Actor portrayal, not actual patient.
sUA level:
7.3 mg/dL
BMI:
28
G6PD:
normal
A1C:
7.2%
Renal function:
normal
Allopurinol:
800 mg QD
(for the past year)
Metformin:
850 mg QD
Linagliptin:
5 mg QD
Colchicine:
0.6 mg QD for prophylaxis
Actor portrayal, not actual patient.
sUA level:
8.4 mg/dL
BMI:
31
G6PD:
normal
BP:
128/80 mm Hg
Renal function:
normal
Allopurinol:
600 mg QD
(for the past year)
Losartan:
50 mg QD
Colchicine:
0.6 mg QD for prophylaxis
Prednisone:
40 mg QD for active flares
| Before |
|---|
| sUA level: 10.4 mg/dL |
| BMI: 38.5 |
| Swollen/tender joints: Chronic pain in multiple joints |
| Tophi: Visible tophi |
| Flares: >2/year |
| After |
|---|
| sUA level: <1 mg/dL |
| Tophi: Reduced |
| Before |
|---|
| Allopurinol: 7 years with increasing doses |
| Colchicine: 7 years while flaring |
| Febuxostat: 1 year |
Enlarge
| After |
|---|
| Colchicine: 0.6 mg as needed |
| KRYSTEXXA: 8 mg every 2 weeks |
| Methotrexate: 15 mg orally per week |
Enlarge
Best results seen at 6-12 months.1 Optimal treatment duration has not been
established.1 Individual results may vary.
The primary endpoint in MIRROR RCT was defined as the proportion of patients achieving
and maintaining an sUA level of <6 mg/dL for at least 80% of the time during Month 6;
71% of KRYSTEXXA with methotrexate patients (N=100) vs 39% of KRYSTEXXA alone patients
(N=52) met the primary endpoint (P<0.0001)1
Tophi Resolution was a secondary endpoint that was defined as 100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression at Month 12; 54% (28/52) of patients receiving KRYSTEXXA with methotrexate achieved tophi resolution vs 31% (9/29) of patients receiving KRYSTEXXA alone (P=0.048).1,3
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) co-administered with 15 mg/week oral methotrexate and 1 mg/day oral folic acid (n=100) vs KRYSTEXXA with placebo (n=52).1,4
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.
KRYSTEXXA is not indicated for the treatment of pain.
ACR, American College of Rheumatology; BMI, body mass index; sUA, serum uric acid.
sUA >6
Is their uric acid level
>6 mg/dL?
TOPHI
Do they have
nonresolving tophi?
ORAL ULT FAILURE
Have they been taking
the maximum
medically appropriate
dose of ULTs?
PAINFUL FLARES
Have they had 2 or
more painful flares in
the past year?
Once you decide KRYSTEXXA is right for your patient, you can begin by downloading the Patient Enrollment Form (PEF).
How can reducing antidrug antibodies improve patient response?
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.
