Martínez-López-de-Castro Noemi, Álvarez-Payero Miriam, Samartín-Ucha Marisol, Martín-Vila Alicia, Piñeiro-Corrales Guadalupe, Rodríguez-Rodríguez María, Maceiras-Pan Francisco José, Melero-González Rafael Benito, Pego-Reigosa Jose María
Department of Pharmacy, University Hospital Complex of Vigo, Pontevedra, Spain.
Galicia Sur Biomedical Foundation, University Hospital Complex of Vigo Estrada Clara Campoamor, Pontevedra, Spain.
Eur J Rheumatol. 2020 Apr;7(2):53-59. doi: 10.5152/eurjrheum.2019.19123. Epub 2020 Jan 2.
The marketing of biological therapies transformed the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. But there is still concern about patient safety and management in daily clinical practice. The aim of this study was to estimate risk factors of the adverse effects in a cohort of Spanish patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.
A single institution, descriptive, retrospective, cohort study was developed from January 2009 to December 2016. Patients diagnosed with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis on biological therapies were included. Undesirable events affecting patients during biological therapy, their clinical implications and the use of health resources related to adverse effects were collected.
Three hundred and sixty-two patients corresponding to 478 biological therapy lines were analysed. It implied 1192 years of monitoring. There were 57 adverse effects per 100 biological patient-years and 4.8 serious adverse effects per 100 biological patient-years. The only significant factor for a likely serious adverse effect was having a Charlson Index ≥10, OR of 6.2 (CI 95%: 3.4-11.1, p<0.001). Around 15 % of patients with adverse effects were admitted to hospital and 25% received attention at the Emergency Department.
Over half of the patients with arthropathies on biological therapy can suffer adverse effect during treatment but only 8.5% of these effects are serious. Special vigilance must be paid to patients with a higher number of comorbidities because they are more likely to experience serious adverse effects.
生物疗法的推广改变了类风湿关节炎、强直性脊柱炎和银屑病关节炎的治疗方式。但在日常临床实践中，患者安全及管理问题仍令人担忧。本研究旨在评估一组西班牙类风湿关节炎、强直性脊柱炎和银屑病关节炎患者发生不良反应的风险因素。
开展一项单机构、描述性、回顾性队列研究，研究时间为2009年1月至2016年12月。纳入接受生物疗法治疗的类风湿关节炎、强直性脊柱炎和银屑病关节炎患者。收集生物治疗期间影响患者的不良事件、其临床意义以及与不良反应相关的医疗资源使用情况。
分析了对应478个生物治疗疗程的362例患者。这意味着1192年的监测。每100个生物治疗患者年中有57例不良反应，每100个生物治疗患者年中有4.8例严重不良反应。发生严重不良反应的唯一显著因素是查尔森指数≥10，比值比为6.2（95%置信区间：3.4 - 11.1，p<0.001）。约15%发生不良反应的患者住院，25%在急诊科接受治疗。
接受生物治疗的关节病患者中，超过一半在治疗期间会出现不良反应，但其中只有8.5%为严重不良反应。必须特别警惕合并症较多的患者，因为他们更易发生严重不良反应。
