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Gout treatment with pegloticase was well tolerated in a dialysis-dependent population, researchers found in a small study.

In an analysis of 42 patients with uncontrolled gout currently undergoing routine outpatient dialysis, most received on-label pegloticase (Krystexxa) consisting of biweekly infusions, with a median of three infusions, reported Anthony Bleyer, MD, of Wake Forest School of Medicine in Winston-Salem, North Carolina, and colleagues.

In total, nine patients (21%) received 12 or more pegloticase infusions, and the median interval between doses was 14 days (average of 19.5 days).

The findings were presented as a poster at the virtual National Kidney Foundation Spring Clinical Meeting.

"To date, we have limited literature around the use of pegloticase in chronic kidney disease patients receiving dialysis, though we know that people with chronic kidney disease are more likely to develop gout," Bleyer explained to 乌鸦传媒.

"Some of the medications that we commonly use to treat gout are either not well studied or are associated with side effects in dialysis patients, so we wanted to better understand if treatment with pegloticase could benefit this patient population, given the significant burden uncontrolled gout can place on a person's health and quality of life," he added.

The therapy appears to be well tolerated, given the fact that almost a quarter of patients received at least 12 infusions while on dialysis, he noted.

"While the real-world evidence is promising, these findings were not particularly surprising, as emerging research has shown the potential around the use of pegloticase in other patients with kidney-related issues," he said.

Acting as a pegylated recombinant uricase enzyme, pegloticase first gained FDA approval in September 2010 for the treatment of gout in adults who are refractory to standard treatments. However, of note, dialysis-dependent patients were excluded from phase III trials.

For the analysis, the researchers looked to the U.S. Renal Data System (USRDS), which houses data on Medicare patients who have undergone either kidney transplantation or have initiated dialysis. They identified patient claims from 2012-2017 with a diagnostic code for end-stage renal disease (ESRD) who were prescribed pegloticase.

The 42 patients included in the analysis had been undergoing routine outpatient dialysis both before and after being prescribed pegloticase. Most were receiving hemodialysis (76%), while others were undergoing either continuous ambulatory peritoneal dialysis (4.8%) or continuous cycling peritoneal dialysis (19%).

At an average age of 54, about 76% of the patients were men and more than half were white.

Diabetes was the most common cause of ESRD (38.1%), followed by hypertension (26.2%) and glomerulonephritis (16.7%). The most common comorbidities among these patients at the start of dialysis were diabetes (45.2%), hypertension (81.0%), and congestive heart failure (23.8%).

The average duration of dialysis in this group was about 32 months; three patients (7%) underwent a kidney transplant prior to pegloticase initiation and four (10%) had a kidney transplant after initiation.

In total, the 42 patients received 401 pegloticase infusions, which were more often given at outpatient hospital visits (58%), with the rest during office-based labs (42%).

Almost all patients were taking erythropoiesis-stimulating agents (ESAs) before and after pegloticase treatment. However, there was a significant drop in average monthly ESA dose after pegloticase treatments seen among this group, with a mean dose reduction of 14,574 units per patient (95% CI 358-28,779, P=0.047).

"This unexpected and interesting finding merits further targeted investigation," Bleyer and co-authors noted.

On the other hand, average hemoglobin levels before and after pegloticase use remained stable for these patients (10.9 ± 1.3 g/dL vs 10.4 ± 1.6 g/dL).

"Ultimately, gout is a treatable condition," Bleyer told 乌鸦传媒. "With that said, the long-term effects of gout can have serious implications for dialysis patients and should be treated with the urgency it requires."

"Our findings illustrate that pegloticase has the potential to be an effective treatment for severe gout that has been refractory to treatment or left untreated for many years, even in dialysis patients," he said.

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