Kobayashi Tetsu, Kamada Izumi, Komura Junko, Toyoshima Satoshi, Ishii-Watabe Akiko
Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tokyo, Japan.
Faculty of Pharmacy, Musashino University, Tokyo, Japan.
Pharmacoepidemiol Drug Saf. 2017 Aug;26(8):917-924. doi: 10.1002/pds.4218. Epub 2017 Jun 14.
The objective of this study is to specify the most reported adverse events as preferred terms (PTs) and to compare the reported adverse events about some properties including the number of report and time-to-onset (TTO) distribution of the originator of filgrastim Neupogen® and its biosimilars in Europe, using VigiBase®.
We identified the biosimilar which was reported as the suspected drug in more than 100 individual case safety reports in Europe. Then, we specified the top ranking 10 PTs in the cases reported with Neupogen® or each biosimilar as the suspected drug. We also compared the TTO of the most reported PTs using the data about the onset date of the PT and the start date of filgrastim. We used Kolmogorov-Smirnov method to detect significant difference.
The total ICSR numbers with Neupogen® and 3 biosimilars, Zarzio®, Nivestim®, and Tevagrastim® were 1,301, 295, 156, and 127, respectively, in Europe. The most reported PTs with Neupogen® were bone pain, pyrexia, and dyspnoea. The TTO of bone pain and pyrexia with Zarzio® (N: 22 and 16, median: 1 and 0.5 days) were significantly shorter than those with Neupogen® (P < 0.01, N: 72 and 33, median: 3.5 and 3 days), respectively. The most reported PTs with biosimilars were drug ineffective and neutropenia.
The difference in the TTO was identified between originator filgrastim Neupogen and its biosimilar regarding some PTs, which may suggest the difference in their safety profile. Copyright © 2017 John Wiley & Sons, Ltd.
本研究的目的是将报告最多的不良事件指定为首选术语（PTs），并使用VigiBase®比较欧洲非格司亭（Neupogen®）及其生物类似药在报告数量和发起者的发病时间（TTO）分布等一些属性方面报告的不良事件。
我们确定了在欧洲100多份个体病例安全报告中被报告为可疑药物的生物类似药。然后，我们在报告中以Neupogen®或每种生物类似药为可疑药物的病例中指定了排名前10的PTs。我们还使用有关PT发病日期和非格司亭开始日期的数据比较了报告最多的PTs的TTO。我们使用Kolmogorov-Smirnov方法检测显著差异。
在欧洲，非格司亭（Neupogen®）和3种生物类似药Zarzio®、Nivestim®和Tevagrastim®的ICSR总数分别为1301、295、156和127。Neupogen®报告最多的PTs是骨痛、发热和呼吸困难。Zarzio®的骨痛和发热的TTO（N：22和16，中位数：1和0.5天）分别显著短于Neupogen®（P < 0.01，N：72和33，中位数：3.5和3天）。生物类似药报告最多的PTs是药物无效和中性粒细胞减少。
在一些PTs方面，已确定非格司亭（Neupogen®）与其生物类似药在TTO上存在差异，这可能表明它们在安全性方面存在差异。版权所有© 2017 John Wiley & Sons, Ltd。
