Lack of Uptake of Prophylactic Human Papilloma Virus Vaccine Among Women With Systemic Lupus Erythematosus Seen at a Regional Medical Center.

BACKGROUND/OBJECTIVE: Women with systemic lupus erythematosus (SLE) are at increased risk for cervical neoplasia likely due to infection with high-risk human papillomavirus (HR-HPV) and should be considered for HPV vaccination. We sought to determine the frequency of HR-HPV infection and uptake of HPV vaccination in our regional female lupus population. METHODS: For this medical records review study, data were analyzed from our electronic health records EPIC for women with International Classification of Diseases-10 or International Classification of Diseases -9 billing codes for SLE seen June 6, 2007, to May 1, 2017. This study was approved by the Central Michigan University/Covenant Medical Center institutional review board. Statistical analyses consisted of Student t test, χ, and Z test for proportions using SPSS v. 24 software. RESULTS: A total of 1349 women with SLE were identified, mean age of 53 years, 70.8% white, 20.8% African American, with 49% exposed to cigarette smoke. High-risk HPV testing performed in 195 (14.5%; mean age, 50 years) showed 16.9% (33/195) were positive, with those testing positive for HR-HPV being slightly younger (p < 0.05).Comparing our proportion testing positive for HR-HPV (0.169) versus National Health and Nutrition Examination Survey (0.088), we calculated a Z = 3.99 (p < 0.001) indicating HPV infection is significantly higher (2×) in our female SLE cohort. Only 16.0% (38/238) of the 238 women eligible to receive an HPV vaccine were tested for HR-HPV with 9 being positive and only 4.6% (11/238) vaccinated. CONCLUSIONS: Human papillomavirus infection is a serious health issue in women with SLE, but HPV testing and vaccination rates remain low. Efforts should be directed to promote awareness of the importance of HPV vaccination in this high-risk population.

The effect of history of abnormal pap smear or preceding HPV infection on the humoral immune response to Quadrivalent Human Papilloma virus (qHPV) vaccine in women with systemic lupus erythematosus.

OBJECTIVE: To determine if natural human papillomavirus (HPV) infection would induce an anamnestic response to quadrivalent (qHPV) vaccine in women with Systemic Lupus Erythematosus (SLE). METHODS: Thirty four women (19-50 years) with mild to moderate and minimally active or inactive SLE received standard qHPV vaccine. Neutralizing antibody titers to HPV 6, 11, 16 and18 were evaluated pre- and post- vaccine using HPV competitive Luminex Immunoassay. For each HPV type, logistic regressions were performed to explore the relationship between a positive titer at baseline with their final geometric mean titer and with the rise in titer. Fisher's Exact Test was used to assess the association of at least one positive HPV antibody test at baseline and history of abnormal pap. RESULTS: History of abnormal pap smear/cervical neoplasia occurred in 52.9%. Baseline anti HPV antibody titers: 21% = negative for all 4 HPV types, 79% = positive for ≥1 of the HPV types. Statistical analysis showed: those with a history of abnormal pap smear/cervical neoplasia were likely to have a positive anti-HPV antibody result pre-vaccine to ≥ 1 of the 4 types, p = 0.035 Fisher's Exact Test. In general, HPV exposed women showed higher post vaccine GMTs than HPV unexposed women with higher point estimates. However, when examining the rise in titers using logistic regression, there was no evidence of an anamnestic response. CONCLUSION: Prior HPV infection and cervical neoplasia in SLE are linked with no anamnestic response to HPV vaccine. This supports not checking HPV-antibodies pre-vaccine. Women with SLE should be vaccinated for HPV.

The safety and immunogenicity of Quadrivalent HPV (qHPV) vaccine in systemic lupus erythematosus.

OBJECTIVE: This study evaluated the safety and immunogenicity of qHPV vaccine in SLE. METHODS: Subjects: 34 women ages 19-50years (yrs.) with mild to moderate SLE & minimally active or inactive SLE received qHPV vaccine at the standard dosing schedule. EXCLUSION CRITERIA: active SLE disease (SELENA-SLEDAI>2), history of severe SLE disease, deep venous thrombosis, on >400mg/day of hydroxychloroquine, on >15mg/day of prednisone, or active infections. Patients were monitored for adverse events (AE), SLE flare, generation of thrombogenic antibodies and thrombosis. Antibody (Ab) levels to HPV 6, 11, 16 & 18 were measured by HPV competitive Luminex Immunoassay and Geometric Mean Titers (GMTs) were calculated for each HPV type. Seroconversion was assessed for those seronegative at baseline. RESULTS: The women in the study: African-American (79%), mean age=38.1years, mean age at diagnosis of SLE=28.6years, 35.3% had a history of smoking, 91% had 4 or more sexual partners, 50% had a history of sexually transmitted diseases, and 27.3% used condoms on a regular basis. Vaccine site reactions (VSRs) occurred in 62%, all mild. Ninety-seven percent experienced at least 1 non vaccine adverse event (nvAE) with a total of 493 nvAEs in 33 patients, of which 90% were mild and none were related to vaccine or SLE. There were 9 serious AEs, none were related to vaccine or SLE, all resolved. No patient experienced an SLE flare, thrombosis, or generation of thrombogenic antibodies. Seroconversion rate was 100% with mean GMTs comparable to Gardasil® package insert data. CONCLUSION: In this SLE vaccine study, qHPV vaccine was generally safe, well tolerated, and highly immunogenic. This clinical trial is registered on Clinical Trials.gov under number, NCT01741012 and was conducted under the FDA IND BB14113.