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 and TOPHI RESOLUTION

KRYSTEXXA with methotrexate quickly dissolved tophi and reduced uric acid burden1

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Primary endpoint

up arrow>80%relative improvement in efficacy

KRYSTEXXA with methotrexate (MTX) provided >80% relative improvement in patient response.1

The primary 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 6.1

check-list
*Primary endpoint defined by 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 coadministered with 15 mg oral methotrexate QW and 1 mg oral folic acid QD (n=100) vs KRYSTEXXA alone (n=52).1,2
QD, every day; QW; once weekly; Q2W, once every 2 weeks; sUA, serum uric acid.

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

74% relative improvement in tophi resolution1*

54% (28/52) of patients receiving KRYSTEXXA with methotrexate vs

31% (9/29) of patients receiving KRYSTEXXA alone1

TOPHI RESOLUTION
Tophi resolution was defined as 100% resolution of at least 1 target tophus, no new tophi appearing, and no single tophus showing progression at Month 12.1
*Among patients with digital photography of tophi at baseline.

Tophus response after using KRYSTEXXA with methotrexate1

  • FEET

  • HANDS

A series of Dual Energy Computed Tomography (DECT) scans before and after KRYSTEXXA with methotrexate treatment, from baseline to 6 months to 12 months, showing reduced uric acid deposits in a foot A series of Dual Energy Computed Tomography (DECT) scans before and after KRYSTEXXA with methotrexate treatment, from baseline to 6 months to 12 months, showing reduced uric acid deposits in a foot A series of Dual Energy Computed Tomography (DECT) scans before and after KRYSTEXXA with methotrexate treatment, from baseline to 6 months to 12 months, showing reduced uric acid deposits in a foot
A series of Dual Energy Computed Tomography (DECT) scans before and after KRYSTEXXA with methotrexate treatment, from baseline to 6 months to 12 months, showing reduced uric acid deposits in a hand A series of Dual Energy Computed Tomography (DECT) scans before and after KRYSTEXXA with methotrexate treatment, from baseline to 6 months to 12 months, showing reduced uric acid deposits in a hand A series of Dual Energy Computed Tomography (DECT) scans before and after KRYSTEXXA with methotrexate treatment, from baseline to 6 months to 12 months, showing reduced uric acid deposits in a hand
Photos and images are from a patient in MIRROR trial.
Best results seen at 6-12 months.1
Optimal treatment duration has not been established.1 Individual results may vary.1
MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase.

Gout flares

Mobilization flares in the first 3 months can be a sign that KRYSTEXXA is working to mobilize urate from tissue deposits. Mobilization flares are common with the use of all ULTs.1
ULTs, urate-lowering therapies.

Interested in how KRYSTEXXA may resolve tophi?

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Safety

The addition of methotrexate reduced infusion reactions.11

See the Data

Learn more about patients who might benefit from KRYSTEXXA

linda

Linda

Occupation:
Accountant

55-year-old with hypertension diagnosed with gout 4 years ago

Actor portrayal, not actual patient.

Learn About Linda
pat-james

James

Occupation:
Middle school teacher

52-year-old with diabetes diagnosed with gout 15 years ago

Actor portrayal, not actual patient.

Learn About James
patient-bet

Bet

Occupation:
Stay-at-home parent

43-year-old diagnosed with gout over 20 years ago

Real patient.

Learn About Bet

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. Arthritis Rheumatol. 2023;75:293-304.
    • 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.