MAURICIO LEVY NETO

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  • article 80 Citação(ões) na Scopus
    Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases
    (2011) SAAD, Carla G. S.; BORBA, Eduardo F.; AIKAWA, Nadia E.; SILVA, Clovis A.; PEREIRA, Rosa M. R.; CALICH, Ana Luisa; MORAES, Julio C. B.; RIBEIRO, Ana C. M.; VIANA, Vilma S. T.; PASOTO, Sandra G.; CARVALHO, Jozelio F.; FRANCA, Ivan L. A.; GUEDES, Lissiane K. N.; SHINJO, Samuel K.; SAMPAIO-BARROS, Percival D.; CALEIRO, Maria T.; GONCALVES, Celio R.; FULLER, Ricardo; LEVY-NETO, Mauricio; TIMENETSKY, Maria do Carmo S.; PRECIOSO, Alexander R.; BONFA, Eloisa
    Background Despite the WHO recommendation that the 2010-2011 trivalent seasonal flu vaccine must contain A/California/7/2009/H1N1-like virus there is no consistent data regarding its immunogenicity and safety in a large autoimmune rheumatic disease (ARD) population. Methods 1668 ARD patients (systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic sclerosis, psoriatic arthritis (PsA), Behcet's disease (BD), mixed connective tissue disease, primary antiphospholipid syndrome (PAPS), dermatomyositis (DM), primary Sjogren's syndrome, Takayasu's arteritis, polymyositis and Granulomatosis with polyangiitis (Wegener's) (GPA)) and 234 healthy controls were vaccinated with a non-adjuvanted influenza A/California/7/2009(H1N1) virus-like strain flu. Subjects were evaluated before vaccination and 21 days post-vaccination. The percentage of seroprotection, seroconversion and the factor increase in geometric mean titre (GMT) were calculated. Results After immunisation, seroprotection rates (68.5% vs 82.9% p < 0.0001), seroconversion rates (63.4% vs 76.9%, p < 0.001) and the factor increase in GMT (8.9 vs 13.2 p < 0.0001) were significantly lower in ARD than controls. Analysis of specific diseases revealed that seroprotection significantly reduced in SLE (p < 0.0001), RA (p < 0.0001), PsA (p=0.0006), AS (p=0.04), BD (p=0.04) and DM (p=0.04) patients than controls. The seroconversion rates in SLE (p < 0.0001), RA (p < 0.0001) and PsA (p=0.0006) patients and the increase in GMTs in SLE (p < 0.0001), RA (p < 0.0001) and PsA (p < 0.0001) patients were also reduced compared with controls. Moderate and severe side effects were not reported. Conclusions The novel recognition of a diverse vaccine immunogenicity profile in distinct ARDs supports the notion that a booster dose may be recommended for diseases with suboptimal immune responses. This large study also settles the issue of vaccine safety. (ClinicalTrials.gov #NCT01151644)
  • article 15 Citação(ões) na Scopus
    Pandemic unadjuvanted influenza A (H1N1) vaccine in dermatomyositis and polymyositis: Immunogenicity independent of therapy and no harmful effect in disease
    (2012) SHINJO, Samuel Katsuyuki; MORAES, Julio Cesar Bertacini de; LEVY-NETO, Mauricio; AIKAWA, Nadia Emi; RIBEIRO, Ana Cristina de Medeiros; SAAD, Carla Goncalves Schahin; PRECIOSO, Alexander; SILVA, Clovis Artur; BONFA, Eloisa
    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.(c) 2012 Elsevier Ltd. All rights reserved.
  • conferenceObject
    EARLIER ONSET AND BRAINSTEM INVOLVEMENT AS KEY FEATURES IN A BRAZILIAN NEURO-BEHCET'S DISEASE COHORT
    (2017) PRADO, L. L.; TINONE, G.; CALLEGARO, D.; SAAD, C. G. S.; LEVY-NETO, M.; GONCALVES, C.
  • conferenceObject
    The higher response of pandemic influenza vaccination in Takayasu'arteritis: A prospectively controlled study
    (2013) CALICH, A. L.; SHINJO, S. T.; RIBEIRO, A. C.; AIKAWA, N. E.; LEVY-NETO, M.; SAAD, C. G.; PRECIOSO, A. R.; TIMENETSKY, M. D. C.; BONFA, E.; PEREIRA, R. M.
  • conferenceObject
    IS H1N1 INFLUENZA VACCINE SAFE AND EFFECTIVE IN PATIENTS WITH SSc?
    (2012) ANDRADE, D.; SEGURO, L.; RIBEIRO, A.; MORAES, J.; SAAD, C.; AIKAWA, N.; CALICH, A.; VIANA, V.; PASOTO, S.; LEVY-NETO, M.; LAURINDO, I.; TIMENESTSKY, M.; PRECIOSO, A.; BONFA, E.; SAMPAIO-BARROS, P.
    Introduction. Immunosuppressed patients are potentially at risk to suffer from life-threatening pulmonary infections caused by H1N1. Although pulmonary disease is an important cause of morbidity in patients with SSc, low rates of influenza vaccination are still observed in this population due to lack of information and fear of adverse events. The recent WHO recommendation that the 2010–2011 trivalent seasonal flu vaccine must contain A/California/7/2009/H1N1-like virus reinforces the need to access the safety and efficacy of H1N1 vaccination in SSc patients. Patients and methods. One hundred twenty-seven patients and 234 controls were vaccinated with adjuvant-free influenza A/California/7/2009 (pH1N1) vaccine. All participants were evaluated pre- and 21 days post-vaccination and serology for anti-H1N1 was performed by haemagglutination inhibition (HI) assay (HIA). Efficacy was assessed by seroprotection and seroconversion rates and the factor increase in geometric mean antibody titre (GMT). Participants received a 21-day symptom diary card and were instructed to report local and systemic adverse events. Severe side effects were considered if hospitalization was required. Results. SSc patients had mean age of 52 (5.3) years, mean disease duration of 11.96 (7.9) years and a female predominance (93%). Of SSc patients, 69.3% had limited cutaneous disease, whereas 30.7% had diffuse cutaneous disease. Half of the patients were on immunosuppressant therapy (mostly AZA, MTX and CYC). Thirteen (10%) patients were taking CSs, but only two patients received a daily dose > 10 mg of prednisone. SSc patients and controls presented similar pre-vaccination GMT (11.2 vs 9.3; P = 0.094) and seroprotection rates (18.1 vs. 11.5%; P = 0.110). After vaccination seroprotection rates (81.1 vs 82.9%; P = 0.668) and GMT (134.4 vs. 122.9; P = 0.654) rose in both groups. Seroconversion rates (72.4 vs 76.9%; P = 0.372) and factor increase in GMT (12.0 vs 13.2; P = 0.553) were comparable in both groups. Disease-modifying antirheumatic drugs were not associated with reduced vaccination responses (P > 0.05). Immunization was well tolerated with mild local (7.1 vs 14.1%; P = 0.058) and minor systemic reactions (23.6 vs 25.6%; P = 0.704) in patients and controls, respectively. No severe side effect was reported.Conclusion. Vaccination against H1N1 was safe and induced a satisfactory response in patients with SSc, including in those under immunosuppressive therapy. Due to the inherent risks of lower respiratory infections in this group of patients, physicians should consider annually influenza vaccination recommendation.