title: Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection.
abstract: BACKGROUND
  Although the role of immunoglobulin E (IgE) in immunity against helminth parasites is unclear, there is concern that therapeutic antibodies that neutralize IgE (anti-IgE) may be unsafe in subjects at risk of helminth infection.
  
  
  OBJECTIVE
  We conducted an exploratory study to investigate the safety of omalizumab (anti-IgE) in subjects with allergic asthma and/or perennial allergic rhinitis at high risk of intestinal helminth infection. The primary safety outcome was risk of infections with intestinal helminths during anti-IgE therapy.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled trial was conducted in 137 subjects (12-30 years) at high risk of geohelminth infection. All subjects received pre-study anthelmintic treatment, followed by 52 weeks' treatment with omalizumab or placebo.
  
  
  RESULTS
  Of the omalizumab subjects 50% (34/68) experienced at least one intestinal geohelminth infection compared with 41% (28/69) of placebo subjects [odds ratio (OR) 1.47, 95% confidence interval (CI) 0.74-2.95, one-sided P=0.14; OR (adjusted for study visit, baseline infection status, gender and age) 2.2 (0.94-5.15); one-sided P=0.035], providing some evidence for a potential increased incidence of geohelminth infection in subjects receiving omalizumab. Omalizumab therapy was well tolerated, and did not appear to be associated with increased morbidity attributable to intestinal helminths as assessed by clinical and laboratory adverse events, maximal helminth infection intensities and additional anthelmintic requirements. Time to first infection (OR 1.30, 95% CI 0.79-2.15, one-sided P=0.15) was similar between treatment groups. Infection severity and response to anthelmintics appeared to be unaffected by omalizumab therapy.
  
  
  CONCLUSIONS
  In this exploratory study of allergic subjects at high risk of helminth infections, omalizumab therapy appeared to be safe and well tolerated, but may be associated with a modest increase in the incidence of geohelminth infection.
authors.affiliation: ProAR, Faculdade de Medicina da Bahia-UFBA, Instituto de Investigação em Imunologia (iii), CNPq, Salvador, BA, Brazil. cruz.aa@terra.com.br
authors.forename: A A
authors.initials: AA
authors.lastname: Cruz
authors.forename: F
authors.initials: F
authors.lastname: Lima
authors.forename: E
authors.initials: E
authors.lastname: Sarinho
authors.forename: G
authors.initials: G
authors.lastname: Ayre
authors.forename: C
authors.initials: C
authors.lastname: Martin
authors.forename: H
authors.initials: H
authors.lastname: Fox
authors.forename: P J
authors.initials: PJ
authors.lastname: Cooper
mesh_terms: D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D000075202:Contraindications; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006373:Helminthiasis / Q000150:complications*; D006801:Humans; D007073:Immunoglobulin E / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D000069444:Omalizumab; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D012307:Risk Factors
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069444:Omalizumab; D007073:Immunoglobulin E