title: Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease.
abstract: OBJECTIVE
  To assess the immunogenicity and safety of non-adjuvanted influenza A H1N1/2009 vaccine in patients with juvenile autoimmune rheumatic disease (ARD) and healthy controls, because data are limited to the adult rheumatologic population.
  
  
  METHODS
  A total of 237 patients with juvenile ARD [juvenile systemic lupus erythematosus (JSLE), juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), juvenile scleroderma, and vasculitis] and 91 healthy controls were vaccinated. Serology for anti-H1N1 was performed by hemagglutination inhibition assay. Seroprotection rate, seroconversion rate, and factor-increase in geometric mean titer (GMT) were calculated. Adverse events were evaluated.
  
  
  RESULTS
  Age was comparable in patients and controls (14.8 ± 3.0 vs 14.6 ± 3.7 years, respectively; p = 0.47). Three weeks after immunization, seroprotection rate (81.4% vs 95.6%; p = 0.0007), seroconversion rate (74.3 vs 95.6%; p < 0.0001), and the factor-increase in GMT (12.9 vs 20.3; p = 0.012) were significantly lower in patients with juvenile ARD versus controls. Subgroup analysis revealed reduced seroconversion rates in JSLE (p < 0.0001), JIA (p = 0.008), JDM (p = 0.025), and vasculitis (p = 0.017). Seroprotection (p < 0.0001) and GMT (p < 0.0001) were decreased only in JSLE. Glucocorticoid use and lymphopenia were associated with lower seroconversion rates (60.4 vs 82.9%; p = 0.0001; and 55.6 vs 77.2%; p = 0.012). Multivariate logistic regression including diseases, lymphopenia, glucocorticoid, and immunosuppressants demonstrated that only glucocorticoid use (p = 0.012) remained significant.
  
  
  CONCLUSIONS
  This is the largest study to demonstrate a reduced but adequate immune response to H1N1 vaccine in patients with juvenile ARD. It identified current glucocorticoid use as the major factor for decreased antibody production. The short-term safety results support its routine recommendation for patients with juvenile ARD. ClinicalTrials.gov; NCT01151644.
authors.affiliation: Faculdade de Medicina da Universidade de São Paulo, Disciplina de Reumatologia, Av. Dr. Arnaldo 455, Cerqueira César, Sao Paulo, SP, Brazil 01246-903.
authors.forename: Nadia E
authors.initials: NE
authors.lastname: Aikawa
authors.forename: Lucia M A
authors.initials: LM
authors.lastname: Campos
authors.forename: Clovis A
authors.initials: CA
authors.lastname: Silva
authors.forename: Jozelio F
authors.initials: JF
authors.lastname: Carvalho
authors.forename: Carla G S
authors.initials: CG
authors.lastname: Saad
authors.forename: Guilherme
authors.initials: G
authors.lastname: Trudes
authors.forename: Alberto
authors.initials: A
authors.lastname: Duarte
authors.forename: Joao L
authors.initials: JL
authors.lastname: Miraglia
authors.forename: Maria do Carmo S
authors.initials: Mdo C
authors.lastname: Timenetsky
authors.forename: Vilma S T
authors.initials: VS
authors.lastname: Viana
authors.forename: Ivan L A
authors.initials: IL
authors.lastname: França
authors.forename: Eloisa
authors.initials: E
authors.lastname: Bonfa
authors.forename: Rosa M R
authors.initials: RM
authors.lastname: Pereira
mesh_terms: D000293:Adolescent; D001171:Arthritis, Juvenile / Q000188:drug therapy* / Q000276:immunology*; D002648:Child; D005938:Glucocorticoids / Q000276:immunology / Q000627:therapeutic use*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control; D011446:Prospective Studies; D012216:Rheumatic Diseases / Q000188:drug therapy* / Q000276:immunology*; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D007252:Influenza Vaccines