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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Graphic of a shield showing that KRYSTEXXA has been approved for 14 years
ABOUT KRYSTEXXA

KRYSTEXXA works differently from oral gout medicines1

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ON THIS PAGE:

TRUSTED BY EXPERTS

Pegloticase is the only uncontrolled gout treatment recommended by the 2020 ACR Guidelines.2,*
*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
ACR, American College of Rheumatology; sUA, serum uric acid.

KRYSTEXXA is an infused biologic that converts urate into allantoin1

Artist's rendition of KRYSTEXXA mechanism of action, displaying that only 10% of uric acid filtered through the kidneys is excreted while nearly all of allantoin filtered through the kidneys is excreted Artist's rendition of KRYSTEXXA mechanism of action, displaying that only 10% of uric acid filtered through the kidneys is excreted while nearly all of allantoin filtered through the kidneys is excreted

Administering methotrexate, an immunomodulator, with KRYSTEXXA can reduce immunogenicity1,†

When some patients receive a biologic, their immune system may see the drug as a foreign threat and develop antidrug antibodies (ADAs).1
ADAs can stop the biologic from working and lead to increased risk of infusion reactions.1
Giving an immunomodulator along with the biologic can reduce ADA formation. This should help to reduce the risk of infusion reactions and may improve patient response.1,3

Letting your patients know what to expect during treatment

An everyday analogy may be a helpful way to explain to your patients how KRYSTEXXA dissolves crystal buildup within the body.
IMAGINE A SNOWY DAY…
snowy-1
Urate crystals build up over time in your body, similar to how snow collects on the sidewalk6,7
snowy-2
KRYSTEXXA is an enzyme that helps urate crystals dissolve, similar to how salt melts snow3,5
snowy-3
Dissolved urate crystals leave the body through the urine, similar to how melted snow flows down a drain3,5
This is a visual illustration of how KRYSTEXXA works over multiple treatments. Results may vary.

KRYSTEXXA Treatment

Giving your patients an overview of KRYSTEXXA treatment

Expand All
  • Hourglass icon

    KRYSTEXXA is a short-term treatment3

    • It’s not a medication patients will take for the rest of their lives
    • Optimal treatment duration has not been established; best results were seen at 6-12 months3
  • Calendar icon

    Recommended dosing is KRYSTEXXA coadministered with methotrexate3,†

    • 4 weeks prior to treatment, initiate 15 mg oral methotrexate weekly with 1 mg folic acid daily3
    • Administer 8 mg of KRYSTEXXA as an intravenous infusion every 2 weeks
    • Continue 15 mg methotrexate weekly with 1 mg folic acid daily throughout treatment with KRYSTEXXA8
    †KRYSTEXXA alone may be used in patients for whom methotrexate is contraindicated or not clinically appropriate.
  • Medical notepad icon

    Preinfusion lab work is required3

    • Confirm the patient has normal G6PD activity and has discontinued other urate-lowering therapies‡
    • Perform sUA test prior to each infusion to ensure sUA <6 mg/dL
    ‡G6PD deficiency is an abnormally low level of glucose-6-phosphate dehydrogenase. Patients of African, Mediterranean, and Southern Asian ancestry have a higher risk of G6PD deficiency.
  • Checklist icon

    Before each infusion3,9

    • Confirm sUA level was tested, preferably in the last 48 hours
    • Administer pretreatment medications per prescribing orders of the doctor
  • Clock icon

    Infusion length3

    • 2-hour infusion (minimum)
  • RX pad icon

    After each infusion3,8

    • Observe patients for approximately an hour postinfusion
    • Remind patients of their next sUA test, upcoming infusion appointments, and any premedications they should continue taking, including corticosteroids, antihistamines, 15 mg oral methotrexate weekly with 1 mg folic acid daily3
  • Spinning hourglass icon

    Therapy duration3

    • Best results for KRYSTEXXA with methotrexate were seen at 6-12 months of treatment3
    • Optimal treatment duration has not been established

  • Possible side effects seen with KRYSTEXXA with methotrexate3

    • In the MIRROR clinical trial, common side effects seen in ≥5% of patients were
      • Gout flares
      • Arthralgia
      • COVID-19
      • Nausea
      • Fatigue
†KRYSTEXXA alone may be used in patients for whom methotrexate is contraindicated or not clinically appropriate.
G6PD, glucose-6-phosphate dehydrogenase; sUA, serum uric acid.

