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
CKD

KRYSTEXXA with methotrexate has been studied in patients with CKD and uncontrolled gout1

CKD, chronic kidney disease.
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No dose adjustment 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 m2.2,*,†
*In the KRYSTEXXA with methotrexate arm.
†Baseline eGFR was missing for 1 patient.3
eGFR, estimated glomerular filtration rate.

Mean change from baseline (Week -6) in eGFR through Week 523

Based on a retrospective analysis of patients in the MIRROR RCT

Patients treated with KRYSTEXXA experienced stability in mean eGFR from baseline through Week 52 of the MIRROR trial.3

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

KRYSTEXXA has not been studied to reverse damage to the kidneys. The data in the chart is not statistically significant.
Change in eGFR was not a pre-specified endpoint of the MIRROR trial and not powered to detect change in renal function.

CFB, change from baseline; MTX, methotrexate.

  • KRYSTEXXA with MTX3

  • KRYSTEXXA alone3

Chart showing change from baseline (Week -6) through Week 52 in estimated glomerular filtration rate of patients on KRYSTEXXA with methotrexate, with a change of 4.6 mL/min/1.73m^2 at Week 52 Chart showing change from baseline (Week -6) through Week 52 in estimated glomerular filtration rate of patients on KRYSTEXXA with methotrexate, with a change of 4.6 mL/min/1.73m^2 at Week 52
Chart showing change from baseline (Week -6) through Week 52 in estimated glomerular filtration rate of patients on KRYSTEXXA alone, with a change of 1.7 mL/min/1.73m^2 at Week 52 Chart showing change from baseline (Week -6) through Week 52 in estimated glomerular filtration rate of patients on KRYSTEXXA alone, with a change of 1.7 mL/min/1.73m^2 at Week 52

Want to know more about the connection between CKD and gout?

Connect with the KRYSTEXXA team to learn about patients with CKD included in the MIRROR trial.

Learn More

Significant improvement

In the MIRROR RCT, KRYSTEXXA with MTX improved patient response during both Months 6 and 12.1,‡

See the Data

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

sUA, serum uric acid.

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

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.
    • Botson JK, et al. ACR Open Rheumatol. 2023;5:407-418.
    • Abdellatif A, et al. Am J Kidney Dis. 2023;81(suppl 1):S67.

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.