Undergoing 5 days of therapy with the IL-1 receptor antagonist anakinra can serve as an effective treatment option for acute gout flares, as anakinra’s efficacy was shown to be noninferior to 5 days of usual treatment, according to a study published in Rheumatology.
Researchers of this randomized, placebo-controlled, double-blind, active comparator, noninferiority trial assessed the safety and efficacy of IL-1 receptor antagonist anakinra for the treatment of acute gout flares. Participants with a crystal-proven acute gout flare (n=88; >90% men) were randomly assigned to receive an anakinra injection plus placebo pill (n=43) or treatment as usual plus placebo injection (free choice of naproxen, prednisone, or colchicine; n=45). The placebo pills were identical to the pills in the treatment as usual group (and were offered an equivalent number of times daily to match either naproxen, prednisone, or colchicine), and the placebo injections were identical to the anakinra injections.
The study’s primary end point was change in pain from baseline and the average 5-point numeric rating scale (NRS) pain score from 2 to 4 days. Noninferiority was established if the upper bound of the 95% CI of numeric difference in changed scores did not exceed 0.4 in favor of treatment as usual for either the per-protocol (PP) or intention-to-treat (ITT) populations. Secondary outcomes included pain improvement, safety, tenderness, swelling, and treatment response after 5 days of treatment, which were assessed using binary logistic regression models and linear mixed models.
Anakinra was shown to be noninferior to treatment as usual in both the PP population (mean difference -0.132; 95% CI, -0.44 to 0.18) and ITT population (mean difference, -0.178; 95% CI, -0.44 to 0.08). Similar reductions in gout symptoms were reported by both groups, with more participants in the anakinra group achieving >50% decreases in NRS pain scores after 2 days compared with the treatment as usual group, although these results were not statistically significant (odds ratio, 1.41; 95% CI, 0.53-3.73). No serious adverse events occurred in either treatment group, and over half of adverse events reported by participants (n=21; 58.3%) were seen in the treatment as usual group.
Although this study did take place in a hospital setting and therefore may not be generalizable to a primary care setting for the treatment of other types of acute gout patients, study investigators did conclude that anakinra can be an effective treatment option for acute gout flares.
Study funding was provided by Swedish Oprhan Biovitrum AB.
Janssen CA, Oude Voshaar MAH, Vonkeman HE, et al. Anakinra for the treatment of acute gout flares: a randomized, double-blind, placebo-controlled, active-comparator, non-inferiority trial [published online January 2, 2019]. Rheumatology (Oxford). doi: 10.1093/rheumatology/key402