ABSTRACT
OBJECTIVES: The 2009 pandemic A/H1N1 influenza outbreak represented a theoretical risk for patients with autoimmune diseases (AID), especially those immunosuppressed. This study was undertaken to evaluate immunogenicity and tolerance of seasonal (SFV) and A/H1N1 flu vaccines (HFV) in AID patients. METHODS: This prospective, open, monocentre, vaccine phase-III study on 199 patients with AID (systemic necrotising vasculitides, progressive systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome and others), treated or not with immunosuppressants, was conducted from September 2009 to June 2010, to evaluate SFV and HFV efficacy and safety. Subjects received SFV (1 dose, Mutagrip®) and/or non-adjuvant HFV (Panenza®, 2 doses at a 3-week interval). The primary judgment criterion was the seroprotection rate. Secondary outcome measures were seroconversion rates, vaccine tolerance, and numbers of flu syndromes, and AID flares and relapses throughout the 6 month observation period. RESULTS: After SFV inoculation, 1% of the patients became febrile, 18% developed local reactions, 80% were seroprotected and 38% seroconverted. After HFV immunisation, 4% of the patients developed a fever, 23% had local reactions, 65% were seroprotected and 83% seroconverted. Twelve patients developed 15 flu syndromes (3 patients developed 2 syndromes each); 2 of these episodes were temporally consistent with vaccination; 1 patient died of septic shock unrelated to vaccination. Nineteen mild AID flares occurred during follow-up, only 6 being temporally consistent with HFV and SFV. CONCLUSIONS: Our findings demonstrated the safety and efficacy of SFV and HFV in AID patients.
Subject(s)
Autoimmune Diseases/complications , Influenza A Virus, H1N1 Subtype/immunology , Influenza Vaccines/immunology , Influenza, Human/prevention & control , Pandemics/prevention & control , Seasons , Adult , Aged , Aged, 80 and over , Antibodies, Viral/blood , Autoimmune Diseases/drug therapy , Autoimmune Diseases/immunology , Female , Humans , Immunization Schedule , Immunosuppressive Agents/therapeutic use , Influenza Vaccines/administration & dosage , Influenza Vaccines/adverse effects , Influenza, Human/complications , Influenza, Human/immunology , Influenza, Human/virology , Linear Models , Male , Middle Aged , Paris , Patient Safety , Prospective Studies , Recurrence , Risk Assessment , Risk Factors , Time Factors , Young AdultABSTRACT
The Canadian Vasculitis research network (CanVasc) is composed of physicians from different medical specialties, including rheumatology and nephrology and researchers with expertise in vasculitis. One of its aims was to develop recommendations for the diagnosis and management of antineutrophil cytoplasm antibody (ANCA)-associated vasculitides in Canada. This executive summary features the 19 recommendations and 17 statements addressing general AAV diagnosis and management, developed by CanVasc group based on a synthesis of existing international guidelines, other published supporting evidence and expert consensus considering the Canadian healthcare context.