title: H1N1 vaccines in a large observational cohort of patients with inflammatory bowel disease treated with immunomodulators and biological therapy.
abstract: BACKGROUND
  Safety data are lacking on influenza vaccination in general and on A (H1N1)v vaccination in particular in patients with inflammatory bowel disease (IBD) receiving immmunomodulators and/or biological therapy.
  
  
  OBJECTIVE
  The authors conducted a multicentre observational cohort study to evaluate symptoms associated with influenza H1N1 adjuvanted (Pandemrix, Focetria, FluvalP) and non-adjuvanted (Celvapan) vaccines and to assess the risk of flare of IBD after vaccination. Patients with stable IBD treated with immunomodulators and/or biological therapy were recruited from November 2009 until March 2010 in 12 European countries. Harvey-Bradshaw Index and Partial Mayo Score were used to assess disease activity before and 4 weeks after vaccination in Crohn's disease (CD) and ulcerative colitis (UC). Vaccination-related events up to 7 days after vaccination were recorded.
  
  
  RESULTS
  Of 575 patients enrolled (407 CD, 159 UC and nine indeterminate colitis; 53.9% female; mean age 40.3 years, SD 13.9), local and systemic symptoms were reported by 34.6% and 15.5% of patients, respectively. The most common local and systemic reactions were pain in 32.8% and fatigue in 6.1% of subjects. Local symptoms were more common with adjuvanted (39.3%) than non-adjuvanted (3.9%) vaccines (p < 0.0001), whereas rates of systemic symptoms were similar with both types (15.0% vs 18.4%, p = 0.44). Among the adjuvanted group, Pandemrix more often induced local reactions than FluvalP and Focetria (51.2% vs 27.6% and 15.4%, p < 0.0001). Solicited adverse events were not associated with any patient characteristics, specific immunomodulatory treatment, or biological therapy. Four weeks after vaccination, absence of flare was observed in 377 patients with CD (96.7%) and 151 with UC (95.6%).
  
  
  CONCLUSIONS
  Influenza A (H1N1)v vaccines are well tolerated in patients with IBD. Non-adjuvanted vaccines are associated with fewer local reactions. The risk of IBD flare is probably not increased after H1N1 vaccination.
authors.affiliation: Gastroenterology Unit, Cliniques Universitaires UCL Mont-Godinne, Yvoir, Belgium. jfrahier@gmail.com
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Rahier
authors.forename: Pavol
authors.initials: P
authors.lastname: Papay
authors.forename: Julia
authors.initials: J
authors.lastname: Salleron
authors.forename: Shaji
authors.initials: S
authors.lastname: Sebastian
authors.forename: Manuela
authors.initials: M
authors.lastname: Marzo
authors.forename: Laurent
authors.initials: L
authors.lastname: Peyrin-Biroulet
authors.forename: Valle
authors.initials: V
authors.lastname: Garcia-Sanchez
authors.forename: Walter
authors.initials: W
authors.lastname: Fries
authors.forename: Dirk P
authors.initials: DP
authors.lastname: van Asseldonk
authors.forename: Klaudia
authors.initials: K
authors.lastname: Farkas
authors.forename: Nanne K
authors.initials: NK
authors.lastname: de Boer
authors.forename: Taina
authors.initials: T
authors.lastname: Sipponen
authors.forename: Pierre
authors.initials: P
authors.lastname: Ellul
authors.forename: Edouard
authors.initials: E
authors.lastname: Louis
authors.forename: Simon T C
authors.initials: ST
authors.lastname: Peake
authors.forename: Uri
authors.initials: U
authors.lastname: Kopylov
authors.forename: Jochen
authors.initials: J
authors.lastname: Maul
authors.forename: Badira
authors.initials: B
authors.lastname: Makhoul
authors.forename: Gionata
authors.initials: G
authors.lastname: Fiorino
authors.forename: Yazdan
authors.initials: Y
authors.lastname: Yazdanpanah
authors.forename: Maria
authors.initials: M
authors.lastname: Chaparro
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D005260:Female; D006801:Humans; D016867:Immunocompromised Host; D007155:Immunologic Factors / Q000627:therapeutic use*; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000276:immunology; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index
chemical_list: D000276:Adjuvants, Immunologic; D007155:Immunologic Factors; D007252:Influenza Vaccines