Review safety results from the pivotal clinical trials for KRYSTEXXA.
These results were obtained before the Stopping Rules were established using sUA levels as a predictive biomarker for infusion outcomes.
KRYSTEXXA PHASE 3 SAFETY SUMMARY: ADVERSE EVENTS
The sUA Stopping Rules were not in place during phase 3 trials
MOST COMMON SERIOUS ADVERSE REACTIONS OCCURRING IN ≥5% OF PATIENTS TREATED WITH KRYSTEXXA1,2*
•Gout Flares: 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)
•Infusion Reactions: 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)
•Severe Infusion Reactions: 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)†
•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
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
96% of patients who completed the pivotal clinical trials chose to continue receiving KRYSTEXXA in an open-label extension study.2
- KRYSTEXXA [prescribing information]. Horizon Pharma Rheumatology LLC.
- Baraf HS, et al. J Clin Rheumatol. 2014;20(8):427-432.