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Patients on KRYSTEXXA and methotrexate experienced 94% REDUCTION IN MSU DEPOSITION AT MONTH 123,4*

Patients on KRYSTEXXA and methotrexate experienced 94% REDUCTION IN MSU DEPOSITION AT MONTH 123,4*

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

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

Individual results may vary. The optimal treatment duration for KRYSTEXXA has not been established.3

*Data above represents mean MSU volume depletion measured by DECT imaging of 6 patients treated with KRYSTEXXA with methotrexate.4

DECT, dual-energy computed tomography; MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; MSU, monosodium urate; RCT, randomized controlled trial.

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

MSU volume reduction over time4†

BEST RESULTS WERE SEEN AT 6-12 MONTHS3

The optimal treatment duration for KRYSTEXXA has not been established.3

Chart showing change from baseline in MSU volume, with a 94% reduction at Month 12 in patients treated with KRYSTEXXA with methotrexateKrystexxa with methotrexate

†Data above represents mean MSU volume depletion measured by DECT imaging of 6 patients treated with KRYSTEXXA with methotrexate.4

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Safety

The addition of methotrexate reduced infusion reactions.1

See the Data

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of patient with no visible tophi Actor portrayal of patient with no visible tophi Actor portrayal of patient with no visible tophi

Michelle

Occupation:
Nurse

59-year-old with no visible tophi, but has pain and tenderness in her hands; diagnosed with gout 5 years ago

Learn About Michelle

Actor portrayal, not actual patient.

Actor portrayal of patient with pain who was diagnosed with gout years ago Actor portrayal of patient with pain who was diagnosed with gout years ago Actor portrayal of patient with pain who was diagnosed with gout years ago

Andrew

Occupation:
Real estate agent

56-year-old with hypertension and pain in hands and feet; diagnosed with gout 8 years ago

Learn About Andrew

Actor portrayal, not actual patient.

Real KRYSTEXXA patient, Bet Real KRYSTEXXA patient, Bet Real KRYSTEXXA patient, Bet

Occupation:
Stay-at-home parent

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

Learn About Bet

Real patient.

KRYSTEXXA is not indicated for the treatment of pain.

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.

  • Sundy JS, et al. JAMA. 2011;306:711-720.
  • Schlesinger N, et al. Arthritis Rheumatol. 2017;69(suppl 10):1-4426.
  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
  • Dalbeth N, et al. Arthritis Rheumatol. 2022;74(Suppl 9).