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Background <p>Oral lichen planus (OLP) and oral lichenoid lesions (OLL) are immune-mediated conditions that may occur in response to medications or vaccines. Although hepatitis B vaccination is widely considered safe, isolated case reports have suggested a possible link to OLP/OLL. However, large-scale epidemiologic data are lacking.</p> Methods <p>A matched-cohort study was conducted using real-world data from the TriNetX database. The initial dataset included 112,444 patients who received hepatitis B vaccination and 7,002,541 unvaccinated individuals. After one-to-one propensity score matching, each cohort comprised 112,444 subjects. The primary outcome was the onset of OLP/OLL within 30 days post-index, identified via ICD-10 codes and confirmed histologically.</p> Results <p>OLP/OLL occurred in 423 vaccinated patients (0.736%) and in 316 unvaccinated individuals (0.281%), with a significant group difference (<i>p</i> &lt; 0.001, Log-Rank test). The risk ratio was 1.400 (95% CI: 1.210–1.619), and the odds ratio was 1.401 (95% CI: 1.211–1.622).</p> Conclusion <p>This study demonstrates a statistically significant but modestly increased risk of OLP/OLL following hepatitis B vaccination. Given the small effect size and observational design, the findings should be interpreted as hypothesis-generating. Further prospective studies are warranted.</p>

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The potential association between oral lichen planus and vaccination against hepatitis B. A real-world study analyzing data from approximately 200,000 patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月26日

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  • Borislav Todorov,
  • Max Heiland,
  • Susanne Nahles,
  • Robert Preissner,
  • Saskia Preissner,
  • Moritz Hertel

摘要

Background

Oral lichen planus (OLP) and oral lichenoid lesions (OLL) are immune-mediated conditions that may occur in response to medications or vaccines. Although hepatitis B vaccination is widely considered safe, isolated case reports have suggested a possible link to OLP/OLL. However, large-scale epidemiologic data are lacking.

Methods

A matched-cohort study was conducted using real-world data from the TriNetX database. The initial dataset included 112,444 patients who received hepatitis B vaccination and 7,002,541 unvaccinated individuals. After one-to-one propensity score matching, each cohort comprised 112,444 subjects. The primary outcome was the onset of OLP/OLL within 30 days post-index, identified via ICD-10 codes and confirmed histologically.

Results

OLP/OLL occurred in 423 vaccinated patients (0.736%) and in 316 unvaccinated individuals (0.281%), with a significant group difference (p < 0.001, Log-Rank test). The risk ratio was 1.400 (95% CI: 1.210–1.619), and the odds ratio was 1.401 (95% CI: 1.211–1.622).

Conclusion

This study demonstrates a statistically significant but modestly increased risk of OLP/OLL following hepatitis B vaccination. Given the small effect size and observational design, the findings should be interpreted as hypothesis-generating. Further prospective studies are warranted.