Background/Purpose:

The management of patients with gout remains suboptimal, leading to increasing frequency and severity of recurrent flares that eventually lead to joint destruction and deformity, with patients experiencing a severely compromised quality of life. Colchicine is considered the standard of care in the treatment and prophylaxis of patients with gout flares. The AGREE (Acute Gout Flare Receiving Colchicine Evaluation) trial established that low-dose (LD) colchicine is as effective as high-dose (HD) colchicine in achieving flare control, by reducing the median time to 50% joint pain reduction (HD colchicine 24.5 hrs; LD colchicine 24 hrs). Patients in both colchicine grps also achieved significant reductions (≥2 units) in mean pain scores relative to placebo (PBO) at 24 and 32 hrs after the initial dose. This post-hoc analysis from AGREE examined improvement in target joint pain scores at 16 hours after the initial dose versus PBO, time-to-response, and use of rescue medication.

Methods: 184 patients experiencing an acute gout flare (ACR criteria) were randomly assigned to HD colchicine (4.8 mg: 1.2 mg initially, then 0.6 mg q1hr x 6; n=52), LD colchicine (1.8 mg: 1.2 mg initially, then 0.6 mg at 1 hr; n=74), or PBO (n=58). Mean baseline pain scores were 6.8 for PBO and 6.9 for both HD and LD colchicine (0 to 10 Likert scale)After confirmation of gout flare, pain intensity scores, as well as adverse events (AEs), were recorded over the next 72 hrs. Rescue medications, such as NSAIDs, were permitted if intolerable pain continued after taking at least 1 dose of study drug. Uric acid–lowering therapy was not to be discontinued at the onset of flare.

Results:

At 16 hrs there was a significant treatment response in the LD colchicine grp (1.7 unit reduction from baseline in target joint pain score; P=0.0366) versus PBO. After 24 hours, reductions in target joint pain scores were consistently superior to PBO (mean 2.0 and 2.2 unit reductions in the HD and LD colchicine grps, respectively; 0.7 unit reduction for PBO). For time-to-response, the median time to 50% reduction from baseline in target joint pain score was 32 hrs for HD colchicine and 24.5 hrs for the LD colchicine grp. An insufficient number of patients in the PBO grp achieved this target. A significantly greater number of patients (P=0.0273) assigned to placebo used rescue medication through the 24 hour post-dose assessment compared to those received LD colchicine (50% and 31.1%, respectively). The time to the use of rescue medication was also earlier in the PBO grp (24 hrs) versus 36.5 hrs for LD colchicine). Rates of AEs were similar between LD and PBO grps, but greater than PBO in the HD grp.

Conclusion: This study establishes that LD colchicine provides significant pain relief as soon as 16 hr after dosing. By contrast, NSAIDs commonly prescribed for gout flares (Naprosyn, Indomethacin) have shown significant pain reduction by 48 hrs at the earliest. In addition, in this study, use of rescue medication was significantly lower in LD vs.PBO grps while the safety profile for LD colchicine was comparable to PBO. These results further support the use of low dose colchicine for treatment of acute gout flares.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/colchicine-as-assessed-by-target-joint-pain-scores-is-effective-at-16-hours-in-patients-with-acute-gout-flares/