title: Tick-borne encephalitis (TBE) vaccine to medically immunosuppressed patients with rheumatoid arthritis: A prospective, open-label, multi-centre study.
abstract: BACKGROUND
  Tick-borne Encephalitis (TBE) is endemic in south-eastern Sweden as well as in the Baltic regions, Central Europe and Russia. Ageing and immunosuppressed individuals are more prone to severe disease and neurological complications. We assessed the immunogenicity of TBE-vaccine in rheumatoid arthritis (RA) patients treated with tumor necrosis factor-inhibitors (TNFi) and/or methotrexate (MTX).
  
  
  METHODS
  TBE vaccine, FSME-Immune(®) or Encepur(®), was administered to non-immune RA patients as well as age and gender matched healthy controls. Individuals <60 years of age were given three doses at month 0, 1, 12. Individuals ≥ 60 years old were given an additional priming dose at month 3, i.e. a total of four doses. Tick-borne encephalitis neutralizing antibodies were assessed by a rapid fluorescent focus inhibition test.
  
  
  RESULTS
  The study population consisted of 66 patients and 56 age and gender matched healthy controls. Median age was 58.5 years. The patients were either treated with TNFi (n=16), TNFi+MTX (n=36) or MTX (n=14). After the last TBE-vaccine dose, given one year after the first, 39% of the patients compared to 79% of the healthy controls had seroprotective levels (p=<0.05).
  
  
  CONCLUSIONS
  Standard TBE-vaccine schedule does not confer enough immunogenicity in this group of immunosuppressed patients, who should be carefully informed about a higher risk for vaccination failure and risk of infection when exposed in high-endemic areas.
authors.affiliation: Karolinska Institutet, Dept. of Medicine/Solna, Unit for Infectious Diseases, SE 17176 Stockholm, Sweden. Electronic address: katarina.brodin-hertzell@capiostgoran.se.
authors.forename: Katarina Brodin
authors.initials: KB
authors.lastname: Hertzell
authors.affiliation: Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, SE 751 85 Uppsala, Sweden.
authors.forename: Karlis
authors.initials: K
authors.lastname: Pauksens
authors.affiliation: Karolinska Institutet, Dept. of Medicine/Solna, Unit for Infectious Diseases, SE 17176 Stockholm, Sweden; Centre for Clinical Research, Sörmland, Uppsala University, SE 631 88 Eskilstuna, Sweden. Electronic address: lars.rombo@gmail.com.
authors.forename: Lars
authors.initials: L
authors.lastname: Rombo
authors.affiliation: Dept. of Rheumatology, Inst. of Medical Sciences, Uppsala University, SE 751 85 Uppsala, Sweden. Electronic address: ann.knight@akademiska.se.
authors.forename: Ann
authors.initials: A
authors.lastname: Knight
authors.affiliation: Public Health Agency of Sweden, Nobels väg 18, SE 17182 Solna, Sweden. Electronic address: sirkka@vene.se.
authors.forename: Sirkka
authors.initials: S
authors.lastname: Vene
authors.affiliation: Karolinska Institutet, Dept. of Medicine/Solna, Unit for Infectious Diseases, SE 17176 Stockholm, Sweden; Dept. of Communicable Diseases Control and Prevention, Box 17533, SE-11891 Stockholm, Sweden. Electronic address: helena.hervius-askling@ki.se.
authors.forename: Helena H
authors.initials: HH
authors.lastname: Askling
mesh_terms: D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000276:immunology*; D004675:Encephalitis, Tick-Borne / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D016867:Immunocompromised Host; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D014765:Viral Vaccines / Q000276:immunology / Q000627:therapeutic use*
chemical_list: D000914:Antibodies, Viral; C464914:Encepur; D014409:Tumor Necrosis Factor-alpha; D014765:Viral Vaccines; D008727:Methotrexate
keywords: Immunosuppression; Methotrexate; Rheumatoid arthritis; TNF-inhibitors; Tick-borne encephalitis; Vaccination