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An sUA level of 6 mg/dL is not low enough for many patients with gout1
sUA level (mg/dL) Impact on urate burden
6.0-6.8 Slows progression of gout; urate burden remains essentially unchanged.
4.1-5.9 Begins to slowly dissolve visible and nonvisible tophi.
0-4.0 Potential to resolve tophi and reduce the urate burden faster.

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.2*

Rendition of tophi the size of a marble

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

sUA, serum uric acid.

REDUCTION OF URATE DEPOSITION

ONGOING URATE DEPOSITION

  • 0-4.0 mg/dL2,3
  • 4.1-5.9 mg/dL2,4
  • 6.0-6.8 mg/dL2,5,6
  • >6.8 mg/dL7,8

0-4.0 mg/dL2,3

Potential to

  • Resolve tophi faster
  • Expedite the reduction of urate burden
  • 0-4.0 mg/dL2,3
  • 4.1-5.9 mg/dL2,4
  • 6.0-6.8 mg/dL2,5,6
  • >6.8 mg/dL7,8

4.1-5.9 mg/dL2,4

Potential to

  • Slow dissolution of tophi (visible and nonvisible)2,4
  • Decrease flare frequency2,4
  • 0-4.0 mg/dL2,3
  • 4.1-5.9 mg/dL2,4
  • 6.0-6.8 mg/dL2,5,6
  • >6.8 mg/dL7,8

6.0-6.8 mg/dL2,5,6

Potential to

  • Slow gout progression
  • Maintain urate burden, and flares can continue
  • 0-4.0 mg/dL2,3
  • 4.1-5.9 mg/dL2,4
  • 6.0-6.8 mg/dL2,5,6
  • >6.8 mg/dL7,8

>6.8 mg/dL7,8

Potential to

  • Continue to deposit urate in the joints and tissues, including in the organs
  • Flares can increase in frequency

Many patients fail to achieve target urate levels with oral ULTs6,10,11

Uric acid removal becomes even more challenging in patients with CKD.9,12

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

Radiograph of gout patient's hand showing bone erosion
Radiograph of gout patient's hand showing bone erosion

300 mg allopurinol/day for 12 months (n = 251)

80 mg febuxostat/day for 12 months (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; ULT, urate-lowering therapies.

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.5‡

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.

ACR, American College of Rheumatology.

Learn about Bet, a patient who benefited from KRYSTEXXA

Actor portrayal of gout 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.

  • Ruoff G, et al. Postgrad Med Epub. 2016;128(7):706-15.
  • Perez-Ruiz F. Rheumatology (Oxford). 2009;48(Suppl 2):ii9-ii14.
  • Araujo EG, et al. RMD Open. 2015;1(1):e000075.
  • Shoji A, et al. Arthritis Rheum. 2004;51:321-325.
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  • Maiuolo J, et al. Int J Cardiol. 2016;213:8-14.
  • Doghramji PP, et al. Postgrad Med. 2012;124(6):98-109.
  • Vargas-Santos AB, et al. Am J Kidney Dis. 2017;70(3):422-439.
  • Becker MA, et al. Semin Arthritis Rheum. 2015;45(2):174-183.
  • Becker MA, et al. N Engl J Med. 2005;353(23):2450-2461.
  • Krishnan E. PloS One. 2012;7(11):e50046.