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Long-term safety of pegloticase in chronic gout refractory to conventional treatment.
Ann Rheum Dis 2013; 72(9):1469-74AR

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.

Authors+Show Affiliations

Rheumatology Section, The University of Chicago, Chicago, IL 60611-1713, USA. mbecker@medicine.bsd.uchicago.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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 -