Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data

dc.contributor.authorBirck, Marina G.
dc.contributor.authorLukusa, Luck
dc.contributor.authorChoquette, Denis
dc.contributor.authorBoire, Gilles
dc.contributor.authorMaksymowych, Walter P.
dc.contributor.authorSingh, Harminder
dc.contributor.authorAfif, Waqqas
dc.contributor.authorBernatsky, Sasha
dc.date.accessioned2024-10-01T17:56:06Z
dc.date.available2024-10-01T17:56:06Z
dc.date.issued2024-09-27
dc.date.updated2024-10-01T03:45:38Z
dc.description.abstractAbstract Background Safety remains a significant concern for biologic drugs, and studies are needed to ensure a comparable safety profile for biosimilars and their legacy treatments. Using Canadian administrative health data from 2015–2019, we compared the incidence of serious infection between biosimilars and bio-originators initiators for etanercept and infliximab, two of the most commonly used biologics during this time. Methods We performed a retrospective cohort study using pan-Canadian data (except Quebec) from the National Prescription Drug Utilization Information System linked to hospitalization data. We studied new users of infliximab or etanercept (January/2015-December/2019) and compared incidence rates of serious infection, defined as those which required hospitalization, by using Cox regression models adjusted by biological sex, age at treatment initiation, prior corticosteroid or biologic, province, and calendar year. Results We studied 6,583 etanercept users (mean age 62) and 7,202 infliximab users (mean age 45). Hospitalization with infections occurred in 7% of infliximab and 2% of etanercept users. Comparing the risk of infection between biosimilar to bio-originator, the adjusted hazard ratio (95% confidence interval) was 1.33 (0.77, 2.30) for etanercept and 0.93 (0.72, 1.18) for infliximab. Conclusions Our study found no clear difference between etanercept and infliximab biosimilars and their bio-originators for infection incidence, suggesting a similar safety profile.
dc.identifier.citationBMC Rheumatology. 2024 Sep 27;8(1):47
dc.identifier.urihttps://doi.org/10.1186/s41927-024-00415-5
dc.identifier.urihttp://hdl.handle.net/1993/38646
dc.language.rfc3066en
dc.rights.holderThe Author(s)
dc.titleIncidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data
dc.typeJournal Article
Files
Original bundle
Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
41927_2024_Article_415.pdf
Size:
976.79 KB
Format:
Adobe Portable Document Format
Description:
License bundle
Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
license.txt
Size:
770 B
Format:
Item-specific license agreed to upon submission
Description: