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PEER PERSPECTIVE

A NEPHROLOGIST’S EXPERIENCE WITH KRYSTEXXA

Given the 10-fold increase in gout prevalence among patients with moderate-to-severe chronic kidney disease, more and more nephrologists are looking for and treating uncontrolled gout.1

Watch Dr. Payam Shakouri tell the story of the first patient he treated with KRYSTEXXA and sign up to be notified via email when more videos of nephrologists sharing their stories are available.

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GOUT PATIENTS ARE OUR PATIENTS

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Gout Patients Are Our Patients
With Nephrologist Payam Shakouri, MD

My name is Dr. Payam Shakouri, I'm a nephrologist, and I practice in Hudson Valley, New York.

I'm constantly chasing hemoglobin level, anemia, phosphorus. Are they clearing enough? Is their eGFR low? I was trained gout is not my problem. Give it to the primary doctor or the rheumatologist. I don't have time. Why should I treat gout?

I saw data that showed one-third of patients with moderate-to-advanced kidney disease have gout. And when I saw this I said, “Well, that cannot be true. That means 1 out of 3 of my patients have gout?” And I pull up all the patients' medications lists, and to my surprise, 1 in 4 or 1 in 3 was on treatment for gout.

Now that I look at it, it just makes sense. Uric acid is very hard to eliminate. Every time your kidney is impaired, your rate of deposition and reabsorption increases. So, it is a disease of the kidney. And the worse the kidney disease, the worse the gout.

And I looked at it and I thought, “Oh this makes sense, but I really don't have time. I have so much to do with my patients, I can't just add gout to it.” Until I had this patient, a very, very sick patient, 67-year-old lady with advanced kidney disease and heart failure.

And, you couldn't see tophi, per se, but her joints were deformed, and they were swollen. Out of desperation I said, well she has joint disease. Let me just order a full rheumatological workup. And I look, and the only thing that's highlighted, it says her uric acid is 8. And I said, “Do you have gout?”

She said, “Yeah, I have gout. But you don't have to worry about that. I'm on medication for it.” So, this is where it clicked. This patient thinks her gout is being treated because she's on medication for it. And I thought, well, let's try KRYSTEXXA on her.

We talked about the side effect profile and the drug profile. As with any urate-lowering therapy, there is a risk of flares. There is also a risk of anaphylaxis and infusion reactions.

We started her on it and within a week, her uric acid level fell to 0. Zero. Just like that. Within a few weeks, she started having improvement in her symptoms.

Now as my understanding has evolved, if I have a patient who even has 1 joint involvement who's on treatment for allopurinol and getting flare-ups, which means he has uncontrolled gout, I would consider starting this patient on KRYSTEXXA.

Kidney disease makes gout worse, that is a fact, and we know that. So, it is the job of a nephrologist to treat it. That's the bottom line.

I am Dr. Payam Shakouri, I'm a nephrologist, and these are our patients.

“[Gout] is a disease of the kidney. And the worse the kidney disease, the worse the gout.1-3

Dr. Payam Shakouri NEPHROLOGIST

Dr. Payam Shakouri outlines the key moments that led him to be adamant about treating uncontrolled gout and tells the story of his first KRYSTEXXA patient.

Sign up to be notified via email when more videos of nephrologists sharing their stories are available.

PATIENTS WITH MODERATE-TO-SEVERE CKD HAVE A 10-FOLD INCREASE IN GOUT PREVALENCE1*

Prevalence of gout in patients with CKD by eGFR
(Age-standardized prevalence, %)1*

An eGFR of <60 mL/min appears to be a threshold that dramatically increases the prevalence of gout.1

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. eGFR (mL/min/1.73m2) >90 (normal) 60-89 (mild) 30-58 (moderate) <30 (severe) Prevalence of gout (%) 2.9% 4.6% 27.9% 33.3%

An eGFR of <60 mL/min appears to be a threshold that dramatically increases the prevalence of gout.1

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.1

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

References
  1. Krishnan E. PLoS One. 2012;7:1-9.
  2. Terkeltaub R, et al. Arthritis Res Ther. 2006;8(suppl 1):1-9.
  3. Dalbeth N, et al. BMC. 2013;14:363. doi: 10.1186/1471-2474-14-363.
  4. Yood RA, et al. BMC Res Notes. 2014;7:1-6.

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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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