Conclusion
In summary, the GMIM criteria effectively capture a change in disease severity in chronic refractory gout patients treated with pegloticase. It may serve as an evidence-based tool for assessment of therapies used to treat patients with similar baseline disease severity.
Abbreviations
GAS: Gout Activity Score; GIS: Gout Impact Scale; GMIM: Gout Multivariable Improvement Measure; HAQ: Health Assessment Questionnaire; KING: Kick-off of the Italian Network for Gout; OLE: Open-label extension; OMERACT: Outcome Measures in Rheumatology; PGA: Patient global assessment; RCT: Randomized controlled trial; SJC: Swollen joint count; sU: Serum urate; TJC: Tender joint count; ULT: Urate-lowering therapy; VAS: Visual analog scale
Acknowledgements
Not applicable.
Funding
This analysis was supported by Horizon Therapeutics, which did not influence the analysis or the conclusions reported in this communication.
Availability of data and materials
The data and analytic methods that support the findings of this study are available to qualified investigators by request to the corresponding author.
Ethics approval and consent to participate
The design of the two identical RCTs of pegloticase and their OLE that provided the data analyzed in this study (Clinicaltrials.gov identifiers: NCT00325195, NCT01356498) received institutional review board approval for each site, and written informed consent and Health Insurance Portability and Accountability Act assurances were completed for each participant prior to enrollment.
Consent for publication
Not applicable.
Arthritis Res Ther. 2020;22(164) © 2020 BioMed Central, Ltd.
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