Details

Autor(en) / Beteiligte

• Iribarren, Carlos, MD, MPH, PhD
• Rahmaoui, Abdelkader, MD
• Long, Aidan A., MD
• Szefler, Stanley J., MD
• Bradley, Mary S., MS
• Carrigan, Gillis, PhD, MSc
• Eisner, Mark D., MD, MPH
• Chen, Hubert, MD, MPH
• Omachi, Theodore A., MD, MBA
• Farkouh, Michael E., MD, MSc
• Rothman, Kenneth J., DrPH

Titel

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

Ist Teil von

• Journal of allergy and clinical immunology, 2017-05, Vol.139 (5), p.1489-1495.e5

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2017

Link zum Volltext

Quelle

Electronic Journals Library

Beschreibungen/Notizen

• Abstract Background EXCELS was a postmarketing commitment to the US Food and Drug Administration to assess long-term safety of omalizumab in an observational setting, focusing predominantly on malignancies. Objective To examine a potential association between omalizumab and cardiovascular (CV)/cerebrovascular (CBV) events in EXCELS. Methods Cohort study of patients (≥12 years of age) with moderate-to-severe allergic asthma followed ≤5 years, treated with omalizumab (n = 5007) or not treated with omalizumab (n = 2829) at baseline. Analyses included overall CV/CBV events, but focused on the subset of arterial thromboembolic events (ATE), comprising CV death, myocardial infarction, ischemic stroke, transient ischemic attack, or unstable angina. A prespecified analysis for the endpoint of ATE was conducted to control for available potential confounders. A blinded independent expert panel adjudicated all events. Results At baseline, cohorts had similar demographic characteristics, but severe asthma was more common in the omalizumab versus non-omalizumab cohorts (50% vs 23%). Omalizumab-treated patients had a higher rate of CV/CBV serious adverse events (13.4 per 1000 person-years [PY]) than non-omalizumab–treated patients (8.1 per 1000 PY). ATE rate per 1000 PY was 6.66 (101 patients/15,160 PY) for the omalizumab cohort and 4.64 (46 patients/9904 PY) for the non-omalizumab cohort. After controlling for available confounding factors, the hazard ratio was 1.32 (95% CI, 0.91-1.91). Conclusion Results from this observational study demonstrated a higher incidence rate of CV/CBV events in the omalizumab versus non-omalizumab cohorts. Differences in asthma severity between cohorts likely contributed to this imbalance, but some increase in risk cannot be excluded (NCT00252135). Clinical implications Current asthma management guidelines should not be affected. However, health professionals should be aware of a possible association of omalizumab and serious cardiovascular/cerebrovascular events.