KRYSTEXXA PHASE 3 SAFETY SUMMARY: ADVERSE EVENTS

The KRYSTEXXA Monitoring Protocol was not in place during phase 3 trials

MOST COMMON SERIOUS ADVERSE REACTIONS OCCURRING IN ≥5% OF PATIENTS TREATED WITH KRYSTEXXA1,2*

  • 77% of patients who received KRYSTEXXA (65 out of 85) experienced gout flares, compared to 81% of patients who received placebo (35 out of 43)
  • 26% of patients who received KRYSTEXXA (22 out of 85) experienced infusion reactions, compared to 5% of patients who received placebo (2 out of 43)
  • 5% of patients who received KRYSTEXXA (4 out of 85) experienced severe infusion reactions (anaphylaxis), compared to 0% of patients who received placebo (0 out of 43)

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

In the pivotal clinical trials, no patients with infusion reactions required intubation, mechanical ventilator support, or hospitalization. There were no infusion-related deaths.2

*If the same subject in a given group had more than 1 occurrence in the same preferred term or event category, the subject was counted only once.

Post hoc analysis criteria defined using National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.

KRYSTEXXA (pegloticase) vial packaging KRYSTEXXA (pegloticase) vial packaging KRYSTEXXA (pegloticase) vial packaging

ADMINISTRATION AND SAFETY GUIDANCE1

  • KRYSTEXXA should be administered in healthcare settings, by healthcare providers prepared to manage anaphylaxis and infusion reactions
    • Patients should be premedicated with antihistamines and corticosteroids
    • Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported
  • Other most common adverse reactions occurring in at least 5% of patients treated with KRYSTEXXA: nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, and vomiting

96% of patients who completed the pivotal clinical trials chose to continue receiving KRYSTEXXA in an open-label extension study.2

MONITORING
PROTOCOL

In a post hoc analysis, preinfusion sUA was revealed as a powerful biomarker for predicting infusion reactions. From this, a simple monitoring protocol was established.

See the Protocol

LOWERING
sUA LEVELS

View the effects KRYSTEXXA had on patients’ sUA levels, including sUA levels after the first infusion.

  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
  • Baraf HS, et al. J Clin Rheumatol. 2014;20(8):427-432.