FRI0343 Safety and efficacy of varicella vaccine in patients with juvenile rheumatic diseases: A five years experience

Background There are case reports of severe disseminated varicella-zoster virus (VZV) infections in patients on methotrexate (MTX) or anti-TNF therapy. The severity of these infections can be significantly reduced in those vaccinated Objectives The aims of this study were: to evaluate the safety and...

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Published inAnnals of the rheumatic diseases Vol. 71; no. Suppl 3; p. 430
Main Authors Pileggi, G.S., de Souza, C.B.S., Ferriani, V.P.L.
Format Journal Article
LanguageEnglish
Published London BMJ Publishing Group Ltd and European League Against Rheumatism 01.06.2013
BMJ Publishing Group LTD
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Summary:Background There are case reports of severe disseminated varicella-zoster virus (VZV) infections in patients on methotrexate (MTX) or anti-TNF therapy. The severity of these infections can be significantly reduced in those vaccinated Objectives The aims of this study were: to evaluate the safety and immunogenicity of a two dose protocol of varicella vaccine (VV) in susceptible patients with Juvenile Rheumatic Diseases (JRD) on MTX or anti-TNF therapy and to describe the vaccination efficacy over an observational 5-year follow-up period Methods Fifty patients with JRD (1-18 years) and no history of varicella were vaccinated with VV, 32 of them received two doses. IgG anti-VZV antibody (VZV-IgG) titers were measured by ELISA before, 4-6 weeks after each dose of VV, one and five years thereafter. Patients were monitored prospectively during 8 weeks for adverse events related to the vaccine and over a 5-year observational period for exposure to or occurrence of varicella Results All 50 patients were using MTX (mean dose 16 mg/m2/week, range 10 to 27); 23 were also receiving prednisone (range 5-20mg/day) and 5 were on anti-TNF therapy. Seroconversion rates were 50% after one dose of VV1 and 87% (28/32) for patients who received two doses (p<0,01). All 4/32 who did not reach protective titers after two VV doses were taking anti-TNF therapy (3/4 have systemic JIA). The vaccination neither induced overt varicella episodes or severe adverse events, nor underlying disease flare-ups after one or two doses. Twenty patients that received one dose of VV1 completed the five-year period of follow-up. Eleven of them were seronegative after one year: 2/11 developed varicella, six received a VV booster and all became seropositive. Only the 3/20 that refused the booster remained susceptible in the evaluation after 5 years. Among the 28 seroconverted patients that received two doses of VV, only 55% maintained protective VZV-IgG titers after one year, however none of them developed herpes zoster or chickenpox during the follow-up period of 1-3 years, including those with direct exposure to the wild virus in their environmental Conclusions VV should be recommended for seronegative patients for whom immunosuppressive or biological therapy is planned and a protocol with 2 doses of VV should be considered to reach protective titers. If patients are on anti-TNF alpha therapy, additional boosters may be necessary. References Pileggi GCS; Souza, CBS; Ferriani, VPL. Safety and Immunogenicity of Varicella Vaccine in Patients With Juvenile Rheumatic Diseases Receiving Methotrexate and Corticosteroids. Arthritis Care & Research, v. 62, p. 1034-1039, 2010. Disclosure of Interest None Declared
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ISSN:0003-4967
1468-2060
DOI:10.1136/annrheumdis-2012-eular.2800