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MIRROR RCT investigated the use of KRYSTEXXA co-administered with methotrexate1-3

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 clinical trial design, showing Screening less than or equal to 6 weeks (N=152); MTX tolerability assessment at Week -6 through Week -4, with MTX 15 mg PO weekly and Folic acid 1 mg PO daily; Double-blind MTX run-in at Week -4, with MTX 15 mg PO weekly (n=100) and Placebo for MTX PO weekly (N=52); KRYSTEXXA with double-blind MTX period at Day with KRYSTEXXA 8 mg IV every 2 weeks with MTX 15 mg PO weekly and KRYSTEXXA 8 mg IV every 2 weeks with Placebo for MTX 15 mg PO weekly; and Follow-up at Month 12, with all patients completing follow-up visits at 30, 90, and 180 daysKRYSTEXXA MIRROR clinical trial design, showing Screening less than or equal to 6 weeks (N=152); MTX tolerability assessment at Week -6 through Week -4, with MTX 15 mg PO weekly and Folic acid 1 mg PO daily; Double-blind MTX run-in at Week -4, with MTX 15 mg PO weekly (n=100) and Placebo for MTX PO weekly (N=52); KRYSTEXXA with double-blind MTX period at Day with KRYSTEXXA 8 mg IV every 2 weeks with MTX 15 mg PO weekly and KRYSTEXXA 8 mg IV every 2 weeks with Placebo for MTX 15 mg PO weekly; and Follow-up at Month 12, with all patients completing follow-up visits at 30, 90, and 180 days

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) 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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sUA reduction and tophi resolution

See how KRYSTEXXA and methotrexate reduces sUA and resolves tophi quickly.

See the Results

ADAs, antidrug antibodies.

Learn more about patients who might benefit from KRYSTEXXA

Linda Linda Linda

Linda

Occupation:
Accountant

55-year-old with hypertension diagnosed with gout 4 years ago

Learn About Linda

Actor portrayal, not actual patient.

James James James

James

Occupation:
Middle school teacher

52-year-old with diabetes diagnosed with gout 15 years ago

Learn About James

Actor portrayal, not actual patient.

Real KRYSTEXXA patient, Bet Real KRYSTEXXA patient, Bet Real KRYSTEXXA patient, Bet

Occupation:
Stay-at-home parent

43-year-old diagnosed with gout over 20 years ago

Learn About Bet

Real patient.

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.