IS H1N1 INFLUENZA VACCINE SAFE AND EFFECTIVE IN PATIENTS WITH SSc?

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorANDRADE, D.
dc.contributor.authorSEGURO, L.
dc.contributor.authorRIBEIRO, A.
dc.contributor.authorMORAES, J.
dc.contributor.authorSAAD, C.
dc.contributor.authorAIKAWA, N.
dc.contributor.authorCALICH, A.
dc.contributor.authorVIANA, V.
dc.contributor.authorPASOTO, S.
dc.contributor.authorLEVY-NETO, M.
dc.contributor.authorLAURINDO, I.
dc.contributor.authorTIMENESTSKY, M.
dc.contributor.authorPRECIOSO, A.
dc.contributor.authorBONFA, E.
dc.contributor.authorSAMPAIO-BARROS, P.
dc.date.accessioned2013-10-11T21:16:42Z
dc.date.available2013-10-11T21:16:42Z
dc.date.issued2012
dc.description.abstractIntroduction. 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.
dc.description.conferencedateFEB 02-04, 2012
dc.description.conferencelocalMadrid, SPAIN
dc.description.conferencename2nd Systemic Sclerosis World Congress
dc.description.indexMEDLINE
dc.description.sponsorshipClinicalTrials.gov, #NCT01151644
dc.identifier.citationRHEUMATOLOGY, v.51, suppl.2, p.23-23, 2012
dc.identifier.issn1462-0324
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/2741
dc.language.isoeng
dc.publisherOXFORD UNIV PRESS
dc.relation.ispartofRheumatology
dc.rightsrestrictedAccess
dc.rights.holderCopyright OXFORD UNIV PRESS
dc.subject.wosRheumatology
dc.titleIS H1N1 INFLUENZA VACCINE SAFE AND EFFECTIVE IN PATIENTS WITH SSc?
dc.typeconferenceObject
dc.type.categorymeeting abstract
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.author.externalANDRADE, D.:Univ Sao Paulo, Fac Med, Dept Rheumatol, Sao Paulo, Brazil
hcfmusp.author.externalTIMENESTSKY, M.:Univ Sao Paulo, Fac Med, Dept Rheumatol, Sao Paulo, Brazil
hcfmusp.contributor.author-fmusphcLUCIANA PARENTE COSTA SEGURO
hcfmusp.contributor.author-fmusphcANA CRISTINA DE MEDEIROS RIBEIRO
hcfmusp.contributor.author-fmusphcJULIO CESAR BERTACINI DE MORAES
hcfmusp.contributor.author-fmusphcCARLA GONCALVES SCHAHIN SAAD
hcfmusp.contributor.author-fmusphcNADIA EMI AIKAWA
hcfmusp.contributor.author-fmusphcANA LUISA GARCIA CALICH
hcfmusp.contributor.author-fmusphcVILMA DOS SANTOS TRINDADE VIANA
hcfmusp.contributor.author-fmusphcSANDRA GOFINET PASOTO
hcfmusp.contributor.author-fmusphcMAURICIO LEVY NETO
hcfmusp.contributor.author-fmusphcIEDA MARIA MAGALHAES LAURINDO
hcfmusp.contributor.author-fmusphcALEXANDER ROBERTO PRECIOSO
hcfmusp.contributor.author-fmusphcELOISA SILVA DUTRA DE OLIVEIRA BONFA
hcfmusp.contributor.author-fmusphcPERCIVAL DEGRAVA SAMPAIO BARROS
hcfmusp.description.beginpage23
hcfmusp.description.endpage23
hcfmusp.description.issuesuppl 2
hcfmusp.description.volume51
hcfmusp.origemWOS
hcfmusp.origem.wosWOS:000301974300053
hcfmusp.publisher.cityOXFORD
hcfmusp.publisher.countryENGLAND
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