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

KRYSTEXXA can change the course of uncontrolled gout1

KRYSTEXXA is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.1

Evaluate Your Gout Patients Using2

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

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.

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

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

Improved
Confidence

As seen in the MIRROR RCT, fewer infusion reactions were seen with improved patient response,* so that you can confidently prescribe KRYSTEXXA with methotrexate to reduce years of urate burden1

*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

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

Need more data?

The KRYSTEXXA team is available to share our demonstrated efficacy in a clinical trial and safety data.

Request Support

CKD & gout

Discover the link between CKD and gout.1

See the Data
CKD, chronic kidney disease.

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of gout and CKD patient, Richard

Richard, stage 4 CKD

Occupation:
Bus driver

52-year-old with stage 4 CKD;
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, stage 3b CKD

Occupation:
Dental hygienist

45-year-old with stage 3b CKD;
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 gout and CKD Stage 3b patient, Adam

Adam, stage 3b CKD

Occupation:
Former EMT

Diagnosed with gout over
20 years ago

Real patient.

Learn About Adam
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patients and practice.
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Support for your patients

Managing 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

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.

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.