Journal Article

Pandemic unadjuvanted influenza A (H1N1) vaccine in dermatomyositis and polymyositis: Immunogenicity independent of therapy and no harmful effect in disease

Aikawa, Nádia Emi, Bonfá, Eloisa, Shinjo, Samuel Katsuyuki, Silva, Clovis Artur, de Moraes, Júlio César Bertacini, Levy-Neto, Maurício, de Medeiros Ribeiro, Ana Cristina, Schahin Saad, Carla Gonçalves, Precioso, Alexander

2012

Overview

► Pre- and post-vaccination disease and muscle parameters were comparable. ► The vaccine was well tolerated without any severe adverse effects during follow-up. ► Seroconversion, seroprotection rate, GMTs and FI in the GMTs were comparable. The goal of the present study was to evaluate the influence of the influenza A H1N1/2009 vaccine on dermatomyositis/polymyositis (DM/PM) disease parameters and the potential deleterious effect of therapy on immune response. Thirty-seven DM and 21 PM patients (Bohan and Peter's criteria) were gender- and age-matched to 116 healthy controls. Seroprotection, seroconversion, the geometric mean titers (GMTs) and the factor increase (FI) in the GMTs were calculated. Disease safety was determined from a muscle enzyme analysis and the DM/PM scores [patient's visual analog scale (VAS), physician's VAS, manual muscle strength (MMT-8)] evaluated pre- and post-vaccination. The mean age (43.1±9.9 vs. 43.8±8.4 years, p=0.607) and gender distribution (p=1.00) were comparable between the patients and controls. After 21 days, seroconversion (p=0.394), seroprotection (p=0.08), GMT (p=0.573) and the FI in the GMT (p=0.496) were similar in both groups. The disease and muscle parameters remained stable throughout the study, including the creatine kinase (p=0.20) and aldolase levels (p=0.98), the physicians’ VAS (p=1.00), the patients’ VAS (p=1.00) and the MMT-8 (p=1.00). Regarding the influence of treatment, the seroconversion rates were comparable between the controls and patients undergoing treatment with glucocorticoid (GC) (p=0.969), GC >0.5mg/kg/day (p=0.395) and GC+immunosuppressors (p=0.285). Vaccine-related adverse events were mild and similar in the DM/PM and control groups (p>0.05). Our data support the administration of the pandemic influenza A H1N1/2009 vaccination in DM/PM, as we found no short-term harmful effects related to the disease itself and adequate immunogenicity in spite of therapy. Further studies are necessary to identify any long-term adverse effects in patients with these diseases.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Adult / adverse effects / Age / Allergy and Immunology / Applied microbiology / Autoantibodies - immunology / Autoantibody / Biological and medical sciences / Confidence intervals / Creatine kinase / Data processing / Dermatomyositis / Dermatomyositis - immunology / Disease / Enzymes / Female / fructose-bisphosphate aldolase / Fundamental and applied biological sciences. Psychology / Gender / Glucocorticoids / Hospitalization / Hospitals / Humans / Immune response / Immunogenicity / Influenza / Influenza A / Influenza A Virus, H1N1 Subtype - immunology / Influenza Vaccines - adverse effects / Influenza Vaccines - immunology / Influenza Vaccines - therapeutic use / Male / Microbiology / Middle Aged / Miscellaneous / muscle strength / Muscles / Muscular strength / pandemic / Pandemics / Patients / physicians / Polymyositis / Polymyositis - immunology / Rheumatic diseases / Seroconversion / Side effects / Swine flu / Vaccination / Vaccines / Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) / Virology