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Oral HPV-Related Epithelial Proliferation during Fingolimod Therapy: First Case Report and Review of the Literature
Journal article   Open access   Peer reviewed

Oral HPV-Related Epithelial Proliferation during Fingolimod Therapy: First Case Report and Review of the Literature

Kittiphoj Tikkhanarak, Jay Saepoo, Nidhi Handoo, Emily Lanzel, Sherry Timmons, Ryan Frost and John Hellstein
Head & neck pathology (Totowa, N.J.), Vol.20(1), 8
01/08/2026
DOI: 10.1007/s12105-025-01881-0
PMCID: PMC12783387
PMID: 41505028
url
https://doi.org/10.1007/s12105-025-01881-0View
Published (Version of record) Open Access

Abstract

Fingolimod, an immunomodulatory agent used in the treatment of multiple sclerosis, has been associated with an increased risk of human papillomavirus (HPV)-related mucocutaneous lesions due to its immunosuppressive effects. We report the first documented case of oral mucosal HPV-related epithelial proliferation in a patient undergoing long-term fingolimod therapy. A 36-year-old male presented with multiple mildly papillomatous gingival lesions, during ongoing fingolimod (Gilenya ) therapy for eight years. Histopathologic examination revealed parakeratinized stratified squamous epithelium with acanthosis, papillary projections supported by fibrovascular cores, and koilocytosis. HPV DNA testing demonstrated the presence of low-risk HPV types 6/11. The clinical presentation, histopathologic features, and supporting laboratory findings, in the context of long-term immunomodulatory therapy, were consistent with an HPV-related epithelial proliferation potentially associated with fingolimod use. This case expands the anatomic spectrum of HPV-associated epithelial proliferations as a potential adverse effect of fingolimod therapy in patients with multiple sclerosis, broadening clinical awareness beyond the reported cutaneous and anogenital presentations.
Adult Fingolimod Hydrochloride - adverse effects Humans Immunosuppressive Agents - adverse effects Male Multiple Sclerosis - drug therapy Papillomavirus Infections - chemically induced Papillomavirus Infections - pathology UIOWA OA Agreement

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