Hands

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

DECT scan of gouty tophi in hand

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).

Image of kidney with gout crystals under microscope

Nickeleit V et al, Uric acid nephropathy and end-stage renal disease–review of a non-disease, Nephrol Dial Transplant, 1997, 12(9), 1832-1838, by permission of Oxford University Press.

Heart

Microtophus in the intima of a left anterior descending artery.

Image of heart with gout crystals under microscope

Reproduced from Prevalence of birefringent crystals in cardiac and prostatic tissues, an observational study, Park JJ, et al, BMJ Open. 2014;1-6. Used with permission from BMJ Publishing Group Ltd.

Many patients fail to achieve target urate levels with oral ULTs8,11,12

Uric acid removal becomes even more challenging in patients with CKD.10,13

Percentages of patients treated with allopurinol and febuxostat who reached target sUA level2†

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.12

CKD, chronic kidney disease; ULT, urate-lowering therapy.

Need more data?

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

ACR Guidelines

ACR Guidelines strongly recommend pegloticase for your patients with uncontrolled gout.7‡

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.7,14

ACR, American College of Rheumatology; sUA, serum uric acid.

Learn about patients who might benefit from KRYSTEXXA

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.

  • Edwards NL. In: Klippel JK, et al, eds. Primer on the Rheumatic Diseases. 13th ed. Springer; 2008:241-249.
  • Doghramji PP, et al. Postgrad Med. 2012;124(6):98-109.
  • Nickeleit V, et al. Nephrol Dial Transplant. 1997;12(9):1832-1838.
  • Park JJ, et al. BMJ Open. 2014;4(7):e005308.
  • 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.
  • 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.
  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.