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Evaluate Your Gout Patients Using “STOP”2

Click any card to learn more about STOP

Evaluate Your Gout Patients Using “STOP”2

Click any card to learn more about STOP

Hand Icon SUA >6 Is their uric acid level >6 mg/dL? Hand Icon TOPHI Do they have nonresolving tophi? Hand Icon ORAL ULT FAILURE Have they been taking the maximum medically appropriate dose of ULTs? Hand Icon PAINFUL FLARES Have they had 2 or more painful flares in the past year?

Uncontrolled gout is not defined by having all of the criteria above. KRYSTEXXA is not indicated for the treatment of pain.

sUA, serum uric acid; ULT, urate-lowering therapy.

Uncontrolled gout is not defined by having all of the criteria above. KRYSTEXXA is not indicated for the treatment of pain.

sUA, serum uric acid; ULT, urate-lowering therapy.

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

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

Secondary endpoint

94% relative improvement in patient response

KRYSTEXXA with methotrexate provided 94% relative improvement in patient response.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/dL3

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

KRYSTEXXA alone: 20/52 patients during Month 6 and 16/52 patients during 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 trial period

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

Interested in how KRYSTEXXA may resolve tophi?

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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 more about patients who might benefit from KRYSTEXXA

Actor portrayal of patient with no visible tophi Actor portrayal of patient with no visible tophi Actor portrayal of patient with no visible tophi

Michelle

Occupation:
Nurse

59-year-old with no visible tophi, but has pain and tenderness in her hands; diagnosed with gout 5 years ago

Learn About Michelle

Actor portrayal, not actual patient.

Actor portrayal of patient with pain who was diagnosed with gout years ago Actor portrayal of patient with pain who was diagnosed with gout years ago Actor portrayal of patient with pain who was diagnosed with gout years ago

Andrew

Occupation:
Real estate agent

56-year-old with hypertension and pain in hands and feet; diagnosed with gout 8 years ago

Learn About Andrew

Actor portrayal, not actual patient.

Real KRYSTEXXA patient, Bet Real KRYSTEXXA patient, Bet Real KRYSTEXXA patient, Bet

Occupation:
Stay-at-home parent

43-year-old diagnosed with gout over 20 years ago

Learn About Bet

Real patient.

KRYSTEXXA is not indicated for the treatment of pain.

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.
  • FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72:744-760.
  • Data on File. Horizon, March 2022.
  • Data on File. Horizon, December 2023.