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Hands

DECT imaging of urate deposits on the bones and joints. Green areas depict the uric acid crystal depositions.

DECT scan of gout patient showing urate deposition in hands

DECT, dual-energy computed tomography.

DECT image courtesy of Dr Jürgen Rech.

Kidney

Tophus with central urate deposition surrounded by mononuclear inflammatory cells and scattered giant cells (arrow).

Biopsy of gout patient showing urate deposition and tophi in kidneys

Nickeleit V, et al. Nephrol Dial Transplant. 1997;12(9):1832-1838. Used with permission from Oxford University Press.

Heart

Microtophus in the intima of a left anterior descending artery.

Image of gout patient showing tophi in heart

Reproduced from Prevalence of birefringent crystals in cardiac and prostatic tissues, an observational study, Park JJ, et al, BMJ Open. 2014;4(7):3005308. Used with permission from BMJ Publishing Group Ltd.

KRYSTEXXA has not been studied to reverse damage to the kidneys or heart.

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*

marble-scaler

*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 URIC ACID DEPOSITION

ONGOING URATE DEPOSITION

  • 0-4.0 mg/dL1,2
  • 4.1-5.9 mg/dL1,8
  • 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
    uric acid burden
  • 0-4.0 mg/dL1,2
  • 4.1-5.9 mg/dL1,8
  • 6.0-6.8 mg/dL1,3,4
  • >6.8 mg/dL5,7

4.1-5.9 mg/dL1,8

Potential to

  • Slow dissolution of tophi (visible and nonvisible)1,9
  • Decrease flare frequency1,9
  • 0-4.0 mg/dL1,2
  • 4.1-5.9 mg/dL1,8
  • 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/dL1,8
  • 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

Uric acid removal becomes even more challenging in patients with CKD.6,12

Percentages of patients treated with allopurinol and febuxostat who reached target sUA level12†

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

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; ULT, urate-lowering therapy.

Need more data?

The KRYSTEXXA team is available to share more information about urate deposits and tophi.

Request Support

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

ACR, American College of Rheumatology.

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 4 patient, Lisa Actor portrayal of gout and CKD Stage 4 patient, Lisa Actor portrayal of gout and CKD Stage 4 patient, Lisa

Lisa, CKD stage 4

Occupation:
Office manager

58-year-old with CKD stage 4 due to ADPKD, diagnosed with gout 7 years ago

Learn About Lisa

Actor portrayal, not actual patient.

ADPKD, autosomal dominant polycystic kidney disease.

Actor portrayal of gout and kidney transplant patient, Harold Actor portrayal of gout and kidney transplant patient, Harold Actor portrayal of gout and kidney transplant patient, Harold

Harold, transplant patient

Occupation:
Journalist

64-year-old with type 2 diabetes, hypertension, and end-stage renal disease

Learn About Harold

Actor portrayal, not actual patient.

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(1):e000075.
  • FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72(6):744-760.
  • Schumacher HR Jr, et al. Arthritis Rheumatol. 2008;59(11):1540-1548.
  • Maiuolo J, et al. Int J Cardiol. 2016;213:8-14.
  • Vargas-Santos AB, et al. Am J Kidney Dis. 2017;70(3):422-439.
  • Doghramji PP, et al. Postgrad Med. 2012;124(6):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(2):174-183.
  • Becker MA, et al. N Engl J Med. 2005;353(23):2450-2461.
  • Krishnan E. PLoS One. 2012;7(11):e50046.