Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Juvenile Autoimmune Rheumatic Diseases Patients.
Aikawa1, Nadia E., Campos1, Lucia M.A., Silva1, Clovis A., Saad1, Carla G.S., Carvalho1, Jozelio F., Trudes1, Guilherme, Duarte1, Alberto J.S.
Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
Fundação Butantan, São Paulo, Brazil
Instituto Adolfo Lutz, São Paulo, Brazil
University of Sao Paulo, São Paulo, Brazil
Disciplina de Reumatologia da FMUSP, Sao Paulo, Brazil
In 2010 the Advisory Committee on Immunization Practices from the Center for Disease Control and Prevention recommended that all children and adolescents should receive the trivalent seasonal influenza vaccine containing the A/California/7/2009(H1N1)-like virus. There are, however, no data evaluating the immunogenicity and safety of the non-adjuvanted influenza A H1N1/2009 vaccine in a large cohort of juvenile autoimmune rheumatic diseases (ARD) patients.
237 juvenile ARD patients [juvenile systemic lupus erythematosus (JSLE), juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), juvenile scleroderma and primary vasculitis] and 91 age-matched healthy controls were vaccinated with a non-adjuvanted preparation of influenza A/California/7/2009 (H1N1) virus-like vaccine. Subjects were >= 9 and <= 21 years old. All participants were evaluated pre- and 21 days post-vaccination and serology for anti-H1N1 antibody was performed by hemagglutination inhibition (HI) assay. Seroprotection (percentage of subjects with HI antibody titer >= 1:40), seroconversion (percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post vaccination HI titer >= 1:40 or a pre-vaccination HI titer > 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer) rates, geometric mean titres (GMT) and factor increase (FI) in GMT (ratio of the GMT after vaccination to the GMT before vaccination) were calculated. Adverse events were also evaluated.
Age was comparable in juvenile ARD patients and controls (14.8 ± 3.0 vs. 14.6 ± 3.7 years, p=0.47). Three weeks after immunization, seroprotection rates (81.4 vs. 95.6%; p=0.0007), seroconversion rates (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 juvenile ARD patients versus controls. Subgroup analysis comparing with controls revealed reduced seroconversion rates in JSLE (p<0.0001), JIA (p=0.008), JDM (p=0.025) and primary vasculitis (p=0.017). Additionally, seroprotection (p<0.0001) and GMT (p<0.0001) were decreased solely in JSLE. Glucocorticoid use and lymphopenia were associated with lower seroconversion rate (60.4 vs. 82.9%, p=0.0001 and 55.6 vs. 77.2%, p=0.012), compared to patients without these conditions. Multivariate logistic regression including each disease (JSLE, JIA, JDM, primary vasculitis), lymphopenia, glucocorticoid and immunosuppressants use revealed that only glucocorticoid use remained significant (OR 0.20, 95%CI 0.060.70, p=0.012).
This is the largest study to demonstrate a reduced immune response to 2009 influenza A (H1N1) vaccine in juvenile ARD patients and it identified current glucocorticoid use as the major factor for this deleterious effect. The short-term safety supports its routine recommendation for juvenile ARD patients and the indication of a second boost in patients under this therapy. (ClinicalTrials.gov, #NCT01151644)
To cite this abstract, please use the following information:
Aikawa, Nadia E., Campos, Lucia M.A., Silva, Clovis A., Saad, Carla G.S., Carvalho, Jozelio F., Trudes, Guilherme, et al; Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Juvenile Autoimmune Rheumatic Diseases Patients. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :865