Public Release:  Study shows the HPV vaccine Gardasil doesn't increase disease activity in SLE patients

European League Against Rheumatism

Results of a Chinese study showed that the HPV vaccine did not have significant effects on the number of disease flares or antibody measures in patients with inactive SLE receiving stable doses of medications after administration, and therefore was determined safe to use to prevent HPV in this group of patients. SLE, an autoimmune disorder, affects nine times as many women as men1 and studies have shown that the rate of HPV in this group is significantly higher than in the healthy population.2 Vaccination is therefore an important consideration in protecting SLE patients from HPV infection, which has been shown to be responsible for cervical cancer.

"Our study set out to investigate whether vaccination with Gardasil increased disease flares in patients with SLE," said Professor Chi Chiu Mok from the Tuen Mun Hospital, Hong Kong. "The causal relationship between vaccination and flare wasn't clear, however what we do know is that the rate of flares was not increased post vaccination, confirming that, in the cohort studied, Gardasil was safe for use."

In the duration of the six-month study, there were three mild/moderate mucocutaneous flares (flares that occur in mucous-lined areas of the body), which were all controlled with usual treatment regimens. The rate of flare-ups observed in this study (rate: 0.08/patient/year) was numerically lower than the rate observed in a cohort of SLE patients observed over a 5 year period (0.10/patient/year) though the reason for this is unknown.

Furthermore there were no significant changes in the levels of various antibody measures used to assess level of disease activity. Disease flares (measured by the Systemic Lupus Erythematosus National Assessment (SELENA) flare instrument), disease activity scores (measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)) and physicians' global assessment (PGA) scores were also the same from baseline to two and six months.

Female patients who fulfilled four ACR criteria for SLE were recruited for the study. The 50 women were between the ages of 18 and 35 (mean age 25.8 ±3.9 years) and had received a stable dose of prednisolone and/or other immunosuppressives (the normal treatment for patients with SLE) within three months of the study. The Gardasil vaccine was given at baseline, two months and six months by intramuscular injection, and various disease scores and antibody measures were recorded and analysed.

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Abstract Number: THU0414

References:

1 PubMed Health. Systemic Lupus Erythematosus. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001471/ Accessed 10 May 2011

2 Brunk, D. SLE Patients Have Higher HPV Rates, Riskier Subtypes. Rheumatology News 2009;8(7):18

NOTES TO EDITORS: For further information on this study, or to request an interview with the study lead, please do not hesitate to contact the EULAR congress Press Office upstairs in Room N12 of the Congress Centre during EULAR 2011 or on: Email: eularpressoffice@uk.cohnwolfe.com
Rory Berrie:
Onsite tel: +44 7901 513 297
Dimple Natali:
Onsite tel: +44 7900 138 904

About EULAR

The European League Against Rheumatism (EULAR) is the organisation which represents the patient, health professional and scientific societies of rheumatology of all the European nations. In line with The European Union of Medical Specialists (UEMS), EULAR defines rheumatology as including rheumatic diseases of the connective tissue, locomotor and musculoskeletal systems. The aims of EULAR are to stimulate, promote, and support the research, prevention, treatment and rehabilitation of rheumatic diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with rheumatic diseases. Diseases of the bone and joints such as rheumatoid arthritis and osteoarthritis cause disability in 4-5% of the adult population and are predicted to rise as people live longer. EULAR 2011 is set to be the biggest rheumatology event in Europe with over 15,000 scientists, physicians, allied health professionals, and related audiences in attendance from over 100 countries. Over the course of the congress, almost 300 oral and more than 1600 poster abstract presentations will be featured, with 300 invited speaker lectures taking place in more than 140 sessions. To find out more about the activities of EULAR, visit: www.eular.org

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