Efficacy and safety of rilonacept for recurrent pericarditis: Results from a phase II clinical trial

Allan L. Klein*, David Lin, Paul C. Cremer, Saifullah Nasir, Sushil Allen Luis, Antonio Abbate, Andrew Ertel, Martin Lewinter, Anna Beutler, Fang Fang, John F. Paolini

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

34 Scopus citations


Objective Recurrent pericarditis (RP) incurs significant morbidity. Rilonacept inhibits both interleukin-1 alpha (IL-1α) and IL-1β; these cytokines are thought to play a major role in RP. This phase II study evaluated rilonacept efficacy and safety in RP. Methods This multicentre, open-label study enrolled adult patients with idiopathic or postpericardiotomy RP, symptomatic (≥2 pericarditis recurrences) or corticosteroid (CS) dependent (≥2 recurrences prior). Patients received rilonacept 320 mg SC load/160 mg SC weekly maintenance in a 6-week base treatment period (TP) followed by an optional 18-week on-treatment extension period (EP) (option to wean background therapy). Results Outcomes: pericarditis pain (numeric rating scale (NRS)) and inflammation (C reactive protein (CRP)) for symptomatic patients; disease activity after CS taper for CS-dependent patients. Secondary outcomes: health-related quality of life (HRQOL), pericarditis manifestations and additional medications. 25 unique patients enrolled, while 23 completed the EP (seven colchicine failures and five CS failures). In symptomatic patients, NRS and CRP decreased; response was observed after first rilonacept dose. NRS decreased from 4.5 at baseline to 0.7, and CRP decreased from 4.62 mg/dL at baseline to 0.38 mg/dL at end of TP. Median time to CRP normalisation: 9 days. Pericarditis manifestations resolved. 13 patients on CS at baseline completed the EP; 11 (84.6%) discontinued CS, and 2 tapered; CRP and NRS remained low without recurrence. Mean HRQOL scores improved in symptomatic patients. One serious adverse event (SAE) resulted in discontinuation of rilonacept. Conclusions Rilonacept led to rapid and sustained improvement in pain, inflammation (CRP and pericarditis manifestations) and HRQOL. CSs were successfully tapered or discontinued; safety was consistent with known rilonacept safety profile. Trial registration number NCT03980522.

Original languageEnglish (US)
Pages (from-to)488-496
Number of pages9
Issue number6
StatePublished - Mar 1 2021


  • inflammatory markers
  • pericardial disease
  • pericarditis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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