Leon Leticia, Gomez Alejandro, Vadillo Cristina, Pato Esperanza, Rodriguez-Rodriguez Luis, Jover Juan Angel, Abasolo Lydia
Rheumatology Unit, Hospital Clínico San Carlos; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IDISSC), Madrid; and Health Sciences, Universidad Camilo José Cela, Madrid, Spain.
Rheumatology Unit, Hospital Clínico San Carlos, Madrid, Spain.
Clin Exp Rheumatol. 2018 Jan-Feb;36(1):29-35. Epub 2017 Jun 6.
Biological DMARDs are widely used in the treatment of rheumatoid arthritis (RA) but their relationship with adverse drug reaction (ADR) is important. RA is now known to increase in incidence and prevalence with age. Our objective was to assess the incidence of severe ADR in the long term, compare safety between the different bDMARDs and identify other possible risk factors for severe ADR in elderly RA patients.
A 14-year retrospective longitudinal study was performed. RA patients followed in an out-patient clinic starting bDMARDs after the age of 65 were included.
discontinuation due to a severe ADR related to bDMARDs (etanercept, infliximab, adalimumab, rituximab, golimumab, certolizumab, abatacept and tocilizumab). Covariables: sociodemographic, clinical and therapy. Incidence rates of discontinuation were estimated using survival techniques and comparison between bDMARDs discontinuation rates and other associated factors were run by Cox regression models.
We analysed 286 courses of bDMARDs therapy in 146 elderly patients (604 patient-years). 78% were women, with a mean age at diagnosis of 66.5±7 years, and a median time to the start of the first bDMARDs of 6±4 years. The incidence of discontinuation due to severe ADR estimated was 10.2% patient-years, with a median survival of around 7 years. The most frequent cause was infections. Etanercept had the lowest risk of severe ADR compared to other bDMARDs.
Our study reflects the 'real world' experience in elderly RA patients on bDMARDs, with non-selected patients for a 14-year follow-up.
生物性抗风湿药物（DMARDs）广泛应用于类风湿关节炎（RA）的治疗，但其与药物不良反应（ADR）的关系至关重要。目前已知RA的发病率和患病率会随着年龄增长而升高。我们的目的是评估长期严重ADR的发生率，比较不同生物性DMARDs之间的安全性，并确定老年RA患者发生严重ADR的其他可能风险因素。
进行了一项为期14年的回顾性纵向研究。纳入在门诊开始使用生物性DMARDs且年龄在65岁及以上的RA患者。
因与生物性DMARDs（依那西普、英夫利昔单抗、阿达木单抗、利妥昔单抗、戈利木单抗、赛妥珠单抗、阿巴西普和托珠单抗）相关的严重ADR而停药。协变量：社会人口统计学、临床和治疗情况。使用生存技术估计停药发生率，并通过Cox回归模型比较生物性DMARDs停药率与其他相关因素。
我们分析了146例老年患者（604患者年）的286个生物性DMARDs治疗疗程。78%为女性，诊断时的平均年龄为66.5±7岁，开始首次生物性DMARDs治疗的中位时间为6±4年。估计因严重ADR导致停药的发生率为10.2%患者年，中位生存期约为7年。最常见的原因是感染。与其他生物性DMARDs相比，依那西普发生严重ADR的风险最低。
我们的研究反映了老年RA患者使用生物性DMARDs的“真实世界”经验，对未经过筛选的患者进行了14年的随访。
