title: Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab.
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.
  
  
  CONCLUSIONS
  Results from EXCELS suggest that omalizumab therapy is not associated with an increased risk of malignancy.
authors.affiliation: Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, and Harvard Medical School, Cambridge, Mass. Electronic address: aalong@mgh.harvard.edu.
authors.forename: Aidan
authors.initials: A
authors.lastname: Long
authors.affiliation: Genentech, South San Francisco, Calif.
authors.forename: Abdelkader
authors.initials: A
authors.lastname: Rahmaoui
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Rothman
authors.affiliation: Dana-Farber Cancer Institute, Boston, Mass.
authors.forename: Eva
authors.initials: E
authors.lastname: Guinan
authors.affiliation: Genentech, South San Francisco, Calif.
authors.forename: Mark
authors.initials: M
authors.lastname: Eisner
authors.affiliation: Genentech, South San Francisco, Calif.
authors.forename: Mary S
authors.initials: MS
authors.lastname: Bradley
authors.affiliation: Division of Research, Kaiser Permanente Medical Care Program, Oakland, Calif.
authors.forename: Carlos
authors.initials: C
authors.lastname: Iribarren
authors.affiliation: Genentech, South San Francisco, Calif.
authors.forename: Hubert
authors.initials: H
authors.lastname: Chen
authors.affiliation: Genentech, South San Francisco, Calif.
authors.forename: Gillis
authors.initials: G
authors.lastname: Carrigan
authors.affiliation: Genentech, South San Francisco, Calif.
authors.forename: Karin
authors.initials: K
authors.lastname: Rosén
authors.affiliation: Children's Hospital Colorado and University of Colorado Denver School of Medicine, Denver, Colo.
authors.forename: Stanley J
authors.initials: SJ
authors.lastname: Szefler
mesh_terms: D000328:Adult; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy* / Q000453:epidemiology* / Q000401:mortality; D015331:Cohort Studies; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011446:Prospective Studies; D012306:Risk; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000453:epidemiology* / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab
keywords: Cancer; EXCELS; allergic asthma; anti-IgE; safety