Pegloticase: in treatment-refractory chronic gout.
Summary of "Pegloticase: in treatment-refractory chronic gout."
Intravenous pegloticase offers a novel approach to treating chronic gout refractory to conventional therapy. Pegloticase is a recombinant polyethylene glycol-conjugated form of uricase (a uric acid-specific enzyme lacking in humans) that catalyses the oxidation of uric acid to allantoin. In randomized, placebo-controlled, double-blind, 6-month, phase III trials, intravenous pegloticase 8 mg every 2 or 4 weeks provided sustained reductions in plasma uric acid levels to less than the therapeutic target of 6 mg/dL in a substantial proportion of patients with chronic gout who were refractory to, or intolerant of, conventional urate-lowering therapy. Pegloticase 8 mg every 2 weeks was associated with disease-modifying benefits relative to placebo, as shown by significant improvements from baseline in tophi resolution, frequency of gout flares and tender joint count, and clinically relevant and statistically significant improvements from baseline in health-related quality-of-life parameters related to disability, pain and physical function. Pegloticase 8 mg every 4 weeks was also significantly more effective than placebo with regard to most, but not all, of these endpoints. Preliminary data from an open-label extension of the phase III trials indicate that long-term treatment with pegloticase 8 mg every 2 or 4 weeks may maintain plasma uric acid normalization in patients who experienced a sustained uric acid response during the phase III trials. The most common serious adverse events associated with pegloticase are gout flares, infusion reactions and anaphylaxis. In addition, exacerbation of pre-existing congestive heart failure was reported in 2% of patients receiving pegloticase 8 mg every 2 weeks in the phase III trials.
Adis, a Wolters Kluwer Business, Auckland, New Zealand.
This article was published in the following journal.
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22035516
- DOI: http://dx.doi.org/10.2165/11202830-000000000-00000
Medical and Biotech [MESH] Definitions
Anemia, Refractory, With Excess Of Blasts
Chronic refractory anemia with granulocytopenia, and/or thrombocytopenia. Myeloblasts and progranulocytes constitute 5 to 40 percent of the nucleated marrow cells.
Leukemia, Myeloid, Accelerated Phase
The phase of chronic myeloid leukemia following the chronic phase (LEUKEMIA, MYELOID, CHRONIC-PHASE), where there are increased systemic symptoms, worsening cytopenias, and refractory LEUKOCYTOSIS.
A severe sometimes chronic anemia, usually macrocytic in type, that does not respond to ordinary antianemic therapy.
Uricosuric that acts by increasing uric acid clearance. It is used in the treatment of gout.
An anti-inflammatory agent used in the treatment of rheumatoid arthritis. It also has uricosuric properties and has been used to treat gout.
A high plasma urate concentration (PUA), related to loss of urate oxidase in evolution, is postulated to protect humans from oxidative injury. This hypothesis has broad clinical relevance, but support...
The approval of febuxostat, a non-purine-analogue inhibitor of xanthine oxidase, by the European Medicines Agency and the US Food and Drug Administration heralds a new era in the treatment of gout. Th...
Gout is an ancient disease. Despite significant advances in the understanding of its risk factors, etiology, pathogenesis, prevention, and treatment, millions of people with gout experience repeated a...
Around 1.4% of the UK population have gout, the prevalence of which increases with age to around 3% in women and 7% in men aged over 75 years.1-3 Acute gout is intensely painful and can reduce patient...
The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i....
The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in pati...
The purpose of this study is to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent f...
This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment....
This is a questionnaire study aimed at learning about physicians' views on the treatment of Gout.