Patient name/age: Bet, 43
Occupation: Stay-at-home parent
sUA >6 mg/dL
2/year
visible tophi
MIRROR was a 52-week, randomized double-blind trial conducted in adult patients with chronic gout refractory to conventional therapy to evaluate administration of KRYSTEXXA 8 mg Q2W co-administered with 15 mg oral methotrexate QW and 1 mg oral folic acid QD vs KRYSTEXXA alone.1,2
*After randomization, clinicians had the ability to dose-adjust methotrexate but chose not to.
†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
IV, intravenous; MTX, methotrexate; PO, provided orally; QD, every day; QW, every week; Q2W, every 2 weeks; sUA, serum uric acid.
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 | 8.9 (2.5) | 9.3 (1.7) |
Time since 1st gout diagnosis, mean (SD), years | 13.7 (10.6) | 14.3 (10.8) |
Presence of tophi, n (%), yes | 52 (52.0) | 29 (55.8) |
Stage 3 CKD, n (%) | 33 (33.3) | 16 (30.8) |
BMI, body mass index; CKD, chronic kidney disease; ITT, intent to treat; RCT, randomized controlled trial; SD, standard deviation; sUA, serum uric acid.
Connect with the KRYSTEXXA team to discuss.
In the MIRROR RCT, KRYSTEXXA with MTX improved patient response at both 6 and 12 months.1‡
‡The primary efficacy endpoint was the proportion of responders, defined as achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 6. The secondary efficacy endpoint was the proportion of responders, defined as achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12.
sUA, serum uric acid; MTX, methotrexate.
sUA >6 mg/dL
2/year
visible tophi
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.
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.
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.
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.
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.
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.