Format

Send to

Choose Destination
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.

Author information

1
Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, and Harvard Medical School, Cambridge, Mass. Electronic address: aalong@mgh.harvard.edu.
2
Genentech, South San Francisco, Calif.
3
RTI Health Solutions, Research Triangle Park, NC.
4
Dana-Farber Cancer Institute, Boston, Mass.
5
Division of Research, Kaiser Permanente Medical Care Program, Oakland, Calif.
6
Children's Hospital Colorado and University of Colorado Denver School of Medicine, Denver, Colo.

Abstract

BACKGROUND:

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.

OBJECTIVE:

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

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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

KEYWORDS:

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

Comment in

PMID:
24679845
DOI:
10.1016/j.jaci.2014.02.007
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center