Evaluation of optic neuritis following human papillomavirus vaccination

Abstract

To assess the relationship between human papillomavirus (HPV) vaccination and occurrence of optic neuritis (ON) and to evaluate a claims-based algorithm for identification of ON. Females of 9-26 year olds in the HealthCore's Integrated Research Database (HIRD SM ) with and without claims evidence of HPV vaccination between 2007 and 2012 were included in this study. Potential ON cases were identified using the claims-based algorithm, positive predictive value (PPV) was determined using medical chart review. For the claims analysis, two study designs, a self-controlled temporal scan statistic and a retrospective matched cohort analysis, were used. ON was defined based on an algorithm developed using diagnosis and procedure codes from the medical claims. The PPV for ON cases using charts that had enough information for reviewers to make a determination was 62.5% (95% CI: 49.5%-74.3%). With the selfcontrolled temporal scan statistic, the primary analysis restricting on recommended vaccination schedule timing showed an increased risk of potential ON after second dose (RR D 3.39; p D 0.03), this finding was not confirmed for any of the additional analyses performed for individual or combined doses. With the cohort design, there was no increased risk of potential ON following vaccination in either individual or combined dose analyses. The risk of potential ON was higher among participants with a history of prior autoimmune diseases. In conclusion, identifying confirmed ON cases through administrative claims data proved challenging. The claims-based analysis in this study did not provide evidence for an association of ON with HPV vaccination.

Identifying signals of interest when screening for drug‐outcome associations in health care data

“…If a short‐term exposure (e.g. vaccines) leads to an increased risk that is clustered in time, this may strengthen our belief in a causal association , whereas a uniformly increased risk might suggest confounding due to differences in characteristics among those who use versus do not use the drug rather than a true effect of the drug itself. Assessment of temporality might even extend to assessing the occurrence of outcomes before exposure, such as when using the symmetry design .…”

Systematic Review and Meta-analysis of Postlicensure Observational Studies on Human Papillomavirus Vaccination and Autoimmune and Other Rare Adverse Events

“…8 More than 60 different autoimmune and rare adverse events were studied. Some studies focused on any autoimmune diseases (n = 4), 28,31,32,35 others (n = 18) 8,9, [18][19][20][21][22][23][24][25][26][27]29,30,33,34,36,37 targeted specific outcomes. Type 1 diabetes mellitus was the most frequently studied (in 11 studies).…”

“…Type 1 diabetes mellitus was the most frequently studied (in 11 studies). 8,9,18,19,24,28,31-33,35,37 Autoimmune thyroiditis diseases 8,9,19,24,28,32,35,37 including Hashimoto and Grave diseases, hypothyroidism and other hyperthyroidism, and immune thrombocytopenia purpura 8,9,18,19,24,28,32,35 (ITP) were assessed in 8 studies: Crohn disease 21,24,28,32,35,37 in 6 studies, Bell palsy, 24,28,31,32,35 coeliac disease, 9,28,31,32,35 juvenile rheumatoid arthritis, 8,9,24,35 optic neuritis, 8,24,27,28,36 rheumatoid arthritis, 8,9,28,31,32 ulcerative colitis 24,28,31,…”

“…Four studies 9,19,21,29 among 7 including data on Guillain-Barre syndrome (GBS) provided risk estimates. Fourteen studies 8,18,20,23,24,[26][27][28][29][30][31][32]34,36 concerned 4vHPV vaccine exposure, while 4 studies 22,25,35,37 assessed 2vHPV vaccine exposure. Two studies 9,21 provided risk estimates separately for 4vHPV and 2vHPV vaccine exposures.…”

Infections, Vaccines and Autoimmunity: A Multiple Sclerosis Perspective

“…Comparison between the unvaccinated and 2-year post-vaccination periods showed no increased risk of MS after the HPV vaccination [83]. Furthermore, administrative claims data from the largest US medical insurance subsidiary showed no increased risk of optic neuritis development within 60 days after HPV vaccination [84]. Recent meta-analysis included six different HPV studies and was not able to determine any increase in the risk for MS [85].…”