Bellan Mattia, Scotti Lorenza, Ferrante Daniela, Calzaducca Elisa, Manfredi Giulia Francesca, Sainaghi Pier Paolo, Barone-Adesi Francesco
Department of Translational Medicine (DiMet), Università del Piemonte Orientale (UPO), Via Solaroli 17, 28100 Novara, Italy.
Department of Internal Medicine and Rheumatology Unit, Azienda Ospedaliero-Universitaria Maggiore Della Carità, 28100 Novara, Italy.
J Clin Med. 2022 May 24;11(11):2955. doi: 10.3390/jcm11112955.
Biological disease-modifying anti-rheumatic drugs (bDMARDs) are widely used for the management of rheumatoid arthritis, although their benefits are counterweight by an increased risk of infections. In the present study, we used administrative data to compare the risk of severe infections among different classes of bDMARDs. A retrospective cohort study was conducted using Administrative Health Databases of the Piedmont Region, Italy. Relevant data were obtained from: (1) the inhabitants registry, (2) hospital discharge records, and (3) the co-payment exemption registry and (4) drug claims registry. Fine and Gray competing risk models were fitted to evaluate the association between the use of different types of bDMARDs and occurrence of severe infection accounting for treatment interruption as competing risk. A total of 1780 new users of bDMARDs were identified. Among them, 50 hospitalizations for infection occurred during the study period. The use of Tocilizumab was associated with an increased risk of infection, compared to tumor necrosis factor (TNF) inhibitor drugs (sub-distribution hazard ratios-sHR: 2.510; 95% CI: 1.279-4.926), whereas no difference in the risk of severe infection was found for abatacept (sHR: 0.584; 95% CI: 0.234-1.457). bDMARDs treatment is generally safe in clinical practice with slight but important differences among classes. The increased risk of infection associated with tocilizumab use should be taken into account when balancing the risk and benefits of starting a treatment with this drug.
生物性病情改善抗风湿药物（bDMARDs）被广泛用于类风湿性关节炎的治疗，尽管其益处被感染风险增加所抵消。在本研究中，我们使用管理数据比较了不同类别bDMARDs发生严重感染的风险。利用意大利皮埃蒙特地区的行政卫生数据库进行了一项回顾性队列研究。相关数据来自：（1）居民登记册，（2）医院出院记录，（3）共付豁免登记册和（4）药物报销登记册。采用Fine和Gray竞争风险模型来评估不同类型bDMARDs的使用与严重感染发生之间的关联，并将治疗中断视为竞争风险。共确定了1780名bDMARDs的新使用者。其中，在研究期间有50例因感染住院。与肿瘤坏死因子（TNF）抑制剂药物相比，使用托珠单抗与感染风险增加相关（亚分布风险比 - sHR：2.510；95%置信区间：1.279 - 4.926），而阿巴西普在严重感染风险方面未发现差异（sHR：0.584；95%置信区间：0.234 - 1.457）。在临床实践中，bDMARDs治疗总体上是安全的，但不同类别之间存在细微但重要的差异。在权衡使用该药物开始治疗的风险和益处时，应考虑到与托珠单抗使用相关的感染风险增加。
