Lampropoulos Christos E, Orfanos Philippos, Bournia Vasiliki-Kalliopi, Karatsourakis Theofilos, Mavragani Clio, Pikazis Dimitrios, Manoussakis Menelaos N, Tzioufas Athanasios G, Moutsopoulos Haralampos M, Vlachoyiannopoulos Panayiotis G
Department of Pathophysiology, Medical School, National University of Athens, Greece.
Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National University of Athens, Athens, Greece.
Clin Exp Rheumatol. 2015 Mar-Apr;33(2):216-24. Epub 2015 Feb 9.
Treatment of rheumatoid arthritis (RA) with disease-modifying anti-rheumatic drugs (DMARDs), either synthetic (sDMARDs) or biologic agents (bDMARDs) has significantly improved disease outcome. However, the impact of therapy-related adverse events (AEs), mild, moderate or serious, on disease outcome is under debate. The purpose of the study was to test the hypothesis that AEs, including infections, are rather common in patients receiving bDMARDs than in those receiving sDMARDs.
Analysis of the medical records of patients followed in a single outpatient clinic was performed. In total, 1403 adults (295 men, 1108 women) were included in the analysis (969 treated with sDMARDs only, 434 with bDMARDs). All AEs and infections were recorded and their severity was graded according to international criteria. Incident rates were calculated and Kaplan-Meier plots as well as Cox proportional-hazards models were performed to examine the association of treatment groups with the risk of any AE.
The risk of any AE, irrespective of severity, was significantly higher in patients with bDMARDs with the adjusted hazard ratio being 1.98 (95% CI: 1.64 to 2.39). Patients in the biologic group treated initially with infliximab or adalimumab had a higher risk of AE compared to patients receiving etanercept or other biologic agents. Among patients treated with methotrexate, those receiving a dose below 10 mg had a higher risk of any AE when compared to those receiving higher doses.
The risk of any AE among RA patients treated with bDMARDs was significantly higher compared to those treated with sDMARDs.
使用改善病情抗风湿药物（DMARDs）治疗类风湿关节炎（RA），无论是合成药物（sDMARDs）还是生物制剂（bDMARDs），都显著改善了疾病结局。然而，治疗相关不良事件（AE），无论轻度、中度还是重度，对疾病结局的影响仍存在争议。本研究的目的是检验以下假设：包括感染在内的不良事件在接受bDMARDs治疗的患者中比接受sDMARDs治疗的患者更常见。
对在单一门诊诊所随访的患者病历进行分析。总共1403名成年人（295名男性，1108名女性）纳入分析（969名仅接受sDMARDs治疗，434名接受bDMARDs治疗）。记录所有不良事件和感染情况，并根据国际标准对其严重程度进行分级。计算发病率，并进行Kaplan-Meier曲线分析以及Cox比例风险模型分析，以检验治疗组与任何不良事件风险之间的关联。
无论严重程度如何，接受bDMARDs治疗的患者发生任何不良事件的风险显著更高，调整后的风险比为1.98（95%CI：1.64至2.39）。与接受依那西普或其他生物制剂治疗的患者相比，最初接受英夫利昔单抗或阿达木单抗治疗的生物制剂组患者发生不良事件的风险更高。在接受甲氨蝶呤治疗的患者中，与接受较高剂量的患者相比，接受剂量低于10mg的患者发生任何不良事件的风险更高。
与接受sDMARDs治疗的类风湿关节炎患者相比，接受bDMARDs治疗的患者发生任何不良事件的风险显著更高。
