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Gout Flare State Definitions Help Describe Disease Burden

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However, gout flare states of patient acceptable symptom state, low disease activity, or not achieving either were not associated with EQ-5D-3L or HAQ.

Most people with gout were able to achieve patient acceptable symptom state (PASS) or low disease activity (LDA) in the second 6 months after initiating allopurinol, and these disease state definitions aligned with gout flare burden on patients.1

“…the majority of studies of urate-lowering therapies (ULTs) have used serum urate as a “surrogate” measure for gout flares. However, the burden of gout flares is multifaceted and includes the number of flares as well as the severity of each individual flare. Defining the overall flare burden for people with gout has been challenging due to variable reporting and lack of a validated flares severity definition,” lead investigator Lisa K. Stamp, MBChB, PhD, University of Otago, Christchurch, and Health New Zealand, Te Whatu Ora Waitaha, New Zealand, and colleagues wrote.1

Stamp and colleagues aimed to determine the relationship between gout flare states (PASS or LDA, and not in LDA or PASS) and patient reported outcomes after initiating allopurinol. PASS and LDA were defined in a 2021 study as corresponding to 0 and 1 gout flare in the last 6 months, respectively.2 The current research is a post-hoc analyses of a previous 12-month randomized controlled trial that evaluated colchicine prophylaxis in patients with gout receiving escalating doses of allopurinol.3

There were 183 participants out of an original 200 enrolled that remained in the study at month 6 and 172 at month 12. They had a mean age of 56 (standard deviation [SD], 15.7) years and most were male (93%). Participants had a mean of 11.2 years (SD, 10.1) of gout duration and a median of 2 (IQR, 2-4) flares in the preceding 6 months.1

Over the 12-month period, 32 (17.9%) participants achieved PASS, 25 (14.0%) achieved LDA, and 122 (68.2%) did not achieve either. In the first 6 months, 61 (31.9%) participants achieved PASS, 37 (19.4%) achieved LDA, and 93 (48.7%) neither. In the final 6 months, 68 (38%) participants achieved PASS, 34 (19%) achieved LDA, and 77 (43%) neither. Investigators found no significant differences in the proportion of participants fulfilling each of the 3 states in either the first or last 6 months or over the entire 12-month period between randomized groups.1

Stamp and colleagues found no association between gout flare states and the EQ-5D-3L or Health Assessment Questionnaire. There was a statistically significant association between consequences, identity, and concern scores, 3 of 8 items on Brief Illness Perception Questionnaire, with a gradient of increasing scores across the 3 states of PASS, LDA, and non-LDA/PASS at both months 1-6 and 7-12. These findings were further supported by combining PASS/LDA status and comparing to non-LDA/PASS.1

“Herein we have shown that people with gout can achieve both gout flare LDA and PASS, but it is hard within the first year of urate lowering therapy, and 6 month (sic) of colchicine treatment does not lead to improvements in gout flare states in the 12 months after starting ULT. Importantly, the gout flare states PASS, LDA, and non-LDA/PASS were consistently associated with 3 BIPQ domains, increasing consequences, identity and concern scores validating the impact of these gout flare states on people with gout,” Stamp and colleagues wrote.1

The investigators noted limitations of the study, including some loss to follow-up and the short study design, stating that longer trials may be required to see the full effects of ULT on achieving PASS or LDA, as gout flares can increase soon after initiating ULT. They also noted that they did not ask participants if they considered their flare frequency aligned with the ascribed disease state.

“These data contribute to our understanding of the impact and burden of gout flares in people with gout highlighting their concern about this core clinical manifestation of the disease. In the long-term, excellent serum urate control is important. However, it is also essential healthcare professionals support people with gout to prevent and manage flares as a core part of gout management,” Stamp and colleagues concluded.1

REFERENCES
  1. Stamp LK, Frampton C, Stewart S, et al. Relationship between gout flare states and patient-reported outcomes following allopurinol initiation. Arthritis Care Res. Published online January 2, 2025. doi: 10.1002/acr.25494
  2. Taylor W, Dalbeth N, Saag KG, et al. Flare Rate Thresholds for Patient Assessment ofDisease Activity States in Gout. J Rheumatol. 2021;48(2):293-8.
  3. Stamp L, Horne A, Mihov B, et al. Is prophylaxis required with start-low go-slowallopurinol dose escalation in gout? A randomised non-inferiority double-blind placebo-controlled trial. Ann Rheum Dis. 2023;82(12):1626-34

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