Anakinra for corticosteroid-dependent and colchicine-resistant pericarditis: The IRAP (International Registry of Anakinra for Pericarditis) study

Author:

Imazio Massimo1,Andreis Alessandro1,De Ferrari Gaetano Maria1,Cremer Paul C2,Mardigyan Vartan3,Maestroni Silvia4,Luis Sushil Allen5,Lopalco Giuseppe6,Emmi Giacomo7,Lotan Dor8,Marcolongo Renzo9,Lazaros George10,De Biasio Marzia11,Cantarini Luca12,Dagna Lorenzo13,Cercek Andreja Cerne14,Pivetta Emanuele15,Varma Beni2,Berkson Laeora3,Tombetti Enrico16,Iannone Florenzo6,Prisco Domenico7,Caforio Alida Linda P9,Vassilopoulos Dimitrios10,Tousoulis Dimitrios10,De Luca Giacomo13,Giustetto Carla1,Rinaldi Mauro1,Oh Jae K5,Klein Allan L2,Brucato Antonio16,Adler Yehuda8

Affiliation:

1. Coordinating Center: University Cardiology, A.O.U. Città della Salute e della Scienza di Torino, Italy

2. Heart and Vascular Institute, Cleveland Clinic, USA

3. McGill University, Jewish General Hospital, Canada

4. Internal Medicine Division, Ospedale Papa Giovanni XXIII, Italy

5. Department of Cardiovascular Medicine, Mayo Clinic, USA

6. Department of Emergency and Organ Transplantation (DETO), University of Bari, Italy

7. Department of Experimental and Clinical Medicine, University of Firenze, Italy

8. Leviev Heart Center, Chaim Sheba Medical Center (affiliated to Tel Aviv University), Israel

9. Department of Cardiac Thoracic Vascular Sciences and Public Health, Policlinico Universitario, Italy

10. 1st Cardiology Clinic, Hippokration General Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece

11. Cardiology Department, Udine Hospital, Italy

12. Research Center of Systemic Autoinflammatory Diseases, University of Siena, Italy

13. Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Hospital, Italy

14. Department of Cardiology, University Medical Center Ljubljana, Slovenia

15. Emergency Medicine Division and High Dependency Unit and CPO Piemonte, A.O.U. Città della Salute e della Scienza di Torino, Italy

16. Dipartimento Scienze Cliniche e biomediche Luigi Sacco, ASST Fatebenefratelli-Sacco, Università degli Studi di Milano, Italy

Abstract

Aims Novel therapies are needed for recurrent pericarditis, particularly when corticosteroid dependent and colchicine resistant. Based on limited data, interleukin-1 blockade with anakinra may be beneficial. The aim of this multicentre registry was to evaluate the broader effectiveness and safety of anakinra in a ‘real world’ population. Methods and results This registry enrolled consecutive patients with recurrent pericarditis who were corticosteroid dependent and colchicine resistant and treated with anakinra. The primary outcome was the pericarditis recurrence rate after treatment. Secondary outcomes included emergency department visits, hospitalisations, corticosteroid use and adverse events. Among 224 patients (46 ± 14 years old, 63% women, 75% idiopathic), the median duration of disease was 17 months (interquartile range 9–33). Most patients had elevated C-reactive protein (91%) and pericardial effusion (88%). After a median treatment of 6 months (3–12), pericarditis recurrences were reduced six-fold (2.33–0.39 per patient per year), emergency department admissions were reduced 11-fold (1.08–0.10 per patient per year), hospitalisations were reduced seven-fold (0.99–0.13 per patient per year). Corticosteroid use was decreased by anakinra (respectively from 80% to 27%; P < 0.001). No serious adverse events occurred; adverse events consisted mostly of transient skin reactions (38%) at the injection site. Adverse events led to discontinuation in 3%. A full-dose treatment duration of over 3 months followed by a tapering period of over 3 months were the therapeutic schemes associated with a lower risk of recurrence. Conclusion In patients with recurrent pericarditis, anakinra appears efficacious and safe in reducing recurrences, emergency department admissions and hospitalisations.

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine,Epidemiology

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