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APPROPRIATE GOUT PATIENTS WITH CKD FOR KRYSTEXXA

While gout is often considered a rheumatologic condition, there are significantly more nephrologists than rheumatologists to manage gout in patients with CKD.1,2

See if you could manage gout in any of your patients with CKD by using KRYSTEXXA.

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PATIENTS WITH MODERATE-TO-SEVERE CKD HAVE A 10-FOLD INCREASE IN GOUT PREVALENCE3*

An eGFR of <60 mL/min appears to be a threshold that dramatically increases the prevalence of gout.3

Prevalence of gout in patients with CKD by eGFR
(Age-standardized prevalence, %)3*

Bar graph and line chart combined. An eGFR of ≥90 mL/min corresponds to a 2.9% prevalence of gout. An eGFR of 60-89 mL/min corresponds to a 4.6% prevalence of gout. An eGFR of 30-59 mL/min corresponds to a 27.9% prevalence of gout. An eGFR of <30 mL/min corresponds to a 33.3% prevalence of gout.

CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate.

*Post hoc, cross-sectional analysis of National Health and Nutrition Examination Survey (NHANES) data from 2009 to 2010 of adults >20 years of age.3

A post hoc analysis showed that 49% of patients in the KRYSTEXXA pivotal clinical trials had either stage 3 or 4 CKD as determined by eGFR.4

CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate.

*Post hoc, cross-sectional analysis of National Health and Nutrition Examination Survey (NHANES) data from 2009 to 2010 of adults >20 years of age.3

DO YOU HAVE PATIENTS LIKE DAVE OR LISA IN YOUR PRACTICE?

PATIENT HISTORY
  • 57-year-old with stage 3b CKD
  • Diagnosed with gout 8 years ago
  • Patient’s third flare this year resolved 2 weeks ago; he is not currently complaining of pain
LABORATORY WORKUP
  • sUA level: 7.5 mg/dL
  • G6PD: normal
  • Albuminuria: 100 mg/g
  • eGFR: 33 mL/min/1.73 m2
  • A1C: 7.3%
CURRENT TREATMENTS
  • Colchicine: 0.3 mg PRN
  • Febuxostat: 80 mg QD
  • Sitagliptin: 25 mg QD
  • Losartan: 50 mg QD

~1 in 4 adults with an eGFR <60 mL/min have gout

compared to ~1 in 34 adults with normal renal function3†

PATIENT HISTORY
  • 58-year-old with stage 4 CKD
  • Diagnosed with gout 7 years ago
  • Patient has reported 3 flares this year, but is not currently complaining of pain
  • Has a small bump on her toe and has difficulty walking or wearing shoes
LABORATORY WORKUP
  • sUA level: 7.9 mg/dL
  • G6PD: normal
  • Albuminuria: 80 mg/g
  • eGFR: 29 mL/min/1.73 m2
  • BP: 128/78 mm Hg
CURRENT TREATMENTS
  • Colchicine: 0.3 mg PRN
  • Febuxostat: 40 mg QD
  • Losartan: 50 mg QD

>15-fold increase

in gout prevalence among women with CKD compared to women with normal renal function3†

BP=blood pressure
Profile is representative of patient population.
Based on NHANES 2009-2010 database.3


CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

If I have a patient who even has 1 joint involvement who’s on treatment for allopurinol and getting flare-ups, I would consider starting this patient on KRYSTEXXA.

Hear more about why nephrologist Payam Shakouri now actively treats uncontrolled gout in his patients with CKD.

Watch Video
Dr. Payam Shakouri Nephrologist

KRYSTEXXA IS SAFE AND EFFECTIVE FOR CHRONIC GOUT PATIENTS WITH COMORBID CHRONIC KIDNEY DISEASE4,5

Pivotal clinical trials

32% of patients in the pivotal clinical trials had creatinine clearance <62.5 mL/min4

Estimation of glomerular filtration rate (eGFR) from serum creatinine remains the clinical standard worldwide to determine renal function.6-9

Pie chart Pie chart

Post hoc analysis

38% of patients had stage 3 CKD and
11% had stage 4 CKD, as determined by eGFR5

Patients with CKD can be effectively treated with KRYSTEXXA without dose adjustment4

References
  1. American College of Rheumatology. https://www.rheumatology.org/portals/0/files/ACR-Workforce-Study-2015.pdf. Accessed November 20, 2018.
  2. The American Society of Nephrology. https://www.asn-online.org/education/training/workforce/Nephrology_Workforce_Study_Report_2016.pdf. Accessed November 20, 2018.
  3. Krishnan E. PLoS One. 2012;7:1-9.
  4. KRYSTEXXA (pegloticase) [prescribing information] Horizon.
  5. Yood RA, et al. BMC Res Notes. 2014;7:1-6.
  6. Levey AS, et al. Ann Intern Med. 1999;130(6):461-470.
  7. Levey AS, et al. Ann Intern Med. 2009;150(9):604-612.
  8. Michels WM, et al. Clin J Am Soc Nephrol. 2010;5(6):1003-1009.
  9. Poggio ED, et al. J Am Soc Nephrol. 2005;16(2):459-466.

At Horizon, we are closely monitoring the COVID-19 pandemic and its effect on our communities. For patients on KRYSTEXXA, our current focus is to provide support to avoid disruptions in therapy. To contact a member of our support team, click here.

For more information, read our update on COVID-19.

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Indications and Usage

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Important Safety Information

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

INDICATIONS AND USAGE

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. 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 studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

INDICATIONS AND USAGE

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. 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 studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

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