Resistant or recurrent acute pericarditis: A new therapeutic opportunity?

Massardier, Claire; Dauphin, Claire; Eschalier, Romain; Lusson, Jean René; Soubrier, Martin

doi:10.1016/j.ijcard.2014.09.192

Cited by 11 publications

(8 citation statements)

References 11 publications

(8 reference statements)

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“…The study hypothesis was that anakinra could reduce the expected recurrence rate from 80% to 10%. [6][7][8][9][11][12][13][14][15] Event-free survival was estimated by the Kaplan-Meier method. A 2-sided log-rank test was used to compare the time to flare between randomization and the end of month 8 in the 2 treatment groups.…”

Section: Discussionmentioning

confidence: 99%

“…Corticosteroids impair growth in children, and Picco et al 6 described the first 3 patients, all children, successfully treated with anakinra; at present, 10 reports describing 46 patients (adults and children) have been published. [6][7][8][11][12][13][14][15][16][17] The 2015 guidelines of the European Society of Cardiology 18 stated that anakinra, azathioprine, and high-dose intravenous immunoglobulins may Research Preliminary Communication be considered in corticosteroid-dependent recurrent pericarditis that is resistant or intolerant to colchicine, but the level of evidence was low (C, based on case series and expert opinion). This study is the first randomized, placebo-controlled trial of anakinra for idiopathic recurrent pericarditis showing that anakinra is a potential option for this subset of patients.…”

Section: Discussionmentioning

confidence: 99%

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Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence

Brucato

Imazio

Gattorno

et al. 2016

JAMA

269

221

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IMPORTANCE Anakinra, an interleukin 1β recombinant receptor antagonist, may have potential to treat colchicine-resistant and corticosteroid-dependent recurrent pericarditis. OBJECTIVE To determine the efficacy of anakinra for colchicine-resistant and corticosteroid-dependent recurrent pericarditis. DESIGN, SETTING, AND PARTICIPANTS The Anakinra-Treatment of Recurrent Idiopathic Pericarditis (AIRTRIP) double-blind, placebo-controlled, randomized withdrawal trial (open label with anakinra followed by a double-blind withdrawal step with anakinra or placebo until recurrent pericarditis occurred) conducted among 21 consecutive patients enrolled at 3 Italian referral centers between June and November 2014 (end of follow-up, October 2015). Included patients had recurrent pericarditis (with Ն3 previous recurrences), elevation of C-reactive protein, colchicine resistance, and corticosteroid dependence. INTERVENTIONS Anakinra was administered at 2 mg/kg per day, up to 100 mg, for 2 months, then patients who responded with resolution of pericarditis were randomized to continue anakinra (n = 11) or switch to placebo (n = 10) for 6 months or until a pericarditis recurrence. MAIN OUTCOMES AND MEASURES The primary outcomes were recurrent pericarditis and time to recurrence after randomization. RESULTS Eleven patients (7 female) randomized to anakinra had a mean age of 46.5 (SD, 16.3) years; 10 patients (7 female) randomized to placebo had a mean age of 44 (SD, 12.5) years. All patients were followed up for 12 months. Median follow-up was 14 (range, 12-17) months. Recurrent pericarditis occurred in 9 of 10 patients (90%; incidence rate, 2.06% of patients per year) assigned to placebo and 2 of 11 patients (18.2%; incidence rate, 0.11% of patients per year) assigned to anakinra, for an incidence rate difference of −1.95% (95% CI, −3.3% to −0.6%). Median flare-free survival (time to flare) was 72 (interquartile range, 64-150) days after randomization in the placebo group and was not reached in the anakinra group (P <.001). During anakinra treatment, 20 of 21 patients (95.2%) experienced transient local skin reactions: 1 (4.8%) herpes zoster, 3 (14.3%) transaminase elevation, and 1 (4.8%) ischemic optic neuropathy. No patient permanently discontinued the active drug. No adverse events occurred during placebo treatment. CONCLUSION AND RELEVANCE In this preliminary study of patients with recurrent pericarditis with colchicine resistance and corticosteroid dependence, the use of anakinra compared with placebo reduced the risk of recurrence over a median of 14 months. Larger studies are needed to replicate these findings as well as to assess safety and longer-term efficacy.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence

Brucato

Imazio

Gattorno

et al. 2016

JAMA

269

221

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“…Interleukin-1 blockade with anakinra is of growing interest in this setting because it may have the potential to dramatically reduce pericarditis recurrences, although strong evidence-based data are lacking in literature 7 . Indeed, current knowledge about anakinra use in RRP patients is based on 14 case reports [8][9][10][11][12][13][14][15][16][17][18][19][20][21] , 4 case series on 10-14 patients [22][23][24][25] , one randomized and controlled trial on 21 patients 26 . The generalizability of such limited findings in a real-world clinical setting, involving different patient populations and single center practice is a key question.…”

Section: Introductionmentioning

confidence: 99%

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

Imazio

Andreis

Ferrari

et al. 2019

Eur J Prev Cardiolog

118

104

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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.

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“…7 We reported the use of this treatment to replace corticosteroids as second-line treatment, in a diabetic patient and in a patient with stable rheumatoid polyarthritis. 54 The randomized study against placebo reported at the last American Congress of Rheumatology undoubtedly confirms the efficacy of anakinra 55 : 21 patients with IRAP on corticosteroids were treated with anakinra (eleven) or placebo (ten) in combination with their treatment for 6 months. After the disappearance of pain and normalization of CRP, they were weaned from all other treatment.…”

Section: Anakinramentioning

confidence: 85%

Recurrent pericarditis: current challenges and future prospects

Dauphin¹,

Merlin²,

Chalard³

et al. 2016

RRCC

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Recurrent pericarditis, usually idiopathic, is difficult to treat. Previous etiological studies can eliminate potentially serious causes that require specific treatment. The pathophysiology of "idiopathic" pericarditis involves autoimmunity and autoinflammation in various degrees and is usually caused by a microbacteriological or postinjury trigger. It requires multidisciplinary care to provide individualized treatment to each patient: treatment escalation by increments, then weaning should be guided by clinical examination but also CRP and potential magnetic resonance imaging. The role of immunomodulators, especially anakinra, should be revisited. Their efficacy is remarkable, and they could be considered for second-line treatment, preferably with corticosteroids (at least among certain selected patients), especially after the failure of prolonged and high-dose standard therapy with aspirin/nonsteroidal anti-inflammatory drugs and colchicine.

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Resistant or recurrent acute pericarditis: A new therapeutic opportunity?

Cited by 11 publications

References 11 publications

Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence

Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence

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

Recurrent pericarditis: current challenges and future prospects

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