Caporali Roberto, Pallavicini Francesca Bobbio, Filippini Matteo, Gorla Roberto, Marchesoni Antonio, Favalli Ennio Giulio, Sarzi-Puttini Piercarlo, Atzeni Fabiola, Montecucco Carlomaurizio
Rheumatology Unit, University of Pavia, IRCCS Policlinico S. Matteo Foundation, 27100 Pavia, Italy.
Autoimmun Rev. 2009 Jan;8(3):274-80. doi: 10.1016/j.autrev.2008.11.003. Epub 2008 Nov 17.
It has been found that tumour necrosis factor(TNF)-alpha plays a pivotal role in the pathogenesis of rheumatoid arthritis (RA), and the development of drugs targeting this molecule has extended the therapeutical approaches to RA patients. A number of observational studies of large patient series have also been published over the last few years, many of which have been based on national registries designed to monitor the efficacy and safety of anti-TNF agents, and allow healthcare institutions to control expenditure. Registry data can also help in identifying clinical and laboratory findings capable of predicting response. It has been suggested that the percentage of responding patients is lower in everyday clinical practice than that observed in RCTs, possibly because of patient selection, the use of a washout period before inclusion (which may artificially increase disease activity), and differences in doses, co-morbidities and adherence to therapy. A number of safety concerns have been raised since the introduction of anti-TNF agents, and they are now contraindicated in patients with advanced heart failure; however, the most widely debated current issues regard infections and neoplastic diseases. Moreover, the marketing of new and expensive biological agents has made strictly necessary to create systems capable of monitoring their safety and effectiveness in everyday practice, including the use of longitudinal observational studies. As the first published registry of anti-TNFalpha-treated patients in Italy, Lombardy Rheumatology Network (LORHEN) is already making its contribution in this direction.
现已发现，肿瘤坏死因子（TNF）-α在类风湿关节炎（RA）的发病机制中起关键作用，针对该分子的药物研发拓展了RA患者的治疗方法。过去几年还发表了许多对大量患者系列的观察性研究，其中许多基于旨在监测抗TNF药物疗效和安全性的国家登记系统，以便医疗机构控制支出。登记数据也有助于识别能够预测反应的临床和实验室检查结果。有人认为，日常临床实践中反应患者的比例低于随机对照试验（RCT）中的观察结果，这可能是由于患者选择、纳入前使用洗脱期（这可能人为增加疾病活动度）以及剂量、合并症和治疗依从性方面的差异。自引入抗TNF药物以来，人们提出了一些安全问题，目前晚期心力衰竭患者禁用此类药物；然而，当前最受广泛争议的问题是感染和肿瘤性疾病。此外，新的昂贵生物制剂的上市使得建立能够监测其在日常实践中的安全性和有效性的系统变得极为必要，包括使用纵向观察性研究。作为意大利首个发表的抗TNFα治疗患者登记系统，伦巴第风湿病网络（LORHEN）已经在这个方向上做出了贡献。
