Postapproval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States-Based Rheumatoid Arthritis Registry.
Postapproval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States-Based Rheumatoid Arthritis Registry.
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DOI：
10.1002/acr2.11232
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发表时间：
2021-03
影响因子：
3.4
通讯作者：
Kavanaugh A
中科院分区：
文献类型：
--
作者：
Kremer JM;Bingham CO 3rd;Cappelli LC;Greenberg JD;Madsen AM;Geier J;Rivas JL;Onofrei AM;Barr CJ;Pappas DA;Litman HJ;Dandreo KJ;Shapiro AB;Connell CA;Kavanaugh A
托法替尼是一种口服Janus激酶抑制剂，用于治疗类风湿性关节炎（RA）。我们比较了美国（US）Corrona RA登记研究中开始使用托法替尼和开始使用新型生物学疾病缓解抗风湿药物（bDMARD）的患者的5年不良事件（AE）发生率（IR）。IRS在2012年11月6日至2014年12月31日期间，估计托法替尼和bDMARD启动者中主要心血管不良事件（MACE）、严重感染事件（SIE）、带状疱疹（HZ）、恶性肿瘤和死亡的（首起事件数量/100患者年），不考虑剂量/方案（美国食品药品监督管理局托法替尼批准）和2018年7月31日（随访至2019年1月31日）。倾向评分（PS）的方法被用来控制非随机处方的做法。使用多变量校正的考克斯回归计算风险比（HR）以比较发生率。急性（MACE、SIE、HZ和静脉血栓栓塞事件[VTE]）和长期（恶性肿瘤和死亡）事件使用不同的风险窗。对VTE进行了连续性评估。对于MACE、SIE和HZ，分别纳入了1999（3152.1患者年）和8358（12869.4年）例托法替尼和bDMARD启动者;对于恶性肿瘤/死亡，分别纳入了1999（4505.6患者年）和6354（16670.8患者年）例启动者。各队列的AE发生率相似，但HZ除外，托法替尼组的AE发生率显著高于bDMARD组（PS截尾校正HR 2.32; 95%置信区间[CI] 1.43 - 3.75）。托法替布和bDMARD组分别发生45起（0起严重）和88起（5起严重）HZ事件。敏感性分析显示了相似的结果。托法替尼和bDMARD的VTE IR（95% CI）分别为0.29（0.13 - 0.54）和0.33（0.24 - 0.45）。在这项登记研究分析中，两个队列的MACE、SIE、恶性肿瘤、死亡和VTE发生率相似;托法替尼启动者的HZ发生率高于bDMARD启动者。
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared 5‐year adverse event (AE) incidence rates (IRs) between patients initiating tofacitinib and those initiating new biological disease‐modifying antirheumatic drugs (bDMARDs) within the United States (US) Corrona RA registry. IRs (number of first events/100 patient‐years) of major adverse cardiovascular events (MACE), serious infection events (SIEs), herpes zoster (HZ), malignancies, and death were estimated among tofacitinib and bDMARD initiators, regardless of dose/schedule, between November 6, 2012 (US Food and Drug Administration tofacitinib approval), and July 31, 2018 (follow‐up through January 31, 2019). Propensity score (PS) methods were used to control for nonrandom prescribing practices. Hazard ratios (HRs) were calculated to compare rates using multivariable‐adjusted Cox regression. Different risk windows were used for acute (MACE, SIEs, HZ, and venous thromboembolic events [VTEs]) and long‐term (malignancy and death) events. VTEs were assessed descriptively. For MACE, SIEs, and HZ, 1999 (3152.1 patient‐years) and 8358 (12 869.4 years) tofacitinib and bDMARD initiators were included, respectively; for malignancy/death, 1999 (4505.6 patient‐years) and 6354 (16 670.8 patient‐years) initiators were included, respectively. AE rates were similar across cohorts, except for HZ, which was significantly higher with tofacitinib versus bDMARDs (PS‐trimmed adjusted HR 2.32; 95% confidence interval [CI] 1.43‐3.75). There were 45 (zero serious) and 88 (five serious) HZ events with tofacitinib and bDMARDs, respectively. Sensitivity analyses demonstrated similar results. VTE IRs (95% CI) were 0.29 (0.13‐0.54) and 0.33 (0.24‐0.45) for tofacitinib and bDMARDs, respectively. In this registry analysis, both cohorts had similar MACE, SIE, malignancy, death, and VTE rates; HZ rates were higher for tofacitinib initaitors than for bDMARD initiators.
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影响因子：
27.4
作者：
Cohen SB;Tanaka Y;Mariette X;Curtis JR;Lee EB;Nash P;Winthrop KL;Charles-Schoeman C;Thirunavukkarasu K;DeMasi R;Geier J;Kwok K;Wang L;Riese R;Wollenhaupt J
通讯作者：
Wollenhaupt J
影响因子：
4.7
作者：
Tanaka, Yoshiya;Suzuki, Makoto;Zwillich, Samuel H.
通讯作者：
Zwillich, Samuel H.
影响因子：
4.9
作者：
Strangfeld, Anja;Hierse, Franka;Zink, Angela
通讯作者：
Zink, Angela
影响因子：
--
作者：
Fleischmann, Roy;Cutolo, Maurizio;Zwillich, Samuel H.
通讯作者：
Zwillich, Samuel H.
影响因子：
158.5
作者：
van Vollenhoven, Ronald F.;Fleischmann, Roy;Wilkinson, Bethanie
通讯作者：
Wilkinson, Bethanie