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Abstract Number: 2054

Rapid Tophus Resolution in Chronic Refractory Gout Patients Treated with Pegloticase

Brian F. Mandell1, Herbert S. B. Baraf2, Anthony Yeo3 and Peter E. Lipsky4, 1Rheumatology, Cleveland Clinic, Cleveland, OH, 2The Center for Rheumatology and Bone Research, Wheaton, MD, 3Horizon Pharma, Lake Forest, IL, 4AMPEL BioSolutions, LLC, Charlottesville, VA

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: tophaceous gout and uric acid

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Session Information

Date: Tuesday, November 7, 2017

Title: Metabolic and Crystal Arthropathies Poster II

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

 

 

Background/Purpose: It has been suggested that the velocity of resolution of tophi in chronic tophaceous gout is related to serum uric acid (sUA) levels.1 However, few subjects with a persistent sUA <4.0 mg/dL have been studied. Pegloticase is a recombinant uricase conjugated to polyethylene glycol approved in the U.S. for chronic refractory gout that profoundly decreases sUA in responders to <1 mg/dL.2 The results from the pegloticase randomized clinical trials (RCTs) permitted determination of the impact of persistent, very low sUA levels on the velocity of tophus resolution.

Methods: This analysis used results from two RCTs of 6-months duration.2,3 Photographs were taken of hands, feet and up to 2 other locations. Serial standardized digital images of tophi were analyzed by a blinded reader using computer-assisted quantitative measurement software. Subjects were defined as responders and non-responders (NRs) based upon persistent sUA lowering.2

Results: A total of 952 tophi were analyzed in 87 subjects; 341 in 30 responders; 361 in 36 NRs receiving pegloticase infusions; and 250 in 21 subjects receiving placebo infusions. At baseline, the mean tophus areas were 644.7 ± 789.2 mm2 (mean ± SD) in responders, 820.0 ± 1349 mm2 in NRs, and 777.2 ± 1056.0 mm2 in placebo-treated subjects (3 group comparison, not significantly different). Achievement of tophus resolution in the three groups is summarized in Figure 1. By regression analysis, the velocity of tophus reduction over 6 months of treatment was 66.4 mm2/mo in responders (P<0.0001 comparing all visits). The mean time for complete resolution of tophi in responders was 9.7 mo (range 5.2 Ð 23.1 mo). By contrast, in NRs, the velocity of resolution was -74.9 mm2/mo from dose 1 to dose 7 (P<0.0001) and +23.5 mm2/mo from dose 7 to the final dose (P>0.05), reflecting the loss of urate lowing effect in the NRs during the latter 3 months. The sUA AUC during the 6 months of the RCT was calculated for all subjects. There was a significant negative correlation between the velocity of tophus resolution and sUA AUC (r= -0.31, P=0.0032) Figure 2. Baseline age, BMI, gender, race, total tophus area and tophus location did not significantly influence velocity of tophus resolution.

Conclusion: Pegloticase treatment causes a rapid resolution of tophi in responders. However, there is considerable heterogeneity in the velocity of tophus reduction.

  1. Perez-Ruiz F, et al. Arthritis Rheum. 2002;47:356.
  2. Sundy JS, et al. JAMA. 2011;306:711.
  3. Becker MA, et al. Ann Rheum Dis. 2013;72:146

 

 

 

 

 

 

 

 

 

 

 

 

Figure 1.        Tophus resolution in responders, NRs, and placebo-  treated subjects

 

Figure 2.        sUA vs velocity of tophus reduction in responders, NRs, and placebo subjects

 

 

 

 


Disclosure: B. F. Mandell, Horizon Pharma, 2,Horizon Pharma, 2,Horizon Pharma, 5,Horizon Pharma, 5; H. S. B. Baraf, Takeda, Horizon Pharma, 2,Takeda, Horizon Pharma, Ironwood, 5,Horizon Pharma, 8; A. Yeo, Horizon Pharma, 5; P. E. Lipsky, Horizon Pharma, 5.

To cite this abstract in AMA style:

Mandell BF, Baraf HSB, Yeo A, Lipsky PE. Rapid Tophus Resolution in Chronic Refractory Gout Patients Treated with Pegloticase [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/rapid-tophus-resolution-in-chronic-refractory-gout-patients-treated-with-pegloticase/. Accessed .
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