Anti-influenza H1N1/2009 vaccine in autoimmune rheumatic diseases patients

Abstract

The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients. Patients under immunosuppressive therapy have indication for immunization against H1N1 A/California/7/2009-like virus. There are, however, concerns about possibility of reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity in these patients. The lack of studies evaluating the efficacy and safety of the vaccine against H1N1 A/California/7/2009-like virus in these autoimmune rheumatic patients led to the development of this research. The objectives of this study are to evaluate the humoral response and safety of the vaccine H1N1 A/California/7/2009-like virus in immunosuppressed patients with rheumatic diseases compared to healthy controls. We have recruited 2665 patients including: rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus (SLE), dermatomyositis (DM), with mixed connective tissue disease, systemic vasculitis, systemic sclerosis (SSc) , with Sjögren's syndrome, antiphospholipid syndrome, juvenile idiopathic arthritis, juvenile SLE and juvenile DM, followed at Rheumatology Outpatient Division, HC-FMUSP and Unit Pediatric Rheumatology Children's Institute, HC-FMUSP. The control group recruited was 200 healthy employees of ICHC-FMUSP and 80 healthy children. All subjects were vaccinated against H1N1 A/California/7/2009-like virus (Instituto Butantan/Sanofi Pasteur S.A.). Blood samples were collected to measure levels of antibodies to H1N1 A/California/7/2009-like virus (inhibiting hemagglutination titer) and to characterize autoantibody profile immediately prior to vaccination and 21 days after vaccination. Side effects were also analyzed in this period. All patients with rheumatoid arthritis, spondyloarthritis, SLE, systemic vasculitis, juvenile idiopathic arthritis, juvenile SLE, and juvenile DM were assessed before and 21 days after vaccination for clinical, laboratory parameters of disease activity. Concomitant treatment was evaluated in all patients. (AU)