Association Between Tumor Necrosis Factor Inhibitors and the Risk of Hospitalization or Death Among Patients With Immune-Mediated Inflammatory Disease and COVID-19.
Association Between Tumor Necrosis Factor Inhibitors and the Risk of Hospitalization or Death Among Patients With Immune-Mediated Inflammatory Disease and COVID-19.
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DOI：
10.1001/jamanetworkopen.2021.29639
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发表时间：
2021-10-01
影响因子：
13.8
通讯作者：
Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect); the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD); and the COVID-19 Global Rheumatology Alliance (GRA)
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文献类型：
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作者：
Izadi Z;Brenner EJ;Mahil SK;Dand N;Yiu ZZN;Yates M;Ungaro RC;Zhang X;Agrawal M;Colombel JF;Gianfrancesco MA;Hyrich KL;Strangfeld A;Carmona L;Mateus EF;Lawson-Tovey S;Klingberg E;Cuomo G;Caprioli M;Cruz-Machado AR;Mazeda Pereira AC;Hasseli R;Pfeil A;Lorenz HM;Hoyer BF;Trupin L;Rush S;Katz P;Schmajuk G;Jacobsohn L;Seet AM;Al Emadi S;Wise L;Gilbert EL;Duarte-García A;Valenzuela-Almada MO;Isnardi CA;Quintana R;Soriano ER;Hsu TY;D'Silva KM;Sparks JA;Patel NJ;Xavier RM;Marques CDL;Kakehasi AM;Flipo RM;Claudepierre P;Cantagrel A;Goupille P;Wallace ZS;Bhana S;Costello W;Grainger R;Hausmann JS;Liew JW;Sirotich E;Sufka P;Robinson PC;Machado PM;Griffiths CEM;Barker JN;Smith CH;Yazdany J;Kappelman MD;Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect); the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD); and the COVID-19 Global Rheumatology Allianc;Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect); the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD); and the COVID-19 Global Rheumatology Alliance (GRA)
在免疫介导的炎症性疾病（IMID）患者中，与其他治疗方案相比，在COVID-19诊断时接受肿瘤坏死因子（TNF）抑制剂单药治疗是否与COVID-19不良结局相关？在这项纳入6077例IMID和COVID-19患者的队列研究中，与TNF抑制剂单药治疗相比，TNF抑制剂联合硫唑嘌呤/6-巯基嘌呤治疗、甲氨蝶呤单药治疗、硫唑嘌呤/6-巯基嘌呤单药治疗或Janus激酶抑制剂单药治疗均与显著更高的住院或死亡几率相关。这项研究的结果支持在流感大流行期间继续使用TNF抑制剂单药治疗IMID患者。尽管肿瘤坏死因子（TNF）抑制剂因其能够改善免疫介导的炎症性疾病（IMID）中的共享免疫途径而在全球范围内被广泛使用，但COVID-19对接受TNF抑制剂的IMID患者的影响仍不充分。在IMID成人患者中，与其他常用的免疫调节治疗方案相比，检查接受TNF抑制剂单药治疗与COVID-19相关住院或死亡风险之间的相关性。这项队列研究是对来自3个国际COVID-19登记中心的数据的汇总分析，这些登记中心包括2020年3月12日至2021年2月1日期间患有风湿性疾病、炎症性肠病和银屑病的个体。临床医生使用在线数据输入门户直接报告COVID-19结局以及IMID和确诊或疑似COVID-19患者的人口统计学和临床特征。纳入诊断为炎性关节炎、炎性肠病或银屑病的成人（年龄≥18岁）。治疗暴露类别包括TNF抑制剂单药治疗（参比治疗）、TNF抑制剂联合甲氨蝶呤治疗、TNF抑制剂联合硫唑嘌呤/6-巯基嘌呤治疗、甲氨蝶呤单药治疗、硫唑嘌呤/6-巯基嘌呤单药治疗和Janus激酶（Jak）抑制剂单药治疗。主要结局为COVID-19相关住院或死亡。使用多水平多变量logistic回归模型对3个登记中心的数据进行登记水平分析和汇总分析，调整人口统计学和临床特征，并考虑国家、日历月和登记水平相关性。共有来自74个国家的6077例患者纳入分析;其中3215例（52.9%）来自欧洲，3563例（58.6%）为女性，平均（SD）年龄为48.8（16.5）岁。最常见的IMID诊断为类风湿性关节炎（2146例患者[35.3%]）和克罗恩病（1537例患者[25.3%]）。共有1297例患者（21.3%）住院，189例患者（3.1%）死亡。在汇总分析中，与接受TNF抑制剂单药治疗的患者相比，在接受TNF抑制剂联合硫唑嘌呤/6-巯基嘌呤治疗的患者中观察到更高的住院或死亡几率（比值比[OR]，1.74; 95% CI，1.17-2.58; P = 0.006），硫唑嘌呤/6-巯基嘌呤单药治疗（OR，1.84; 95%CI，1.30-2.61; P = .001），甲氨蝶呤单药治疗（OR，2.00; 95% CI，1.57-2.56; P < .001），和Jak抑制剂单药治疗（OR，1.82; 95%CI，1.21-2.73; P = 0.004），但在接受TNF抑制剂联合甲氨蝶呤治疗的患者中，（OR，1.18; 95% CI，0.85-1.63; P = .33）。在解释潜在报告偏倚的分析和仅基于症状排除COVID-19诊断患者的敏感性分析中获得了类似的结果。在这项队列研究中，在IMID患者中，与其他常用的免疫调节治疗方案相比，TNF抑制剂单药治疗与COVID-19不良结局的风险较低相关。这项队列研究使用了来自3个国际注册中心的数据，以检查接受肿瘤坏死因子单药治疗与患有免疫介导的炎症性疾病的成年患者中COVID-19相关住院或死亡风险之间的相关性。
Is receipt of tumor necrosis factor (TNF) inhibitor monotherapy at the time of COVID-19 diagnosis associated with adverse COVID-19 outcomes compared with other treatment regimens among patients with immune-mediated inflammatory diseases (IMIDs)? In this cohort study of 6077 patients with IMIDs and COVID-19, TNF inhibitors in combination with azathioprine/6-mercaptopurine therapy, methotrexate monotherapy, azathioprine/6-mercaptopurine monotherapy, or Janus kinase inhibitor monotherapy were each associated with significantly higher odds of hospitalization or death compared with TNF inhibitor monotherapy. This study’s findings support the continued use of TNF inhibitor monotherapy among individuals with IMIDs during the pandemic. Although tumor necrosis factor (TNF) inhibitors are widely prescribed globally because of their ability to ameliorate shared immune pathways across immune-mediated