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SECONDARY ENDPOINT

KRYSTEXXA CAN PROVIDE COMPLETE RESOLUTION OF TOPHI IN MONTHS, NOT YEARS1

The secondary endpoint of the pivotal clinical trials was complete resolution of at least 1 target tophus, with no new or progressive tophi, in 6 months.2

Pie chart

AT 3 MONTHS

22%

of patients (n=62) achieved complete resolution of tophi

(P=0.01)1

Pie chart

AT 6 MONTHS

45%

of patients (n=62) achieved complete resolution of tophi

(P<0.002)1

These results include patients who experienced a complete response as well as patients who experienced an incomplete response in the primary endpoint.3

SELECT IMPORTANT SAFETY INFORMATION

  • Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA

COMPLETE RESOLUTION OF TOPHI OVER TIME WITH KRYSTEXXA1,4

  • Comparison of hand before and after treatment with KRYSTEXXA

    BASELINE

  • Comparison of hand before and after treatment with KRYSTEXXA

    3 months

  • Comparison of hand before and after treatment with KRYSTEXXA

    6 months

Individual presentation and results may vary, even in patients without sustained response.

Tophus assessment was conducted using Computer-Assisted Photographic Evaluation in Rheumatology (CAPER) methodology.1

  • 45% of all patients (both complete* and incomplete responders) met the secondary endpoint of tophus resolution vs 8% with placebo1
  • While incomplete responders did not meet the primary endpoint for durability of response, 26% (5/19) of patients with incomplete response still achieved complete resolution of tophi1,2

*Complete response—defined as complete resolution of at least 1 tophus without development of new tophi or progressive enlargement of any other tophus—was prespecified as a secondary efficacy endpoint in the randomized controlled trials and as secondary clinical outcomes in the open-label extension study.1

SELECT IMPORTANT SAFETY INFORMATION

  • 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 infusions

THE URATE BURDEN IS REDUCED IN KRYSTEXXA-TREATED PATIENTS5

In an independent, prospective, observational study (N=10) to investigate the effect of urate-lowering therapy with KRYSTEXXA, DECT scans were used to measure the regression level of both visible and nonvisible tophi before and after therapy.5

Pretreatment DECT scans were obtained on hands and feet in 7 patients and on feet alone in 3 patients. Follow-up images of the same areas were taken posttherapy.5

LOWERING OF sUA LEVEL DECREASED THE TOPHUS VOLUME5†

PATIENTS WITH INCOMPLETE sUA RESPONSE (n=5)

PATIENTS WITH COMPLETE sUA RESPONSE (n=5)

47.97% mean reduction of tophus volume within 22 weeks

LOWERING OF sUA LEVEL DECREASED THE TOPHUS VOLUME5†

PATIENTS WITH INCOMPLETE sUA RESPONSE (n=5)

47.97% mean reduction of tophus volume within 22 weeks

PATIENTS WITH COMPLETE sUA RESPONSE (n=5)

94.76% mean reduction of tophus volume within 28 weeks

Green areas indicate tophi.

†This study examined the effects of intensive lowering of uric acid with KRYSTEXXA and the resolution of tophi in patients with uncontrolled gout. Patients had a mean disease duration range of 4.6 years. Patients received KRYSTEXXA 8 mg/dL every 2 weeks for a mean of 13 weeks (±10 weeks). Individual results may vary.5

2 of 5 patients who had to discontinue KRYSTEXXA due to mild infusion reactions had a 73% and 29% tophus volume reduction with as few as 2 infusions.5

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MONITORING
PROTOCOL

In a post hoc analysis, preinfusion sUA was revealed as a powerful biomarker for predicting infusion reactions. From this, a simple monitoring protocol was established.

See the protocol

IDENTIFYING
PATIENTS

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

Review patient characteristics
Full Important Safety Information

For U.S. Healthcare Professionals Patient Site

Full Prescribing Information

Medication Guide

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.

Full Important Safety Information

For U.S. Healthcare Professionals Patient Site

Full Prescribing Information

Medication Guide

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.

  • Baraf HS, et al. Arthritis Res Ther. 2013;15(5):R137.
  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
  • Sundy JS, et al. JAMA. 2011;306(7):711-720.
  • Data on file. Horizon, May 2017.
  • Araujo EG, et al. RMD Open. 2015;1(1):e000075.