title: Efficacy and safety of vaccination against pandemic 2009 influenza A (H1N1) virus among patients with rheumatic diseases.
abstract: OBJECTIVE
  To assess the efficacy and safety of vaccination against pandemic H1N1 virus in patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) compared with healthy controls.
  
  
  METHODS
  The study population comprised 41 RA patients, 21 SLE patients, 17 PsA patients, 15 AS patients, and 25 healthy controls. All were vaccinated using the Novartis MF59-adjuvanted H1N1v monovalent influenza vaccine. The immunogenicity of the vaccine was assessed on day 1 and again 4 weeks later by hemagglutination inhibition assay. Geometric mean titers and seroconversion rates were calculated for each group. The safety of the vaccine was evaluated using the 28-joint Disease Activity Score (DAS28) for RA and PsA, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
  
  
  RESULTS
  The proportion of baseline protective levels of antibodies against H1N1 was similar in all but the AS group, in which it was lower. The geometric mean titers increased significantly in all 5 groups. A substantial proportion of patients and controls responded to the vaccine. The healthy controls demonstrated a better response than each of the other groups: 84% versus 56% for RA, 67% for SLE, 59% for PsA, and 53% for AS. Multivariate logistic regression analysis identified RA and PsA as parameters of significantly lower response. The DAS28, BASDAI, and SLEDAI remained unchanged after vaccination.
  
  
  CONCLUSIONS
  Vaccination against pandemic H1N1 using an adjuvanted H1N1v monovalent influenza is safe and induced an appropriate response in patients with RA, SLE, PsA, and AS.
authors.affiliation: Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel. oribe14@netvision.net.il
authors.forename: Ori
authors.initials: O
authors.lastname: Elkayam
authors.forename: Sharon
authors.initials: S
authors.lastname: Amir
authors.forename: Ella
authors.initials: E
authors.lastname: Mendelson
authors.forename: Mitchell
authors.initials: M
authors.lastname: Schwaber
authors.forename: Itamar
authors.initials: I
authors.lastname: Grotto
authors.forename: Jonathan
authors.initials: J
authors.lastname: Wollman
authors.forename: Uri
authors.initials: U
authors.lastname: Arad
authors.forename: Ayelet
authors.initials: A
authors.lastname: Brill
authors.forename: Daphna
authors.initials: D
authors.lastname: Paran
authors.forename: David
authors.initials: D
authors.lastname: Levartovsky
authors.forename: Irena
authors.initials: I
authors.lastname: Wigler
authors.forename: Dan
authors.initials: D
authors.lastname: Caspi
authors.forename: Michal
authors.initials: M
authors.lastname: Mandelboim
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology / Q000627:therapeutic use; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D012216:Rheumatic Diseases / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D007252:Influenza Vaccines