Degli Esposti Luca, Piccinni Carlo, Sangiorgi Diego, Perrone Valentina, Aledda Lucia, Marrosu Maria Giovanna, Lombardo Fabio
Clicon Srl, Health, Economics, and Outcomes Research, Via Salara, 36, 48100, Ravenna, Italy.
Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Neurol Sci. 2017 Apr;38(4):589-594. doi: 10.1007/s10072-016-2806-4. Epub 2017 Jan 11.
This study was aimed to describe changes of Disease-Modifying Treatments (DMT) in an Italian cohort of patients with multiple sclerosis (MS) and to identify predictors of therapeutic modifications. Patients with MS and treated with the first-line injectable DMT (interferons-IFNs or glatiramer) between 1/7/2009 and 31/10/2012 were selected from administrative databases of the MS Center of Cagliari (Sardinia, Italy). Socio-demographic, therapeutic, and clinical information was collected in the 6 months preceding the index date. All patients were followed for 36 months to evaluate therapeutic changes in terms of non-adherence, switch, temporary discontinuation, and permanent interruption. Predictors of changes were estimated by multivariable regression models. Data on 1698 patients were collected: glatiramer was prescribed in 27% of cases, IFNβ-1b in 22%, IFNβ-1a-im in 20%, IFNβ-1a-sc-44mcg in 19%, and IFNβ-1a-sc-22mcg in 12%. Non-adherence was observed in 25% of cases, therapeutic switch in 30%, discontinuation in 37%, and permanent interruption in 28%. The risk of non-adherence was higher for IFNβ-1b, compared with IFNβ-1a-im (adjOR = 1.73). Therapeutic switch occurred especially in patients recently diagnosed (each year from diagnosis causes a decrease of this risk adjHR = 0.97); the risk of discontinuation was higher with EDSS = 4-6 and 7-9 (adjHR = 1.52 and 4.42, respectively). The risk of permanent interruption increased with the augmentation of disability (adjHR = 1.67 and 5.43 for EDSS 4-6 and 7-9). This study mirrored a detailed framework of DMT prescription and identified factors related to changes in the MS therapy. These findings could support healthcare providers in the evaluation and maximization of benefits associated with a long-term DMT.
本研究旨在描述意大利多发性硬化症(MS)患者队列中疾病修正治疗(DMT)的变化情况,并确定治疗调整的预测因素。2009年7月1日至2012年10月31日期间接受一线注射用DMT(干扰素-IFN或格拉替雷)治疗的MS患者,从意大利撒丁岛卡利亚里MS中心的行政数据库中选取。在索引日期前6个月收集社会人口统计学、治疗和临床信息。对所有患者进行36个月的随访,以评估治疗依从性、换药、暂时停药和永久停药方面的治疗变化。通过多变量回归模型估计变化的预测因素。收集了1698例患者的数据:27%的病例使用格拉替雷,22%使用IFNβ-1b,20%使用IFNβ-1a-im,19%使用IFNβ-1a-sc-44mcg,12%使用IFNβ-1a-sc-22mcg。25%的病例观察到治疗不依从,30%的病例进行了治疗换药,37%的病例停药,28%的病例永久中断治疗。与IFNβ-1a-im相比,IFNβ-1b治疗不依从的风险更高(调整后比值比=1.73)。治疗换药尤其发生在近期诊断的患者中(从诊断起每年这种风险降低,调整后风险比=0.97);扩展残疾状态量表(EDSS)评分为4-6和7-9时停药风险更高(调整后风险比分别为1.52和4.42)。永久中断治疗的风险随着残疾程度的增加而增加(EDSS 4-6和7-9时调整后风险比分别为1.67和5.43)。本研究反映了DMT处方的详细框架,并确定了与MS治疗变化相关的因素。这些发现可为医疗保健提供者评估和最大化长期DMT相关益处提供支持。