ATTACG - Anakinra versus Treatment as usual in the Treatment of ACute Gout
Acute gout is a common form of inflammatory arthropathy characterized by severe pain and reduced physical functioning. The current standard treatments (colchicine, corticosteroids or NSAIDs) are therefore designed to rapidly relieve the pain and inflammation in the affected joints. Although gout is one of the most well understood rheumatic diseases, currently available treatment options are frequently contra-indicated or poorly tolerated by gout patients, which frequently presents in the presence of significant multi-morbidity (hypertension and renal disease).
For this complex group of gout patients a new agent, the IL-1β inhibitor canakinumab, was registered in the Netherlands for the treatment of acute gout in 2013. However, this agent is limited by the high cost per treatment (> € 10,000 ). Anakinra (Kineret), a DNA recombinant IL-1 receptor antagonist, is a medicinal product currently registered for the treatment of rheumatoid arthritis. The clinical efficacy and safety of anakinra in acute gout have been investigated and reported in a handful of case series or small open-label studies. These studies provide a proof of concept of the plausibility and clinical importance of a large scale clinical trial. The goal of the ATTACG research project is to determine whether anakinra could be a safe, more applicable and possibly more effective agent to treat gouty arthritis.
The project is a multicenter clinical study in the Netherlands where 200 crystal-proven gout patients will be randomized to a treatment with anakinra or with 1 of the current standard of care treatments (this can be colchicine, naproxen or prednisone). Patients will simultaneously start with urate lowering therapy. The primary endpoint will be the difference in pain after 3 days of treatment. Patients will be followed-up to a year in order to evaluate the cost-effectiveness of this treatment strategy.
Participating hospitals include MST in Enschede, ZGT in Almelo/Hengelo, VieCuri in Venlo, Rijnstate Hospital in Arnhem, Röpcke-Zweers Hospital in Hardenberg, MCL in Leeuwarden and Bernhoven Hospital. The inclusion of patients started in February 2016 and is expected to continue for a year.