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

REFER AND BREAK THE CYCLE OF FLARE. DOSE. REPEAT.

UNCONTROLLED GOUT: REFER IT OUT
KRYSTEXXA is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.1
When gout remains uncontrolled despite therapy, you can help break the cycle and limit disease progression. Refer your patients not responding to treatment to a gout specialist, who can administer the next step of therapy to help them combat this stubborn and debilitating disease.

Evaluate Your Gout Patients Using "STOP"2

Click any card to learn more about STOP
sUA >6
Is their uric acid level >6 mg/dL?
TOPHI
Do they have nonresolving tophi?
ORAL ULT FAILURE
Have they been taking the maximum medically appropriate dose of ULTs?
PAINFUL FLARES
Have they had 2 or more painful flares in the past year?
Click to rotate
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.
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Improved efficacy

Improved efficacy

71% (71/100) KRYSTEXXA with methotrexate patient response* vs 39% (20/52) compared to KRYSTEXXA alone during Month 6 (P<0.0001)1

Reduced infusion reactions

Reduced infusion reactions

4% (4/96) KRYSTEXXA with methotrexate vs 31% (15/49) compared to KRYSTEXXA alone1

*The primary efficacy endpoint was the proportion of responders, defined as patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 6.1
The MIRROR RCT was a 52-week, randomized, double-blind, placebo-controlled trial, conducted in adult patients with chronic gout refractory to conventional therapy, to evaluate administration of KRYSTEXXA (8 mg Q2W) co-administered with 15 mg/week oral methotrexate and 1 mg/day oral folic acid (n=100) vs KRYSTEXXA with placebo (n=52).1,3
Trusted by Experts

Pegloticase is the only uncontrolled gout treatment
recommended by the 2020 ACR Guidelines2,†

For your uncontrolled gout patients who:

Serum Uric Acid levels icon
Fail to reach sUA target on oral therapies (eg, allopurinol or febuxostat)2
AND HAVE
Gout flares icon
Frequent flares
(≥2 flares per year)2
AND/OR
Tophi icon
Nonresolving tophi2
‡In the KRYSTEXXA clinical trials, uncontrolled gout was defined as ongoing gout symptoms (≥1 tophus, ≥2 gout flares a year, and/or chronic gouty arthritis) with failure to normalize sUA under 6 mg/dL after at least 3 months of xanthine oxidase inhibitors at the maximum medically appropriate dose or a self-reported contraindication.1,3
ACR, American College of Rheumatology.

Trusted for over 14 years, KRYSTEXXA is the first and only approved biologic for uncontrolled gout

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Support for your patients

Managing your uncontrolled gout can involve a lot of moving parts. Amgen By Your Side is a support program for patients prescribed KRYSTEXXA. Our dedicated team is your patient’s partner, committed to providing nonmedical support so they can start and continue treatment as you prescribe.

See Support Program

Need more data?

The KRYSTEXXA team is available to share more about the systemic nature of uncontrolled gout.

Request Support

Systemic burden

Uncontrolled gout is a chronic and systemic disease that can damage bones, joints, and vital organs.4,5

Learn More
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body's organs.

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.
    • Doghramji PP, et al. Postgrad Med. 2012;124:98-109.
    • Khanna PP, et al. J Clin Med. 2020;9:3024.

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.