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Primary endpoint

up arrow>80%relative
improvement in efficacy

KRYSTEXXA with methotrexate 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

KRYSTEXXA with methotrexate1

KRYSTEXXA
alone1

Pie chart comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone in Month 6, with 71% (N=71/100) of KRYSTEXXA with methotrexate achieving the primary endpoint

vs

Pie charts comparing responders of KRYSTEXXA with methotrexate and KRYSTEXXA alone in Month 6, with 39% (N=20/52) with KRYSTEXXA alone achieving the primary endpoint

P<0.0001

52-week, randomized, double-blind trial conducted in adult patients with chronic gout refractory to conventional therapy to evaluate KRYSTEXXA 8 mg Q2W co-administered with 15 mg oral methotrexate QW and 1 mg oral folic acid QD vs KRYSTEXXA alone.1,2

Primary endpoint defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 6.1

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

QD, every day; QW; once weekly; Q2W, once every 2 weeks; sUA, serum uric acid.

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
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 handA 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 DECT images from a patient in MIRROR trial.

*Best results seen at 6-12 months.1

†Optimal treatment duration has not been established. Individual results may vary.

DECT, dual-energy computed tomography; 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?

Connect with the KRYSTEXXA team to discuss.

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Safety

The addition of methotrexate reduces infusion reactions.

See the Data

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of gout patient, James Actor portrayal of gout patient, James Actor portrayal of gout patient, James

Actor portrayal, not actual patient.

James

Occupation:
Middle school teacher

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

Learn About James

Actor portrayal of gout and CKD Stage 3b patient, bet Actor portrayal of gout and CKD Stage 3b patient, bet Actor portrayal of gout and CKD Stage 3b patient, bet

Real patient

Bet

Occupation:
Stay-at-home parent

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

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.

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.

  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
  • Botson J, et al. J Clin Rheumatol. 2022;28:e129-e134.