Cardiovascular and cerebrovascular events among patients receiving omalizumab: Results from EXCELS, a prospective cohort study in moderate to severe asthma.

Abstract

BACKGROUND:

EXCELS, a postmarketing observational cohort study, was a commitment to the US Food and Drug Administration to assess the long-term safety of omalizumab in an observational setting, focusing predominantly on malignancies.

OBJECTIVE:

The aim of this study was to examine a potential association between omalizumab and cardiovascular (CV)/cerebrovascular (CBV) events in EXCELS.

METHODS:

Patients (≥12 years of age) with moderate to severe allergic asthma and who were being treated with omalizumab (n = 5007) or not (n = 2829) at baseline were followed up for ≤5 years. Analyses included overall CV/CBV events, but focused on the subset of arterial thromboembolic events (ATEs), comprising CV death, myocardial infarction, ischemic stroke, transient ischemic attack, and unstable angina. A prespecified analysis of the end point of ATE was conducted to control for available potential confounders. A blinded independent expert panel adjudicated all events.

RESULTS:

At baseline, the 2 cohorts had similar demographic characteristics, but severe asthma was more common in the omalizumab versus the non-omalizumab group (50% vs 23%). Omalizumab-treated patients had a higher rate of CV/CBV serious adverse events (13.4 per 1,000 person years [PYs]) than did non-omalizumab-treated patients (8.1 per 1,000 PYs). The ATE rates per 1,000 PYs were 6.66 (101 patients/15,160 PYs) in the omalizumab cohort and 4.64 (46 patients/9,904 PYs) in the non-omalizumab cohort. After control for available confounding factors, the hazard ratio was 1.32 (95% CI, 0.91-1.91).

CONCLUSION:

This observational study demonstrated a higher incidence rate of CV/CBV events in the omalizumab versus the non-omalizumab cohort. Differences in asthma severity between cohorts likely contributed to this imbalance, but some increase in risk cannot be excluded.

• Authors: Carlos Iribarren, Abdelkader Rahmaoui, Aidan A Long, Stanley J Szefler, Mary S Bradley, Gillis Carrigan, Mark D Eisner, Hubert Chen, Theodore A Omachi, Michael E Farkouh, Kenneth J Rothman
• Journal: The Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 139 Issue 5 Pg. 1489-1495.e5 (May 2017) ISSN: 1097-6825 [Electronic] United States
• PMID: 27639934 (Publication Type: Journal Article, Observational Study)
• Copyright: Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anti-Asthmatic Agents
• Omalizumab

Topics

• Adult
• Anti-Asthmatic Agents (adverse effects, therapeutic use)
• Asthma (drug therapy, epidemiology)
• Cardiovascular Diseases (epidemiology)
• Cerebrovascular Disorders (epidemiology)
• Female
• Humans
• Incidence
• Male
• Middle Aged
• Omalizumab (adverse effects, therapeutic use)
• Product Surveillance, Postmarketing
• Prospective Studies