Initiation of tumor necrosis factor-α antagonists and the risk of hospitalization for infection in patients with autoimmune diseases.
Initiation of tumor necrosis factor-α antagonists and the risk of hospitalization for infection in patients with autoimmune diseases.
复制标题
DOI：
10.1001/jama.2011.1692
复制
发表时间：
2011-12-07
影响因子：
120.7
通讯作者：
Curtis, Jeffrey R.
中科院分区：
文献类型：
--
作者：
Grijalva, Carlos G.;Chen, Lang;Delzell, Elizabeth;Baddley, John W.;Beukelman, Timothy;Winthrop, Kevin L.;Griffin, Marie R.;Herrinton, Lisa J.;Liu, Liyan;Ouellet-Hellstrom, Rita;Patkar, Nivedita M.;Solomon, Daniel H.;Lewis, James D.;Xie, Fenglong;Saag, Kenneth G.;Curtis, Jeffrey R.
尽管肿瘤坏死因子α（TNF-α）拮抗剂越来越多地用于替代非生物对照药物，但其安全性特征仍不完整。确定与非生物对照药物相比，启动TNF-α拮抗剂治疗是否与严重感染风险增加相关。在美国多机构合作中，我们收集了类风湿性关节炎（RA）、炎症性肠病（IBD）和银屑病、银屑病关节炎或强直性脊柱炎（PsO-PsA-AS）患者的回顾性队列（1998-2007年），并结合了来自Kaiser Permanente北方加州、新泽西和宾夕法尼亚州药物援助计划、田纳西州医疗补助和国家医疗补助/医疗保险的数据。在疾病特异性倾向评分（PS）匹配队列中，使用考克斯回归模型，以非生物制剂作为参考，比较TNF-α拮抗剂和非生物制剂治疗方案。基线糖皮质激素使用作为单独的协变量进行评价。开始TNF-α拮抗剂或非生物治疗方案后前12个月内需要住院治疗的感染（严重感染）。研究队列包括使用TNF-α拮抗剂和对照药物的10484例RA、2323例IBD和3213例PsO-PsA-AS PS匹配对。总的来说，我们确定了1171例严重感染，其中大多数（53%）是肺炎和皮肤软组织感染。在RA患者中，严重感染住院率为8.16（TNF-α拮抗剂）和7.78（对照治疗方案）/100人-年（校正风险比[aHR]：1.07（95% CI：0.93-1.23））。在IBD患者中，发生率为10.91和9.60/100人-年（aHR：1.13，（0.85-1.50））。在PsO-PsA-AS患者中，发生率分别为5.41和5.19/100人-年（aHR：1.10，（0.80-1.53））。在RA患者中，与依那西普和阿达木单抗相比，英夫利西单抗与严重感染显著增加相关（aHR：1.27（1.08-1.49）和1.23（1.02-1.48））。基线糖皮质激素使用与感染的剂量依赖性增加相关。在自身免疫性疾病患者中，与非生物制剂治疗方案相比，启动TNF-α拮抗剂治疗与因严重感染住院的风险增加无关。
Although tumor necrosis factor alpha (TNF-α) antagonists are increasingly used in place of non-biologic comparator medications, their safety profile remains incomplete. To determine whether initiation of TNF-α antagonists compared with non-biologic comparators is associated with an increased risk of serious infections. Within a US multi-institutional collaboration, we assembled retrospective cohorts (1998–2007) of patients with rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis, psoriatic arthritis or ankylosing spondylitis (PsO-PsA-AS) combining data from Kaiser Permanente Northern California, New Jersey and Pennsylvania Pharmaceutical Assistance programs, Tennessee Medicaid and National Medicaid/Medicare. TNF-α antagonists and non-biologic regimens were compared in disease specific-propensity score (PS) matched cohorts using Cox regression models with non-biologics as reference. Baseline glucocorticoid use was evaluated as a separate covariate. Infections requiring hospitalization (serious infections) during the first 12 months after initiation of TNF-α antagonists or non-biologic regimens. Study cohorts included 10484 RA, 2323 IBD and 3213 PsO-PsA-AS PS-matched pairs using TNF-α antagonists and comparator medications. Overall, we identified 1171 serious infections, most of which (53%) were pneumonia and skin and soft tissue infections. Among RA patients, serious infection hospitalization rates were 8.16 (TNF-α antagonists) and 7.78 (comparator regimens) per 100 person-years (adjusted hazard ratio [aHR]: 1.07 (95% CI: 0.93–1.23)). Among IBD patients, rates were 10.91 and 9.60 per 100 person-years (aHR: 1.13, (0.85–1.50)). Among PsO-PsA-AS patients, rates were 5.41 and 5.19 per 100 person-years (aHR: 1.10, (0.80–1.53)). Among RA patients, infliximab was associated with a significant increase in serious infections compared with etanercept and adalimumab (aHRs: 1.27 (1.08–1.49) and 1.23 (1.02–1.48)). Baseline glucocorticoid use was associated with a dose-dependent increase in infections. Among patients with autoimmune diseases, compared to treatment with non-biologic regimens, initiation of TNF-α antagonists was not associated with an increased risk of hospitalizations for serious infections.
登录
查看更多内容
影响因子：
27.4
作者：
Curtis, Jeffrey R.;Xie, Fenglong;Delzell, Elizabeth
通讯作者：
Delzell, Elizabeth
影响因子：
5.5
作者：
Grijalva, Carlos G.;Kaltenbach, Lisa;Griffin, Marie R.
通讯作者：
Griffin, Marie R.
影响因子：
2.6
作者：
Grijalva, Carlos G.;Chung, Cecilia P.;Griffin, Marie R.
通讯作者：
Griffin, Marie R.
影响因子：
5.5
作者：
Galloway, James B.;Hyrich, Kimme L.;Symmons, Deborah P. M.
通讯作者：
Symmons, Deborah P. M.
DOI：
10.1016/s0197-2456(00)00104-5
发表时间：
2000-12-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Hsieh, FY;Lavori, PW
通讯作者：
Lavori, PW