Patient populations of interest
KRYSTEXXA may be an appropriate treatment for your patients with uncontrolled gout who have an sUA >6 mg/dL and whose signs and symptoms are inadequately controlled despite treatment with xanthine oxidase inhibitors at the maximum medically appropriate dose, including patients with co-morbid chronic kidney disease (CKD).1,2
The 2012 American College of Rheumatology (ACR) Guidelines recommend lowering sUA level to a minimum of <6 mg/dL. Moreover, the ACR recommends lowering the sUA level sufficiently to durably improve the signs and symptoms of gout, which may require a therapeutic sUA level of <5 mg/dL.3
Screen patients for G6PD* deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.
*KRYSTEXXA is contraindicated for patients with G6PD deficiency. G6PD deficiency is an abnormally low level of glucose-6-phosphate dehydrogenase. Patients of African, Mediterranean, and Southern Asian ancestry have a higher risk of G6PD deficiency.1
KRYSTEXXA IS EFFECTIVE FOR UNCONTROLLED GOUT PATIENTS WITH OR WITHOUT VISIBLE TOPHI1,2
The pivotal clinical trials of KRYSTEXXA included patients without visible tophi but with other signs and symptoms of gout.1
Individual presentation and results may vary, even in patients without sustained response.
Not all patients with uncontrolled gout have visible tophi
•30% of patients had no visible tophi in the pivotal clinical trial1
•All patients had failed to reach sUA <6 mg/dL despite ≥3 months of the maximum medically appropriate dose of allopurinol (or had a medical contraindication to allopurinol)2
KRYSTEXXA IS SAFE AND EFFECTIVE FOR PATIENTS WITH UNCONTROLLED GOUT AND CKD1,2
Pivotal clinical trials
Estimation of glomerular filtration rate (eGFR) from serum creatinine remains the clinical standard worldwide to determine renal function.4-7
Post hoc analysis
11% had stage 4 CKD, as determined by eGFR2
Patients with CKD can be effectively treated with KRYSTEXXA without dose adjustment1
•CKD patients experienced similar reductions in sUA levels compared with patients without CKD1,2
oThere was no difference in efficacy of KRYSTEXXA across CKD stages 1, 2, 3, and 4
•The safety profile of KRYSTEXXA was demonstrated to be the same in patients with or without CKD, and across all CKD stages1,2
•KRYSTEXXA did not affect the eGFR during the 25-week treatment period2
No dose adjustment is required for patients with renal impairment.
A phase 1 study (N=12) was conducted in non-gout patients with CKD stage 5 (end-stage renal disease, or ESRD) to evaluate the effect of hemodialysis on the pharmacokinetics of a single dose of KRYSTEXXA8
This study showed no effect of hemodialysis on the safety or efficacy of KRYSTEXXA8
•CKD stage 5 (ESRD) patients are routinely excluded from clinical trials for gout and were also excluded from the KRYSTEXXA pivotal clinical trials8,9
•The results of a single injection indicated that8:
oReductions in sUA levels were similar to those achieved in the pivotal clinical trials
oKRYSTEXXA was not removed during dialysis treatment
oIn this study, KRYSTEXXA was well tolerated and there did not appear to be a change in the incidence, type, or severity of adverse events
- KRYSTEXXA [prescribing information]. Horizon Pharma Rheumatology LLC.
- Yood RA, et al. BMC Res Notes. 2014;7:54.
- Khanna D, et al. Arthritis Care Res (Hoboken). 2012;64(10):1431-1446.
- Levey AS, et al. Ann Intern Med. 1999;130(6):461-470.
- Levey AS, et al; Ann Intern Med. 2009;150(9):604-612.
- Michels WM, et al. Clin J Am Soc Nephrol. 2010;5(6):1003-1009.
- Poggio ED, et al. J Am Soc Nephrol. 2005;16(2):459-466.
- Bleyer AJ, et al. Clin Nephrol. 2015;83(5):286-292.
- Sundy JS, et al. JAMA. 2011;306(7):711-720.