KRYSTEXXA®

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Primary endpoint

Pie chart with 42% in center Pie chart with 42% in center
Pie chart with 42% in center

42% of patients had a complete sUA response1

42% of patients had a complete sUA response1

These patients maintained sUA levels below 6 mg/dL ≥80% of the time during Months 3 and 6 vs 0% for placebo (P<0.001). Approximately 24 hours after the first dose, mean sUA level in these patients was <1 mg/dL.1

Secondary endpoint

Pie chart with 45% in centerPie chart with 45% in center
Pie chart with 45% in center

At 6 months, 45% of patients (n=62) achieved complete resolution of tophi (P<0.002)1

At 6 months, 45% of patients (n=62) achieved complete resolution of tophi (P<0.002)1

Tophi resolution was defined as 100% resolution of at least 1 target tophus, no new tophi appearing, and no single tophus showing progression.

Safety data from pivotal clinical trials

  • 5% of patients who received KRYSTEXXA (4 out of 85) experienced severe infusion reactions (anaphylaxis) compared to 0% of patients who received placebo (0 out of 43)1*
    • The majority of infusion reactions in the pivotal clinical trials were resolved by slowing or interrupting the infusion, and restarting at the same or a slower rate. No patients required intubation, mechanical ventilator support, or hospitalization2

Adverse Reactions Occurring in 5% or More of Patients Treated With KRYSTEXXA Compared With Placebo1

ADVERSE EVENT KRYSTEXXA 8 MG
EVERY TWO WEEKS (N=85) n† (%)		 PLACEBO (N=43) n (%)
Gout flare 65 (77%) 35 (81%)
Infusion reaction 22 (26%) 2 (5%)
Nausea 10 (12%) 1 (2%)
Contusion‡ or Ecchymosis‡ 9 (11%) 2 (5%)
Nasopharyngitis 6 (7%) 1 (2%)
Constipation 5 (6%) 2 (5%)
Chest pain 5 (6%) 1 (2%)
Anaphylaxis 4 (5%) 0 (0%)
Vomiting 4 (5%) 1 (2%)

*Post hoc analysis criteria defined using National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network Criteria.1,2

†If the same subject in a given group had more than 1 occurrence in the same preferred term event category, the subject was counted only once.1

‡Most did not occur on the day of infusion and could be related to other factors (eg, concomitant medications relevant to contusion or ecchymosis, or insulin dependent diabetes mellitus).1

sUA: A biomarker that informs the safety and efficacy of KRYSTEXXA in clinical practice

Bar chart comparing incidence of infusion reactions based on sUA levels (Per 100 infusions), with 0.4 reactions in the placebo group, 0.5 in the sUA less than or equal to 6 mg/dL group, and 4.8 in the sUA above 6 mg/dL group

Bar chart comparing incidence of infusion reactions based on sUA levels (Per 100 infusions), with 0.4 reactions in the placebo group, 0.5 in the sUA less than or equal to 6 mg/dL group, and 4.8 in the sUA above 6 mg/dL group

Adapted with permission from Baraf HSB, et al. J Clin Rheumatol. 2014;20:427-432.

§Based on infusion reactions per patient.2

sUA, serum uric acid.

Monitoring protocol

Close monitoring of sUA within 48 hours prior to infusions can significantly reduce infusion reactions.1,3

sUA can help identify patients at risk for infusion reactions1,3

For use after
first infusion

Patients Level Icons

Take a preinfusion sUA measurement, preferably within 48 hours prior to each infusion

Patients Level IconsPatients Level Icons

Continue treatment if the preinfusion sUA level is ≤6 mg/dL

Discontinue treatment if levels increase above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed

sUA, serum uric acid.

Please view the KRYSTEXXA MIRROR RCT safety and efficacy data on this site.

MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase.

UNDERSTANDING THE SAFETY DATA

From pivotal clinical trials to clinical practice

Pivotal clinical trials: double-blind protocol masked the causes leading to higher infusion reaction risk2,3

  • During the pivotal clinical trials, the relationship among sUA levels, antidrug antibodies, and infusion reactions was unknown
    • Antidrug antibodies are common to biologic therapies4
    • Identifying the development of antidrug antibodies is often difficult5
  • Antidrug antibodies can lead to decreased efficacy and an increased risk of infusion reactions4
    • In the pivotal clinical trials, an sUA >6 mg/dL often reflected the development of antidrug antibodies to pegloticase2,6

Types of infusion reactions in the pivotal clinical trials
INFUSION REACTIONS FREQUENCY (%)
Hives 10.6
Chest discomfort 9.5
Chest pain 9.5
Reddening of the skin 9.5
Itching of the skin 9.5
Difficulty breathing 7.1

The majority of infusion reactions in the pivotal clinical trials were resolved by slowing or interrupting the infusion and restarting at the same or a slower rate2||

||Approximately 75% of infusion reactions with a recorded intervention.

