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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MSU DEPLETION

Lowering of MSU volume deposition was observed in patients taking KRYSTEXXA1

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Patients on KRYSTEXXA with methotrexate saw 89% MSU depletion at Month 6 and 97% at Month 121,*

Analysis is exploratory and has not been adjusted for multiple comparisons. No clinical or statistical conclusions can be drawn.

*Data above represents mean MSU volume depletion measured by DECT imaging of 5 out of 6 patients treated with KRYSTEXXA with methotrexate who maintained sUA response through 52 weeks.1

Images are from DECT scans. These images are from the same patient in MIRROR RCT.

The optimal treatment duration for KRYSTEXXA has not been established.2 Individual results may vary.

DECT, dual-energy computed tomography; MSU, monosodium urate.

BEST RESULTS WERE SEEN AT 6-12 MONTHS3

DECT image of uric acid deposits from gout in feet of KRYSTEXXA with methotrexate patient at baseline DECT image of uric acid deposits from gout in feet of KRYSTEXXA with methotrexate patient at baseline
DECT image of uric acid deposits from gout in feet of KRYSTEXXA with methotrexate patient at 3 months DECT image of uric acid deposits from gout in feet of KRYSTEXXA with methotrexate patient at 3 months
DECT image of uric acid deposits from gout in feet of KRYSTEXXA with methotrexate patient at 6 months DECT image of uric acid deposits from gout in feet of KRYSTEXXA with methotrexate patient at 6 months
DECT image of uric acid deposits from gout in feet of KRYSTEXXA with methotrexate patient at 12 months DECT image of uric acid deposits from gout in feet of KRYSTEXXA with methotrexate patient at 12 months

MSU volume reduction over time1,†

89% of urate burden was reduced at Month 6 and 97% at Month 121,†

Chart showing change from baseline in MSU volume, with a 94% reduction at Month 12 in 6 patients treated with KRYSTEXXA with methotrexate
†Data above represents mean MSU volume depletion measured by DECT imaging of 5 out of 6 patients treated with KRYSTEXXA with methotrexate who maintained sUA response through 52 weeks.1
The optimal treatment duration for KRYSTEXXA has not been established.2

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Safety

Learn about the safety profile of KRYSTEXXA.

See the Data

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

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
    • Dalbeth N, et al. Joint Bone Spine. 2024;91:105715.
    • KRYSTEXXA (pegloticase) [prescribing information] Horizon.

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.