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Long-term safety of pegloticase in chronic gout refractory to conventional treatment.

Abstract

OBJECTIVE

To evaluate the long-term safety (up to 3 years) of treatment with pegloticase in patients with refractory chronic gout.

METHODS

This open-label extension (OLE) study was conducted at 46 sites in the USA, Canada and Mexico. Patients completing either of two replicate randomised placebo-controlled 6-month trials received pegloticase 8 mg every 2 weeks (biweekly) or every 4 weeks (monthly). Safety was evaluated as the primary outcome, with special interest in gout flares and infusion-related reactions (IRs). Secondary outcomes included urate-lowering and clinical efficacy.

RESULTS

Patients (n=149) received a mean±SD of 28±18 pegloticase infusions and were followed for a mean of 25±11 months. Gout flares and IRs were the most frequently reported adverse events; these were least common in patients with a sustained urate-lowering response to treatment and those receiving biweekly treatment. In 10 of the 11 patients with a serious IR, the event occurred when uric acid exceeded 6 mg/dl. Plasma and serum uric acid levels remained <6 mg/dl in most randomised controlled trial (RCT)-defined pegloticase responders throughout the OLE study and were accompanied by sustained and progressive improvements in tophus resolution and flare incidence.

CONCLUSIONS

The safety profile of long-term pegloticase treatment was consistent with that observed during 6 months of RCT treatment; no new safety signals were identified. Improvements in clinical status, in the form of flare and tophus reduction initiated during RCT pegloticase treatment in patients maintaining goal range urate-lowering responses were sustained or advanced during up to 2.5 years of additional treatment.

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  • Authors+Show Affiliations

    ,

    Rheumatology Section, The University of Chicago, Chicago, IL 60611-1713, USA. mbecker@medicine.bsd.uchicago.edu

    , , , , , ,

    Source

    Annals of the rheumatic diseases 72:9 2013 Sep 01 pg 1469-74

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Chronic Disease
    Drug Resistance
    Enzymes, Immobilized
    Female
    Gout
    Gout Suppressants
    Humans
    Male
    Middle Aged
    North America
    Polyethylene Glycols
    Recurrence
    Treatment Outcome
    Urate Oxidase
    Uric Acid

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    23144450

    Citation

    Becker, Michael A., et al. "Long-term Safety of Pegloticase in Chronic Gout Refractory to Conventional Treatment." Annals of the Rheumatic Diseases, vol. 72, no. 9, 2013, pp. 1469-74.
    Becker MA, Baraf HS, Yood RA, et al. Long-term safety of pegloticase in chronic gout refractory to conventional treatment. Ann Rheum Dis. 2013;72(9):1469-74.
    Becker, M. A., Baraf, H. S., Yood, R. A., Dillon, A., Vázquez-Mellado, J., Ottery, F. D., ... Sundy, J. S. (2013). Long-term safety of pegloticase in chronic gout refractory to conventional treatment. Annals of the Rheumatic Diseases, 72(9), pp. 1469-74. doi:10.1136/annrheumdis-2012-201795.
    Becker MA, et al. Long-term Safety of Pegloticase in Chronic Gout Refractory to Conventional Treatment. Ann Rheum Dis. 2013 Sep 1;72(9):1469-74. PubMed PMID: 23144450.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Long-term safety of pegloticase in chronic gout refractory to conventional treatment. AU - Becker,Michael A, AU - Baraf,Herbert S B, AU - Yood,Robert A, AU - Dillon,Aileen, AU - Vázquez-Mellado,Janitzia, AU - Ottery,Faith D, AU - Khanna,Dinesh, AU - Sundy,John S, Y1 - 2012/11/10/ PY - 2012/11/13/entrez PY - 2012/11/13/pubmed PY - 2013/10/18/medline KW - Gout KW - Rheumatoid Arthritis KW - Treatment SP - 1469 EP - 74 JF - Annals of the rheumatic diseases JO - Ann. Rheum. Dis. VL - 72 IS - 9 N2 - OBJECTIVE: To evaluate the long-term safety (up to 3 years) of treatment with pegloticase in patients with refractory chronic gout. METHODS: This open-label extension (OLE) study was conducted at 46 sites in the USA, Canada and Mexico. Patients completing either of two replicate randomised placebo-controlled 6-month trials received pegloticase 8 mg every 2 weeks (biweekly) or every 4 weeks (monthly). Safety was evaluated as the primary outcome, with special interest in gout flares and infusion-related reactions (IRs). Secondary outcomes included urate-lowering and clinical efficacy. RESULTS: Patients (n=149) received a mean±SD of 28±18 pegloticase infusions and were followed for a mean of 25±11 months. Gout flares and IRs were the most frequently reported adverse events; these were least common in patients with a sustained urate-lowering response to treatment and those receiving biweekly treatment. In 10 of the 11 patients with a serious IR, the event occurred when uric acid exceeded 6 mg/dl. Plasma and serum uric acid levels remained <6 mg/dl in most randomised controlled trial (RCT)-defined pegloticase responders throughout the OLE study and were accompanied by sustained and progressive improvements in tophus resolution and flare incidence. CONCLUSIONS: The safety profile of long-term pegloticase treatment was consistent with that observed during 6 months of RCT treatment; no new safety signals were identified. Improvements in clinical status, in the form of flare and tophus reduction initiated during RCT pegloticase treatment in patients maintaining goal range urate-lowering responses were sustained or advanced during up to 2.5 years of additional treatment. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/23144450/full_citation L2 - http://ard.bmj.com/cgi/pmidlookup?view=long&amp;pmid=23144450 DB - PRIME DP - Unbound Medicine ER -