AIRTRIP
Anakinra-Treatment of Recurrent Idiopathic Pericarditis
Doente / População Intervenção / Exposição Comparação Desfecho
In 21 patients with colchicine-resistant, corticosteroid-dependent recurrent pericarditis, continued anakinra markedly reduced recurrent pericarditis after randomised withdrawal compared with a switch to placebo.
N
21
Desenho
Double-blind randomised-withdrawal RCT after an open-label run-in
Desfecho
Recurrent pericarditis and time to recurrence after randomisation
Relevância
3
Resultado18.2 % vs 90 %; median flare-free survival 72 days on placebo and not reached with anakinra (p<0.001). Transient injection-site reactions in 95.2 %.
Brucato A, Imazio M, Gattorno M, et al. JAMA. 2016;316(18):1906-1912. 10.1001/jama.2016.15826
Discussão e crítica
Tiny, single-country, and the randomised-withdrawal design enriches for responders, so the effect size is almost certainly inflated. It was the first randomised proof that interleukin-1 blockade breaks the corticosteroid-dependency cycle.