Efficacy

nsr-effi-71

KRYSTEXXA with methotrexate can help to reduce sUA levels3,§

KRYSTEXXA with methotrexate showed significant improvement in patient response** during Months 6 and 12 vs KRYSTEXXA alone3
Seventy-one percent of patients receiving KRYSTEXXA with methotrexate (n=71/100) met the primary endpoint and reduced their sUA to <6 mg/dL for at least 80% of the time during Month 6 vs 39% of patients receiving KRYSTEXXA alone (n=20/52) (P<0.0001)3
nsr-effi-60
Sixty percent of patients receiving KRYSTEXXA with methotrexate (n=60/100) met the secondary endpoint and reduced their sUA <6 mg/dL for at least 80% of the time during Month 12 vs 31% of patients receiving KRYSTEXXA alone (n=16/52) (P=0.0003)3
§A multicenter, randomized double-blind trial of KRYSTEXXA with methotrexate vs KRYSTEXXA alone in adult subjects with uncontrolled gout.3
**The endpoints were the proportion of responders, defined as patients achieving and maintaining sUA <6 mg/dL at least 80% of the time.3
nsr-effi-54

KRYSTEXXA with methotrexate can help resolve tophi3,10

KRYSTEXXA with methotrexate showed significant improvement in complete tophi resolution vs KRYSTEXXA alone3,10,††
Fifty-four percent of patients (n=28/52) met the secondary endpoint and had complete resolution of at least 1 target tophus, with no new or progressive tophi, within the first year vs 31% (n=9/29) receiving KRYSTEXXA alone (P=0.048)3,8
††Among patients with digital photograph of tophi at baseline.3

Tophus response after using KRYSTEXXA with methotrexate3

6-12 months of KRYSTEXXA may reverse years of urate deposition3

Photos and DECT images from a patient in MIRROR trial.
DECT is a dual-energy computed tomography. It can reveal urate deposits (in green) throughout the body, including soft tissue deposits, like tendons and ligaments.
Best results were seen at 6-12 months.3
Optimal treatment duration has not been established.3 Individual results may vary.

  • FEET

  • HANDS

Baseline photo showing visible tophi in foot as well as uric acid deposits in DECT scan Photo showing no visible tophi in foot as well as no uric acid deposits in DECT scan after 52 weeks of treatment
Baseline photo showing visible tophi in foot as well as uric acid deposits in DECT scan Photo showing no visible tophi in hand as well as no uric acid deposits in DECT scan after 52 weeks of treatment
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).3,8

Patient Profiles

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.
Laboratory Workup

sUA level:

8.2 mg/dL

G6PD:

normal

BMI:

29

BP:

128/80

Current Treatment

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 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 Treatments

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”

KRYSTEXXA can help real patients get their gout back under control

Before & after KRYSTEXXA with methotrexate

REAL PATIENT
Patient name/age:
Bet, 43
Occupation:
Stay-at-home parent
TRUSTED BY EXPERTS
Pegloticase is the only uncontrolled gout treatment recommended by the 2020 ACR Guidelines2
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.
Tophi resolution was a secondary endpoint in MIRROR RCT and was defined as 100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression at Month 12.3,8
54% (28/52) of patients receiving KRYSTEXXA with methotrexate achieved tophi resolution vs 31% (9/29) of patients receiving KRYSTEXXA alone (P=0.048).3,11
“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.”
Listen to Bet's Story
KRYSTEXXA is not indicated for the treatment of pain.
ACR, American College of Rheumatology; BMI, body mass index; sUA, serum uric acid.

KRYSTEXXA can help real patients get their gout back under control

Before & after KRYSTEXXA with methotrexate

Patient name/age:
REAL PATIENT
Michael, 60s
Occupation:
Architect
TRUSTED BY EXPERTS
Pegloticase is the only uncontrolled gout treatment recommended by the 2020 ACR Guidelines2
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
Flares: 1-2/month
Swollen, tender joints: Chronic pain in multiple joints
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
Febuxostat: 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.3 Optimal treatment duration has not been established.3 Individual results may vary.
Tophi resolution was a secondary endpoint in MIRROR RCT and was defined as 100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression at Month 12.12
54% (28/52) of patients receiving KRYSTEXXA with methotrexate achieved tophi resolution vs 31% (9/29) of patients receiving KRYSTEXXA alone (P=0.048).3,12

“KRYSTEXXA gave me hope. Without my nephrologist’s confidence and determination to help me, I would never have gotten my gout under control.”
Listen to Michael's Story

sUA, serum uric acid.

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
    • Keenan RT, et al. Semin Arthritis Rheum. 2021;51:347-352.
    • FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72:744-760.
    • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    • Terkeltaub R, et al. Arthritis Res Ther. 2006;8(suppl 1):S4.
    • McDonagh EM, et al. Pharmacogenet Genomics. 2014;24:464-476.
    • Cohen R, et al. J Pediatr Gastroenterol Nutr. 2019;69:551-556.
    • Schett G, et al. RMD Open. 2015;1(suppl 1):e000046.
    • Doghramji PP, et al. Postgrad Med. 2012;124:98-109.
    • Botson JK, et al. Arthritis Rheumatol. 2023;75:293-304.
    • Keenan RT, et al. Rheumatol Ther. 2019;6:299-304.
    • Data on File. Horizon, December 2021.
    • 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.