Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials.
Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials.
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DOI：
10.3324/haematol.2017.171041
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发表时间：
2017-10
期刊：
影响因子：
10.1
通讯作者：
Burger JA
中科院分区：
文献类型：
--
作者：
Brown JR;Moslehi J;O'Brien S;Ghia P;Hillmen P;Cymbalista F;Shanafelt TD;Fraser G;Rule S;Kipps TJ;Coutre S;Dilhuydy MS;Cramer P;Tedeschi A;Jaeger U;Dreyling M;Byrd JC;Howes A;Todd M;Vermeulen J;James DF;Clow F;Styles L;Valentino R;Wildgust M;Mahler M;Burger JA
一流的布鲁顿的酪氨酸激酶抑制剂伊布替尼已被证明在B细胞恶性肿瘤中具有临床获益;然而，6-16%的伊布替尼患者报告了房颤（AF）。我们汇总了1505例慢性淋巴细胞白血病和套细胞淋巴瘤患者的数据，这些患者入组了4项大型、随机、对照研究，以描述使用伊曲替尼治疗AF及其管理的特征。16.6个月时，伊布替尼的AF发生率为6.5% [95%置信区间（CI）：4.8，8.5]，而对照药物为1.6%（95%CI：0.8，2.8），36个月随访时为10.4%（95%CI：8.4，12.9）;估计的累积发生率：13.8%（95%CI：11.2，16.8）。AF患者中，伊布替尼治疗、既往AF病史和年龄≥ 65岁是AF的独立风险因素。在AF患者中，伊布替尼组（44.9%;对照组，16.7%）多发性AF事件更常见。大多数（85.7%）AF患者未停用伊布替尼，超过一半的患者在研究中接受常见的抗凝/抗血小板药物治疗。使用伊鲁替尼时，低级别出血更常见，但严重出血不常见（伊鲁替尼，2.9%;对照药物，2.0%）。尽管该数据集可能低估了患有合并症的老年非试验患者的AF发生率，但这些结果表明，临床试验患者的AF通常是可管理的，无需停用伊鲁替尼（clinicaltrials.gov标识符：01578707、01722487、01611090、01646021）。
The first-in-class Bruton’s tyrosine kinase inhibitor ibrutinib has proven clinical benefit in B-cell malignancies; however, atrial fibrillation (AF) has been reported in 6–16% of ibrutinib patients. We pooled data from 1505 chronic lymphocytic leukemia and mantle cell lymphoma patients enrolled in four large, randomized, controlled studies to characterize AF with ibrutinib and its management. AF incidence was 6.5% [95% Confidence Interval (CI): 4.8, 8.5] for ibrutinib at 16.6-months versus 1.6% (95%CI: 0.8, 2.8) for comparator and 10.4% (95%CI: 8.4, 12.9) at the 36-month follow up; estimated cumulative incidence: 13.8% (95%CI: 11.2, 16.8). Ibrutinib treatment, prior history of AF and age 65 years or over were independent risk factors for AF. Multiple AF events were more common with ibrutinib (44.9%; comparator, 16.7%) among patients with AF. Most (85.7%) patients with AF did not discontinue ibrutinib, and more than half received common anticoagulant/antiplatelet medications on study. Low-grade bleeds were more frequent with ibrutinib, but serious bleeds were uncommon (ibrutinib, 2.9%; comparator, 2.0%). Although the AF rate among older non-trial patients with comorbidities is likely underestimated by this dataset, these results suggest that AF among clinical trial patients is generally manageable without ibrutinib discontinuation (clinicaltrials.gov identifier: 01578707, 01722487, 01611090, 01646021).
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影响因子：
11.4
作者：
Kamel, S.;Horton, L.;Tam, C. S.
通讯作者：
Tam, C. S.
影响因子：
6.5
作者：
Thompson, Philip A.;Levy, Vincent;Cymbalista, Florence
通讯作者：
Cymbalista, Florence
影响因子：
51.1
作者：
Wang, Michael L.;Lee, Hun;Zhang, Leo
通讯作者：
Zhang, Leo
影响因子：
20.3
作者：
Byrd, John C.;Furman, Richard R.;O'Brien, Susan
通讯作者：
O'Brien, Susan
伊布替尼与奥法木单抗在既往治疗过的慢性淋巴细胞白血病中的比较。
DOI：
10.1056/nejmoa1400376
发表时间：
2014-07-17
期刊：
The New England journal of medicine
影响因子：
--
作者：
Byrd JC;Brown JR;O'Brien S;Barrientos JC;Kay NE;Reddy NM;Coutre S;Tam CS;Mulligan SP;Jaeger U;Devereux S;Barr PM;Furman RR;Kipps TJ;Cymbalista F;Pocock C;Thornton P;Caligaris-Cappio F;Robak T;Delgado J;Schuster SJ;Montillo M;Schuh A;de Vos S;Gill D;Bloor A;Dearden C;Moreno C;Jones JJ;Chu AD;Fardis M;McGreivy J;Clow F;James DF;Hillmen P;RESONATE Investigators
通讯作者：
RESONATE Investigators