May 26, 2011 The human papillomavirus (HPV) vaccine, Gardasil, does not increase the incidence of flares (unpredictable worsening of symptoms signaling increased disease activity) in patients with systemic lupus erythematosus (SLE), or lupus, and has a tolerable safety profile, according to results presented at the EULAR 2011 Annual Congress.
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 men and studies have shown that the rate of HPV in this group is significantly higher than in the healthy population. 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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