inflammatory diseases (IMIDs), the impact of COVID-19 among individuals with IMIDs who are receiving TNF inhibitors remains insufficiently understood. To examine the association between the receipt of TNF inhibitor monotherapy and the risk of COVID-19–associated hospitalization or death compared with other commonly prescribed immunomodulatory treatment regimens among adult patients with IMIDs. This cohort study was a pooled analysis of data from 3 international COVID-19 registries comprising individuals with rheumatic diseases, inflammatory bowel disease, and psoriasis from March 12, 2020, to February 1, 2021. Clinicians directly reported COVID-19 outcomes as well as demographic and clinical characteristics of individuals with IMIDs and confirmed or suspected COVID-19 using online data entry portals. Adults (age ≥18 years) with a diagnosis of inflammatory arthritis, inflammatory bowel disease, or psoriasis were included. Treatment exposure categories included TNF inhibitor monotherapy (reference treatment), TNF inhibitors in combination with methotrexate therapy, TNF inhibitors in combination with azathioprine/6-mercaptopurine therapy, methotrexate monotherapy, azathioprine/6-mercaptopurine monotherapy, and Janus kinase (Jak) inhibitor monotherapy. The main outcome was COVID-19–associated hospitalization or death. Registry-level analyses and a pooled analysis of data across the 3 registries were conducted using multilevel multivariable logistic regression models, adjusting for demographic and clinical characteristics and accounting for country, calendar month, and registry-level correlations. A total of 6077 patients from 74 countries were included in the analyses; of those, 3215 individuals (52.9%) were from Europe, 3563 individuals (58.6%) were female, and the mean (SD) age was 48.8 (16.5) years. The most common IMID diagnoses were rheumatoid arthritis (2146 patients [35.3%]) and Crohn disease (1537 patients [25.3%]). A total of 1297 patients (21.3%) were hospitalized, and 189 patients (3.1%) died. In the pooled analysis, compared with patients who received TNF inhibitor monotherapy, higher odds of hospitalization or death were observed among those who received a TNF inhibitor in combination with azathioprine/6-mercaptopurine therapy (odds ratio [OR], 1.74; 95% CI, 1.17-2.58; P = .006), azathioprine/6-mercaptopurine monotherapy (OR, 1.84; 95% CI, 1.30-2.61; P = .001), methotrexate monotherapy (OR, 2.00; 95% CI, 1.57-2.56; P < .001), and Jak inhibitor monotherapy (OR, 1.82; 95% CI, 1.21-2.73; P = .004) but not among those who received a TNF inhibitor in combination with methotrexate therapy (OR, 1.18; 95% CI, 0.85-1.63; P = .33). Similar findings were obtained in analyses that accounted for potential reporting bias and sensitivity analyses that excluded patients with a COVID-19 diagnosis based on symptoms alone. In this cohort study, TNF inhibitor monotherapy was associated with a lower risk of adverse COVID-19 outcomes compared with other commonly prescribed immunomodulatory treatment regimens among individuals with IMIDs. This cohort study uses data from 3 international registries to examine the association between the receipt of tumor necrosis factor monotherapy and the risk of COVID-19–associated hospitalization or death among adult patients with immune-mediated inflammatory diseases.
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DOI：
10.1016/j.medj.2020.11.005
发表时间：
2020-12-18
期刊：
Med (New York, N.Y.)
影响因子：
--
作者：
Robinson PC;Liew DFL;Liew JW;Monaco C;Richards D;Shivakumar S;Tanner HL;Feldmann M
通讯作者：
Feldmann M
影响因子：
24.5
作者：
Ungaro, Ryan C.;Brenner, Erica J.;Kappelman, Michael D.
通讯作者：
Kappelman, Michael D.
影响因子：
82.9
作者：
Del Valle DM;Kim-Schulze S;Huang HH;Beckmann ND;Nirenberg S;Wang B;Lavin Y;Swartz TH;Madduri D;Stock A;Marron TU;Xie H;Patel M;Tuballes K;Van Oekelen O;Rahman A;Kovatch P;Aberg JA;Schadt E;Jagannath S;Mazumdar M;Charney AW;Firpo-Betancourt A;Mendu DR;Jhang J;Reich D;Sigel K;Cordon-Cardo C;Feldmann M;Parekh S;Merad M;Gnjatic S
通讯作者：
Gnjatic S
影响因子：
29.4
作者：
Toruner, Murat;Loftus, Edward V., Jr.;Egan, Laurence J.
通讯作者：
Egan, Laurence J.
影响因子：
2
作者：
Austin, Peter C.
通讯作者：
Austin, Peter C.