Anakinra may be a ‘viable treatment option’ for gout
medwireNews: Findings from a randomized trial suggest that treatment with the interleukin (IL)-1 receptor antagonist anakinra is noninferior to usual care for the treatment of gout flares.
The study, carried out at seven hospitals in the Netherlands, included 43 patients diagnosed with an acute flare of gouty arthritis who were randomly assigned to receive a 5-day treatment course with either subcutaneous anakinra 100 mg/day or the most appropriate usual care as decided by rheumatologists and patients.
Of the 45 patients allocated to the usual treatment group, 18 received colchicine (0.5 mg up to three times daily), 14 were given prednisone (35 mg/day), and 13 were given naproxen (500 mg up to twice daily); all treatments in this arm were administered orally.
As reported in Rheumatology, the team assessed the average pain score on a five-point scale at days 2–4, finding comparable improvements from baseline among patients given anakinra versus usual care. The estimated marginal mean difference between groups was 0.132 in favor of anakinra in the per-protocol analysis, and 0.178 in favor of anakinra in the intention-to-treat population.
Carly Janssen (University of Twente, Enschede, the Netherlands) and study co-authors say that anakinra was “consistently numerically superior” to usual care, and the upper bounds of the 95% confidence intervals did not surpass the noninferiority margin, demonstrating “at least [noninferiority] of anakinra compared with conventional therapies for the treatment of acute gout flares.”
These findings were supported by improvements in other measures of gout-related symptoms over the study period, say the researchers. Indeed, mean patient global assessment scores improved from 4.9 to 7.3 points in the anakinra group and from 4.4 to 6.7 points in the usual care arm, while a numerically greater proportion of patients given anakinra achieved at least a 50% reduction in joint pain scores on a 10-point numeric scale.
A total of 34.9% of patients in the anakinra group and 46.7% of those in the usual care group experienced adverse events, including musculoskeletal pain (16.2 vs 8.2%), musculoskeletal stiffness, swelling, or spasms (13.5 vs 8.2%), diarrhea (8.1 vs 18.4%) and nausea (8.1 vs 10.2%). Janssen and colleagues note that “evaluation of the reported [adverse events] did not reveal any severe, uncommon or unexpected safety outcomes.”
Taken together, “[t]hese findings suggest that anakinra might be a viable treatment option for gout flares,” write the investigators.
They add that considering the high costs associated with canakinumab – the only IL-1 inhibitor currently approved for gout in Europe – anakinra may provide “a cost-effective alternative for gout patients seen in daily practice who are difficult to treat with conventional therapies.”
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