Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Use of Pegloticase in Chronic Gout Refractory to Conventional Therapy Is Associated with Significant Clinical Benefit: Tender Joint and Swollen Joint Counts and Patient Global Assessment (Health Assessment Questionnaire).
Mandel3, David R., Baraf1, Herbert, Rehrig5, Claudia, Horowitz6, Zebulun D., Ottery4, Faith D., Yood2, Robert A.
Arthritis & Rheumatism Association, Wheaton, MD
Fallon Clinic, Worcester, MA
Private Practive, Mayfield Village, OH
Savient Pharmaceuticals, Inc
Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc., Baskingridge, NJ
To assess the therapy response of pegloticase for a spectrum of non-flare, non-tophus, gout-related rheumatologic variables in patients (pts) with treatment refractory chronic gout (TRCG) in 2 replicate Phase 3, randomized, double-blind, placebo-controlled trials (RCTs).
TRCG was defined as: >=3 flares in the previous 18 months, or >=1 tophus, or gouty arthropathy; serum urate >8.0 mg/dL; and prior failure of maximum medically appropriate dose of allopurinol or contraindication to allopurinol. 212 pts were treated with IV pegloticase or placebo (PBO) in the Phase 3 RCTs. Pts were randomized to PGL 8 mg q2wk (n=85), 8 mg q4wk (n=84), or PBO (n=43) and were infused every 2 weeks for 6 months in a blinded fashion. Primary response endpoint was plasma uric acid (PUA) <6.0 mg/dL 80% of the time in months 3 and 6. Data were pooled for secondary endpoints: reduction of tophus size, gout flare incidence, swollen joints (SJ), tender joints (TJ), pt-reported outcomes by SF-36 and Health Assessment Questionnaire (HAQ). Change from baseline for each secondary rheumatologic variable was compared by regimen and PUA responder status.
Baseline characteristics: 82% male; mean age 55 yrs; high degree of comorbidity: hypertension (71%), chronic kidney disease (43%), cardiovascular disease (31%), and diabetes (22%). As previously reported at ACR 2008, both pegloticase groups were significantly superior to PBO for the primary efficacy endpoint in both studies. Tender joint or swollen joint counts (Table 1) and HAQ-Patient Global Assessment (Table 2), assessed for change from baseline to last visit (last observation carried forward) or week 25, were significant for pooled PGL vs PBO (<=0.001). Changes within each pegloticase group were consistently better in PUA responders® vs non-responders (NR).
Table 1. Tender Joint and Swollen Joint Counts
Table 2. HAQ Patient Global Assessment
Successful pegloticase therapy in patients with chronic gout refractory to conventional urate-lowering therapy (defined as UA < 6 mg/dL 80% of the time in months 3 and 6 during replicate Phase 3 trials), is associated with improvement in tender joint and swollen joint counts and Patient Global Assessment.
To cite this abstract, please use the following information:
Mandel, David R., Baraf, Herbert, Rehrig, Claudia, Horowitz, Zebulun D., Ottery, Faith D., Yood, Robert A.; Use of Pegloticase in Chronic Gout Refractory to Conventional Therapy Is Associated with Significant Clinical Benefit: Tender Joint and Swollen Joint Counts and Patient Global Assessment (Health Assessment Questionnaire). [abstract]. Arthritis Rheum 2010;62 Suppl 10 :166