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J Allergy Clin Immunol. 2014 Sep;134(3):560-567.e4. doi: 10.1016/j.jaci.2014.02.007. Epub 2014 Mar 27.

Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab.

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Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, and Harvard Medical School, Cambridge, Mass. Electronic address:
Genentech, South San Francisco, Calif.
RTI Health Solutions, Research Triangle Park, NC.
Dana-Farber Cancer Institute, Boston, Mass.
Division of Research, Kaiser Permanente Medical Care Program, Oakland, Calif.
Children's Hospital Colorado and University of Colorado Denver School of Medicine, Denver, Colo.



The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) assessed the long-term safety of omalizumab in a clinical practice setting as part of a phase IV US Food and Drug Administration postmarketing commitment.


We sought to evaluate long-term safety in omalizumab-treated and nonomalizumab-treated patients. Primary outcome measures focused on assessment of malignancies.


EXCELS was a prospective observational cohort study in patients (≥12 years of age) with moderate-to-severe allergic asthma. There were 2 cohorts: omalizumab (taking omalizumab at baseline) and nonomalizumab (no history of omalizumab treatment). Primary outcomes included all confirmed, incident, study-emergent primary malignancies (malignancies), including and excluding nonmelanoma skin cancer (NMSC); all malignancies were externally adjudicated.


The omalizumab cohort had a higher proportion of patients with severe asthma compared with the nonomalizumab cohort (50.0% vs 23.0%). Median follow-up was approximately 5 years for both cohorts. Crude malignancy rates were similar in the omalizumab and nonomalizumab cohorts, with a rate ratio of 0.84 (95% CI, 0.62-1.13) for all malignancies and 0.98 (95% CI, 0.71-1.36) for all malignancies excluding NMSC. Kaplan-Meier plots of time to first confirmed study-emergent primary malignancy were similar for the 2 treatment cohorts. Cox proportional hazards modeling, adjusting for confounders and risk factors, resulted in a hazard ratio (omalizumab vs nonomalizumab) of 1.09 (95% CI, 0.87-1.38) for all malignancies and 1.15 (95% CI, 0.83-1.59) for all malignancies excluding NMSC.


Results from EXCELS suggest that omalizumab therapy is not associated with an increased risk of malignancy.


Cancer; EXCELS; allergic asthma; anti-IgE; safety

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