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Pie chart with 33% in centerPie chart with 33% in center

KRYSTEXXA can be used without dose adjustment1

33%* of patients in the MIRROR RCT had an eGFR >40 and <60 mL/min/1.73 m2.1

*Data collected from Clinical Study Report.

eGFR, estimated glomerular filtration rate; MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial.

Mean Change from Baseline (Week -6) in eGFR through Week 242

Based on a retrospective analysis of patients in the MIRROR RCT

Patients treated with KRYSTEXXA experienced stability in mean eGFR from baseline through Week 24 of the MIRROR trial.

CFB, change from baseline; eGFR, estimated glomerular filtration rate; MTX, methotrexate.

KRYSTEXXA has not been studied to reverse damage to the kidneys. The data in the chart represents a numerical improvement and is not statistically significant.

Change in eGFR was not a pre-specified endpoint of the MIRROR trial and not powered to detect change in renal function.

KRYSTEXXA alone
Chart showing change from baseline (Week -6) through Week 24 in estimated glomerular filtration of patients on KRYSTEXXA alone, with a change of 4.34 mL/min/1.73m^2 at Week 24 Chart showing change from baseline (Week -6) through Week 24 in estimated glomerular filtration of patients on KRYSTEXXA alone, with a change of 4.34 mL/min/1.73m^2 at Week 24 Chart showing change from baseline (Week -6) through Week 24 in estimated glomerular filtration of patients on KRYSTEXXA alone, with a change of 4.34 mL/min/1.73m^2 at Week 24

Interested in how KRYSTEXXA may help reduce sUA?

Connect with the KRYSTEXXA team to discuss.

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Significant improvement

In the MIRROR RCT, KRYSTEXXA with MTX improved patient response at both 6 and 12 months.1†

See the Data

†The primary efficacy endpoint was the proportion of responders, defined as achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 6. The secondary efficacy endpoint was the proportion of responders, defined as achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12.

MTX, methotrexate; sUA, serum uric acid.

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of gout and CKD Stage 3b patient, David Actor portrayal of gout and CKD Stage 3b patient, David Actor portrayal of gout and CKD Stage 3b patient, David

David, CKD stage 3b

Occupation:
College professor

57-year-old with CKD stage 3b due to type 2 diabetes, diagnosed with gout 8 years ago

Learn About David

Actor portrayal, not actual patient.

Actor portrayal of gout and CKD Stage 3b patient, Susan Actor portrayal of gout and CKD Stage 3b patient, Susan Actor portrayal of gout and CKD Stage 3b patient, Susan

Susan, CKD stage 3b

Occupation:
Dental hygienist

45-year-old with CKD stage 3b, diagnosed with gout 3 years ago

Learn About Susan

Actor portrayal, not actual patient.

Real KRYSTEXXA patient, Michael, with a 30-year history of gout Real KRYSTEXXA patient, Michael, with a 30-year history of gout Real KRYSTEXXA patient, Michael, with a 30-year history of gout

Michael, CKD stage 3b

Occupation:
Architect

30-year history of gout

Learn About Michael

Real patient.

CKD, chronic kidney disease.

CKD, chronic kidney disease.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

  • 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. Delayed hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
  • Screen patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency.

CONTRAINDICATIONS:

  • In patients with G6PD deficiency.
  • In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

WARNINGS AND PRECAUTIONS

Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. 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 formally studied in patients with congestive heart failure, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥5%) are:

KRYSTEXXA co-administration with methotrexate trial:

KRYSTEXXA with methotrexate: gout flares, arthralgia, COVID-19, nausea, and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reaction, pain in extremity, hypertension, and vomiting.

KRYSTEXXA pre-marketing placebo-controlled trials:

gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

INDICATION

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.

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

Please see Full Prescribing Information, including Boxed Warning.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

  • 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. Delayed hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
  • Screen patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency.

CONTRAINDICATIONS:

  • In patients with G6PD deficiency.
  • In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

WARNINGS AND PRECAUTIONS

Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. 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 formally studied in patients with congestive heart failure, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥5%) are:

KRYSTEXXA co-administration with methotrexate trial:

KRYSTEXXA with methotrexate: gout flares, arthralgia, COVID-19, nausea, and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reaction, pain in extremity, hypertension, and vomiting.

KRYSTEXXA pre-marketing placebo-controlled trials:

gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

INDICATION

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.

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

Please see Full Prescribing Information, including Boxed Warning.

  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
  • Abdellatif A, et al. Poster presented at: 2022 American Society of Nephrology; November 3-6, 2022.