RHAPSODY

Rilonacept Inhibition of Interleukin-1 Alpha and Beta for Recurrent Pericarditis

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 86 patients with recurrent pericarditis and an elevated C-reactive protein level, continued weekly rilonacept prolonged time to first pericarditis recurrence compared with randomised withdrawal to placebo.

Disegno

Phase-3 double-blind randomised-withdrawal RCT (86 enrolled in run-in, 61 randomised)

Esito

Time to first adjudicated pericarditis recurrence

Rilevanza

RisultatoRecurrence 7 % vs 74 % (HR 0.04; 95 % CI 0.01–0.18; p<0.001). Median time to recurrence 8.6 weeks on placebo, not reached with rilonacept.

Klein AL, Imazio M, Cremer P, et al. N Engl J Med. 2021;384(1):31-41. 10.1056/NEJMoa2027892

Discussione e critica

Only run-in responders were randomised and the placebo arm was abruptly de-escalated from an effective drug, which exaggerates the contrast; there is no active comparator and no stopping-rule data. It is still the largest and methodologically strongest trial ever done in recurrent pericarditis.