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THE LEVEL OF URATE CRYSTAL BURDEN MAY NOT BE VISUALLY APPARENT1-3

A separate DECT scanning study by Choi et al (N=20) found that the urate burden was greater than expected from physical examination.4

Urate crystal deposition is systemic and can accumulate almost anywhere in the body, including joints, tendons, and organs.4,5

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Deposition of monosodium urate crystals detected using DECT (displayed in green).
Images courtesy of Dr Jürgen Rech.
Individual patient presentations may vary.3

4x more urate deposits were found using DECT vs thorough clinical examination3*

*In a study evaluating the utility of DECT scanning in assessing urate deposits in gout patients (N=20).3

THIELE ET AL FOUND TOPHACEOUS MATERIAL IN 100% OF PATIENTS WITH GOUTY HANDS AND FEET (N=23)1†

†Tophi status for 1 patient was not recorded to be either nonvisible or visible.

An ultrasound study of patients with gouty arthritis and involved joints by Thiele et al found:

NONVISIBLE TOPHI

59%

(13/22)

VISIBLE TOPHI

41%

(9/22)

†Tophi status for 1 patient was not recorded to be either nonvisible or visible.

CHRONIC INFLAMMATION INDUCED BY URATE CRYSTAL DEPOSITION LEADS TO JOINT DAMAGE6-8

Imaging highlights the links between urate crystal deposition, tophus formation, the resulting inflammation, and bone erosion.6,7

Coronal View

Axial View

Coronal View

T1-weighted coronal image showing multiple erosions, with a large lesion at the distal ulna (circle).7

Axial View

T1-weighted axial image confirming erosion and tophus (circle).7

Images used with permission from McQueen F et al. Rheumatology (Oxford). 2014;53(1):95-103. Individual presentation may vary.

VISIBLE AND NONVISIBLE TOPHI HAVE BEEN ASSOCIATED WITH STRUCTURAL JOINT DAMAGE4,8-11

Dalbeth et al (2015) found a close relationship between urate crystal deposition, tophus formation, and structural joint damage.8

Both nonvisible and visible tophi were associated with higher bone erosion scores8

  • In a prospective study (N=92), a strong linear relationship was observed in the frequency of joints affected by urate crystals with radiographic erosion score (P<0.0001)8§
  • Erosion was present in 73% (112/153) of joints with crystal deposition8

Adapted with permission from Dalbeth N et al. Ann Rheum Dis. 2015;74(6):1030-1036.

‡Erosion score was measured according to the Sharp/van der Heijde scoring method. The 10 metatarsophalangeal joints (5 per foot) are scored for the presence and extent of erosion on a scale from 0 to 10, with 0 being a normal joint.8

§Plain radiographs and DECT scans of the feet were used to examine the relationship between joint damage and urate crystal deposition in tophaceous gout.8

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A member of the KRYSTEXXA team is available to further discuss the prevalence and consequences of urate burden in gout.

LOWERING
sUA LEVELS

View the effects KRYSTEXXA had on patients’ sUA levels, including sUA levels after the first infusion.

See sUA data

COMPLETE TOPHI
RESOLUTION

See the data on how effective KRYSTEXXA is in lowering sUA levels and resolving tophi.

View tophi resolutions
Full Important Safety Information

For U.S. Healthcare Professionals Patient Site

Full Prescribing Information

Medication Guide

INDICATIONS AND USAGE

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Important Safety Information

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

INDICATIONS AND USAGE

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. 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 studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

Full Important Safety Information

For U.S. Healthcare Professionals Patient Site

Full Prescribing Information

Medication Guide

INDICATIONS AND USAGE

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Important Safety Information

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

INDICATIONS AND USAGE

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. 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 studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

  • Thiele RG, et al. Rheumatology. 2007;46:1116-1121.
  • Bongartz T, et al. Ann Rheum Dis. 2015;74:1072-1077.
  • Choi HK, et al. Ann Rheum Dis. 2009;68:1609-1612.
  • Doghramji PP, et al. Postgrad Med. 2012;124:98-109.
  • Park JJ, et al. BMJ Open. 2014;4:1-6.
  • Rees F, et al. Nat Rev Rheumatol. 2014;10:271-283.
  • McQueen FM, et al. Rheumatology (Oxford). 2014;53:95-103.
  • Dalbeth N, et al. Ann Rheum Dis. 2015;74:1030-1036.
  • Yu KH, et al. Rheumatology. 2004;43:191-194.
  • McQueen FM, et al. Nat Rev Rheumatol. 2012;8:173-181.
  • Desai MA, et al. Radiographics. 2011;31:1365-1375.