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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sUA REDUCTION

KRYSTEXXA with methotrexate provided relative improvement in patient response during both Months 6 and 121

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sUA>6

Is their uric acid level
>6 mg/dL?

endpoint-efficacy

TOPHI

Do they have
nonresolving tophi?

tophi-treatment

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.
PRIMARY ENDPOINT

Patient relative response improved by >80% using KRYSTEXXA with methotrexate during Month 61

Complete sUA responders
The primary efficacy endpoint was the proportion of responders, defined by patients achieving and maintaining sUA <6mg/dL for at least 80% of the time during Month 6.1
In the pivotal clinical trials for KRYSTEXXA, 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).1,3
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
SECONDARY ENDPOINT

KRYSTEXXA with methotrexate provided 94% relative improvement in patient response during Month 121

Complete sUA responders
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

sUA DROP

KRYSTEXXA responders rapidly achieved and maintained an sUA level <1 mg/dL3

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

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

  • KRYSTEXXA with MTX

  • KRYSTEXXA alone

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

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Tophi resolution

KRYSTEXXA with methotrexate may provide tophi resolution.1

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

CKD, chronic kidney disease.

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.
    • Sundy JS, et al. JAMA. 2011;306:711-720.
    • Data on File. Horizon, March 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.