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FRI0589 The Impact of Gout Flares on Patient-Reported Assessments of Pain and Disability
  1. P. Khanna1,
  2. S. Baumgartner2,
  3. J. Robinson2,
  4. E. Tafesse3,
  5. R. Morlock2
  1. 1University of Michigan, Ann Arbor
  2. 2Ardea Biosciences, Inc., San Diego
  3. 3Astrazeneca, Wilmington, United States

Abstract

Background Lesinurad (RDEA594) is a selective uric acid reabsorption inhibitor (SURI) investigated for the treatment of gout in combination with xanthine oxidase inhibitors. In two Phase 3 clinical trials examining lesinurad in combination with allopurinol, patients with non-tophaceous gout demonstrated a reduction in gout flares over the 12-month study periods.

Objectives Investigate the relationship between gout flares and patient-reported assessments of pain and disability during the first 3 and last 3 months of two 1-year clinical trials assessing lesinurad in non-tophaceous gout patients with inadequate response to standard of care (NCT01510158 and NCT01493531).

Methods CLEAR 1 and CLEAR 2 were 12-month, randomized, double-blind, phase III trials to evaluate lesinurad (200 mg or 400 mg oral, daily) in combination with allopurinol (ALLO) vs ALLO + placebo. Gout flares were collected using an electronic patient diary and all flares reported in the diary were assessed. Patient-reported assessments of pain and disability included a Global Pain Scale and the HAQ-DI. A global measure of health utilty, the SF-6D, was derived from the SF-36v2. A pooled analysis of non-tophaceous patients in CLEAR 1 and CLEAR 2 assessed patient-reported measures for those with 0 flares, 1 flare, 2 flares and 3 or more flares, across treatment arms, during the first 3 months of the study (months 1 to 3) and during the final 3 months of the study (months 10 to 12), irrespective of treatment.

Results Patients in the CLEAR 1 and CLEAR 2 clinical trials (N=1062) were primarily male (94.8%), mean±SD age was 51.5±11.1 years and duration since gout diagnosis was 11.1±9.1 years. Most patients (87.8%) received ALLO 300 mg (range: 200–900 mg) daily. Irrespective of treatment, during the first 3 months of the study 41%, 22%, 15% and 22% patients reported 0, 1, 2 and 3 or more flares, respectively. During the final 3 months of the study 61%, 19%, 9% and 11% patients reported 0, 1, 2 and 3 or more flares, respectively. For both the HAQ-DI and Pain VAS, during the first 3 months and last 3 months of the study, the best (lowest) HAQ-DI and Pain VAS scores were reported in patients with 0 flares and the worst (highest) scores were reported in patients with 3 or more flares. The best (highest) SF-6D health utility scores, during the first 3 months and last 3 months of the study, were found in patients with no flares and the worst (lowest) scores were found in those with 3 or more flares.

Conclusions Non-tophaceous patients with the lowest number of flares, during the first and last 3 months of treatment, reported the most favorable HAQ-DI, pain and health utility measures. A majority of patients experiences zero flares during the final 3 months of the study period.

Acknowledgement Research sponsored by Ardea Biosciences/AstraZeneca. Editorial support was provided by PAREXEL and funded by AstraZeneca.

Disclosure of Interest P. Khanna Grant/research support from: AstraZeneca, S. Baumgartner Employee of: Ardea Biosciences, Inc., a member of the AstraZeneca Group, J. Robinson Employee of: Ardea Biosciences, Inc., a member of the AstraZeneca Group, E. Tafesse Employee of: AstraZeneca, R. Morlock Employee of: AstraZeneca

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