Severity of infusion reactions in the pivotal clinical trials2¶
Incidence of infusion reactions by severity in the RCT
INFUSION REACTION SEVERITY PEGLOTICASE BIWEEKLY (N=85) n (%) PLACEBO (N=43#) n (%)
Mild 7 (8) 0
Moderate 11 (13) 2 (5)
Severe 4 (5) 0

There were 4 cases of severe infusion reactions identified by investigators that were retrospectively reclassified as anaphylaxis by the FDA (N=85)2

Only the most severe episode is showing if a patient had more than 1 event.2

#Thirty-nine of these patients entered the OLE study and were treated with pegloticase.2

OLE, open label extension; RCT, randomized, controlled trial.

Characterization of severe infusion reactions: All were resolved on site2
PATIENT INFUSION REACTIONS TREATMENT OUTCOME
PATIENT 1 1 INFUSION REACTIONSDifficulty breathing, swelling of the tongue TREATMENTInfusion discontinued
(Benadryl®: 25 mg IV)		 OUTCOMEInfusion reaction resolved
PATIENT 2 2 INFUSION REACTIONSDifficulty breathing, hives, elevated heart rate, elevated blood pressure TREATMENTInfusion discontinued
(Benadryl®; Ventolin®)		 OUTCOMEInfusion reaction resolved
PATIENT 3 3 INFUSION REACTIONSFlushing, itchy skin, low blood pressure, elevated heart rate, hives** TREATMENTInfusion discontinued
(Benadryl®; Demerol®)		 OUTCOMEInfusion reaction resolved
PATIENT 4 4 INFUSION REACTIONSItchy eye, puffy eye, chest discomfort, throat irritation, joint pain, back pain TREATMENTInfusion discontinued OUTCOMEInfusion reaction resolved

**Patient did not take full premedication regimen.2

All trademarks appearing herein are the property of their respective owners.

Of the 4 cases reclassified as anaphylaxis,
3 likely would have been prevented using the KRYSTEXXA Monitoring Protocol

In the pivotal clinical trials, no patients with infusion reactions required intubation, mechanical ventilator support, or hospitalization. There were no infusion-related deaths

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KRYSTEXXA Monitoring Protocol

Dedicated members of the KRYSTEXXA team are available to offer
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Preparing for treatment

There are several steps that will help prepare patients for infusion and ensure proper administration of KRYSTEXXA.

See Step-by-Step Instructions

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of gout and CKD patient, RichardActor portrayal of gout and CKD patient, Richard Actor portrayal of gout and CKD patient, Richard

Richard, CKD stage 4

Occupation:
Bus driver

52-year-old with CKD stage 4; 3 flares in the last year and no visible tophi

Learn About Richard

Actor portrayal, not real patient.

Actor portrayal of gout and CKD Stage 3b patient, Susan Actor portrayal of gout and CKD Stage 3b patient, Susan Actor portrayal of gout and CKD Stage 3b patient, Susan

Susan, CKD stage 3b

Occupation:
Dental hygienist

45-year-old with CKD stage 3b; 3 flares in the last year and 1 small tophus on her left hand for the past 2 years

Learn About Susan

Actor portrayal, not real patient.

Real KRYSTEXXA patient, Michael, with a 30-year history of gout Real KRYSTEXXA patient, Michael, with a 30-year history of gout Real KRYSTEXXA patient, Michael, with a 30-year history of gout

Occupation:
Architect

60-year-old diagnosed with gout over 30 years ago

Learn About Michael

Real patient.

CKD, chronic kidney disease.

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.
  • Baraf HSB, et al. J Clin Rheumatol. 2014;20;427-432.
  • Keenan RT, et al. Rheumatol Ther. 2019;6:299-304.
  • Strand V, et al. BioDrugs. 2017;31:299-316.
  • Lombardi G, et al. BMJ Open. 2016;6:1-7.
  • Sundy JS, et al. JAMA. 2011;306:711-720.
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