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Evaluation of Proposed Criteria for Remission and Evidence-Based Development of Criteria for Complete Response in Patients With Chronic Refractory Gout.

ABSTRACT: Objective:The objective of this study is to assess criteria for gout remission and to use the results to inform criteria for a complete response (CR). Methods:A post hoc analysis of two clinical trials was undertaken to determine the frequency with which subjects with chronic refractory gout who were treated with pegloticase met remission criteria. Mixed modeling was then employed to identify the components that best correlated with time to maximum benefit. Results:Of the 56 subjects treated with biweekly pegloticase for whom adequate data were collected, 48.2% met the remission criteria. When subjects with persistent lowering of urate levels were examined separately, 27 of 32 (84.4%) met the criteria for remission. In contrast, even when the requirement for lowering of serum urate levels was waived, only 2 of 24 (8.3%) subjects without persistent lowering of urate levels and 0 of 43 subjects receiving placebo met criteria. Mixed modeling indicated that in addition to urate levels, assessment of tophi, swollen joints, and tender joints and patient global assessment best correlated with time to maximum benefit. Using these criteria of CR, 23 of the responders (71.9%) met the criteria. All patients who achieved a CR maintained it for a mean duration of 507.4 days. Finally, 64% of persistent responders to monthly pegloticase also met criteria for CR. Conclusion:These results have validated the proposed remission criteria for gout and have helped define criteria for CR in individuals with chronic gout treated with pegloticase. This composite CR index can serve as an evidence-based target to inform the design and end points of future clinical trials.

SUBMITTER: Schlesinger N

PROVIDER: S-EPMC6857961 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe conventional one-size-fits-all approach has been criticized for almost all drugs used especially for chronic diseases, including gout. The present study was aimed to explore the need of individualization and optimization of the dose of anti-gout medications among gout patients.MethodsCross-sectional study was carried out among 384 randomly selected new gout patients visiting two gout treatment centers at Lalitpur Metropolitan City, Nepal and who were taking antigout medications. Patients not taking anti-gout medications and not showing willingness to participate were excluded. The eGFR was calculated with the CKD Epidemiology Collaboration (CKD-EPI) creatinine equation (2009). Doses to be individualized were decided based on the Renal Drug Handbook and verified with the BNF 80. Data were analyzed via R 4.0.3 by applying the multinomial logistic regression to analyze statistical significance of risk with various predictors, and considering a p-value <0.05 statistically significant. Comorbidities were coded as per the ICD-11 coding and medicines were coded according to the WHO Guidelines for ATC classification and DDD assignment 2020.ResultsThe high risk of progression to CKD increased in the age range 54-63 and ≥84 years by 17.77 and 43.02 times, respectively. Also, high risk increased by 29.83 and 20.2 times for the overweight and the obese respectively. Aceclofenac 100mg was prescribed for maximum patients (30.5%). Need of dose individualization was realized in 30 patients, with maximum (7) in case of etoricoxib 90mg. Various glucocorticoids were prescribed for 36.9% patients, out of whom 3.8%required dose individualization and 15.9% patients with xanthine oxidase inhibitors, out of whom 1.3% required dose individualization.ConclusionThirty cases required dose individualization, which was although minimal but could have meaningful impact on the clinical success of the individual patient. Based on the recommendation on dose individualization, those patients could be optimized on their therapy on future follow ups.

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Evaluation of Proposed Criteria for Remission and Evidence-Based Development of Criteria for Complete Response in Patients With Chronic Refractory Gout.

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