Background/Purpose: Patients with recurrent pericarditis either do not respond or are intolerant to treatment with NSAIDs drugs, corticosteroids and colchicine. We aimed to assess the safety and efficacy of anakinra in patients with cortico-dependent idiopathic recurrent pericarditis.

Methods: We did a double-blind randomised controlled withdrawal trial between June2014 and June2015. We enrolled 21 patients aged 45.4 years (7 males) from 3 Italian centres, who had a history of idiopathic recurrent pericarditis with at least 2 previous recurrences, CRP elevation during recurrence (>1 mg/dL) and on therapy with corticosteroids. 20 adults patients took 100 mg of anakinra subcutaneously daily for 2 months, 1 child received 2 mg/kg/day. 11 patients were then randomly assigned to continue anakinra for additional 6 months or until a flare of the pericarditis and 10 were randomly assigned to receive placebo at the same dose and timing. Primary endpoint: time to flare of pericarditis. Flare was defined as recurrence of typical pain and CRP elevation. We analysed all patients who were treated as per protocol. The trial is registered (NCT02219828)

Results: Mean n° of recurrences in the patients before this study was 6.6 with a clinical history of recurrent pericarditis lasting 27.7 months on average. All patients completed successfully the open lead-in course with a complete response to the treatment, CRP normalization and discontinuation of all the other drugs. Flares of pericarditis occurred in all the 10 patients randomized to placebo and none of the 11 patients randomized to anakinra during the double-blind treatment (p<0.0001). Median time to flare of pericarditis was 48.2 days for patients given placebo; insufficient events had occurred in the anakinra group for median time to flare to be assessed (p< 0.00001). During study the frequency of adverse events differed in the two treatment groups. The most common side effect was a local reaction at the injection site, observed in 20 of 21 cases (95.2%) during the initial open-label phase; generally disappeared over one month, and only one patient discontinued the study for this side effect. Two serious events were reported, both in the anakinra treated patients (p=0.47): 1 patient developed skin herpes zoster during the open-label phase, 1 developed ischemic optic neuropathy at the fifth month of the double-blind period; she is a 70 years old woman, hypertensive and with hypercholesterolemia, but the exact mechanism of the optic neuropathy is debatable.

Conclusion: Inhibition of  IL1 with anakinra is a rational alternative treatment for selected patients with severe cortico-dependent recurrent pericarditis and multiple failure of conventional therapies with colchicine.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/anakinra-in-patients-with-cortico-dependent-idiopathic-recurrent-pericarditis-a-randomised-double-blind-placebo-controlled-withdrawal-trial/