Among patients with gout, the wide variation of flare patterns presents a challenge for reporting flares in clinical trials, according to study results published in BMC Rheumatology.1

Results also indicated that time-dependent reporting strategies correlated strongly with other measures of gout disease severity, and thus, may be a more accurate way of measuring flare burden.

The study included 120 patients with gout from a randomized controlled trial (Clinical trial registration number: ACTRN12609000479202). Researchers examined daily flare diary entries, including self-reports of flare and pain scale. They analyzed detailed pain-by-time plots for different methods of flare reporting for both self-reports and the classification tree (CART)-defined flares, which was described by Gaffo et al in 2012.2 The concurrent validity for different methods of flare reporting was then determined.

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Results of the study indicated that single gout flares had a “typical” average pattern: time to maximal pain <24 hours, resolution ≤14 days, and complete resolution between symptomatic episodes. However, individual pain-by-time plots of patients showed wide variation in pain intensity, duration, and frequency of flares. Over the 4-month study period, 84% (n=101) of patients experienced at least 1 self-reported “typical” flare, and 70% (n=84) experienced at least 1 self-reported flare that was not “typical.” In addition, 66% (n=79) of patients experienced at least 1 Gaffo CART-defined “typical” flare, and 45% (n=54) experienced at least 1 Gaffo CART-defined flare that was not “typical.”

Researchers found that the time to first self-reported flare had a poor correlation with other measures of gout activity and methods of flare reporting. They found that the number of days with flare (either self-reported or Gaffo-defined) and the area under the pain-by-time curve had the strongest correlation with other measures of severity of disease, and indicated a more accurate assessment of flare burden.

Study limitations included not being able to determine whether continuous reports of flares represented a prolonged flare or several new flares because flare sites were not recorded, and the possibility that some gout flares were not captured because measures of disease activity were evaluated on a monthly basis.

“Reporting the occurrence of a flare during a specified time period may not adequately represent the overall impact of flare [because of] variation in duration, pain level, and intensity of inflammation,” the researchers wrote.

Disclosure: The original clinical trial was supported by LactoPharma. Please see the original reference for a full list of authors’ disclosures.


1. Teoh N, Gamble GD, Horne A, Taylor WJ, Palmano K, Dalbeth, N.The challenges of gout flare reporting: mapping flares during a randomized controlled trial [published online July 9, 2019]. BMC Rheumatol. doi:10.1186/s41927-019-0075-6

2. Gaffo AL, Schumacher HR, Saag KG, et al. Developing a provisional definition of flare in patients with established gout. Arthritis Rheum. 2012;64(5):1508-1517.

This article originally appeared on Rheumatology Advisor