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Primary endpoint

up arrow>80%relative improvement in efficacy

KRYSTEXXA with methotrexate (MTX) provided >80% relative improvement in patient response.1

The primary efficacy endpoint was the proportion of responders, defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 6.1

sUA, serum uric acid.

KRYSTEXXA
with MTX1

KRYSTEXXA
alone1

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone in Month 6, with 71% (N=71/100) of KRYSTEXXA with methotrexate achieving the primary endpoint vs 39% (N=20/52) with KRYSTEXXA alone

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone in Month 6, with 71% (N=71/100) of KRYSTEXXA with methotrexate achieving the primary endpoint vs 39% (N=20/52) with KRYSTEXXA alone

vs

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone in Month 6, with 39% (N=20/52) with KRYSTEXXA alone achieving the primary endpoint

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone in Month 6, with 39% (N=20/52) with KRYSTEXXA alone achieving the primary endpoint

P<0.0001

sUA, serum uric acid.

Secondary endpoint

94% improvement in patient response

KRYSTEXXA with methotrexate provided 94% relative improvement in patient response in Month 12.1

The secondary efficacy endpoint was the proportion of responders, defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12.1

KRYSTEXXA
with MTX1

KRYSTEXXA
alone1

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone in Month 12, with 60% (N=60/100) of KRYSTEXXA with methotrexate achieving the secondary endpoint vs 31% (N=16/52) with KRYSTEXXA alone

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone in Month 12, with 60% (N=60/100) of KRYSTEXXA with methotrexate achieving the secondary endpoint vs 31% (N=16/52) with KRYSTEXXA alone

vs

31-percent icon

31-percent icon

P<0.0003

KRYSTEXXA responders rapidly achieved and maintained an sUA level <1 mg/dL2

KRYSTEXXA with methotrexate: 71/100 patients at Month 6 and 60/100 patients at Month 12 had a complete sUA response.

KRYSTEXXA alone: 20/52 patients at Month 6 and 16/52 patients at Month 12 had a complete sUA response.

KRYSTEXXA alone

Chart showing sUA dropping below 1 mg/dL after one infusion of KRYSTEXXA, with these levels sustained throughout a 52 week period

Krystexxa alone

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Tophi resolution

KRYSTEXXA with methotrexate helps patients reach an sUA level that dissolves tophi.1*

See the Data

*Tophi resolution was defined as 100% resolution of at least 1 target tophus, no new tophi appearing, and no single tophus showing progression.

Learn about Bet, a patient who benefited from KRYSTEXXA

Real KRYSTEXXA patient, Bet

Patient name/age: Bet, 43
Occupation: Stay-at-home parent

Serum Uric Acid levels iconsUA >6 mg/dL

Gout flares icon2/year

Tophi iconvisible tophi

Learn About Bet

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.
  • Data on File. Horizon, March 2022.