OBJECTIVES: To evaluate the immunogenicity and safety of GARDASIL, a quadrivalent human papillomavirus (HPV) vaccine, in patients with systemic lupus erythematosus (SLE). METHODS: Women with SLE aged 18-35 years who had stable disease were recruited to receive GARDASIL vaccination and an equal number of age-matched healthy women were also vaccinated. Seroconversion rates of antibodies to HPV serotypes 6, 11, 16 and 18 at months 7 and 12 and adverse events (AEs) were compared between patients and controls. The rate of disease flares in SLE participants was compared with matched SLE controls. RESULTS: 50 patients with SLE and 50 healthy controls were studied. The mean age and disease duration of the patients was 25.8±3.9 years and 6.6±4.5 years, respectively. At month 12 the seroconversion rates of anti-HPV serotypes 6, 11, 16 and 18 in patients and controls were 82%, 89%, 95%, 76% and 98%, 98%, 98%, 80%, respectively. In patients with SLE there were no significant changes in the titres of anti-dsDNA, complements, anti-C1q and SLE Disease Activity Index scores from baseline to months 2, 7 and 12. There was one mild/moderate SLE flare at months 0-2, two mild/moderate flares at months 3-6 and six mild/moderate and two severe flares at months 7-12. Disease flares in patients with SLE occurred at a similar frequency to that of 50 matched SLE controls (0.22/patient/year vs 0.20/patient/year, p=0.81). Injection site reaction was the commonest AE (5%), and the incidence of AEs was comparable between patients with SLE and controls. CONCLUSIONS: The quadrivalent HPV vaccine is well tolerated and reasonably effective in patients with stable SLE and does not induce an increase in lupus activity or flares.
OBJECTIVES: To evaluate the immunogenicity and safety of GARDASIL, a quadrivalent human papillomavirus (HPV) vaccine, in patients with systemic lupus erythematosus (SLE). METHODS:Women with SLE aged 18-35 years who had stable disease were recruited to receive GARDASIL vaccination and an equal number of age-matched healthy women were also vaccinated. Seroconversion rates of antibodies to HPV serotypes 6, 11, 16 and 18 at months 7 and 12 and adverse events (AEs) were compared between patients and controls. The rate of disease flares in SLEparticipants was compared with matched SLE controls. RESULTS: 50 patients with SLE and 50 healthy controls were studied. The mean age and disease duration of the patients was 25.8±3.9 years and 6.6±4.5 years, respectively. At month 12 the seroconversion rates of anti-HPV serotypes 6, 11, 16 and 18 in patients and controls were 82%, 89%, 95%, 76% and 98%, 98%, 98%, 80%, respectively. In patients with SLE there were no significant changes in the titres of anti-dsDNA, complements, anti-C1q and SLE Disease Activity Index scores from baseline to months 2, 7 and 12. There was one mild/moderate SLE flare at months 0-2, two mild/moderate flares at months 3-6 and six mild/moderate and two severe flares at months 7-12. Disease flares in patients with SLE occurred at a similar frequency to that of 50 matched SLE controls (0.22/patient/year vs 0.20/patient/year, p=0.81). Injection site reaction was the commonest AE (5%), and the incidence of AEs was comparable between patients with SLE and controls. CONCLUSIONS: The quadrivalent HPV vaccine is well tolerated and reasonably effective in patients with stable SLE and does not induce an increase in lupus activity or flares.
Authors: Sasha Bernatsky; Rosalind Ramsey-Goldman; Jeremy Labrecque; Lawrence Joseph; Jean-Francois Boivin; Michelle Petri; Asad Zoma; Susan Manzi; Murray B Urowitz; Dafna Gladman; Paul R Fortin; Ellen Ginzler; Edward Yelin; Sang-Cheol Bae; Daniel J Wallace; Steven Edworthy; Soren Jacobsen; Caroline Gordon; Mary Anne Dooley; Christine A Peschken; John G Hanly; Graciela S Alarcón; Ola Nived; Guillermo Ruiz-Irastorza; David Isenberg; Anisur Rahman; Torsten Witte; Cynthia Aranow; Diane L Kamen; Kristjan Steinsson; Anca Askanase; Susan Barr; Lindsey A Criswell; Gunnar Sturfelt; Neha M Patel; Jean-Luc Senécal; Michel Zummer; Janet E Pope; Stephanie Ensworth; Hani El-Gabalawy; Timothy McCarthy; Lene Dreyer; John Sibley; Yvan St Pierre; Ann E Clarke Journal: J Autoimmun Date: 2013-02-12 Impact factor: 7.094
Authors: Seoyoung C Kim; Robert J Glynn; Edward Giovannucci; Sonia Hernández-Díaz; Jun Liu; Sarah Feldman; Elizabeth W Karlson; Sebastian Schneeweiss; Daniel H Solomon Journal: Ann Rheum Dis Date: 2014-03-11 Impact factor: 19.103
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