Leon Leticia, Rodriguez-Rodriguez Luis, Freites Dalifer, Arietti Lucia, Morado Inmaculada, Vadillo Cristina, Lamas José Ramón, Fernandez Benjamin, Jover Juan Angel, Abasolo Lydia
Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IDISSC), Madrid; and Universidad Camilo José Cela, Madrid, Spain.
Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IDISSC), Madrid, Spain.
Clin Exp Rheumatol. 2017 Mar-Apr;35 Suppl 103(1):165-170. Epub 2017 Jan 23.
To assess the long-term continuation of methotrexate (MTX) in a cohort of patients with giant cell arteritis (GCA) in daily clinical practice. Factors associated with its discontinuation rate were also investigated.
A longitudinal study from 1991-2014, was performed. GCA patients with MTX and followed-up in a rheumatology outpatient clinic of Madrid during the study period were included.
discontinuation of MTX due to: adverse drug reactions (ADR moderate and severe); inefficacy; sustained clinical response; patient decision. Covariables: sociodemographic, clinical and therapy. Incidence rates (IR) of MTX discontinuation per 100 patient-years with their 95% confidence interval (CI) were estimated using survival techniques. Factors associated to specific discontinuation causes were analysed using Cox models.
We included 108 patients (244 patient-years). The IR was 37.2 [30.3-45.7]. The IR due to ADR, severe ADR, sustained clinical response and inefficacy was 20.8 [15.8-27.4]; 5.7 [3.3-9.6]; 8.2 [5.3-12.7] and 2.8 [1.3-6.0], respectively. Regarding multivariate analysis, younger patients, baseline cardiovascular disease, taking more glucocorticoids and lower initial doses of MTX were associated to a higher discontinuation rate due to inefficacy. Factors influencing the suspension due to ADRs were: older age, baseline. Chronic obstructive pulmonary disease, higher baseline erythrocyte sedimentation rate, several specific clinical patterns at diagnosis, and higher maximum dose of MTX during the follow up. In the final model for sustained clinical response older patients and more recurrences were independently associated to less discontinuation rate.
We provide further data of the potential safety of long-term MTX in the management of GCA. We have also found several factors influencing the continuation of MTX.
在日常临床实践中,评估一组巨细胞动脉炎(GCA)患者长期使用甲氨蝶呤(MTX)的情况。同时研究与MTX停药率相关的因素。
进行了一项1991年至2014年的纵向研究。纳入在研究期间于马德里一家风湿病门诊接受MTX治疗并随访的GCA患者。
MTX停药原因包括:药物不良反应(中度和重度);无效;持续临床缓解;患者决定。协变量:社会人口统计学、临床和治疗因素。使用生存技术估计每100患者年MTX停药的发生率(IR)及其95%置信区间(CI)。使用Cox模型分析与特定停药原因相关的因素。
我们纳入了108例患者(244患者年)。发生率为37.2[30.3 - 45.7]。因药物不良反应、严重药物不良反应、持续临床缓解和无效导致的发生率分别为20.8[15.8 - 27.4];5.7[3.3 - 9.6];8.2[5.3 - 12.7]和2.8[1.3 - 6.0]。在多变量分析中,年轻患者、基线心血管疾病、服用更多糖皮质激素以及MTX初始剂量较低与因无效导致的较高停药率相关。影响因药物不良反应而停药的因素有:年龄较大、基线慢性阻塞性肺疾病、较高的基线红细胞沉降率、诊断时的几种特定临床模式以及随访期间MTX的最大剂量较高。在持续临床缓解的最终模型中,老年患者和更多复发与较低的停药率独立相关。
我们提供了关于长期MTX治疗GCA潜在安全性的进一步数据。我们还发现了几个影响MTX持续使用的因素。