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Evaluate Your Gout Patients Using “STOP”3

Click any card to learn more about STOP

Evaluate Your Gout Patients Using“STOP”2

Click any card to learn more about STOP

sUA>6 Is their uric acid level >6 mg/dL? TOPHI Do they have nonresolving tophi? ORAL ULT FAILURE Have they been taking the maximum medically appropriate dose of ULTs? 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.

Lowering sUA level is necessary to begin depletion of urate burden

Even at an sUA level of 5.4 mg/dL, it would take 2 years to dissolve a tophus the size of a small marble.8*

Image of a marble representing the size of tophi

*According to a long-term follow-up of 24 patients receiving a mean daily dose of 320 mg allopurinol.

KRYSTEXXA has not been studied to reverse damage to any of the body's organs.

REDUCTION OF URATE DEPOSITION

ONGOING URATE DEPOSITION

  • 0-4.0 mg/dL1,2
  • 4.1-5.9 mg/dL1,9
  • 6.0-6.8 mg/dL1,3,4
  • >6.8 mg/dL5-7

0-4.0 mg/dL1,2

Potential to

  • Resolve tophi faster
  • Expedite the reduction of
    urate burden
  • 0-4.0 mg/dL1,2
  • 4.1-5.9 mg/dL1,9
  • 6.0-6.8 mg/dL1,3,4
  • >6.8 mg/dL5-7

4.1-5.9 mg/dL1,9

Potential to

  • Slow dissolution of tophi (visible and nonvisible)
  • Decrease flare frequency
  • 0-4.0 mg/dL1,2
  • 4.1-5.9 mg/dL1,9
  • 6.0-6.8 mg/dL1,3,4
  • >6.8 mg/dL5-7

6.0-6.8 mg/dL1,3,4

Potential to

  • Slow gout progression
  • Urate burden unchanged, and flares can continue
  • 0-4.0 mg/dL1,2
  • 4.1-5.9 mg/dL1,9
  • 6.0-6.8 mg/dL1,3,4
  • >6.8 mg/dL5-7

>6.8 mg/dL5-7

  • Urate continues to deposit in the joints and tissues, including organs
  • Flares can increase in frequency

Many patients fail to achieve target urate levels with oral ULTs4,10,11

2020 ACR Guidelines: When treating, ULT titration should occur over a reasonable timeframe (eg, weeks to months, not months to years) to prevent treatment inertia3

Urate removal becomes even more challenging in patients with CKD6,12

Percentages of patients treated with allopurinol and febuxostat who reached target sUA level11†

Chart showing 21% of patients reached the primary efficacy endpoint when treated with 300mg of allopurinol per day for 52 weeks (n=251). The primary efficacy endpoint was an sUA concentration of <6 mg/dL at each of the last 3 monthly measurements during a 12-month study.
Chart showing 53% of patients reached the primary efficacy endpoint when treated with 80mg of febuxostat per day for 52 weeks (n=255). The primary efficacy endpoint was an sUA concentration of <6 mg/dL at each of the last 3 monthly measurements during a 12 month study.

300 mg allopurinol/day for 52 weeks (n=251)

80 mg febuxostat/day for 52 weeks (n=255)

†The primary efficacy endpoint was an sUA concentration of <6 mg/dL at each of the last 3 monthly measurements.

CKD, chronic kidney disease.

Urate burden

Interested in learning more about uncontrolled gout and sUA? Connect with the KRYSTEXXA team to discuss.

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ACR Guidelines

ACR Guidelines strongly recommend pegloticase for your patients with uncontrolled gout.3‡

See the Data

‡ACR Guidelines recommend pegloticase in patients who have failed to reach sUA target levels on oral urate-lowering therapies at maximum medically appropriate doses and continue to have frequent gout flares (≥2 flares/year) or nonresolving tophi.3,13

ACR, American College of Rheumatology.

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.

  • Perez-Ruiz F. Rheumatology (Oxford). 2009;48(suppl 2):ii9-ii14.
  • Araujo EG, et al. RMD Open. 2015;1:e000075.
  • FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72:744-760.
  • Schumacher HR Jr, et al. Arthritis Rheum. 2008;59:1540-1548.
  • Maiuolo J, et al. Int J Cardiol. 2016;213:8-14.
  • Vargas-Santos AB, et al. Am J Kidney Dis. 2017;70:422-439.
  • Doghramji PP, et al. Postgrad Med. 2012;124:98-109.
  • Perez-Ruiz F, et al. Arthritis Rheum. 2002;47:356-360.
  • Shoji A, et al. Arthritis Rheum. 2004;51:321-325.
  • Becker MA, et al. Semin Arthritis Rheum. 2015;45:174-183.
  • Becker MA, et al. N Engl J Med. 2005;353:2450-2461.
  • Krishnan E. PLoS One. 2012;7:e50046.
  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.