title: Omalizumab and the risk of malignancy: results from a pooled analysis.
abstract: BACKGROUND
  Since initial registration, the omalizumab clinical trial database has expanded considerably, with a doubling of patients exposed in the clinical trial environment. Previous pooled data (2003) from phase I to III studies of omalizumab showed a numeric imbalance in malignancies arising in omalizumab recipients (0.5%) compared with control subjects (0.2%). The previous analysis was based on limited available data, warranting further investigation.
  
  
  OBJECTIVE
  We sought to examine the incidence of malignancy using comprehensive pooled data from clinical trials of omalizumab-treated patients.
  
  
  METHODS
  This pooled analysis included data from 67 phase I to IV clinical trials. The prespecified primary analysis assessed the incidence of primary malignancy in 32 randomized, double-blind, placebo-controlled (RDBPC) trials.
  
  
  RESULTS
  There were 11,459 unique patients in all clinical trials (7,789 received omalizumab). The primary analysis identified malignancies in 25 patients (RDBPC trials): 14 in 4,254 omalizumab-treated patients and 11 in 3,178 placebo-treated patients. Incidence rates per 1,000 patient-years of observation time for omalizumab- and placebo-treated patients were 4.14 (95% CI, 2.26-6.94) and 4.45 (95% CI, 2.22-7.94), respectively; the corresponding rate ratio was 0.93 (95% CI, 0.39-2.27). Primary malignancies were of varying histologic type and occurred in a number of different organ systems; no cluster of histologies was identified.
  
  
  CONCLUSIONS
  In this pooled analysis no association was observed between omalizumab treatment and risk of malignancy in RDBPC trials; the rate ratio was below unity. The data suggest that a causal relationship between omalizumab therapy and malignancy is unlikely.
authors.affiliation: Department of Medicine, University of Wisconsin Medical School, Madison, WI, USA. wwb@medicine.wisc.edu
authors.forename: William
authors.initials: W
authors.lastname: Busse
authors.forename: Roland
authors.initials: R
authors.lastname: Buhl
authors.forename: Carlos
authors.initials: C
authors.lastname: Fernandez Vidaurre
authors.forename: Martin
authors.initials: M
authors.lastname: Blogg
authors.forename: Jin
authors.initials: J
authors.lastname: Zhu
authors.forename: Mark D
authors.initials: MD
authors.lastname: Eisner
authors.forename: Janice
authors.initials: J
authors.lastname: Canvin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000009:adverse effects*; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology / Q000209:etiology*; D000069444:Omalizumab; D012306:Risk; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab