title: Immunogenicity of Influenza Vaccine for Patients with Inflammatory Bowel Disease on Maintenance Infliximab Therapy: A Randomized Trial.
abstract: BACKGROUND
  In patients with inflammatory bowel disease (IBD) on infliximab, data are limited on immune response to influenza vaccine and the impact of vaccine timing. The study aims were to evaluate immune responses to the influenza vaccine in IBD patients on infliximab and the impact of vaccine timing on immune responses.
  
  
  METHODS
  In this randomized study, 137 subjects with IBD on maintenance infliximab therapy were allocated to receive the 2012/2013 inactivated influenza vaccine at the time of infliximab infusion (n = 69) or midway between infusions (n = 68). Serum was collected before and after vaccination for hemagglutination inhibition titers. Serologic protection was defined by postvaccine titer of ≥1:40.
  
  
  RESULTS
  Comparing subjects vaccinated at the time of infliximab with those vaccinated midway, serologic protection was achieved in 67% versus 66% to H1N1 (P = 0.8), in 43% versus 49% to H3N2 (P = 0.5), and in 69% versus 79% to influenza B (P = 0.2). Although solicited adverse events were common (60%), no subject experienced a serious adverse event requiring additional medical attention. Only 6% of subjects had a clinically significant increase in disease activity score, not impacted by vaccine timing.
  
  
  CONCLUSIONS
  Serologic protection to influenza vaccine is achieved in only approximately 45% to 80% of IBD patients on maintenance infliximab therapy varying by antigen. Yet, importantly, vaccine timing relative to infliximab infusion does not affect the achievement of serologic protection, and the influenza vaccine is well tolerated. Therefore, influenza vaccination at any point during infliximab scheduling is recommended for patients with IBD and opportunities to broaden the availability and convenience of influenza vaccine to optimize coverage should be explored.
authors.affiliation: *Division of Pediatric Gastroenterology, Department of Pediatrics, Faculty of Medicine, University of Calgary, Alberta Children's Hospital; †Provincial Laboratory of Public Health (Microbiology); and ‡Division of Gastroenterology, Department of Medicine, Faculty of Medicine, University of Calgary, Foothills Medical Center.
authors.forename: Jennifer
authors.initials: J
authors.lastname: deBruyn
authors.forename: Kevin
authors.initials: K
authors.lastname: Fonseca
authors.forename: Subrata
authors.initials: S
authors.lastname: Ghosh
authors.forename: Remo
authors.initials: R
authors.lastname: Panaccione
authors.forename: Miriam F
authors.initials: MF
authors.lastname: Gasia
authors.forename: Aito
authors.initials: A
authors.lastname: Ueno
authors.forename: Gilaad G
authors.initials: GG
authors.lastname: Kaplan
authors.forename: Cynthia H
authors.initials: CH
authors.lastname: Seow
authors.forename: Iwona
authors.initials: I
authors.lastname: Wrobel
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy / Q000276:immunology* / Q000821:virology; D000069285:Infliximab / Q000627:therapeutic use*; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology*; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D014611:Vaccination; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007166:Immunosuppressive Agents; D007252:Influenza Vaccines; D000069285:Infliximab