PRIMARY ENDPOINT

KRYSTEXXA REDUCES sUA LEVELS IN TREATED PATIENTS2,3

In pivotal clinical trials, there were 2 types of patient responses in the KRYSTEXXA group.2,3

COMPLETE sUA RESPONSE3

These patients met the primary endpoint, which was the proportion of patients with sUA <6 mg/dL for ≥80% of the time in months 3 and 6.

sUA levels throughout the 6-month trials1,2
Efficacy lowering sUA chart Efficacy lowering sUA chart

*Based on the pooled results of replicate, multicenter, randomized, double-blind, placebo-controlled 6-month trials. Patients included adults with chronic gout refractory to conventional therapy. All investigators and patients were blinded to both treatment arm and sUA response.3,5

COMPLETE sUA RESPONSE3

These patients met the primary endpoint, which was the proportion of patients with sUA <6 mg/dL for ≥80% of the time in months 3 and 6.

42%

of patients had a complete response.

These patients maintained sUA levels below 6 mg/dL ≥80% of the time in months 3 and 6 vs 0% for placebo (P<0.001). Approximately 24 hours after the first dose, mean sUA level in these patients was <1 mg/dL.2,3*

icon down arrow The incomplete responders achieved a significant reduction in sUA levels for a mean of 7 weeks, allowing some clearance of the urate burden from baseline. The response was not durable; therefore, they did not meet the primary endpoint.2-4

IMPORTANT LIMITATIONS OF USE

  • KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia

SELECT IMPORTANT SAFETY INFORMATION

  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions

sUA REDUCTION IS SEEN AT FIRST INFUSION

In pivotal clinical trials, all KRYSTEXXA patients experienced a rapid drop in sUA and reached a uric acid level <6 mg/dL after their first infusion.2,3

MEAN sUA DROP 24 HOURS AFTER FIRST INFUSION IN THE PIVOTAL CLINICAL TRIALS3

Efficacy lowering sUA in incomplete responders chart
  • The initial drop in sUA was not durable for some patients2
  • Some patients may develop anti-pegloticase antibodies, which contribute to the loss of treatment response3
    • These patients, who lost treatment response, are referred to as incomplete responders2

After just 1 infusion, KRYSTEXXA begins converting the body’s uric acid burden to a water-soluble substance that can be readily excreted through the urine.3

SELECT IMPORTANT SAFETY INFORMATION

  • Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA

Within a week, her uric acid level fell to 0. Just like that.

Hear more from nephrologist Payam Shakouri about the first patient he treated with KRYSTEXXA.

Dr. Payam Shakouri Nephrologist
Watch video

KRYSTEXXA IS SAFE AND EFFECTIVE FOR CHRONIC GOUT PATIENTS WITH COMORBID CHRONIC KIDNEY DISEASE2,6

Pivotal clinical trials

32% of patients in the pivotal clinical trials had creatinine clearance <62.5 mL/min2

Estimation of glomerular filtration rate (eGFR) from serum creatinine remains the clinical standard worldwide to determine renal function.7-10

Pie chart Pie chart Pie chart

Post hoc analysis

38% of patients had stage 3 CKD and
11% had stage 4 CKD, as determined by eGFR6

Patients with CKD can be effectively treated with KRYSTEXXA without dose adjustment2

  • CKD patients experienced similar reductions in sUA levels compared with patients without CKD2,6
    • There was no difference in efficacy of KRYSTEXXA across CKD stages 1, 2, 3, and 4
  • The safety profile of KRYSTEXXA was demonstrated to be the same in patients with or without CKD, and across all CKD stages2,6
    • KRYSTEXXA did not affect the eGFR during the 25-week treatment period6

      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.

      COMPLETE TOPHI
      RESOLUTION

      See the data on how effective KRYSTEXXA is in lowering sUA levels and resolving tophi.

      INDICATIONS AND USAGE

      KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

      Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

      Important Safety Information

      WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

      Anaphylaxis and infusion reactions have been reported to occur during and 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. KRYSTEXXA should be administered in healthcare settings and 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. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

      CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

      Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

      INDICATIONS AND USAGE

      KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

      Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

      IMPORTANT SAFETY INFORMATION

      WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

      Anaphylaxis and infusion reactions have been reported to occur during and 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. KRYSTEXXA should be administered in healthcare settings and 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. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

      The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

      Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

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

      Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

      CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

      Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

      GOUT FLARES

      An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

      CONGESTIVE HEART FAILURE

      KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

      ADVERSE REACTIONS

      Please see Full Prescribing Information and Medication Guide for more information.

      INDICATIONS AND USAGE

      KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

      Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

      Important Safety Information

      WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

      Anaphylaxis and infusion reactions have been reported to occur during and 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. KRYSTEXXA should be administered in healthcare settings and 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. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

      CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

      Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

      INDICATIONS AND USAGE

      KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

      Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

      IMPORTANT SAFETY INFORMATION

      WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

      Anaphylaxis and infusion reactions have been reported to occur during and 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. KRYSTEXXA should be administered in healthcare settings and 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. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

      The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

      Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

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

      Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

      CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

      Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

      GOUT FLARES

      An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

      CONGESTIVE HEART FAILURE

      KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

      ADVERSE REACTIONS

      Please see Full Prescribing Information and Medication Guide for more information.

      • Fitzgerald JD, et al. Arthritis Res Care (Hoboken). 2020;59:1540-1548.
      • Sundy JS, et al. JAMA. 2011;306(7):711-720.
      • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
      • Data on file. Horizon, December 2016.
      • Baraf HS, et al. Arthritis Res Ther. 2013;15(5):R137.
      • Data on file. Horizon, May 2017.