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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Patient Profiles: Key characteristics

KRYSTEXXA may be an appropriate therapy for your patients with uncontrolled gout1,2

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Learn about:

Meet Richard, a patient you may see in your practice

Patient name/age:
Richard, 52
Occupation:
Bus Driver
Actor portrayal, not actual patient.
Patient history icon
Patient History
  • Stage 4 CKD from 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 artery 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
  • Currently on gout medication; he doesn’t believe his gout is getting any better, but remains silent due to feeling self-conscious
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:

81 mg QD

Treatment history icon
Flare Medication

Prednisone:

40 mg QD as needed

Patient history icon
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
  • Currently on gout medication; he doesn’t believe his gout is getting any better, but remains silent due to feeling self-conscious
No dose adjustment is required for patients with renal impairment.1 Patients with eGFR <40 mL/min/1.73 m2 were excluded in the MIRROR RCT.1,3
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 you may see in your practice

Patient name/age:
Susan, 45
Occupation:
Dental hygienist
Actor portrayal, not actual patient.
Patient history icon
Patient History
  • Stage 3b CKD
  • 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, type 2 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
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.

Before & after KRYSTEXXA with methotrexate

REAL PATIENT

Patient name/age:
REAL PATIENT
Adam, 40s
Occupation:
Former EMT
The ACR Guidelines
STRONGLY RECOMMEND pegloticase for patients like Adam2
Patient history icon
Patient History
  • Lives on a farm in West Virginia with his wife and 4 children
  • Received a kidney transplant at age 19
  • Began to experience gout symptoms shortly after his transplant but remained misdiagnosed for 17 years
  • Developed large tophi in his feet, hands, and elbows, and suffered from multiple flares per year
  • At his worst, Adam could not get out of bed
  • Adam saw multiple doctors until he finally found a specialist, who told him his uric acid levels were very high and diagnosed him with gout. After he realized he was allergic to oral medication, he asked his doctor about KRYSTEXXA
Physical and lab evaluation icon
Physical & Lab Evaluation
Before
sUA level:>14 mg/dL
Tophi: Visible tophi
Swollen, tender joints: Chronic pain in multiple joints
Flares: Multiple flares per year
After
sUA level: <0.5 mg/dL
Tophi: Significant reduction in tophi
Current activities: Able to return to doing the things he likes most: fishing, playing guitar, and traveling
Treatment history icon
Treatment History
Before
Allopurinol: Unable to take due to a severe allergy
Colchicine: Unable to take due to a severe allergy
Febuxostat: Unable to take due to a severe allergy
After
KRYSTEXXA: 8 mg every 2 weeks for 18 months
KRYSTEXXA is not indicated for the treatment of pain.
Best results were seen at 6-12 months.1 Optimal treatment duration has not been established.1 Individual results may vary.
EMT, emergency medical technician.
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.

Before & after KRYSTEXXA with methotrexate

REAL PATIENT

Patient name/age:
REAL PATIENT
Michael, 60s
Occupation:
Architect
The ACR Guidelines
STRONGLY RECOMMEND pegloticase for patients like Michael2
KRYSTEXXA can be coadministered with methotrexate1
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 painful flares in his hands and feet
  • 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
Current activities: Back to sketching/painting and taking 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
Hand with tophi, before Krystexxa, dated January 2021 Enlarge
After
Colchicine: As needed
Methotrexate: 15 mg orally per week
KRYSTEXXA: 8 mg every 2 weeks
Hand with tophi, before Krystexxa, dated January 2021 Enlarge
Hand with reduced tophi, after Krystexxa, dated April 2022 Enlarge

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).1,3

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.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
Graphic of the letter 'S'

sUA >6

Is their uric acid level
>6 mg/dL?

endpoint-efficacy
Graphic of the letter 'T'

TOPHI

Do they have
nonresolving tophi?

tophi-treatment
Graphic of the letter 'O' shaped like a stop sign

ORAL ULT FAILURE

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

urate-deposition-gout
Graphic of the letter 'P'

PAINFUL FLARES

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

gout-flare-treatment
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.1,2,4 KRYSTEXXA is not indicated for the treatment of pain.
ULT, urate-lowering therapy.
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Starting KRYSTEXXA

Once you decide KRYSTEXXA is right for your patient, you can begin by downloading the Patient Enrollment Form (PEF).

See Step-by-Step Instructions

A nephrologist’s perspective

Board-certified nephrologist Jessica Coleman highlights her experience with prescribing KRYSTEXXA to her patients with CKD and uncontrolled gout.

Watch The Video Here

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.
    3. Botson JK, et al. ACR Open Rheumatol. 2023;5:407-418.
    4. Botson JK, et al. Arthritis Rheumatol. 2023;75:293-304.

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.