title: Evaluation of the immunogenicity of the 13-valent conjugated pneumococcal vaccine in rheumatoid arthritis patients treated with etanercept.
abstract: OBJECTIVE
  To prospectively evaluate the immunogenicity of a 13-valent conjugated pneumococcal vaccine (PCV13) in rheumatoid arthritis (RA) patients undergoing etanercept therapy.
  
  
  METHODS
  Twenty-two RA patients treated with etanercept (ETA) in combination with methotrexate (MTX) (n=15) or monotherapy (n=7) for at least one year were included. Altogether 24 osteoarthritis patients not receiving biological or MTX therapy, treating only NSAIDs or analgesics served as controls. All subjects were vaccinated with a single dose (0.5ml) of the PCV13. Pneumococcal antibody levels at baseline, 4 and 8weeks were assessed by a VaccZyme™ Anti-PCP IgG Enzyme Immunoassay Kit. Based on recommendations of the American Academy of Allergy, Asthma & Immunology, an at least two-fold increase in antibody level, as the protective antibody response (pAR) was an indicator of responsiveness (i.e., ratio of postvaccination and prevaccination antibody levels). The antibody levels and their ratios were analysed in a variety of different ways, vaccine safety parameters (fever, infections, changes in regular antirheumatic treatments) were assessed at baseline, 4 and 8weeks after vaccination.
  
  
  RESULTS
  Four weeks after vaccination, the anti-pneumococcal antibody levels significantly increased in both groups. At week 8, antibody levels somewhat decreased in both groups, however, still remained significantly higher compared to baseline. Compared with postvaccination levels at 4 and 8weeks between two groups, the mean protective antibody levels were higher in control group (1st month P=0.016; 2nd month: P=0.039). Possible predictors of pAR were analysed by logistic regression model. In RA, increases of antibody levels at week 8 compared to baseline exerted a negative correlation with age, (Spearman's R=-0,431; P=0.045). There were no clinically significant side effects or reaction after administration of vaccine observed in any of these patients after the 2-month follow-up period, all patients medical condition were stable.
  
  
  CONCLUSIONS
  In RA patients treated with ETA, vaccination with PCV13 is effective and safe, resulting in pAR one and two months after vaccination. Higher age at vaccination was identified as predictors of impaired pAR. The efficacy of vaccination may be more pronounced in younger RA patients. The vaccine is safe in RA patients on ETA.
authors.affiliation: Institute of Clinical Pharmacology, Infectious Diseases and Allergology, Kenézy Gyula Hospital, 2-6, Bartók B street, 4034 Debrecen, Hungary.
authors.forename: Éva
authors.initials: É
authors.lastname: Rákóczi
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary.
authors.forename: Bianka
authors.initials: B
authors.lastname: Perge
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary.
authors.forename: Edit
authors.initials: E
authors.lastname: Végh
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary.
authors.forename: Péter
authors.initials: P
authors.lastname: Csomor
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary.
authors.forename: Anita
authors.initials: A
authors.lastname: Pusztai
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary.
authors.forename: Szilvia
authors.initials: S
authors.lastname: Szamosi
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary.
authors.forename: Nóra
authors.initials: N
authors.lastname: Bodnár
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary.
authors.forename: Sándor
authors.initials: S
authors.lastname: Szántó
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Szücs
authors.affiliation: Department of Rheumatology, Medical and Health Sciences Center, Faculty of Medicine, University of Debrecen, 98, Nagyerdei street, 4032 Debrecen, Hungary. Electronic address: szekanecz.zoltan@med.unideb.hu.
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Szekanecz
mesh_terms: D000368:Aged; D000917:Antibody Formation; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D015331:Cohort Studies; D004797:Enzyme-Linked Immunosorbent Assay; D000068800:Etanercept / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D061214:Patient Safety; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D011018:Pneumonia, Pneumococcal / Q000517:prevention & control*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods
chemical_list: C538862:13-valent pneumococcal vaccine; D018501:Antirheumatic Agents; D022242:Pneumococcal Vaccines; D000068800:Etanercept
keywords: Conjugated pneumococcal vaccine; Etanercept; PCV13; Protective antibody level; Rheumatoid arthritis