Carmona Loreto, Gómez-Reino Juan J
Research Unit, Spanish Society of Rheumatology, Madrid, Spain Marques de Duero 5, 28001 Madrid, Spain.
Arthritis Res Ther. 2006;8(3):R72. doi: 10.1186/ar1941. Epub 2006 Apr 18.
The aim of the present work is to compare drug survival and safety of infliximab, etanercept, and adalimumab (tumor necrosis factor [TNF] antagonists) in spondylarthritis (SpA) with those of rheumatoid arthritis (RA). To this purpose, we analysed the data in BIOBADASER (2000-2005), a drug registry launched in 2000 for long-term follow-up of the safety of these biologics in rheumatic diseases. The rates of drug discontinuation and adverse events (AEs) in SpA (n = 1,524) were estimated and compared with those of RA (n = 4,006). Cox regression analyses were used to adjust for independent factors. Total exposure to TNF antagonists for SpA was 2,430 patient-years and 7,865 for RA. Drug survival in SpA was significantly greater than in RA at 1, 2, and 3 years. The hazard ratio (HR) for discontinuation in SpA compared with RA was 0.66 (95% confidence interval [CI], 0.57-0.76) after adjustment for age, gender, and use of infliximab. The difference remained after controlling for the individual medication and its place in the sequence of treatment. There were fewer SpA patients with AEs (17%) than RA patients (26%; p < 0.001). The HR for AEs in SpA was 0.80 (95% CI, 0.70-0.91) compared with RA after adjustment for age, disease duration, and use of infliximab. In conclusion, due in part to a better safety profile, survival of TNF antagonists in SpA is better than in RA. TNF antagonists are at present a safe and effective therapeutic option for long-term treatment of patients with SpA failing to respond to traditional drugs. Because chronic therapy is necessary, continual review of this issue is necessary.
本研究旨在比较英夫利昔单抗、依那西普和阿达木单抗(肿瘤坏死因子[TNF]拮抗剂)在脊柱关节炎(SpA)与类风湿关节炎(RA)中的药物留存率和安全性。为此,我们分析了BIOBADASER(2000 - 2005年)中的数据,该药物登记处于2000年启动,用于对这些生物制剂在风湿性疾病中的安全性进行长期随访。估计了SpA患者(n = 1524)的药物停用率和不良事件(AE)发生率,并与RA患者(n = 4006)进行比较。采用Cox回归分析来调整独立因素。SpA患者TNF拮抗剂的总暴露时间为2430患者年,RA患者为7865患者年。在1年、2年和3年时,SpA中的药物留存率显著高于RA。在调整年龄、性别和英夫利昔单抗的使用后,SpA与RA相比停药的风险比(HR)为0.66(95%置信区间[CI],0.57 - 0.76)。在控制个体药物及其治疗顺序中的位置后,差异仍然存在。发生AE的SpA患者(17%)少于RA患者(26%;p < 0.001)。在调整年龄、病程和英夫利昔单抗的使用后,SpA与RA相比AE的HR为0.80(95%CI,0.70 - 0.91)。总之,部分由于更好的安全性,TNF拮抗剂在SpA中的留存率优于RA。TNF拮抗剂目前是对传统药物无反应的SpA患者进行长期治疗的安全有效治疗选择。由于需要长期治疗,因此有必要持续审查这个问题。