Relationship of Concomitant Medications on Infusion Related Reactions to Infliximab： A Case-Control Study Using Individual Case Safety Reports Database
- VernacularTitle:Infliximab による 「注入に伴う反応」 と併用薬との関連性 ： 個別症例安全性報告データベースを用いたケースコントロール研究
- Author:
Tetsu KOBAYASHI
1
;
Hiroko SHIBATA
1
;
Akiko ISHII-WATABE
1
Author Information
- Keywords: infliximab; infusion related reaction; antihistamines; individual case safety report
- From:Japanese Journal of Pharmacoepidemiology 2019;24(2):43-52
- CountryJapan
- Language:Japanese
- Abstract: Objective ： Infliximab is a chimeric monoclonal antibody against tumor necrosis factor (TNF) -α that is indicated in the treatment of chronic inflammatory diseases. Infliximab is administered by intravenous infusion and may be associated with infusion related reactions (IRRs). Recent study showed that the use of concomitant antihistamines associated with an increased incidence IRR, using an observational registry database in Canada. The aim of this study was to determine whether the use of concomitant antihistamines associated with an increase in the proportional reporting ratio (PRR) of IRR, using individual case safety reports (ICSRs) with infliximab as one of the suspected drugs, not only from Canada, but also from the United States of America (US), the United Kingdom (UK), and Japan.Design ： Case-control studyMethods ： We used VigiBase, the WHO's global safety report database, in this study. One-to-one propensity-matching analysis was performed in each country using IBM SPSS version 24 to evaluate outcomes. The primary endpoint was the assessment of concomitant medications associated with IRR in the cases treated with infliximab.Results ： There were 35,729, 19,095, 4,618, and 1,565 ICSRs in which some adverse events were reported with infliximab as one of the suspected drugs in Canada, the US, the UK, and Japan, respectively, after the exclusion of ICSRs with unknown patient age or unknown patient sex. IRRs were reported in 2,293, 1,427, 303, and 69 ICSRs, respectively. The use of concomitant antihistamines was significantly associated with an increased PRR of IRR in Canada (p<0.001). The uses of concomitant antihistamines were also significantly associated with an increased PRR of IRR in the US (p<0.001), the UK (p<0.001), and Japan (p＝0.007).Conclusion ： The uses of concomitant antihistamines were associated with an increased PRR of IRR with infliximab in the case-control study using ICSRs from Canada, the US, the UK, and Japan.
