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A comparative clinical trial to assess a standardized escalation dose strategy of interleukin-1 blockade in Kawasaki disease: The ANACOMP trial

Isabelle Kone-Paut*, Artemis Toumazi, Aurelie Bourmaud

Background: Based on the auto-inflammatory pattern of Kawasaki Disease (KD), the most frequent and heart threatening vasculitis in children before five years, we hypothesize that anti-IL-1 blocking agents could bring a rapid and sustained effect on systemic and coronary inflammation in patients with KD. Aims and primary objective: To compare the efficacy of anakinra (IL-1R1 receptor antagonist) with second IVIG infusion, in the second line, on fever in patients with KD, who failed to respond to the first infusion of IVIG. Methods: A multicenter national, 60-day, the randomized controlled open-labeled trial of superiority running in two parallel groups in a 1:1 ratio to arm A: experimental strategy (anakinra) or arm B: control strategy (IV IG + standard care). In arm A, patients will receive anakinra, at a starting dose of 4 mg/kg. Up to H36, the dose of anakinra will be increased every 12h if the patients have fever >38°C, and up to a maximum of 8 mg/kg. The main criterion-evaluating efficacy in both groups is an abatement of fever <38°C within 2 days after initiation of treatment, a decrease of the CRP values from baseline to day 30, reduction in physician and patient’s parent’s assessment of disease activity of at least to 50% between baseline and day 14, and treatment tolerability. In addition, we will assess the resolution of coronary abnormalities; i.e. worst Z score <2.5, by echocardiogram if present on day 45. Conclusion: Anakinra treatment is expected to enhance more frequently than IVIG retreatment a rapid and sustained effect on vascular inflammation.