Key Inclusion/Exclusion Criteria2

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 include4,20:
  • 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/dL9,10

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IDENTIFYING PATIENTS

Tophi are a visible indicator that your patients have uncontrolled gout1

Side by side images of tophi in toes and hands Side by side images of tophi in toes and hands
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TRUSTED BY EXPERTS

Pegloticase is the only uncontrolled gout treatment recommended by the 2020 ACR Guidelines2,*
*ACR Guidelines recommend pegloticase in patients who have failed to reach sUA target levels on oral urate-lowering therapies at maximum medically appropriate doses and continue to have frequent gout flares (≥2 flares/year) or nonresolving tophi.2,3
ACR, American College of Rheumatology; sUA, serum uric acid.

See full ACR Guidelines

Visit the American College of Rheumatology website to download the Guidelines.
According to the Guidelines, ULT titration should occur over weeks to months, not years, to prevent treatment inertia.
Get the Guidelines
Learn about:

Meet Linda, a patient you may see in your practice

Patient name/age:
Linda, 55
Occupation:
Accountant

Actor portrayal, not actual patient.

Patient history icon
Patient History
  • Diagnosed 4 years ago
  • Family has a history of gout
  • Flares: multiple flares in the last year
  • Tophi: 1 small, bothersome tophus on her hand
  • Comorbidities: hypertension
KRYSTEXXA is not indicated for the treatment of pain.
BMI, body mass index; BP, blood pressure; G6PD, glucose-6-phosphate dehydrogenase; QD, every day; sUA, serum uric acid.
KRYSTEXXA is not indicated for the treatment of pain.
A1C, glycated hemoglobin; BID, twice daily; BMI, body mass index; BP, blood pressure; G6PD, glucose-6-phosphate dehydrogenase; MTP, metatarsophalangeal joint; QD, every day; sUA, serum uric acid.
Laboratory Workup

sUA level:

8.2 mg/dL

G6PD:

normal

BMI:

29

BP:

128/80

Current Treatments

Allopurinol:

300 mg QD (for the past year)

Losartan:

50 mg QD

Flare Medication

Colchicine:

0.6 mg QD

Patient Background
  • Linda has been on treatment for some time, but she feels the disease just isn’t getting any better. Linda has missed work due to her disease, and even when present, the pain and distraction have made her much less efficient.

Meet James, a patient you may see in your practice

Patient name/age:
James, 52
Occupation:
Middle school teacher

Actor portrayal, not actual patient.

Patient history icon
Patient History
  • Has been seeing a primary care physician for gout for the last 15 years
    • his disease has rapidly progressed recently
  • Flares: 6 in the last year
    - 3 mitigated with oral flare medication
    - 2 resulted in urgent care visits
    - 1 mitigated with a cortisone injection
  • Tophi: tophi on his hands, feet, specifically ankle and MTP joint, and elbows
  • Comorbidities: Type 2 Diabetes
KRYSTEXXA is not indicated for the treatment of pain.
A1C, glycated hemoglobin; BID, twice daily; BMI, body mass index; G6PD, glucose-6-phosphate dehydrogenase; MTP, metatarsophalangeal; QD, every day; sUA, serum uric acid.
Laboratory Workup

sUA level:

9.3 mg/dL

G6PD:

normal

BMI:

31

A1C:

7.3%

Current Treatment

Allopurinol:

300 mg QD (for the past year)

Metformin:

850 mg QD

Linagliptin:

5 mg QD

Flare Medication

Colchicine:

0.6 mg QD for prophylaxis

Naproxen:

500 mg BID

Patient Background
  • Uncontrolled gout has affected James’s ability to present in class and educate his students due to an increase in gout flares
  • Tophi growth has caused him to feel self-conscious when students talk about his “bumpy hands”

Learn about Bet, a real patient on KRYSTEXXA

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 Bet2
KRYSTEXXA can be coadministered with methotrexate3
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
  • No known comorbidities
Physical and lab evaluation icon
Physical & Lab Evaluation
Before
sUA level: 10.4 mg/dL
BMI: 38.5
Tophi: Visible tophi
Swollen/tender joints: Chronic pain in multiple joints
Flares: >2/year
After
sUA level: <1 mg/dL
Tophi: Reduced
Treatment history icon
Treatment History
Before
Allopurinol: 7 years with increasing doses
Colchicine: 7 years while flaring
Febuxostat: 1 year
Image of visible tophi in hand before KRYSTEXXA treatment Enlarge
BEFORE
After
Colchicine: 0.6 mg as needed
Methotrexate: 15 mg orally per week
KRYSTEXXA: 8 mg every 2 weeks
Image of no visible tophi in hand after KRYSTEXXA treatment Enlarge
AFTER
Best results seen at 6-12 months.1 Optimal treatment duration has not been established.1 Individual results may vary.
The primary endpoint in MIRROR RCT was defined as the proportion of patients achieving and maintaining an sUA level of <6 mg/dL for at least 80% of the time during Month 6; 71% of KRYSTEXXA with methotrexate patients (N=100) vs 39% of KRYSTEXXA alone patients (N=52) met the primary endpoint (P<0.0001).1
Tophi Resolution was a secondary endpoint that was defined as 100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression at Month 12; 54% (28/52) of patients receiving KRYSTEXXA with methotrexate achieved tophi resolution vs 31% (9/29) of patients receiving KRYSTEXXA alone (P=0.048).1,5
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) co-administered with 15 mg/week oral methotrexate and 1 mg/day oral folic acid (n=100) vs KRYSTEXXA with placebo (n=52).1,4
The primary endpoint in MIRROR RCT was defined as the proportion of patients achieving and maintaining an sUA level of <6 mg/dL for at least 80% of the time during Month 6; 71% of KRYSTEXXA with methotrexate patients (N=100) vs 39% of KRYSTEXXA alone patients (N=52) met the primary endpoint (P<0.0001).1
Tophi Resolution was a secondary endpoint that was defined as 100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression at Month 12; 54% (28/52) of patients receiving KRYSTEXXA with methotrexate achieved tophi resolution vs 31% (9/29) of patients receiving KRYSTEXXA alone (P=0.048).1,5
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) co-administered with 15 mg/week oral methotrexate and 1 mg/day oral folic acid (n=100) vs KRYSTEXXA with placebo (n=52).1,4
Best results seen at 6-12 months.3
Optimal treatment duration has not been established.3 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.”
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"2

Click any card to learn more about STOP
sUA >6
Is their uric acid level >6 mg/dL?
TOPHI
Do they have nonresolving tophi?
ORAL ULT FAILURE
Have they been taking the maximum medically appropriate dose of ULTs?
PAINFUL FLARES
Have they had 2 or more painful flares in the past year?

Click to rotate

Uncontrolled gout is defined as having sUA >6 mg/dL along with 2 or more flares per year and/or 1 or more nonresolving tophi while receiving the maximum medically appropriate dose of oral ULT.2-4 KRYSTEXXA is not indicated for the treatment of pain.
sUA, serum uric acid; ULT, urate-lowering therapy.

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KRYSTEXXA with methotrexate

KRYSTEXXA works differently for your patients with uncontrolled gout.

See How It Works

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
    • Perez-Ruiz F. Rheumatology (Oxford). 2009;48(suppl 2):ii9-ii14.
    • FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72:744-760.
    • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    • Botson JK, et al. Arthritis Rheumatol. 2023;75:293-304.
    • Botson JK, et al. ACR Open Rheumatol. 2023;5:407-418.

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.