New data from Savient's KRYSTEXXA Phase III trial on refractory chronic gout

Nov 7 2011

Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced that data providing further clarity and context surrounding the risk for and management of infusion reactions that may occur with KRYSTEXXA® (pegloticase) in the treatment of refractory chronic gout (RCG) patients will be presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in Chicago.  Additionally, the results from several Savient-sponsored studies highlighting the health-related quality of life and economic impact of inadequately-controlled gout and RCG will also be presented at the meeting.

A post-hoc analysis of data from the pivotal Phase III KRYSTEXXA clinical trials and an open-label extension study further characterized the signs and symptoms of infusion reactions and anaphylaxis and their management in the context of the clinical studies. While all patients studied were pre-medicated to decrease the potential risk of these events, the data also confirmed that risk of infusion reactions and anaphylaxis could be mitigated by the monitoring of serum uric acid (SUA) prior to each infusion and discontinuing of KRYSTEXXA treatment when SUA rises to above 6 mg/dL.

"These data contribute to the growing body of evidence supporting the profile and clinical utility of KRYSTEXXA," said John H. Johnson, Chief Executive Officer and President of Savient Pharmaceuticals. "Savient remains focused on educating healthcare professionals about KRYSTEXXA and its role in helping patients who have not found success with available conventional therapies to gain control of their RCG."

Data from health-related quality-of-life studies provided further insights surrounding the management of gout and RCG, and the relationship between symptom severity and patients' work productivity, healthcare resource utilization and medical costs:

• A retrospective examination of real-world practice habits indicated that there is a disconnect between EU gout treatment guidelines and current practice patterns among rheumatologists and primary care physicians in the United States (U.S.). The analysis found that with the availability of oral conventional urate-lowering therapies (ULTs), 64 percent of rheumatologists' patients and 70 percent of primary care physicians' patients had uric acid levels greater than 6 mg/dL; an indicator that their gout was not adequately controlled. In addition, 37.5 percent of patients in rheumatology practices and 14.2 percent of patients in primary care practices had tophi. These data suggest that patients under the care of rheumatologists had higher disease burden than those under the care of primary care physicians.
• Results from a survey of 620 gout patients in the U.S. and select EU countries, including France, Germany, Italy, Spain and the United Kingdom, showed that patients with higher uric acid levels also reported the presence of tophi and experienced an increased number of gout flares.  Patients with tophi endured a greater disease burden compared to those without the deposits, including: greater overall work productivity loss (40.2 percent vs. 21.2 percent), activity impairment (48.7 percent vs. 37.2 percent), and more physician visits (9.0 vs. 6.5) (p<0.05 for all). Further, gout flares also impacted patients' mental and physical well-being. Patients reported a greater deterioration in their quality of life in correlation with the number of gout flares they experienced, as well as work- and social-related impairment.
• Information from a U.S. database analysis of 24,503 gout patients underscored the link between gout symptom severity and the physical and economic cost to the patient.  According to the analysis, patients with tophi who experienced greater than or equal to 3 gout flares during the study had significantly more physician office visits, laboratory services, and ancillary services than patients in the control group without tophi or gout flares (p<0.001). A comparison of patient records revealed that total 12-month costs averaged $21,059 among patients with tophi and greater than or equal to 3 gout flares compared to $10,657 for patients in the control group (p<0.001). In addition, patients with tophi and greater than or equal to 6 gout flares had even higher resource utilization and overall healthcare costs totaling $32,178 compared to the control group (p<0.01).

"The gout epidemiology data presented at the ACR meeting underscore the importance of initiating early treatment with the appropriate medication to minimize the mental, physical and economic impact of gout and refractory chronic gout," commented Herbert S. B. Baraf, M.D., Clinical Professor of Medicine at The George Washington University School of Medicine and an investigator who conducted clinical trials with KRYSTEXXA. "Recently published data demonstrated that treatment with KRYSTEXXA resulted in significant and sustained reductions in uric acid levels and clinical improvements in RCG patients. The data from the post-hoc analysis of the KRYSTEXXA pivotal and extension studies will add to physicians' knowledge of the treatment and provide them with a straightforward approach for managing the risk of potential infusion reactions."