Urate Deposition in Gout | KRYSTEXXA® (pegloticase) for HCPs

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Evaluate Your Gout Patients Using “STOP”²

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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/dL^1,2
4.1-5.9
mg/dL^1,9
6.0-6.8
mg/dL^1,3,4
>6.8
mg/dL^5-7

0-4.0 mg/dL^1,2

Potential to

Resolve tophi faster
Expedite the reduction of urate burden

0-4.0
mg/dL^1,2
4.1-5.9
mg/dL^1,9
6.0-6.8
mg/dL^1,3,4
>6.8
mg/dL^5-7

4.1-5.9 mg/dL^1,9

Potential to

Slow dissolution of tophi (visible and nonvisible)
Decrease flare frequency

0-4.0
mg/dL^1,2
4.1-5.9
mg/dL^1,9
6.0-6.8
mg/dL^1,3,4
>6.8
mg/dL^5-7

6.0-6.8 mg/dL^1,3,4

Potential to

Slow gout progression
Urate burden unchanged, and flares can continue

0-4.0
mg/dL^1,2
4.1-5.9
mg/dL^1,9
6.0-6.8
mg/dL^1,3,4
>6.8
mg/dL^5-7

>6.8 mg/dL^5-7

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

patients fail to achieve target urate levels with oral ULTs^4,10,11

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 CKD^6,12

Percentages of patients treated with allopurinol and febuxostat who reached target sUA level^11†

Chart showing 21% of patients reached the primary efficacy endpoint when treated
with 300mg of allopurinol per day for 52 weeks (n=251). 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.

^†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

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.

References
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.

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.

Key Inclusion/Exclusion Criteria3

Inclusion

Exclusion

Family history, health literacy, and socioeconomic environment are contributing factors to gout becoming uncontrolled18,19

Two major factors contribute to uric acid buildup and crystallization18,19

Genetics

Kidney damage

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URATE BURDEN

The lower the sUA level the faster the urate burden can resolve1-7

Stay informed for your patients and practice.

Evaluate Your Gout Patients Using “STOP”2

Lowering sUA level is necessary to begin depletion 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

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

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

Need more data?

ACR Guidelines

Learn more about patients who might benefit from KRYSTEXXA

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Andrew

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IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATION

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Key Inclusion/Exclusion Criteria³

Family history, health literacy, and socioeconomic environment are contributing factors to gout becoming uncontrolled^18,19

Two major factors contribute to uric acid buildup and crystallization^18,19

The lower the sUA level the faster the urate burden can resolve^1-7

Evaluate Your Gout Patients Using “STOP”²

0-4.0 mg/dL^1,2

4.1-5.9 mg/dL^1,9

6.0-6.8 mg/dL^1,3,4

>6.8 mg/dL^5-7

patients fail to achieve target urate levels with oral ULTs^4,10,11

Urate removal becomes even more challenging in patients with CKD^6,12