Key Inclusion/Exclusion Criteria3

Inclusion

  • Adult patients ≥18 years old with diagnosis of gout
  • Uncontrolled gout, defined as (all required)
    • Serum uric acid (sUA) ≥7 mg/dL
    • Oral urate lowering therapy failure/intolerance
    • ≥1 ongoing gout symptom (≥1 tophus, ≥2 flares in the year prior to screening and/or chronic gouty arthritis)

Exclusion

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • eGFR <40 mL/min/1.73 m2
  • MTX contraindication/known intolerance
  • Elevated LFTs, low albumin or low blood cell counts
eGFR, estimated glomerular filtration rate; LFTs, liver function tests; MTX, methotrexate.

Family history, health literacy, and socioeconomic environment are contributing factors to gout becoming uncontrolled18,19

Two major factors contribute to uric acid buildup and crystallization18,19

Genetics
Gout runs in the family
Kidney damage
Impaired uric acid elimination
Additional contributing factors include4,18,20,21:
  • Diet and lifestyle
  • Age
  • Comorbidities
  • Metabolism
Diet is not a substitute for treatment as dietary restrictions may reduce uric acid levels by only ~1 mg/dL13,22

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UNMET NEED
IMAGE LIBRARY

Explore the visible and nonvisible urate burden throughout the body

Click through the Image Library to see how urate burden affects various organs and joints in the body such as the hands, feet, heart, kidneys, and spine.

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ON THIS PAGE:
  • Hand
  • foot
  • Heart
  • Kidney
  • Spine

When uric acid builds up, it can turn into crystals. These crystals cause painful flares and tophi1

Hand

ACTUAL PATIENT BEFORE KRYSTEXXA
Patient photograph taken in April 2019.
ACTUAL PATIENT BEFORE KRYSTEXXA
Patient photograph taken in September 2021.
Best results were seen at 6 to 12 months.2 The optimal treatment duration for KRYSTEXXA has not been established.2
Image of tophi in hands with both visible and nonvisible buildup
PHOTO OF TOPHI BUILDUP
Image courtesy of Dr Jürgen Rech. Individual results may vary.
Dual Energy CT scan of hand showing visible and nonvisible buildup in gout patient
DECT OF URATE BUILDUP
DECT image courtesy of Dr Jürgen Rech. Individual results may vary. Green areas indicate urate crystal buildup.
DECT, dual-energy computed tomography.
Dual Energy CT scan of hand in gout patient at baseline
DECT image of urate buildup from a patient in MIRROR RCT.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).2,4
DECT, dual-energy computed tomography; MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; QD, once a day; Q2W, once every 2 weeks; QW, once a week; RCT, randomized controlled trial.
MIRROR RCT FROM BASELINE TO 52 Weeks
DECT images from a patient in MIRROR RCT.3 The optimal treatment duration has not been established.2 Individual results may vary.
DECT, dual-energy computed tomography; MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial.

Reducing urate crystal buildup can help prevent future flares and limit permanent damage1,2

Foot

Foot tophi image
Mirror RCT at baseline
Image of tophi buildup from a patient in MIRROR RCT.3
MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial.
Side by side pictures of tophi on foot before and after KRYSTEXXA with methotrexate treatment
MIRROR RCT FROM BASELINE TO 52 WEEKS
Images of tophi response after using KRYSTEXXA with methotrexate from the same patient in MIRROR RCT from baseline to 52 weeks.
Individual results may vary. Best results seen at 6 to 12 months. Optimal treatment duration has not been established. Among patients with digital photography of tophi at baseline, 54% of patients in the KRYSTEXXA with methotrexate group met the secondary endpoint. Tophi resolution was defined as 100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression at Month 12.3,4
MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial.
Dual Energy CT scan of uric acid buildup in foot at baseline
MIRROR RCT AT BASELINE
DECT image of urate buildup from a patient in MIRROR RCT.3
DECT, dual-energy computed tomography; MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial.
Side by side Dual Energy CT scans showing uric acid buildups in a gout patient at baseline and at Week 52 of treatment
MIRROR RCT FROM BASELINE TO 52 WEEKS
DECT images from a patient in MIRROR RCT.3 The optimal treatment duration has not been established. Individual results may vary.4
DECT, dual-energy computed tomography; MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial.

