on a single occasion, the incidence of infusion reactions would have been reduced by approximately 67%, but the success rates for the primary efficacy endpoint would have been reduced by approximately 20%. If KRYSTEXXA had been stopped after 2 consecutive uric acid levels greater than 6 mg/dL, the incidence of infusion reactions would have been half, and there would have been little change in the efficacy outcome.
Trial 1
Pegloticase 8 mg every 2 weeks 43 20 (47%) [32%, 61%] <0.001
Pegloticase 8 mg every 4 weeks 41 8 (20%) [7%, 32%] 0.044
Placebo 20 0 (0%)
Trial 2
Pegloticase 8 mg every 2 weeks 42 16 (38%) [23%, 53%] <0.001
Pegloticase 8 mg every 4 weeks 43 21 (49%) [34%, 64%] <0.001
Placebo 23 0 (0%)
The effect of treatment on tophi was a secondary efficacy endpoint and was assessed using standardized digital photography, image analysis, and a Central Reader blinded to treatment assignment. Approximately 70% of patients had tophi at baseline. A pooled analysis of data from Trial 1 and Trial 2 was performed as pre-specified in the protocols. At Month 6, the percentage of patients who achieved a complete response (defined as 100% resolution of at least one target tophus, no new tophi appear and no single tophus showing progression) was 45%, 26%, and 8%, with KRYSTEXXA 8 mg every 2 weeks, KRYSTEXXA 8 mg every 4 weeks, and placebo, respectively. The difference between KRYSTEXXA and placebo was statistically significant for the every 2 week dosing regimen, but not for the every 4 week dosing regimen.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
KRYSTEXXA is supplied as a clear, colorless, sterile solution in phosphate buffered saline intended for intravenous infusion after dilution. KRYSTEXXA is supplied in a single-use 2 mL glass vial with a Teflon® coated (latex-free) rubber injection stopper to deliver KRYSTEXXA as 8 mg of uricase protein in 1 mL volume.
Storage and Handling
Before the preparation for use, KRYSTEXXA must be stored in the carton and maintained at all times under refrigeration between 2° to 8°C (36° to 46°F). Protect from light. Do not shake or freeze.
Do not use beyond the expiration date stamped.
NDC# 54396-801-01
17 PATIENT COUNSELING INFORMATION
See Medication Guide
17.1 General Information
Provide and instruct patients to read the accompanying Medication Guide before starting treatment and before each subsequent treatment.
17.2 Anaphylaxis and Infusion Reactions
Anaphylaxis and infusion reactions can occur at any infusion while on therapy. Counsel patients on the importance of adhering to any prescribed medications to help prevent or lessen the severity of these reactions.
Educate patients on the signs and symptoms of anaphylaxis, including wheezing, peri-oral or lingual edema, hemodynamic instability, and rash or urticaria.
Educate patients on the most common signs and symptoms of an infusion reaction, including urticaria (skin rash), erythema (redness of the skin), dyspnea (difficulty breathing), flushing, chest discomfort, chest pain, and rash.
Advise patients to seek medical care immediately if they experience any symptoms of an all |
