Safety

Over 2,700 patients have been monitored on Entyvio with more than 1,300 patients treated with Entyvio for more than 2 years.1,2

  • Rate of serious infections and infections similar to placebo.1

    • Low rate of serious infections over time with continued use of Entyvio (Entyvio: 0.07 per patient-year*; placebo: 0.06 per patient-year*).

      • Serious infections, including tuberculosis, sepsis (some fatal), salmonella sepsis, listeria meningitis, and cytomegaloviral colitis, have been reported with Entyvio.

  • Infection rates with Entyvio similar to placebo (Entyvio: 0.85 per patient-year*; placebo: 0.70 per patient-year*).

    • Infections that occurred more commonly with Entyvio involved the upper respiratory tract.

    • Most patients continued on Entyvio after infections were resolved.

  • The discontinuation rates due to adverse events were similar across treatment arms: Entyvio 9%, placebo 10%.

  • 1Low incidence of infusion related reactions (IRR).

    • Observed IRRs generally resolved with no or minimal intervention following the infusion.

    • 4% of patients treated with Entyvio experienced an IRR in GEMINI I and GEMINI II vs. 3% of placebo patients.

  • 1Low immunogenicity rate.

    • 4% immunogenicity in controlled studies of Entyvio.

    • 56 of 1,434 patients who received continuous treatment with Entyvio were anti-Entyvio antibody-positive at any time during treatment.

  • Data do not suggest increased risk for malignancy.1

    • Overall results from the clinical program to date do not suggest an increased risk for malignancy with Entyvio treatment.

      • The number of malignancies was small and long-term exposure was limited.

      • Long-term safety evaluations are ongoing.

*Patient-year: the sum of days treated across all patients/365 days; can be used to express rate of an event over time where exposure to treatment may differ between treatment arms.

  1. Entyvio Summary of Product Characteristics. Takeda Pharmaceuticals. 2014

  2. Entyvio Prescribing Information. Takeda Pharmaceuticals. 2014