Crystal Arthropathies

Gout Flare Variation Hinders Reporting in Clinical Trials

Avatar photoHannah Dellabella
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Patients are often unaware of their increased CV risk related to RA. One study found 95% of patients with RA stratified as having a high risk of CVD underestimated their risk.17 Data show patients with RA are less likely to report angina symptoms, which increases their chances of an unrecognized MI or sudden cardiac death and decreases their likelihood of getting a needed coronary artery bypass graft.18 Some studies have shown interventions to educate RA patients about their risk of CVD have the potential to increase screening for CV risk by PCPs and treatment.19,20 Results from other studies have been less positive. One trial found although educational interventions improved patients’ understanding of their CV risk and prompted intentions to make lifestyle changes, patients did not carry through with their stated intentions.21 Nevertheless, patients should be made aware of all important aspects of their disease.
Patients are often unaware of their increased CV risk related to RA. One study found 95% of patients with RA stratified as having a high risk of CVD underestimated their risk.17 Data show patients with RA are less likely to report angina symptoms, which increases their chances of an unrecognized MI or sudden cardiac death and decreases their likelihood of getting a needed coronary artery bypass graft.18 Some studies have shown interventions to educate RA patients about their risk of CVD have the potential to increase screening for CV risk by PCPs and treatment.19,20 Results from other studies have been less positive. One trial found although educational interventions improved patients’ understanding of their CV risk and prompted intentions to make lifestyle changes, patients did not carry through with their stated intentions.21 Nevertheless, patients should be made aware of all important aspects of their disease.
The study describes the variations of gout flares and assesses the different methods of gout flare reporting in clinical trials.

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.

References

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.

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