COMPLETE RESOLUTION IS POSSIBLE IN MONTHS, NOT YEARS1
Pivotal clinical trials evaluated the efficacy of KRYSTEXXA in lowering total body uric acid levels and the resolution of tophi over time. These trials observed patient response, including durability of response, as a part of this secondary endpoint.
Individual presentation and results may vary, even in patients with sustained response.
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Sign Up NowSECONDARY ENDPOINT
KRYSTEXXA CAN PROVIDE COMPLETE RESOLUTION OF TOPHI IN MONTHS, NOT YEARS1
The secondary endpoint of the pivotal clinical trials was complete resolution of at least 1 target tophus, with no new or progressive tophi, in 6 months.2
AT 3 MONTHS
of patients (n=62) achieved complete resolution of tophi
(P=0.01)1
AT 6 MONTHS
of patients (n=62) achieved complete resolution of tophi
(P<0.002)1
These results include patients who experienced a complete response as well as patients who experienced an incomplete response in the primary endpoint.3
SELECT IMPORTANT SAFETY INFORMATION
- Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA
COMPLETE RESOLUTION OF TOPHI OVER TIME WITH KRYSTEXXA1,4
Baseline
3 months
6 months
Individual presentation and results may vary, even in patients without sustained response.
Tophus assessment was conducted using Computer-Assisted Photographic Evaluation in Rheumatology (CAPER) methodology.1
- 45% of all patients (both complete* and incomplete responders) met the secondary endpoint of tophus resolution vs 8% with placebo1
- While incomplete responders did not meet the primary endpoint for durability of response, 26% (5/19) of patients with incomplete response still achieved complete resolution of tophi1,2
*Complete response—defined as complete resolution of at least 1 tophus without development of new tophi or progressive enlargement of any other tophus—was prespecified as a secondary efficacy endpoint in the randomized controlled trials and as secondary clinical outcomes in the open-label extension study.1
SELECT IMPORTANT SAFETY INFORMATION
- KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusions
THE URATE BURDEN IS REDUCED IN KRYSTEXXA-TREATED PATIENTS5
In an independent, prospective, observational study (N=10) to investigate the effect of urate-lowering therapy with KRYSTEXXA, DECT scans were used to measure the regression level of both visible and nonvisible tophi before and after therapy.5
Pretreatment DECT scans were obtained on hands and feet in 7 patients and on feet alone in 3 patients. Follow-up images of the same areas were taken posttherapy.5
Lowering of sUA level decreased the tophus volume5†
PATIENTS WITH INCOMPLETE sUA RESPONSE (n=5)
PATIENTS WITH COMPLETE sUA RESPONSE (n=5)
PATIENTS WITH COMPLETE sUA RESPONSE (n=5)
Green areas indicate tophi.
†This study examined the effects of intensive lowering of uric acid with KRYSTEXXA and the resolution of tophi in patients with uncontrolled gout. Patients had a mean disease duration range of 4.6 years. Patients received KRYSTEXXA 8 mg/dL every 2 weeks for a mean of 13 weeks (±10 weeks). Individual results may vary.5
2 of 5 patients who had to discontinue KRYSTEXXA due to mild infusion reactions had a 73% and 29% tophus volume reduction with as few as 2 infusions.5
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- Baraf HS, et al. Arthritis Res Ther. 2013;15(5):R137.
- KRYSTEXXA (pegloticase) [prescribing information] Horizon.
- Sundy JS, et al. JAMA. 2011;306(7):711-720.
- Data on file. Horizon, May 2017.
- Araujo EG, et al. RMD Open. 2015;1(1):e000075.