Pandemic unadjuvanted influenza A (H1N1) vaccine in dermatomyositis and polymyositis: immunogenicity independent of therapy and no harmful effect in disease
Samuel Katsuyuki Shinjo, Júlio César Bertacini de Moraes, Maurício Levy-Neto, Nádia Emi Aikawa, Ana Cristina de Medeiros Ribeiro, Carla Gonçalves Schahin Saad, Alexander Precioso, Clovis Artur Silva, Eloisa Bonfá, Samuel Katsuyuki Shinjo, Júlio César Bertacini de Moraes, Maurício Levy-Neto, Nádia Emi Aikawa, Ana Cristina de Medeiros Ribeiro, Carla Gonçalves Schahin Saad, Alexander Precioso, Clovis Artur Silva, Eloisa Bonfá
Abstract
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.
Trial registration: ClinicalTrials.gov NCT01151644.
Copyright © 2012 Elsevier Ltd. All rights reserved.
Source: PubMed