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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sUA REDUCTION

KRYSTEXXA with methotrexate provided significant improvement in patient response*,† during Months 6 and 121

*The primary efficacy endpoint was the proportion of responders, defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 6.1
†The secondary efficacy endpoint was the proportion of responders, defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12.1
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Evaluate Your Gout Patients Using “STOP”2

Click any card to learn more about STOP
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sUA >6

Is their uric acid level
>6 mg/dL?

endpoint-efficacy
Graphic of the letter 'T'

TOPHI

Do they have
nonresolving tophi?

tophi-treatment
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.1-3 KRYSTEXXA is not indicated for the treatment of pain.
sUA, serum uric acid; ULT, urate-lowering therapy.

Primary endpoint

KRYSTEXXA with methotrexate showed significant improvement in patient response‡ vs KRYSTEXXA alone1

KRYSTEXXA with methotrexate showed significant improvement in patient response‡ vs KRYSTEXXA alone during Month 121

‡The primary efficacy endpoint was the proportion of responders, defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 6.1

In the pivotal clinical trials for KRYSTEXXA alone, 42% of patients had sUA response and met the primary endpoint of maintaining sUA <6 mg/dL for ≥80% of the time during Month 3 and Month 6 (n=36/85).1,4

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone during Month 6, with 71% (N=71/100) of KRYSTEXXA with methotrexate achieving the primary endpoint vs 39% (N=20/52) with KRYSTEXXA alone
Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone during Month 6, with 71% (N=71/100) of KRYSTEXXA with methotrexate achieving the primary endpoint vs 39% (N=20/52) with KRYSTEXXA alone

No dose adjustments needed with KRYSTEXXA in patients with renal impairment1

33% of patients in the MIRROR RCT had an eGFR >40 and <60 mL/min/1.73 m2.5,§,**

§In the KRYSTEXXA with methotrexate arm.
**Baseline eGFR was missing for 1 patient.6
eGFR, estimated glomerular filtration rate; MTX, methotrexate

Secondary endpoint

KRYSTEXXA with methotrexate continued to show significant improvement in patient response†† vs KRYSTEXXA alone during Month 121

KRYSTEXXA with methotrexate continued to show significant improvement in patient response†† vs KRYSTEXXA alone1

††The secondary efficacy endpoint was the proportion of responders, defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12.1

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone during Month 12, with 60% (N=60/100) of KRYSTEXXA with methotrexate achieving the secondary endpoint vs 31% (N=16/52) with KRYSTEXXA alone
Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone during Month 12, with 60% (N=60/100) of KRYSTEXXA with methotrexate achieving the secondary endpoint vs 31% (N=16/52) with KRYSTEXXA alone

KRYSTEXXA is the only uncontrolled gout therapy proven to drop sUA levels to <1 mg/dL within 24 hours1

KRYSTEXXA with methotrexate (MTX): 71/100 patients during Month 6 and 60/100 patients during Month 12 had an sUA response.1

KRYSTEXXA alone: 20/52 patients during Month 6 and 16/52 patients during Month 12 had an sUA response.1

  • KRYSTEXXA with MTX7

  • KRYSTEXXA alone7

Chart showing sUA dropping below 1 mg/dL after one infusion of KRYSTEXXA with MTX, with levels close to 0 mg/dL for the first 24 weeks, and sustained low levels throughout a 52 week trial period
Chart showing sUA dropping below 1 mg/dL after one infusion of KRYSTEXXA, with these levels sustained throughout a 52 week trial period

Maintaining a level near 1 mg/dL for 6-12 months may dramatically resolve years of urate crystal buildup1,7

Learn more about sUA reduction data

Connect with the KRYSTEXXA team to discuss.

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Tophi resolution

KRYSTEXXA with methotrexate helps patients reach an sUA level that dissolves tophi.1,‡‡

See the Data

‡‡Tophi resolution was defined as 100% resolution of at least 1 target tophus, no new tophi appearing, and no single tophus showing progression.1

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.

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
    • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    • FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72:744-760.
    • Botson JK, et al. Arthritis Rheumatol. 2023;75:293-304.
    • Sundy JS, et al. JAMA. 2011;306:711-720.
    • Botson JK, et al. ACR Open Rheumatol. 2023;5:407-418.
    • Abdellatif A, et al. Am J Kidney Dis. 2023;81(Suppl 1):S67.
    • Data on File. Horizon, April 2022.
    • Data on File. Horizon, December 2023.

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.