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The MIRROR RCT was a 52-week, randomized double-blind placebo-controlled trial conducted in adult patients with chronic gout refractory to conventional therapy to evaluate administration of KRYSTEXXA 8 mg Q2W coadministered with 15 mg oral methotrexate QW and 1 mg oral folic acid QD (n=100) vs KRYSTEXXA alone (n=52).1,2

KRYSTEXXA MIRROR RCT design, showing Screening (n=278) before Week -6; MTX tolerability period (n=159) at Week -6 through Week -4; Double-blind MTX/PBO run in period with oral MTX (15mg/week)(n=98) and weekly oral PBO for MTX (n=51) at Week -4 through Day 1; Double-blind Pegloticase + MTX/PBO treatment period with IV Pegloticase (8 mg) every 2 weeks + Oral MTX (15 mg/week)(n=96) and IV Pegloticase (8 mg) every 2 weeks + Weekly oral PBO for MTX (n=49) from Day 1 through Week 24, with IV Pegloticase (8 mg) every 2 weeks + Oral MTX (15 mg/week)completed treatment through Week 24 (n=70)and IV Pegloticase (8 mg) every 2 weeks + Weekly oral PBO for MTX completed treatment through Week 24 (n=19), and with IV Pegloticase (8 mg) every 2 weeks + Oral MTX (15 mg/week)completed treatment through Week 52 (n=58)and IV Pegloticase (8 mg) every 2 weeks + Weekly oral PBO for MTX completed treatment through Week 52 (n=16)KRYSTEXXA MIRROR RCT design, showing Screening (n=278) before Week -6; MTX tolerability period (n=159) at Week -6 through Week -4; Double-blind MTX/PBO run in period with oral MTX (15mg/week)(n=98) and weekly oral PBO for MTX (n=51) at Week -4 through Day 1; Double-blind Pegloticase + MTX/PBO treatment period with IV Pegloticase (8 mg) every 2 weeks + Oral MTX (15 mg/week)(n=96) and IV Pegloticase (8 mg) every 2 weeks + Weekly oral PBO for MTX (n=49) from Day 1 through Week 24, with IV Pegloticase (8 mg) every 2 weeks + Oral MTX (15 mg/week)completed treatment through Week 24 (n=70)and IV Pegloticase (8 mg) every 2 weeks + Weekly oral PBO for MTX completed treatment through Week 24 (n=19), and with IV Pegloticase (8 mg) every 2 weeks + Oral MTX (15 mg/week)completed treatment through Week 52 (n=58)and IV Pegloticase (8 mg) every 2 weeks + Weekly oral PBO for MTX completed treatment through Week 52 (n=16)

Study visits with pegloticase infusion at Day 1 and every 2 weeks
through Week 50. Additional noninfusion visits at Weeks 21, 23, and 52.

*100 patients randomized to MTX co-therapy; 52 patients randomized to PBO co-therapy.1

†The primary endpoint was the proportion of Month 6 (Weeks 20, 21, 22, 23, and 24) responders, defined as subjects achieving and maintaining an sUA
level of <6 mg/dL for at least 80% of the time during Month 6.1

Folic acid should be continued daily during treatment of methotrexate.1

IV, intravenous; MTX, methotrexate; PBO, placebo; QD, every day; QW, every week; Q2W, every 2 weeks; sUA, serum uric acid.

Trial patient characteristics (ITT population)3
KRYSTEXXA MIRROR RCT patient population (N=152)
PATIENT CHARACTERISTICS KRYSTEXXA WITH MTX (n=100) KRYSTEXXA ALONE (n=52)
Age, mean (SD) years 55.6 (12.7) 53.0 (12.1)
Sex, male, n (%) 91 (91) 44 (84.6)
BMI, (mean) (SD), kg/m2 32.7 (5.6) 32.7 (7.8)
# of flares in 12 months prior to baseline, mean (SD) 10.6 (12.9) 11.3 (16.7)
sUA, mean (SD), mg/dL 8.7 (1.6) 9.1 (1.7)
Time since 1st gout diagnosis, mean (SD), years 13.7 (10.6) 14.3 (10.8)
Presence of tophi, n (%), yes 74 (74.0) 41 (78.8)
Stage 3 CKD, n (%)‡ 33 (33.3)§ 16 (30.8)

‡Patients with eGFR <40 mL/min/1.73 m² were excluded from study participation.3 
§Baseline eGFR was missing for 1 patient.4
BMI, body mass index; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ITT, intent-to-treat; SD, standard deviation.

Review the Key Inclusion/Exclusion Criteria

See the Data

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Mechanism of action

Learn about the mechanism of action of KRYSTEXXA and how it relates to the kidneys.

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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.
  • Botson JK, et al. Arthritis Rheumatol. 2023;75:293-304.
  • Botson JK, et al. ACR Open Rheumatol. 2023;5:407-418.
  • Abdellatif A, et al. Am J Kidney Dis. 2023;81(suppl 1):S67.