PMID- 22589375 OWN - NLM STAT- MEDLINE DCOM- 20130701 LR - 20151119 IS - 1468-2060 (Electronic) IS - 0003-4967 (Linking) VI - 72 IP - 5 DP - 2013 May TI - Immunogenicity and safety of a quadrivalent human papillomavirus vaccine in patients with systemic lupus erythematosus: a case-control study. PG - 659-64 LID - 10.1136/annrheumdis-2012-201393 [doi] AB - 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. FAU - Mok, Chi Chiu AU - Mok CC AD - Department of Medicine, Tuen Mun and Pok Oi Hospital, New Territories, Hong Kong, SAR China. ccmok2005@yahoo.com FAU - Ho, Ling Yin AU - Ho LY FAU - Fong, Lai Shan AU - Fong LS FAU - To, Chi Hung AU - To CH LA - eng PT - Controlled Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20120515 PL - England TA - Ann Rheum Dis JT - Annals of the rheumatic diseases JID - 0372355 RN - 0 (Antibodies, Viral) RN - 0 (Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18) RN - 0 (Papillomavirus Vaccines) SB - IM MH - Adolescent MH - Adult MH - Alphapapillomavirus/*immunology MH - Antibodies, Viral/blood MH - Case-Control Studies MH - Disease Progression MH - Female MH - Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 MH - Humans MH - Immunocompromised Host/*immunology MH - Lupus Erythematosus, Systemic/*immunology MH - Papillomavirus Infections/immunology/*prevention & control MH - Papillomavirus Vaccines/*administration & dosage/adverse effects/*immunology MH - Prospective Studies MH - Young Adult EDAT- 2012/05/17 06:00 MHDA- 2013/07/03 06:00 CRDT- 2012/05/17 06:00 PHST- 2012/05/17 06:00 [entrez] PHST- 2012/05/17 06:00 [pubmed] PHST- 2013/07/03 06:00 [medline] AID - annrheumdis-2012-201393 [pii] AID - 10.1136/annrheumdis-2012-201393 [doi] PST - ppublish SO - Ann Rheum Dis. 2013 May;72(5):659-64. doi: 10.1136/annrheumdis-2012-201393. Epub 2012 May 15.