Objective:

To analyze the FAERS database to compare the spectrum and time-to-onset of infliximab-related adverse events (AEs) across different administration routes, highlighting the clinical significance of these differences.

Key Findings:

• A total of 178,925 adverse reaction reports associated with infliximab were identified, indicating a substantial dataset for analysis.
• 5,144 events were linked to intravenous administration, while 1,084 events were related to subcutaneous administration, suggesting a notable difference in reporting.
• Infection-related adverse reactions were common with both administration routes, emphasizing the need for vigilance.
• Infusion-related reactions were more frequently associated with intravenous administration, which may influence treatment decisions.
• Delayed hypersensitivity reactions were more prominently reported with subcutaneous administration, indicating a potential area for further investigation.
• Median onset time for intravenous administration was 436.5 days, and for subcutaneous administration, it was 376 days, suggesting differences in patient experiences.

Interpretation:

AEs and the time of onset vary across different administration routes of infliximab, suggesting that clinicians should carefully consider these differences to optimize treatment strategies.

Limitations:

• The study is based on reported data, which may not capture all adverse events, potentially leading to underreporting.
• Real-world data may include variability in patient populations and treatment adherence, which could affect the generalizability of the findings.

Conclusion:

Clinicians should consider the differences in adverse events and onset times between intravenous and subcutaneous infliximab when selecting treatment routes to enhance patient safety and treatment efficacy.