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 Michelle, a patient you may see in your practice

Patient name/age:
Michelle, 59
Occupation:
Nurse

Actor portrayal, not actual patient.

Patient history icon
Patient History
  • Diagnosed with gout 5 years ago by a primary care physician, referred to a rheumatologist last year
  • Flares: 4 in the last year - 2 resulted in emergency room visits
  • Tophi: no visible tophi
  • Comorbidities: diabetes
KRYSTEXXA is not indicated for the treatment of pain. A1C, glycated hemoglobin; BMI, body mass index; G6PD, glucose-6-phosphate dehydrogenase; QD, every day; sUA, serum uric acid.
Laboratory Workup

sUA level:

7.3 mg/dL

BMI:

28

G6PD:

normal

A1C:

7.2%

Renal function:

normal

Current Treatments

Allopurinol:

800 mg QD (for the past year)

Linagliptin:

5 mg QD

Flare Medication

Colchicine:

0.6 mg QD for prophylaxis

Patient Background
  • While Michelle doesn’t have any visible tophi, she does have pain and tenderness in her hands, which has affected her job as a nurse and at home, making it difficult to help her daughter with her newborn
  • Michelle’s father dealt with unspecified arthritis, with similar symptoms to hers
  • At 59, her flares are quite painful, but her own online research led her to the conclusion that flares are completely based on diet, ie, her own fault

Meet Andrew, a patient you may see in your practice

Patient name/age:
Andrew, 56
Occupation:
Real estate agent

Actor portrayal, not actual patient.

Patient history icon
Patient History
  • Diagnosed with gout 8 years ago
  • Flares: 4 in the last year
    - 2 resulted in urgent care visits
    - 2 mitigated with flare prophylaxis
  • Tophi: pea-sized tophus on his right hand for the past 2 years; golf ball–sized tophus on left ankle; both nonresolving
  • Pain: complaining of pain in his hands and feet
  • Comorbidities: hypertension
KRYSTEXXA is not indicated for the treatment of pain. A1C, glycated hemoglobin; BMI, body mass index; G6PD, glucose-6-phosphate dehydrogenase; QD, every day; sUA, serum uric acid.
Laboratory Workup

sUA level:

8.4 mg/dL

BMI:

31

G6PD:

normal

BP:

128/80

Renal function:

normal

Current Treatments

Allopurinol:

600 mg QD (for the past year)

Linagliptin:

50 mg QD

Flare Medication

Colchicine:

0.6 mg QD for prophylaxis

Prednisone:

40 mg QD for active flares

Patient Background
  • When Andrew greets clients, he extends his left hand to shake so they avoid seeing the tophus
  • Increased discomfort and pain due to flares have caused Andrew to remain home more often, sometimes leading to a loss of potential real estate clients. The resulting financial burden is causing him stress and anxiety

Before & After KRYSTEXXA With Methotrexate

REAL PATIENT
Patient name/age:
Bet, 43
Occupation:
Stay-at-home parent
The ACR Guidelines
STRONGLY RECOMMEND pegloticase for patients like Bet1
KRYSTEXXA can be coadministered with methotrexate2
Patient history icon
Patient History
  • A father and husband who loves spending time with his children
  • Has had gout for over 20 years
  • Stopped working construction due to pain and limited mobility
  • No known comorbidities
Physical and lab evaluation icon
Physical & Lab Evaluation
Before
sUA level: >6 mg/dL
BMI: 38.5
Swollen/tender joints: Chronic pain in multiple joints
Tophi: Visible tophi
Flares: >2/year
After
sUA level: <\1 mg/dL
Tophi: Reduced
Functional status: Can walk and perform daily activities
Treatment history icon
Treatment History
Before
Allopurinol: 7 years with increasing doses
Colchicine: 7 years while flaring
Febuxostat: 1 year
Picture of tophi in hand Enlarge
BEFORE
After
Colchicine: 0.6 mg as needed
KRYSTEXXA: 8 mg every 2 weeks
Methotrexate: 15 mg orally per week
Picture of hand after treatment Enlarge
AFTER
Best results seen at 6-12 months.2 Optimal treatment duration has not been established.2 Individual results may vary.
“I wish I had started KRYSTEXXA (with methotrexate) sooner. Now, I go out and do things and not just want to stay at home. I’m definitely in a better place now.”
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. KRYSTEXXA is not indicated for the treatment of pain. ACR, American College of Rheumatology; BMI, body mass index; sUA, serum uric acid.

Evaluate Your Gout Patients Using “STOP”1

Click any card to learn more about STOP
Hand Icon

sUA>6

Is their uric acid level
>6 mg/dL?

endpoint

TOPHI

Do they have
nonresolving tophi?

treating-gout-tophi

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
Uncontrolled gout is not defined by having all of the criteria above. KRYSTEXXA is not indicated for the treatment of pain.
ULT, urate-lowering therapy.

Have a patient who might be ready for KRYSTEXXA?

Connect with the KRYSTEXXA team to discuss the ACR Guidelines and treatment criteria.

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Antidrug antibodies

How can reducing antidrug antibodies improve patient response?

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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.