KRYSTEXXA with methotrexate

Improved Efficacy

up arrow icon up arrow icon>80% relative improvement in patient response at Month 6 when KRYSTEXXA was co-administered with methotrexate: 71% (n=71/100) vs 39% (n=20/52) complete response compared to KRYSTEXXA alone1

up arrow icon up arrow icon 94% relative improvement in patient response at Month 12 when KRYSTEXXA was co-administered with methotrexate: 60% (n=60/100) vs 31% (n=16/52) complete response compared to KRYSTEXXA alone1*

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Relative Reduction in Infusion Reactions

up arrow icon up arrow icon 87% relative reduction in infusion
reactions: 4% (n=4/96) vs 31%
(n=15/49) compared to
KRYSTEXXA alone1

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*Complete response: The endpoints were the proportion of responders, defined as patients achieving and maintaining sUA <6 mg/dL at least 80% of the time during co-administration of KRYSTEXXA with methotrexate.

sUA, serum uric acid.

There are a lot of aspects that we take care of as nephrologists, and I think that part of that means controlling gout.

Hear nephrologist Bhavnish Bucktowarsing discuss why gout can be a silent killer, the risk of systemic inflammation, and his experience treating patients with KRYSTEXXA and methotrexate.

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Okay, and here we go.

My name is Bhavnish Bucktowarsing and I’m a nephrologist in Canton, Ohio. I take care of patients with chronic kidney disease, hypertension and other chronic illnesses.

Gout is recognized mostly as a rheumatological issue, a joint issue, but if you look at it at its core, it’s more of a metabolic disease. People say hypertension and diabetes are silent killers, but you could probably put gout in that domain as well. Once you reach stage 3 kidney disease, your kidney is not doing well, you’re not filtering uric acid. Uric acid goes up, then that causes systemic inflammation. The most common thing I see, is the moment you have uncontrolled gout, those patients tend to have cardiac disease. They have of course chronic kidney disease. I would say a third to even more than that of my patients will have elevated uric acid when I first start seeing them. That’s where the conversation starts about how having a high uric acid level can aggravate those other risk factors around your kidneys. And it really is an eye opener for a lot of patients, they don’t realize it. When it comes to speed of resolution of gout it is very important because you’re in a constant state of systemic uric acid deposition. So, that itself means you’re chronically inflamed and the longer you let that process brew, the longer you’re at risk of having more and more complications from high uric acid levels.

I think the first patient I had was already on 300mg allopurinol, he was flaring twice a year or even more and he had a uric acid of 9.5 when I saw him in the office. And he was miserable. Of course he was seeing me for his kidneys, but every time he would come to me, he would complain about his joints, how they were hurting. This patient, he lived on a farm, he had to be active. Unfortunately, gout was preventing him from doing that. We talked about his joint mobility and how we can try to improve that with KRYSTEXXA infusion. As with many biologic therapies there is a risk of anaphylaxis and infusion reactions. After 2 or 3 months, he was feeling so much better, and he had a smile on his face after a while. I want the best outcome possible, so, I tell them that we’re going to shoot for a treatment time of a year. Really not that much of a time if you think that you’re going to be my patient moving forward pretty much for the rest of your life. Now that he’s finished treatment, it was a just a blip in time, as compared to the entire lifespan that I’m going to be seeing him for. He was able to walk around without having to take pain medications anymore and he was getting back to his activities on the farm.

Well, I think if you look at the studies, especially Mirror RCT, there was an almost 80 – 90% relative improvement in efficacy when you give it with immunomodulation as compared with no immunomodulation, so I talk to them about methotrexate and my regimen would be starting them at 15mg once a week about 4 weeks prior to the first infusion. At 15mg once a week, you’re looking at just enough immunomodulation to control their immune system but it’s not enough to cause other negative side effects on their kidneys. We’re giving them that just so they can tolerate the drug and have better outcomes. So that really made me comfortable prescribing methotrexate.

There’s a lot of aspects that we take care of as nephrologists, and I think that part of that means controlling gout. If you think about having a patient with kidney disease and their uric acid is elevated, it becomes the responsibility of the nephrologist to try to control that gout because the kidneys are not doing what they should be doing. Given the effects that has on other chronic illnesses, it should definitely be within our arsenal of things we can do for our patients to help them get better.

I’m Dr. Bhavnish Bucktowarsing, I’m a nephrologist and these are our patients.

Support for your patients

Managing uncontrolled gout can involve a lot of moving parts. Horizon By Your Side is a patient support program with dedicated team members who take a personalized approach to meet your patients’ unique treatment needs.

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sUA reduction guidelines

Find out what sUA level the American College of Rheumatology recommends to durably improve the signs and symptoms of gout.

Identifying patients

Consider these types of patients with uncontrolled gout and see if KRYSTEXXA could be right for them.

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.

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.

  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.