Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis
Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis
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DOI：
10.1007/s12325-019-01145-8
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发表时间：
2019-11-20
影响因子：
3.8
通讯作者：
Panaccione, Remo
中科院分区：
文献类型：
--
作者：
Burmester, Gerd R.;Gordon, Kenneth B.;Panaccione, Remo
阿达木单抗的安全性特征先前在23，458例多种适应症患者中报告。在这里，我们报告阿达木单抗的长期安全性与斑块状银屑病（Ps），化脓性汗腺炎（HS），类风湿性关节炎（RA），强直性脊柱炎，银屑病关节炎，非放射性轴向脊柱关节炎，外周脊柱关节炎，克罗恩病（CD），溃疡性结肠炎（UC），和非感染性葡萄膜炎（UV）的成人MethodsSafety数据从77个临床试验汇总。安全性评估包括不良事件（AE）和严重AE（SAE），发生后的第一次研究剂量和70天内（5个半衰期）后，最后一次研究dose.ResultsA共29,967例患者，代表56,916患者年（PY）的暴露。最常报告的关注SAE为感染（3.7/100 PY），CD、RA、UV和UC的发生率最高（3.5/100 PY-6.9/100 PY）; Ps（1.8/100 PY）和HS（2.8/100 PY）的严重感染较低。观察到的死亡例数低于年龄和性别校正人群中大多数阿达木单抗治疗患者（包括Ps）的预期死亡例数。缺乏现实生活中的数据和有限的长期数据（>5年），大多数患者的局限性，这种analysis.ConclusionThe阿达木单抗的安全性与以前的研究结果是一致的，没有观察到新的安全信号。
IntroductionThe safety profile of adalimumab was previously reported in 23,458 patients across multiple indications. Here we report the long-term safety of adalimumab in adults with plaque psoriasis (Ps), hidradenitis suppurativa (HS), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, non-radiographic axial spondyloarthritis, peripheral spondyloarthritis, Crohn's disease (CD), ulcerative colitis (UC), and non-infectious uveitis (UV).MethodsSafety data from 77 clinical trials were pooled. Safety assessments included adverse events (AEs) and serious AEs (SAEs) that occurred after the first study dose and within 70 days (5 half-lives) after the last study dose.ResultsA total of 29,967 patients were included, representing 56,916 patient-years (PY) of exposure. The most frequently reported SAE of interest was infection (3.7/100 PY) with highest incidences in CD, RA, UV, and UC (3.5/100 PY-6.9/100 PY); serious infections in Ps (1.8/100 PY) and HS (2.8/100 PY) were lower. The observed number of deaths was below what would be expected in an age- and sex-adjusted population for most adalimumab-treated patients (including Ps). Lack of real-life data and limited long-term data (>5 years) for most patients are limitations of this analysis.ConclusionThe safety profile of adalimumab was consistent with previous findings and no new safety signals were observed.