Bartolomé-García Emma, Usarralde-Pérez Ángela, Sanmartín-Fenollera Patricia, Pérez-Encinas Monserrat
Department of Pharmacy, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.
Eur J Hosp Pharm. 2019 Jan;26(1):23-28. doi: 10.1136/ejhpharm-2017-001286. Epub 2017 Aug 31.
To analyse persistence and adherence in patients with multiple sclerosis receiving first-line treatment with subcutaneous glatiramer acetate 20 mg (GA), subcutaneous interferon β1a (IFNβ1a-sc), intramuscular interferon β1a (IFNβ1a-im) and subcutaneous interferon β1b (IFNβ1b-sc) and to identify associated factors and reasons for discontinuation.
An observational retrospective study was performed between January 1999 and November 2014. Persistence was defined as the time from treatment initiation until discontinuation, and adherence as the number of units dispensed since treatment initiation until its interruption divided by the theoretical number of units needed to cover said period as a percentage. A patient was considered adherent if ≥95%. Persistence was measured using the Kaplan-Meier method and univariate Cox regression; adherence was measured using a univariate binary logistical regression model.
The study included 224 patients. The median persistence was 1349 days (95% CI 1017.4 to 1680.6). Patients receiving IFNβ1a-im continued treatment for a longer time (1720 days; 95% CI 1196.8 to 2243.2), while patients treated with IFNβ1a-sc had the lowest persistence (771 days; 95% CI 377.4 to 1164.6) (HR=1.7; 95% CI 1.02 to 2.72). Patients with Expanded Disability Status Scale (EDSS) 1.5-6 discontinued treatment earlier than those with EDSS 0-1 (HR 1.5; 95% CI 1.01 to 2.25); 94.4% of patients discontinued treatment due to medical decision, primarily due to lack of efficacy (24.6%) and adverse effects (17.4%), while 80.8% of patients had good adherence. GA had the highest adherence, with no major difference from IFNβ1a-im, while IFNβ1b-sc showed the highest non-adherence (OR 3.5; 95% CI 1.29 to 9.28).
The persistence levels obtained were lower than in similar studies. EDSS was identified as an independent predictor of treatment interruption. Acceptable adherence was achieved among the population, comparable to other studies and influenced by the drug.
分析接受皮下注射20mg醋酸格拉替雷（GA）、皮下注射干扰素β1a（IFNβ1a - sc）、肌肉注射干扰素β1a（IFNβ1a - im）和皮下注射干扰素β1b（IFNβ1b - sc）一线治疗的多发性硬化症患者的持续治疗情况和依从性，并确定相关因素及停药原因。
于1999年1月至2014年11月进行了一项观察性回顾性研究。持续治疗时间定义为从开始治疗到停药的时间，依从性定义为从开始治疗到中断期间发放的单位数量除以该时间段所需的理论单位数量，以百分比表示。如果≥95%，则认为患者依从。使用Kaplan - Meier方法和单变量Cox回归测量持续治疗时间；使用单变量二元逻辑回归模型测量依从性。
该研究纳入了224例患者。中位持续治疗时间为1349天（95%CI 1017.4至1680.6）。接受IFNβ1a - im治疗的患者持续治疗时间更长（1720天；95%CI 1196.8至2243.2），而接受IFNβ1a - sc治疗的患者持续治疗时间最短（771天；95%CI 377.4至1164.6）（HR = 1.7；95%CI 1.02至2.72）。扩展残疾状态量表（EDSS）评分为1.5 - 6的患者比EDSS评分为0 - 1的患者更早停药（HR 1.5；95%CI 1.01至2.25）；94.4%的患者因医疗决策停药，主要原因是缺乏疗效（24.6%）和不良反应（17.4%），而80.8%的患者依从性良好。GA的依从性最高，与IFNβ1a - im无显著差异，而IFNβ1b - sc的不依从性最高（OR 3.5；95%CI 1.29至9.28）。
所获得的持续治疗水平低于类似研究。EDSS被确定为治疗中断的独立预测因素。总体人群达到了可接受的依从性，与其他研究相当，且受药物影响。
