Charité Universitätsmedizin Berlin, Berlin, Germany.
Medical College of Wisconsin, Milwaukee, WI, USA.
Adv Ther. 2020 Jan;37(1):364-380. doi: 10.1007/s12325-019-01145-8. Epub 2019 Nov 20.
The 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).
Safety 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.
A 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.
The safety profile of adalimumab was consistent with previous findings and no new safety signals were observed.
阿达木单抗在多个适应证的 23458 例患者中已有安全性报道。本研究报告了阿达木单抗治疗斑块状银屑病（Ps）、化脓性汗腺炎（HS）、类风湿关节炎（RA）、强直性脊柱炎、银屑病关节炎、非放射性中轴型脊柱关节炎、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）成人患者的长期安全性。
汇总了 77 项临床试验的安全性数据。安全性评估包括首次研究剂量后和末次研究剂量后 70 天（5 个半衰期）内发生的不良事件（AE）和严重不良事件（SAE）。
共纳入 29967 例患者，代表 56916 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 发生率最高（3.5/100 PY-6.9/100 PY）；Ps（1.8/100 PY）和 HS（2.8/100 PY）中严重感染发生率较低。大多数接受阿达木单抗治疗的患者（包括 Ps）的观察死亡人数低于年龄和性别调整人群的预期值。缺乏真实世界数据和大多数患者的长期数据（>5 年）是本分析的局限性。
阿达木单抗的安全性与既往研究结果一致，未观察到新的安全性信号。
