我们通过拟合一个多变量有序逻辑模型来预测对特立氟胺的依从性(MMAS - 8),该模型以EDSS变化、性别、既往DMT治疗情况、MSIS - 29、BMQ和SEAMS作为解释变量。2018年至2019年期间,在捷克共和国的10个地点招募了114名患者。平均年龄为41.2岁,64.8%的患者被诊断为CIS,52.4%的患者未接受过DMT治疗,98.1%的患者在基线时更喜欢口服给药。EDSS基线平均值为1.97,在9个月的治疗期间保持不变。ARR基线为0.72,在3个月和9个月后分别降至0.19和0.15。尽管ARR基线高出四倍多,但未接受过治疗的患者在9个月时达到的ARR与之前接受过治疗的患者相当。出现了10例非严重不良反应。在特立氟胺治疗9个月后,根据MMAS - 8,分别有63.3%、21.2%和15.4%的患者具有高、中、低依从性;100%的患者更喜欢口服给药。SEAMS评分(优势比(OR)= 0.91;P = 0.013)和既往DMT治疗情况(OR = 4.28;P = 0.005)是不依从的仅有的显著预测因素。残疾程度、生活质量和对药物的信念对依从性没有可测量的影响。在特立氟胺治疗9个月后,残疾程度和生活质量均保持稳定;复发率显著降低,63.3%的患者具有高依从性,100%的患者更喜欢口服给药。低依从性与既往DMT治疗经历以及适当用药的自我效能低(即对正确服药能力的信心低)有关。