Pegloticase for chronic gout

Anderson, Alan Ross; Singh, Jasvinder A

doi:10.1002/14651858.cd008335.pub2

Cited by 18 publications

(7 citation statements)

References 40 publications

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“…Pegloticase is a more recently approved pegylated mammalian recombinant uricase produced by a genetically modified strain of Escherichia coli that is approved in the United States for treatment of chronic treatment-resistant gout (79). It is not approved for treatment of TLS, and its use in this setting has not been reported.…”

Section: Recombinant Urate Oxidasementioning

confidence: 99%

Onco-Nephrology

Wilson

Berns

2012

Clinical Journal of the American Society of Nephrology

122

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SummaryTumor lysis syndrome (TLS) describes the clinical and laboratory sequelae that result from the rapid release of intracellular contents of dying cancer cells. It is characterized by the release of potassium, phosphorous, and nucleic acids from cancer cells into the blood stream, with the potential to cause hyperkalemia; hyperphosphatemia and secondary hypocalcemia; hyperuricemia; AKI; and, should usual homeostatic mechanisms fail, death. TLS most commonly follows treatment of hematologic malignancies, such as acute lymphocytic or lymphoblastic leukemia, acute myeloid leukemia, and Burkitt lymphoma, but also occurs after treatment of other bulky or rapidly growing tumors, particularly if the patient is highly sensitive to the effects of cytotoxic chemotherapy. Prevention and treatment depend on prompt recognition of patients at risk, volume repletion, allopurinol, rasburicase (a novel recombinant urate oxidase), and, when indicated, dialysis.

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Section: Recombinant Urate Oxidasementioning

confidence: 99%

Onco-Nephrology

Wilson

Berns

2012

Clinical Journal of the American Society of Nephrology

122

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“…In a Phase II clinical trial of 12 weeks (n = 41), patients were divided into four cohorts and received pegloticase during the 12 weeks at a dosage of 4 or 8 mg for every 2 weeks or 8 or 12 mg for every 4 weeks 45–47. These data demonstrate that patients treated with 8 mg of pegloticase for every 2 or 4 weeks had a lytic, ie, very rapid and sustained reduction in plasma uric acid; 4 mg for every 2 weeks was not as effective, and 12 mg for every 4 weeks did not provide additional benefit compared with 8 mg for every 4 weeks.…”

Section: Pegloticase In Clinical Trialsmentioning

confidence: 99%

New advances in the treatment of gout: review of pegloticase

Reinders

Jansen²

2010

TCRM

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Treatment-failure gout (TFG) affects approximately 50,000 patients or about 1% of the overall population of patients with gout in the United States of America. The severity of TFG is manifested by frequent acute attacks of disabling arthritis, chronic deforming joint disease, destructive masses of urate crystals (tophi), progressive physical disability, and poor health-related quality of life. Pegloticase (Krystexxa®; Savient Pharmaceuticals, Inc), a novel PEGylated urate oxidase (uricase) enzyme, has been resubmitted for US Food and Drug Administration approval. In a 6-month, placebo-controlled clinical trial, 8 mg of pegloticase for every 2 weeks induced a lytic decrease of serum urate (sUr) concentrations, leading to dissolution of tophi in 40% of patients at final visit. However, 58% were nonresponders to the defined target sUr of 0.36 mmol/L (80% were nonresponders during months 3 and 6), possibly due to anti-body formation. Also, 26%–31% experienced infusion reactions (IRs) and 77% suffered from gout flares. Although long-term data are awaited, an anti-inflammatory strategy, eg, based on glucocorticosteroids, is needed to prevent pegloticase antibody formation leading to IRs and diminished or shortened efficacy, and might also prevent gout flares. According to the current clinical data, pegloticase might have an important role as a (bridging) treatment in sUr-responsive patients for tophi clearance in severe chronic refractory gout.

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“…The most common underlying diagnosis in patients undergoing elective THA is osteoarthritis (OA), followed by osteonecrosis, congenital hip disorders, and inflammatory arthritis [2]. A systematic review of 67 studies with 2,593 patients with 3,277 hips concluded that osteonecrosis was not associated with higher revision rates after THA compared to the other underlying diagnoses [3], with minor exceptions.…”

Section: Introductionmentioning

confidence: 99%

An underlying diagnosis of osteonecrosis of bone is associated with worse outcomes than osteoarthritis after total hip arthroplasty

Singh

Chen

Inacio

et al. 2017

BMC Musculoskelet Disord

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BackgroundWell-designed studies of complications and readmission rates in patients undergoing total hip arthroplasty (THA) with osteonecrosis are lacking. Our objective was to examine if a diagnosis of osteonecrosis was associated with complications, mortality and readmission rates after THA.MethodsWe analyzed prospectively collected data from an integrated healthcare system’s Total Joint Replacement Registry of adults with osteonecrosis vs. osteoarthritis (OA) undergoing unilateral primary THA during 2001–2012, in an observational cohort study. We examined mortality (90-day), revision (ever), deep (1 year) and superficial (30-day) surgical site infection (SSI), venous thromboembolism (VTE, 90-day), and unplanned readmission (90-day). Age, gender, race, body mass index, American Society of Anesthesiologists class, and diabetes were evaluated as confounders. We used logistic or Cox regression to calculate odds or hazard ratios (OR, HR) with 95% confidence intervals (CI).ResultsOf the 47,523 primary THA cases, 45,252 (95.2%) had OA, and 2,271 (4.8%) had osteonecrosis. Compared to the OA, patients with osteonecrosis were younger (median age 55 vs. 67 years), and were less likely to be female (42.5% vs. 58.3%) or White (59.8% vs. 77.4%). Compared to the OA, the osteonecrosis cohort had higher crude incidence of 90-day mortality (0.7% vs. 0.3%), SSI (1.2% vs. 0.8%), unplanned readmission (9.6% vs. 5.2%) and revision (3.1% vs. 2.4%). After multivariable-adjustment, patients with osteonecrosis had a higher odds/hazard of mortality (OR: 2.48; 95% CI:1.31–4.72), SSI (OR: 1.67, 95%CI:1.11–2.51), unplanned 90-day readmissions (OR: 2.20; 95% CI:1.67–2.91) and a trend towards higher revision rate 1-year post-THA (HR: 1.32; 95% CI: 0.94–1.84), than OA patients.ConclusionsCompared to OA, a diagnosis of osteonecrosis was associated with worse outcomes post-THA. A detailed preoperative discussion including the risk of complications is needed for informed consent from patients with osteonecrosis.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-1385-0) contains supplementary material, which is available to authorized users.

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Pegloticase for chronic gout

Abstract: Trusted evidence. Informed decisions. Better health.

Cited by 18 publications

References 40 publications

Onco-Nephrology

Onco-Nephrology

New advances in the treatment of gout: review of pegloticase

An underlying diagnosis of osteonecrosis of bone is associated with worse outcomes than osteoarthritis after total hip arthroplasty

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