Urate crystals can deposit anywhere in the body, including in organs like the heart1

Heart

Micro tophus photo
Microtophus in the intima of a left anterior descending artery.2
Adapted from Park JJ, et al. BMJ Open. 2014;4:e005308.
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body’s organs.
Micro tophi photo
Microtophi in the adventitia of a right coronary artery.2
Adapted from Park JJ, et al. BMJ Open. 2014;4:e005308.
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body’s organs.
Image of negatively birefringent crystals in gout microscopy
Intracellular negatively birefringent crystals in the intima of a left anterior descending artery (left) as seen with polarizing microscopy. White arrow denotes a first-order red plate axis. Deconvolution confocal microscopy image of the same cell showing intracellular crystals (right).2
Adapted from Park JJ, et al. BMJ Open. 2014;4:e005308.
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body’s organs.

Impaired renal excretion of uric acid is the dominant cause of hyperuricemia in the majority of patients with gout1

Kidney

Image of urate in ducts of renal medulla
Urate has precipitated in ducts of the renal medulla. The affected tubules are dilated and epithelial cells are injured. A small segment of tubular basement membrane seems denuded (arrows). Note: There is no inflammatory response in the interstitium. H&E stained section; x125 original magnification.2
Adapted from Nickeleit V, et al. Nephrol Dial Transplant. 1997;12:1832-1838.
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body’s organs.
Side by side gouty tophi images
Gouty tophus in renal medulla (left; acid fuchsin – orange G stain, x125 original magnification). Center of a tophus with uric acid crystals (right; polarized light; x140 original magnification).2
Adapted from Nickeleit V, et al. Nephrol Dial Transplant. 1997;12:1832-1838.
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body’s organs.
Image of gouty tophus in the renal medulla
Typical gouty tophus in the renal medulla with crystalloid material in the center surrounded by a narrow rim of fibrosis and inflammation. Note: The tophus probably originated from a ruptured collecting duct (arrow). H&E stained section; x50 original magnification.2
Adapted from Nickeleit V, et al. Nephrol Dial Transplant. 1997;12:1832-1838.
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body’s organs.
Images of gouty tophi in joint and kidney
Gouty tophi in joint and kidney. Chalky white urate deposits are visible in the articular cartilage (right). The corresponding kidney (left) shows yellowish areas in the pyramids (arrow) representing fibrosis and urate deposits.2
Adapted from Nickeleit V, et al. Nephrol Dial Transplant. 1997;12:1832-1838.
KRYSTEXXA has not been studied to reverse damage to the kidneys, heart, or any of the body’s organs.

Up to 75% of the urate burden may not be detected upon physical examination1-3

Spine

DECT scans of lower spine showing tophaceous deposits
Sagittal DECT and 3-dimensional DECT reconstruction show extensive tophaceous deposits (in green) in L1/2, L2/3, L3/4, and L4/5 lumbar discs, and also L2-L3 and L4-L5 facet joints.4
Adapted from Lu H, et al. Medicine (Baltimore). 2017;96:e7670.
DECT, dual-energy computed tomography.
DECT scans of lumbar spine showing tophaceous deposits
Sagittal mixed 120-kVp equivalent images of lumbar spine obtained with dual-energy CT demonstrate an intermediate-attenuation mass in the L5-S1 facet joint with bony erosions and narrowing of the neural foramen (arrow, left). Dual-energy material labeling color map overlay shows monosodium urate (green) and bone (blue and pink). Note the monosodium urate crystals crowding the left neural foramen (arrow, right).5
Adapted from Gibney B, et al. Radiology. 2020;296:276.
Photo of tophi from gout in spine
(A) lntraoperative photograph of the chalky white material at the right L2-L3, L4-L5 facet joints (white arrows). (B) Histological examination (H&E, 100x) shows amorphous tophaceous deposit with a multinucleated giant cell reaction.4
Adapted from Lu H, et al. Medicine (Baltimore). 2017;96:e7670.

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.