Review safety results from the pivotal clinical trials for KRYSTEXXA.
These results were obtained before the KRYSTEXXA Monitoring Protocol was established using sUA levels as a predictive biomarker for infusion outcomes.
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.
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
- KRYSTEXXA (pegloticase) [prescribing information] Horizon.
- Baraf HS, et al. J Clin Rheumatol. 2014;20(8):427-432.