Key Inclusion/Exclusion Criteria3

Inclusion

  • Adult patients ≥18 years old with diagnosis of gout
  • Uncontrolled gout, defined as (all required)
    • Serum uric acid (sUA) ≥7 mg/dL
    • Oral urate lowering therapy failure/intolerance
    • ≥1 ongoing gout symptom (≥1 tophus, ≥2 flares in the year prior to screening and/or chronic gouty arthritis)

Exclusion

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • eGFR <40 mL/min/1.73 m2
  • MTX contraindication/known intolerance
  • Elevated LFTs, low albumin or low blood cell counts
eGFR, estimated glomerular filtration rate; LFTs, liver function tests; MTX, methotrexate.

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
Gout runs in the family
Kidney damage
Impaired uric acid elimination
Additional contributing factors include4,18,20,21:
  • Diet and lifestyle
  • Age
  • Comorbidities
  • Metabolism
Diet is not a substitute for treatment as dietary restrictions may reduce uric acid levels by only ~1 mg/dL13,22

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URATE BURDEN

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

Artist's rendition of uric acid crystals
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Evaluate Your Gout Patients Using "STOP"2

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sUA>6

Is their uric acid level
>6 mg/dL?

endpoint

TOPHI

Do they have
nonresolving tophi?

treating-gout-tophi

ORAL ULT FAILURE

Have they been taking
the maximum
medically appropriate
dose of ULTs?

urate-deposition-gout

PAINFUL FLARES

Have they had 2 or
more painful flares in
the past year?

gout-flare-treatment
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.
DECT scan of gout patient showing urate deposition in hands

Hands

DECT imaging of urate deposits on the bones and joints. Green areas depict the uric acid crystal depositions.
DECT, dual-energy computed tomography. DECT image courtesy of Dr Jürgen Rech.
Biopsy from gout patient showing urate deposition and tophus in kidneys

Kidney

Tophus with central urate deposition surrounded by mononuclear inflammatory cells and scattered giant cells (arrow).
Nickeleit V, et al. Nephrol Dial Transplant. 1997;12:1832-1838. Used with permission from Oxford University Press.
Image from gout patient showing tophi in heart

Heart

Microtophus in the intima of a left anterior descending artery.
Reproduced from Prevalence of birefringent crystals in cardiac and prostatic tissues, an observational study, Park JJ, et al, BMJ Open. 2014;4:e005308. Used with permission from BMJ Publishing Group Ltd.
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body's organs.

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/dL1,2
  • 4.1-5.9
    mg/dL1,9
  • 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 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

4.1-5.9 mg/dL1,9

Potential to

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

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/dL1,9
  • 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

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 CKD6,12

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

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

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ACR Guidelines

ACR Guidelines strongly recommend pegloticase for your patients with uncontrolled gout.3‡

See the Data

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of gout and CKD patient, Richard

Richard, CKD stage 4

Occupation:
Bus driver

52-year-old with CKD stage 4; 3 flares in the last year and no visible tophi

Actor portrayal, not actual patient.

Learn About Richard
Actor portrayal of gout and CKD Stage 3b patient, Susan

Susan, CKD stage 3b

Occupation:
Dental hygienist

45-year-old with CKD stage 3b; 3 flares in the last year and 1 small tophus on her left hand for the past 2 years

Actor portrayal, not actual patient.

Learn About Susan
Real KRYSTEXXA patient, Michael, with a 30-year history of gout

Michael, CKD stage 3b

Occupation:
Architect

60-year-old diagnosed with gout over 30 years ago

Real patient.

Learn About Michael

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.