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Flare Rate Thresholds for Patient Assessment of Disease Activity States in Gout

Author

J Rheumatol. 2020 May 1;jrheum.191242. doi: 10.3899/jrheum.191242. Online ahead of print.

William Taylor 1, Nicola Dalbeth 1, Kenneth G Saag 1, Jasvinder A Singh 1, Elizabeth J Rahn 1, Amy S Mudano 1, Yi-Hsing Chen 1, Ching-Tsai Lin 1, Paul Tan 1, Worawit Louthreno 1, Janitzia Vazquez-Mellado 1, Hansel Hernández-Llinas 1, Tuhina Neogi 1, Ana B Vargas-Santos 1, Geraldo Castelar-Pinheiro 1, Rodrigo B Chaves-Amorim 1, Tillman Uhlig 1, Hilde B Hammer 1, Maxim Eliseev 1, Fernando Perez-Ruiz 1, Lorenzo Cavagna 1, Geraldine M McCarthy 1, Lisa K Stamp 1, Martijin Gerritsen 1, Viktoria Fana 1, Francisca Sivera 1, Angelo L Gaffo 1

Author Information

1 Funding for central study coordination and data analysis was provided by Ironwood Pharmaceuticals, which had had no role in the study design or in the collection, analysis, or interpretation of the data, the writing of the manuscript, or the decision to submit the manuscript for publication. Publication of this article was not contingent upon approval by Ironwood Pharmaceuticals. W. Taylor, MBChB, PhD, FRACP, FAFRM, University of Otago, Wellington, New Zealand; N. Dalbeth, MBChB, MD, FRACP, P. Tan, University of Auckland, Auckland, New Zealand; K.G. Saag, MD, MSc, E.J. Rahn, PhD, A.S. Mudano, MPH, University of Alabama at Birmingham, Birmingham, Alabama, USA; J.A. Singh, MD, MPH, A.L. Gaffo, MD, MSPH, University of Alabama at Birmingham, and Birmingham VA Medical Center, Birmingham, Alabama, USA; Y.H. Chen, MD, PhD, C.T. Lin, MD, Taichung Veterans General Hospital, Taichung, Taiwan; W. Louthreno, MD, Chiang Mai University, Chiang Mai, Thailand; J. Vazquez-Mellado, MD, PhD, H. Hernández-Llinas, MD, Hospital General de Mexico, Mexico City, Mexico; T. Neogi, MD, PhD, FRCPC, A.B. Vargas-Santos, MD, Boston University School of Medicine, Boston, Massachusetts, USA; G. Castelar-Pinheiro, MD, PhD, R.B. Chaves-Amorim, MD, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil; T. Uhlig, MD, H.B. Hammer, MD, PhD, Diakonhjemmet Hospital, Oslo, Norway; M. Eliseev, PhD, V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; F. Perez-Ruiz, MD, PhD, Servicio de Reumatologia, Baracaldo, Spain; L. Cavagna, MD, University and IRCCS Policlinico S. Matteo Foundation, Pavia, Italy; G.M. McCarthy, MD, FRCPI, Mater Misericordiae University Hospital, Dublin, Ireland; L.K. Stamp, MBChB, FRACP, PhD, University of Otago-Christchurch, Christchurch, New Zealand; M. Gerritsen, MD, PhD, Westfries Gasthuis, Hoorn, the Netherlands; V. Fana, MD, Copenhagen Center for Artritis Reserch, Righospitalet Glostrup, Denmark; 18F. Sivera, MD, PhD, Hospital General Universitario Elda, Elda, Spain. WT is a consultant for Pfizer, AstraZeneca, Abbvie, and Roche. ND receives grant/research support from AstraZeneca and Amgen; and is a consultant for Takeda, Pfizer, AstraZeneca, Horizon, and Kowa. KGS is a consultant for AstraZeneca, Horizon, Ironwood, SOBI, and Takeda. JAS has received consultant fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio Health, Medscape, WebMD, Clinical Care Options, Clearview Healthcare Partners, Putnam Associates, Spherix, Practice Point Communications, the National Institutes of Health, and the American College of Rheumatology (ACR); owns stock options in Amarin pharmaceuticals and Viking therapeutics; is on the speaker's bureau of Simply Speaking; is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 12 companies; serves on the FDA Arthritis Advisory Committee; is a member of the Veterans Affairs Rheumatology Field Advisory Committee; is the editor and the Director of the University of Alabama at Birmingham Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis; and previously served as a member of the following committees: member, the ACR Annual Meeting Planning Committee (AMPC) and Quality of Care Committees, the Chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee, and the cochair of the ACR Criteria and Response Criteria subcommittee. LKS receives speaker fees from Amgen. AG is a consultant for SOBI and receives grant/research support from Amgen. Address correspondence to Associate Professor A. Gaffo, Shelby Biomedical Research Building 306, University of Alabama at Birmingham, Birmingham, AL 35294, USA. Email: agaffo@uabmc.edu. Accepted for publication April 21, 2020.

Abstract

Objective: To determine the relationship between gout flare rate and self-categorization into remission, low disease activity (LDA), and patient acceptable symptom state (PASS).

Methods: Patients with gout self-categorized as remission, LDA, and PASS, and reported number of flares over the preceding 6 and 12 months. Multinomial logistic regression was used to determine the association between being in each disease state (LDA and PASS were combined) and flare count, and self-reported current flare. A distribution-based approach and extended Youden index identified possible flare count thresholds for each state.

Results: Investigators from 17 countries recruited 512 participants. Remission was associated with a median recalled flare count of zero over both 6 and 12 months. Each recalled flare reduced the likelihood of self-perceived remission compared with being in higher disease activity than LDA/PASS, by 52% for 6 months and 23% for 12 months, and the likelihood of self-perceived LDA/PASS by 15% and 5% for 6 and 12 months, respectively. A threshold of 0 flares in preceding 6 and 12 months was associated with correct classification of self-perceived remission in 58% and 56% of cases, respectively.

Conclusion: Flares are significantly associated with perceptions of disease activity in gout, and no flares over the prior 6 or 12 months is necessary for most people to self-categorize as being in remission. However, recalled flare counts alone do not correctly classify all patients into self-categorized disease activity states, suggesting that other factors may also contribute to self-perceived gout disease activity.