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Research ArticleArticle

Arrhythmic Risk During Acute Infusion of Infliximab: A Prospective, Single-blind, Placebo-controlled, Crossover Study in Patients with Chronic Arthritis

PIETRO ENEA LAZZERINI, MAURIZIO ACAMPA, MOHAMED HAMMOUD, SILVIA MAFFEI, PIER LEOPOLDO CAPECCHI, ENRICO SELVI, STEFANIA BISOGNO, FRANCESCA GUIDERI, MAURO GALEAZZI and FRANCO LAGHI PASINI
The Journal of Rheumatology October 2008, 35 (10) 1958-1965;
PIETRO ENEA LAZZERINI
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  • For correspondence: pietroenea{at}yahoo.it
MAURIZIO ACAMPA
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MOHAMED HAMMOUD
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SILVIA MAFFEI
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PIER LEOPOLDO CAPECCHI
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ENRICO SELVI
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STEFANIA BISOGNO
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FRANCESCA GUIDERI
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MAURO GALEAZZI
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FRANCO LAGHI PASINI
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Abstract

Objective

Reports suggest that infliximab (IFX) may be associated with life-threatening tachyarrhythmias and bradyarrhythmias. We evaluated the prevalence of cardiac rhythm disorders during acute infusion of IFX in a prospective, single-blind, placebo-controlled crossover study of patients with chronic arthritis. Effects of the drug on measures of arrhythmia risk such as QT interval and heart rate variability (HRV) were evaluated.

Methods

Seventy-five patients with spondyloarthritis (SpA; n = 55) or rheumatoid arthritis (RA) underwent an ambulatory 12-channel electrocardiogram (ECG) recording to monitor cardiac arrhythmias, QT interval, and HRV during the infusion of IFX and saline (placebo).

Results

The occurrence of both tachyarrhythmias and bradyarrhythmias was not statistically different during IFX or placebo infusion. During IFX infusion, new-onset ventricular tachyarrhythmias had an 8% incidence (2.7% with placebo; OR 3.17, 95% CI 0.61–16.26) and were more severe. In these patients, mainly with RA, baseline-corrected QT interval and HRV values were significantly prolonged and depressed, respectively, in comparison with subjects without such arrhythmias. IFX acutely produced a significant shift toward a relative vagal prevalence without affecting QT interval measurements.

Conclusion

New-onset cardiac arrhythmias, particularly ventricular tachyarrhythmias, developed during IFX infusion, but their incidence did not achieve statistical significance. We identified some specific risk factors possibly characteristic of the small subset of patients with a higher risk for ventricular arrhythmias. The acute effects of IFX on autonomic balance may substantiate the role of the complex interaction between autonomic nervous system and inflammation during chronic arthritis.

Key Indexing Terms:
  • INFLIXIMAB
  • ARRHYTHMIAS
  • HEART RATE VARIABILITY
  • QT INTERVAL
  • AUTONOMIC NERVOUS SYSTEM
  • INFLAMMATORY REFLEX

Footnotes

  • P.E. Lazzerini, MD, Division of Clinical Immunology; M. Acampa, MD, PhD, Division of Internal Medicine; M. Hammoud, MD, Division of Rheumatology; S. Maffei, MD, Division of Cardiology; P.L. Capecchi, MD, Associate Professor, Division of Clinical Immunology; E. Selvi, MD, PhD; S. Bisogno, MD, PhD; F. Guideri, MD, Research Fellow; M. Galeazzi, MD, Professor, Division of Rheumatology; F. Laghi Pasini, MD, Professor, Division of Clinical Immunology.

    • Accepted for publication May 2, 2008.
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The Journal of Rheumatology
Vol. 35, Issue 10
1 Oct 2008
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Arrhythmic Risk During Acute Infusion of Infliximab: A Prospective, Single-blind, Placebo-controlled, Crossover Study in Patients with Chronic Arthritis
PIETRO ENEA LAZZERINI, MAURIZIO ACAMPA, MOHAMED HAMMOUD, SILVIA MAFFEI, PIER LEOPOLDO CAPECCHI, ENRICO SELVI, STEFANIA BISOGNO, FRANCESCA GUIDERI, MAURO GALEAZZI, FRANCO LAGHI PASINI
The Journal of Rheumatology Oct 2008, 35 (10) 1958-1965;

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Arrhythmic Risk During Acute Infusion of Infliximab: A Prospective, Single-blind, Placebo-controlled, Crossover Study in Patients with Chronic Arthritis
PIETRO ENEA LAZZERINI, MAURIZIO ACAMPA, MOHAMED HAMMOUD, SILVIA MAFFEI, PIER LEOPOLDO CAPECCHI, ENRICO SELVI, STEFANIA BISOGNO, FRANCESCA GUIDERI, MAURO GALEAZZI, FRANCO LAGHI PASINI
The Journal of Rheumatology Oct 2008, 35 (10) 1958-1965;
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