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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Patient Profiles: Key characteristics

KRYSTEXXA with methotrexate may be right for your patients with uncontrolled gout

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Learn about:

Meet Richard

A patient with uncontrolled gout you may see in your practice.
Occupation:
Bus Driver
Patient history icon
Patient History
  • A 52-year-old bus driver with CKD stage 4 with hypertension and a 4-year history of gout
  • Flares: has had 3 flares in the last year, one necessitated an urgent care visit
  • Tophi: no visible tophi
  • Comorbidities: hypertension, coronary heart disease
Patient Background
  • Richard remembers his father missing work due to gout. He is worried that it will affect his job too, as the pain in his feet can make it challenging to drive
  • Time after work is often spent recovering on the couch instead of participating in family activities
  • Currently on gout medication; he doesn’t believe his gout is getting any better, but remains silent due to feeling self-conscious
Actor portrayal, not actual patient.
Physical and lab evaluation icon
Laboratory Workup

sUA level:

6.9 mg/dL

G6PD:

normal

Albuminuria:

76 mg/g

eGFR:

26 mL/min/1.73 m2

BP:

127/79 mm Hg

Current treatment icon
Current Treatments

Allopurinol:

100 mg QD

Atorvastatin:

10 mg QD

Losartan:

50 mg QD

Atenolol:

50 mg QD

Aspirin:

75 mg QD

Treatment history icon
Flare Medication

Prednisone:

40 mg QD as needed

KRYSTEXXA is not indicated for the treatment of pain. BP, blood pressure; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; G6PD; glucose-6-phosphate dehydrogenase; QD, every day; sUA, serum uric acid.

Meet Susan

A patient with uncontrolled gout you may see in your practice.
Occupation:
Dental hygienist
Patient history icon
Patient History
  • A 45-year-old dental hygienist with CKD stage 3b
  • Flares: 3 flares in the last year, complaining of joint pain
  • Tophi: 1 small tophus on her left hand for the past 2 years
  • Comorbidities: hypertension, diabetes
Patient Background
  • An increase in gout flares and joint pain has kept her from participating in school and community activities with her 3 children
  • Her joint pain makes it difficult to use certain tools and perform the fine motor skills needed to do her job effectively. She worries it may lead to permanent disability
  • Some patients have asked about the bump on her hand, making her feel self-conscious and causing anxiety
Actor portrayal, not actual patient.
Physical and lab evaluation icon
Laboratory Workup

sUA level:

7.9 mg/dL

G6PD:

normal

Albuminuria:

200 mg/g

eGFR:

41 mL/min/1.73 m2

BP:

130/82 mm Hg

Current treatment icon
Current Treatments

Allopurinol:

300 mg QD

Losartan:

50 mg QD

Metformin:

850 mg QD

Treatment history icon
Flare Medication

Colchicine:

0.6 mg QD for prophylaxis

Prednisone:

40 mg QD for active flares

KRYSTEXXA is not indicated for the treatment of pain. BP, blood pressure; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; G6PD; glucose-6-phosphate dehydrogenase; QD, every day; sUA, serum uric acid.

Meet Harold

A patient with uncontrolled gout you may see in your practice.
Occupation:
Journalist
Patient history icon
Patient History
  • 64-year-old with type 2 diabetes, hypertension, and end-stage renal disease
  • Underwent preemptive living-donor kidney transplant several years ago
  • Diagnosed with gout 7 years ago, prior to transplant
  • Has had 2 flares this year
  • 2 or more tophi and complains of pain, swollen ankles, and sore elbows
Patient Background
  • Despite his kidney transplant alleviating his anxiety about his kidney disease, Harold still gets frustrated that he can’t yet travel the world like he used to due to uncontrolled gout
Actor portrayal, not actual patient.
Physical and lab evaluation icon
Laboratory Workup

sUA level:

7.3 mg/dL

G6PD:

normal

Albuminuria:

100 mg/g

eGFR:

57 mL/min/1.73 m2

BP:

135/78 mm Hg

Current treatment icon
Current Treatments

Allopurinol:

50 mg QD

Losartan:

50 mg QD

Metformin:

850 mg QD

Canagliflozin:

100 mg QD

Treatment history icon
Rescue Meds

Colchicine:

0.3 mg QD for prophylaxis

Prednisone:

40 mg QD for active flares

Treatment history icon
Antirejection Meds

Antimetabolite

Calcineurin inhibitor

Low-dose steroid

KRYSTEXXA is not indicated for the treatment of pain. BP, blood pressure; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; G6PD; glucose-6-phosphate dehydrogenase; QD, every day; sUA, serum uric acid.

Before & After KRYSTEXXA With Methotrexate

Patient name/age:
REAL PATIENT
Michael, 60s
Occupation:
Architect
Patient history icon
Patient History
  • Loves spending time with his wife and 4 children, though gout kept them from traveling as much as they’d like
  • 30-year history of gout
  • Frequent flares in his hands and feet were so painful, he kept a set of crutches in his car at all times
  • Could not tolerate allopurinol; took colchicine and indomethacin for pain, but still had flares and tophi
  • A nephrologist was the key to Michael’s success. It wasn’t until his nephrologist told him about KRYSTEXXA and took the lead in managing his uncontrolled gout, that things began to change
Physical and lab evaluation icon
Physical & Lab Evaluation
Before
sUA level:10.3 mg/dL
Tophi: Visible tophi
Swollen, tender joints: Chronic pain in multiple joints
Flares: 1-2/month
After
sUA level: 1.5 mg/dL
Tophi: 1 completely resolved, others reduced
Functional Status: Can walk, perform most daily activities, and is back to planning trips with his family
Treatment history icon
Treatment History
Before
Allopurinol: Discontinued due to side effects
Colchicine: As needed during flares
Uloric: Discontinued due to side effects
Enlarge
Before
After
Colchicine: As needed
Methotrexate: 15 mg orally per week
KRYSTEXXA: 8 mg every 2 weeks
Enlarge
AFTER
Best results seen at 6-12 months.1 Optimal treatment duration has not been established.1 Individual results may vary.
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. sUA, serum uric acid.

Evaluate Your Gout Patients Using “STOP”2

Click any card to learn more about STOP
Hand Icon

sUA>6

Is their uric acid level
>6 mg/dL?

endpoint-efficacy

TOPHI

Do they have
nonresolving tophi?

tophi-treatment

ORAL ULT FAILURE

Have they been taking
the maximum
medically appropriate
dose of ULTs?

urate-deposition-gout

PAINFUL FLARES

Have they had 2 or
more painful flares in
the past year?

gout-flare-treatment
Support icon

Have a patient who meets these criteria?

Connect with the KRYSTEXXA team to discuss.
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ACR Guidelines

ACR Guidelines strongly recommend pegloticase for your patients with uncontrolled gout.2*

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Antidrug antibodies

How can reducing antidrug antibodies improve patient response?

See the Data

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
    1. KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    2. FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72:744-760.

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.