tetano
Editor, Senior Moderator
Vaccine
Available online 30 October 2012
In Press, Uncorrected Proof ? Note to users
Cover image
Pandemic unadjuvanted influenza A (H1N1) vaccine in dermatomyositis and polymyositis: Immunogenicity independent of therapy and no harmful effect in disease ☆
Samuel Katsuyuki Shinjo,
J?lio C?sar Bertacini de Moraes,
Maur?cio Levy-Neto,
N?dia Emi Aikawa,
Ana Cristina de Medeiros Ribeiro,
Carla Gon?alves Schahin Saad,
Alexander Precioso,
Clovis Artur Silva1,
Eloisa Bonf?1, Corresponding author contact information, E-mail the corresponding author
Division of Rheumatology, Faculdade de Medicina da Universidade de S?o Paulo, S?o Paulo, Brazil
http://dx.doi.org/10.1016/j.vaccine.2012.10.063,
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 >0.5 mg/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.
Highlights
► 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.
http://www.sciencedirect.com/science/article/pii/S0264410X1201523X
Available online 30 October 2012
In Press, Uncorrected Proof ? Note to users
Cover image
Pandemic unadjuvanted influenza A (H1N1) vaccine in dermatomyositis and polymyositis: Immunogenicity independent of therapy and no harmful effect in disease ☆
Samuel Katsuyuki Shinjo,
J?lio C?sar Bertacini de Moraes,
Maur?cio Levy-Neto,
N?dia Emi Aikawa,
Ana Cristina de Medeiros Ribeiro,
Carla Gon?alves Schahin Saad,
Alexander Precioso,
Clovis Artur Silva1,
Eloisa Bonf?1, Corresponding author contact information, E-mail the corresponding author
Division of Rheumatology, Faculdade de Medicina da Universidade de S?o Paulo, S?o Paulo, Brazil
http://dx.doi.org/10.1016/j.vaccine.2012.10.063,
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 >0.5 mg/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.
Highlights
► 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.
http://www.sciencedirect.com/science/article/pii/S0264410X1201523X