Produção Nacional
Revisado por pares
Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases
2011; BMJ; Volume: 70; Issue: 6 Linguagem: Inglês
10.1136/ard.2011.150250
ISSN1468-2060
AutoresCarla Gonçalves Schahin Saad, Eduardo Ferreira Borba, Nádia Emi Aikawa, Clóvis A. Silva, Rosa Maria Rodrigues Pereira, Ana Luísa Calich, Júlio César Bertacini de Moraes, Ana Cristina de Medeiros Ribeiro, Víctor Viana, Sandra Gofinet Pasoto, Jozélio Freire de Carvalho, I. L. A. Franca, Lissiane Karine Noronha Guedes, Samuel Katsuyuki Shinjo, Percival D. Sampaio‐Barros, M. T. C. Caleiro, Célio Roberto Gonçalves, Ricardo Fuller, Maurício Levy‐Neto, María do Carmo Sampaio Tavares Timenetsky, Alexander Roberto Precioso, Eloísa Bonfá,
Tópico(s)Rheumatoid Arthritis Research and Therapies
ResumoBackground Despite the WHO recommendation that the 2010–2011 trivalent seasonal flu vaccine must contain A/California/7/2009/H1N1-like virus there is no consistent data regarding its immunogenicity and safety in a large autoimmune rheumatic disease (ARD) population. Methods 1668 ARD patients (systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic sclerosis, psoriatic arthritis (PsA), Behçet's disease (BD), mixed connective tissue disease, primary antiphospholipid syndrome (PAPS), dermatomyositis (DM), primary Sjögren's syndrome, Takayasu's arteritis, polymyositis and Granulomatosis with polyangiitis (Wegener's) (GPA)) and 234 healthy controls were vaccinated with a non-adjuvanted influenza A/California/7/2009(H1N1) virus-like strain flu. Subjects were evaluated before vaccination and 21 days post-vaccination. The percentage of seroprotection, seroconversion and the factor increase in geometric mean titre (GMT) were calculated. Results After immunisation, seroprotection rates (68.5% vs 82.9% p<0.0001), seroconversion rates (63.4% vs 76.9%, p<0.001) and the factor increase in GMT (8.9 vs 13.2 p<0.0001) were significantly lower in ARD than controls. Analysis of specific diseases revealed that seroprotection significantly reduced in SLE (p<0.0001), RA (p<0.0001), PsA (p=0.0006), AS (p=0.04), BD (p=0.04) and DM (p=0.04) patients than controls. The seroconversion rates in SLE (p<0.0001), RA (p<0.0001) and PsA (p=0.0006) patients and the increase in GMTs in SLE (p<0.0001), RA (p<0.0001) and PsA (p<0.0001) patients were also reduced compared with controls. Moderate and severe side effects were not reported. Conclusions The novel recognition of a diverse vaccine immunogenicity profile in distinct ARDs supports the notion that a booster dose may be recommended for diseases with suboptimal immune responses. This large study also settles the issue of vaccine safety. ( ClinicalTrials.gov # NCT01151644 )
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