Key Inclusion/Exclusion Criteria2

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 include4,20:
  • 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/dL9,10

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Graphic of a shield showing that KRYSTEXXA has been approved for 14 years
URATE BURDEN

The lower the sUA level, the faster the urate burden can resolve1,2

Artist's rendition of uric acid crystals
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Evaluate Your Gout Patients Using “STOP”3

Click any card to learn more about STOP
Graphic of the letter 'S'

sUA >6

Is their uric acid level
>6 mg/dL?

endpoint
Graphic of the letter 'T'

TOPHI

Do they have
nonresolving tophi?

treating-gout-tophi
Graphic of the letter 'O' shaped like a stop sign

ORAL ULT FAILURE

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

urate-deposition-gout
Graphic of the letter 'P'

PAINFUL FLARES

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

gout-flare-treatment
Uncontrolled gout is defined as having sUA >6 mg/dL along with 2 or more flares per year and/or 1 or more nonresolving tophi while receiving the maximum medically appropriate dose of oral ULT.3-5 KRYSTEXXA is not indicated for the treatment of pain.
sUA, serum uric acid; ULT, urate-lowering therapy.

Target sUA to a normal (<6 mg/dL) level

Lowering serum uric acid (sUA) level is necessary to begin depletion of urate burden1,2

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.6,*
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.10

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/dL1,7
  • 6.0-6.8
    mg/dL1,3,8
  • >6.8
    mg/dL9-11

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/dL1,7
  • 6.0-6.8
    mg/dL1,3,8
  • >6.8
    mg/dL9-11

4.1-5.9 mg/dL1,7

Potential to

  • Slow dissolution of tophi (visible and nonvisible)
  • Decrease flare frequency
  • 0-4.0
    mg/dL1,2
  • 4.1-5.9
    mg/dL1,11
  • 6.0-6.8
    mg/dL1,3,8
  • >6.8
    mg/dL9-11

6.0-6.8 mg/dL1,3,8

  • Slow gout progression
  • Urate burden unchanged, and flares can continue
  • 0-4.0
    mg/dL1,2
  • 4.1-5.9
    mg/dL1,11
  • 6.0-6.8
    mg/dL1,3,4
  • >6.8
    mg/dL9-11

>6.8 mg/dL9-11

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

Many patients fail to reach target sUA level of <6 mg/dL with oral ULTs8,12

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,†

†Treatment inertia is when adjustments are not made to current therapy when it fails to meet patient treatment goals.13

‡The primary efficacy endpoint was an sUA concentration of <6 mg/dL at each of the last 3 monthly measurements.12

The Febuxostat versus Allopurinol Controlled Trial (FACT) study was a phase 3, randomized, double-blind, 52-week, multicenter trial that compared the safety and efficacy of febuxostat with the safety and efficacy of allopurinol in adult subjects with gout who had sUA levels of at least 8 mg/dL.12
ACR, American College of Rheumatology;

Percentage of patients treated with allopurinol or febuxostat who failed to reach target sUA level of <6 mg/dL 12,‡

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)

Allopurinol may have a threshold effect that impacts treatment outcomes13
Threshold Effect

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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.3,12

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of patient with no visible tophi

Michelle

Occupation:
Nurse

59-year-old with no visible tophi, but has pain and tenderness in her hands; diagnosed with gout 5 years ago

Actor portrayal, not actual patient.

Learn About Michelle
Actor portrayal of patient with pain who was diagnosed with gout years ago

Andrew

Occupation:
Real estate agent

56-year-old with hypertension and pain in hands and feet; diagnosed with gout 8 years ago

Actor portrayal, not actual patient.

Learn About Andrew
Real KRYSTEXXA patient, Bet

Bet

Occupation:
Stay-at-home parent

43-year-old diagnosed with gout over 20 years ago

Real patient.

Learn About Bet

KRYSTEXXA is not indicated for the treatment of pain.

Allopurinol may have a threshold effect that impacts treatment outcomes1421

Even at the highest doses, a proportion of patients may not benefit from increased doses of allopurinol1421

Proportion of patients with sUA <6 mg/dL categorized by their final daily allopurinol dose

Chart showing proportion of patients with sUA <6.0 g/dL by their final daily dose of allupurinol. Chart showing proportion of patients with sUA <6.0 g/dL by their final daily dose of allupurinol.

While XOIs can limit the production of uric acid, they do not actively remove saturated urate from the body1522

XOI, xanthine-oxidase inhibitor.

The efficacy analysis was performed post hoc to determine the proportion of patients who met the sUA target of <6 mg/dL when categorized by final allopurinol dose rather than the highest dose during the study.14 Analysis is exploratory and has not been adjusted for multiple comparisons. No clinical or statistical conclusions can be drawn.14

The efficacy analysis was performed post-hoc to determine the proportion of patients who met the sUA target of <6 mg/dL when categorized by final allopurinol dose rather than the highest dose during the study.21

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.
    • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    • Botson JK, et al. Arthritis Rheumatol. 2023;75:293-304.
    • 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.
    • Phillips LS, et al. Ann Intern Med. 2001;135:825-834.
    • Becker MA, et al. N Engl J Med. 2005;353:2450-2461.
    • Graham G, et al. Br J Clin Pharmacol. 2013;76:932-938.

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.